Clinical Evaluation of BackStop in Patients Undergoing Ureteroscopic Lithotripsy

The purpose of this clinical study is to evaluate BackStop, a polymer-based device that is
intended to be used during ureteroscopic lithotripsy to prevent retrograde stone migration.

For information about this clinical trial here at USC or to see if you qualify, contact Ileana Aldana by email at ileana.aldana@med.usc.edu or by phone at (323) 865-0702 for more information.

Inclusion Criteria:

– patient with solitary ureteral stone ranging from 5mm to 15mm diameter

– able to tolerate general anesthesia

– clinical indication for treatment by ureteroscopic lithotripsy

– must be willing and able to participate in any follow-up visits

– provide informed consent

– have a CT scan demonstrating the stone

Exclusion Criteria:

– patients undergoing extracorporeal shock wave lithotripsy (ESWL) or any other
extracorporeal or percutaneous lithotripsy procedure as primary procedure

– any co-morbidity or condition that would necessitate exclusion of patient (physician
opinion)

– renal or ureteral anatomical abnormality

– multiple stones in the indicated ureter

– stones in the indicated kidney

– patient is immunocompromised

– multiple organ dysfunction syndrome

– has an absolute or relative solitary kidney mass

– >= Stage 3 chronic kidney disease

– bilateral ureteral obstructing stones

– staghorn calculi

– impaction of several stone fragments (Steinstrasse)

– uncorrected coagulopathy/thrombocytopenia

– urethral and/or ureteral stricture

– reconstructive urinary surgery

Click here to be directed to the clinicaltrials.gov website for complete and detailed information about this trial.

Completed

A Comparison of the Studer Pouch Versus the T-Pouch Orthotopic Neobladder Urinary Diversion in Bladder Cancer Patients

This is a prospective, randomized study of two types of continent ileal neobladder
construction in patients undergoing cystectomy for primary bladder cancer. Patients will be
randomly assigned to have either a T-pouch or a Studer pouch constructed at the time of their
surgery. They will be followed long-term to determine the relative advantages and
disadvantages of the two types of diversion. The investigators’ hypothesis is that the
inclusion of an antireflux mechanism in the T-pouch will result in significantly fewer
episodes of symptomatic urinary tract infection, and will have a lower incidence of upper
tract dilation and loss of renal function over the long term.

For information about this clinical trial here at USC or to see if you qualify, contact Ileana Aldana by email at ileana.aldana@med.usc.edu or by phone at (323) 865-0702 for more information.

Inclusion Criteria:

– All patients undergoing radical cystectomy for bladder cancer who are considered
candidates for a neobladder reconstruction are eligible for enrollment.

– Diagnosed with primary bladder cancer (any histology).

– Scheduled to undergo a radical cystectomy (cystoprostatectomy in men and anterior
exenteration in women).

– Felt by the treating physician to be a candidate for an orthotopic neobladder urinary
diversion.

– Be competent and willing to sign the informed consent.

– Patients may have received previous radiation therapy or intravesical or systemic
chemotherapy. Patients with documented metastatic disease are not excluded as long as
they are felt to be candidates for a continent neobladder urinary diversion.

Exclusion Criteria:

– Patients undergoing radical cystectomy for any malignancy other than primary bladder
cancer (for example prostate cancer or colon cancer invading the bladder,or a
gynecologic malignancy), or non-malignant disease (such as a neurogenic bladder or
radiation cystitis).

– Unwilling or unable to sign the informed consent.

– Not eligible for an orthotopic neobladder reconstruction.

– A history of other malignancy (except for stage I cancer treated with curative intent
without evidence of recurrence, clinically localized prostate cancer either untreated
or treated with prostatectomy or radiation therapy or hormone therapy,or non-melanoma
skin cancer) within the previous 5 years.

Click here to be directed to the clinicaltrials.gov website for complete and detailed information about this trial.

Active, not recruiting

Safety and Tolerability of GemRIS 225 mg in Subjects With Muscle-Invasive Bladder Cancer

The purpose of this study is to determine if TAR-200, an investigational drug-delivery
system, is safe and tolerable in patients with muscle-invasive bladder cancer (MIBC) between
diagnosis and radical cystectomy (RC).

For information about this clinical trial here at USC or to see if you qualify, contact Ileana Aldana by email at ileana.aldana@med.usc.edu or by phone at (323) 865-0702 for more information.

Inclusion Criteria:

– Histological proof of muscle-invasive transitional cell carcinoma of the bladder
(stage II-III). Subjects with evidence of metastatic nodal disease to the obuturator
or presacral lymph nodes only may be included (N1 M0). Subjects with any degree of
fixation of the pelvic sidewall are not eligible.

– In Arm 1, subjects must have residual visible tumor following TURBT. In Arm 2,
subjects must be fully resected (i.e., no visible tumor or as little tumor as
possible) after restaging TURBT 2-6 weeks prior to Study Day 0.

– Adequate bone marrow, liver, and renal function, as assessed by the following
requirements conducted within 21 days prior to dosing:

1. Hemoglobin ≥ 9.0 g/dL

2. Absolute neutrophil count (ANC) ≥ 1,500/mm3

3. Platelet count ≥ 100,000/mm3

4. Total bilirubin ≤ 1.5xULN (upper limit of normal)

5. Alanine aminotransferase (ALT) and Aspartate aminotransferase (AST) ≤ 2.5xULN

6. Glomerular Filtration Rate (GFR) ≥ 30% (≥ 30 ml/min/1.73 m2)

– Subjects must be willing to undergo a cystoscopy on study for investigational product
removal.

– Eligible for and willing to undergo RC per the attending urologist.

– Subjects must be deemed ineligible for cisplatin-based combination chemotherapy by the
attending medical oncologist.

– Subjects medically eligible for neoadjuvant cisplatin-based combination chemotherapy
who refuse this therapeutic option and understand the risks and benefits of doing so.

– Prior radiation therapy is allowed provided that no radiation therapy was administered
to the urinary bladder.

– Written informed consent and Health Insurance Portability and Accountability Act of
1966 (HIPAA) authorization for release of personal health information.

– Age > 18 years at the time of consent.

Exclusion Criteria:

– Active malignancies within 12 months with the exception of those with a negligible
risk of metastasis or death treated with expected curative outcome.

– Prior systemic chemotherapy for transitional cell carcinoma of the bladder. Any other
prior systemic chemotherapy for a non-urothelial carcinoma must have been completed >
5 years prior to initiation of study.

– Previous exposure to gemcitabine instillations.

– Currently receiving other intravesical chemotherapy.

– Concurrent clinically significant infections as determined by the treating
investigator.

– Presence of any bladder or urethral anatomic feature that in the opinion of the
investigator may prevent the safe placement, indwelling use or removal of TAR-200.

– Documented history of vesicoureteral reflux or the presence of an indwelling ureteral
stent or nephrostomy tube at the time of screening.

– Pelvic radiotherapy administered within less than 6 months prior to enrollment.
Subjects who received radiotherapy ≥ 6 months prior to enrollment must demonstrate no
cystoscopic evidence or symptoms of radiation cystitis.

– Bladder Post-Void Residual Volume (PVR) of > 250-mL.

– Active, uncontrolled urogenital bacterial, viral or fungal infections, including
urinary tract infection that in the opinion of the investigator, contraindicates
participation. Skin/nail fungal infections are not exclusionary. Subjects with active
shingles (varicella zoster infection) will be excluded from the study.

– History or presence of any significant cardiovascular, pulmonary, hepatic, renal,
gastrointestinal, gynecological, endocrine, immunological, dermatological,
neurological or psychiatric disease or disorder that, in the opinion of the
investigator, contraindicates participation.

– History of diagnosis of neurogenic bladder.

– Concomitant immunosuppressive medications, such as methotrexate or TNF inhibitors,
within 2 weeks of Study Day 0, exclusive of steroid doses ≤ 5 mg daily.

– Difficulty providing blood samples.

– Unwilling or unable to provide informed consent or comply with the requirements of
this protocol, including the presence of any condition (physical, mental or social)
that is likely to affect the subject’s return for scheduled visits and follow-up.

– Other unspecified reasons that, in the opinion of the investigator or TARIS, make the
subject unsuitable for enrollment.

Click here to be directed to the clinicaltrials.gov website for complete and detailed information about this trial.

Recruiting

The OLYMPUS Study – Optimized DeLivery of Mitomycin for Primary UTUC Study

The study is investigating the ability of UroGen’s MitoGel™ procedure to treat urothelial
carcinoma tumors from the upper urinary tract. If this treatment will prove to be effective
this will lead to the development of a new treatment approach for patients suffering from Low
Grade Upper Urinary Urothelial Carcinoma (UTUC).

For information about this clinical trial here at USC or to see if you qualify, contact Ileana Aldana by email at ileana.aldana@med.usc.edu or by phone at (323) 865-0702 for more information.

Main Inclusion Criteria:

1. Patient is at least 18 years of age.

2. Naive or recurrent patients with LG, non-invasive UTUC in the pyelocalyceal system.

3. Patient has at least one (1) measurable papillary LG tumor, evaluated visually, ≤ 15
mm. The largest lesion should not exceed 15mm.

4. Biopsy taken from one or more tumors located above the ureteropelvic junction (UPJ)
showing LG urothelial carcinoma. Diagnosed not more than 2 months prior to the
screening.

5. Patient should have at least one remaining papillary LG tumor evaluated visually with
a diameter of at least 5 mm.

6. Wash urine cytology sampled from the pyelocalyceal system documenting the absence of
HG urothelial cancer, diagnosed not more than 2 months prior to the screening.

7. Patient with bilateral LG UTUC may be enrolled if at least one side meets the
inclusion criteria for the trial and if the other kidney does not require further
treatments (The other kidney can be treated prior to the beginning of the study).

Main Exclusion Criteria:

1. Patient received BCG treatment for UC during the 6 months prior to Visit 1.

2. The patient has untreated concurrent urothelial cancer in other locations other than
the target area (unless treated during screening)

3. Carcinoma in situ (CIS) in the past in the urinary tract.

4. Patient has a history of invasive urothelial carcinoma in the urinary tract during the
past 5 (Five) years.

5. Patient has a history of high grade papillary urothelial carcinoma in the urinary
tract during the past 2 (Two) years.

6. Patient is actively being treated or intends to be treated with systemic chemotherapy
during the duration of the trial.

Click here to be directed to the clinicaltrials.gov website for complete and detailed information about this trial.

Recruiting

S1011 Standard or Extended Pelvic Lymphadenectomy in Treating Patients Undergoing Surgery for Invasive Bladder Cancer

RATIONALE: Lymphadenectomy may remove tumor cells that have spread to nearby lymph nodes in
patients with invasive bladder cancer. It is not yet known whether extended pelvic
lymphadenectomy is more effective than standard pelvic lymphadenectomy during surgery.

PURPOSE: This randomized phase II trial is studying standard pelvic lymphadenectomy to see
how well it works compared to extended pelvic lymphadenectomy in treating patients undergoing
surgery for invasive bladder cancer.

For information about this clinical trial here at USC or to see if you qualify, contact Ileana Aldana by email at ileana.aldana@med.usc.edu or by phone at (323) 865-0702 for more information.

DISEASE CHARACTERISTICS:

– Histologically confirmed urothelial carcinoma of the bladder

– Stage T2, T3, or T4a disease

– No clinical stage consistent with a low-risk of node metastasis (CIS only,
T1)

– No T4b disease (fixed lesion)

– Disease that requires primary radical cystectomy and lymph node dissection for
definitive treatment

– No laparoscopic surgery

– Predominant urothelial carcinoma with any of the following elements allowed:

– Adenocarcinoma

– Squamous cell carcinoma

– Micropapillary or minor components of other rare phenotype

– No pure squamous cell carcinoma or adenocarcinoma

– No visceral or nodal metastatic disease proximal to the common iliac bifurcation by
2-view chest x-ray and abdominal-pelvic imaging by computerized tomography or MRI of
the abdomen and pelvis

– No intra-operative pelvic lymph node involvement (confirmed by frozen section) at or
above the bifurcation of the common iliac vessels in any of the extended template

PATIENT CHARACTERISTICS:

– Zubrod performance status 0-2

– ALT and AST ≤ upper limit of normal (ULN)*

– Alkaline phosphatase ≤ ULN*

– Not pregnant or nursing

– Fertile patients must use an effective contraception

– No other prior malignancy except adequately treated basal cell or squamous cell skin
cancer, in situ cervical cancer, or stage I or II cancer from which the patient is in
complete remission for the past 5 years

– Medically suitable to undergo cystectomy, in the physician’s opinion NOTE: *Levels may
be ≥ ULN provided metastatic disease is excluded using dedicated liver imaging, bone
scan, or biopsy.

PRIOR CONCURRENT THERAPY:

– See Disease Characteristics

– No prior partial cystectomy for invasive bladder cancer

– No prior pelvic surgery that would obviate a complete extended lymphadenectomy (e.g.,
aorto-femoral/iliac bypass)

– Prior neoadjuvant chemotherapy for this cancer allowed provided it has been completed
and patient has recovered

– No prior pelvic irradiation

Click here to be directed to the clinicaltrials.gov website for complete and detailed information about this trial.

Recruiting

S1602: Different Strains of BCG With or Without Vaccine in High Grade Non- Muscle Invasive Bladder Cancer

This randomized phase III trial studies Tokyo-172 strain bacillus Calmette-Guerin (BCG)
solution with or without a vaccination using Tokyo-172 strain BCG to see how well it works
compared with TICE BCG solution in treating patients with bladder cancer that has not spread
to muscle. BCG is a non-infectious bacteria that when instilled into the bladder may
stimulate the immune system to fight bladder cancer. Giving different versions of BCG with
vaccine therapy may prevent bladder cancer from returning.

For information about this clinical trial here at USC or to see if you qualify, contact Ileana Aldana by email at ileana.aldana@med.usc.edu or by phone at (323) 865-0702 for more information.

Inclusion Criteria:

– Patients must have histologically proven Ta, carcinoma in situ (CIS) or T1 stage
urothelial cell carcinoma of the bladder within 90 days of registration

– Patients must have had all grossly visible papillary tumors removed within 30 days
prior to registration or cystoscopy confirming no grossly visible papillary tumors
within 30 days prior to registration

– Patients with T1 disease must have cross-sectional imaging of abdomen/pelvis
demonstrating no evidence of metastatic disease (magnetic resonance imaging [MRI] or
computed tomography [CT] scan) within 90 days prior to registration; patients with T1
disease must have re-resection confirming =< T1 disease within 90 days prior to registration - Patients must have high-grade bladder cancer as defined by 2004 World Health Organization (WHO)/International Society of Urological Pathology (ISUP) classification - Patients must not have pure squamous cell carcinoma or adenocarcinoma - Patients' disease must not have micropapillary components - Patients must have no evidence of upper tract (renal pelvis or ureters) cancer confirmed by one of the following tests performed within 90 days prior to registration: CT urogram, intravenous pyelogram, magnetic resonance (MR) urogram, or retrograde pyelograms - Patients must not have nodal involvement or metastatic disease - No other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease free for five years; patients with localized prostate cancer who are being followed by an active surveillance program are also eligible - Patients must have a Zubrod performance status of 0-2 - Patients must not have received prior intravesical BCG - Patients must not have known history of tuberculosis - Patients must be PPD negative within 90 days prior to registration; PPD negativity is defined as < 10 mm diameter induration (palpable, raised hardened area) in the volar forearm at 48-72 hours following injection with standard tuberculin dose (5 units, 0.1 ml) - Patients must be >= 18 years of age

– Patients must not be taking oral glucocorticoids at the time of registration

– Patients must not be planning to receive concomitant biologic therapy, hormonal
therapy, chemotherapy, surgery, or other cancer therapy while on study

– Prestudy history and physical must be obtained within 90days prior to registration

– Patients must not be pregnant or nursing; women/men of reproductive potential must
have agreed to use an effective contraceptive method; a woman is considered to be of
“reproductive potential” if she has had menses at any time in the preceding 12
consecutive months; in addition to routine contraceptive methods, “effective
contraception” also includes heterosexual celibacy and surgery intended to prevent
pregnancy (or with a side-effect of pregnancy prevention) defined as a hysterectomy,
bilateral oophorectomy or bilateral tubal ligation; however, if at any point a
previously celibate patient chooses to become heterosexually active during the time
period for use of contraceptive measures outlined in the protocol, he/she is
responsible for beginning contraceptive measures

– Patients must be offered the opportunity to participate in specimen banking for future
studies to include translational medicine studies

Click here to be directed to the clinicaltrials.gov website for complete and detailed information about this trial.

Recruiting

Atezolizumab in Treating Patients With Recurrent BCG-Unresponsive Non-muscle Invasive Bladder Cancer

This phase II trial studies how well atezolizumab works in treating patients with non-muscle
invasive bladder cancer that has come back and has not responded to treatment with Bacillus
Calmette-Guerin (BCG). Immunotherapy with monoclonal antibodies, such as atezolizumab, may
help the body’s immune system attack the cancer, and may interfere with the ability of tumor
cells to grow and spread.

For information about this clinical trial here at USC or to see if you qualify, contact Ileana Aldana by email at ileana.aldana@med.usc.edu or by phone at (323) 865-0702 for more information.

Inclusion Criteria:

– Patients must have histologically proven, recurrent, non-muscle invasive urothelial
carcinoma of the bladder within 60 days prior to registration; the carcinoma must be
stage T1 high-grade, stage CIS, or stage Ta high-grade

– Patients with mixed urothelial carcinoma and a glandular and/or squamous component
will be eligible for the trial, but the presence of other histologic variants, pure
adenocarcinoma, or pure squamous cell carcinoma, will make a patient ineligible

– Patients must have had all visible tumor resected completely within 60 days prior to
registration; CIS disease is not expected to be completely excised; all patients must
have tumor tissue from the histologic diagnosis of recurrence available for central
pathology review submission; failure to submit these materials will make the patient
ineligible for this study

– Patients must have had cystoscopy confirming no visible papillary tumor within 21 days
prior to registration; (CIS disease is not expected to have been completely excised)

– Patients must have had cytology within 21 days prior to registration; cytology for
patients with CIS component is not expected to be negative for malignant cells; if the
cytology for patients with only Ta/T1 disease is positive for malignant cells, patient
must have had a biopsy of the prostatic urethra within the previous six months

– All patients with T1 urothelial carcinoma must undergo re-transurethral resection of
bladder tumor (TURBT) within 60 days prior to registration, and must have uninvolved
muscularis propria in the pathologic specimen from either the first or the second
TURBT; tissue from the re-resection must be submitted; the TURBT that identified the
recurrent T1 disease may have taken place more than 60 days prior to registration

– Patients must not have had urothelial carcinoma in the prostate or upper urinary tract
within the previous 24 months, or muscle invasive urothelial carcinoma of the bladder
at any time; patients must have a computed tomography (CT) or magnetic resonance
imaging (MRI) of the abdomen and pelvis to rule out upper tract malignancy and
intra-abdominal metastases within 90 days prior to registration

– Patients must be deemed unfit for radical cystectomy by the treating physician, or the
patient must refuse radical cystectomy, which is considered standard of care for these
patients; the reason for patients not to undergo cystectomy will be clearly documented

– Patients must be BCG-unresponsive; a patient is BCG-unresponsive if they meet one or
more of the following criteria:

– Patient has persistent or recurrent high-grade Ta/CIS urothelial carcinoma after
completing therapy with at least induction BCG (>= 5 doses) and first round
maintenance or second induction BCG (>= 2 doses)

– Patient has high grade T1 urothelial carcinoma after induction BCG (>= 5 doses)
only or after induction BCG (>= 5 doses) and first round maintenance or second
induction BCG (>= 2 doses)

– Patient is disease-free at 6 months after starting BCG (i.e., complete response)
but then experiences a high-grade recurrence within 6 months after the last BCG
dose

– All adverse events associated with any prior surgery and intravesical therapy must
have resolved to grade =< 2 prior to registration - Patients must not have had systemic chemotherapy or immunotherapy, including, but not limited to interferon alfa-2b, high dose interleukin 2 (IL-2), pegylated interferon (PEG-IFN), PD-1, anti-PD-L1, intra-tumoral, or vaccine therapies within 6 weeks prior to cycle 1, day 1; patients must not have received or be planning to receive any of the prohibited therapies during protocol treatment; prior intravesical interferon therapy is allowed - Patients must not be planning to receive concomitant other biologic therapy, radiation therapy, intravesical chemotherapy, surgery, or other therapy while on this protocol - Patients must not have received any prior radiation to the bladder for bladder cancer - Patients must not have received treatment with systemic immunosuppressive medications (including, but not limited to, prednisone, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor [anti-TNF] agents) within 4 weeks prior to cycle 1, day 1; exceptions: (1) patients may have received acute, low dose, systemic immunosuppressant medications (e.g., a one-time dose of dexamethasone for nausea); (2) the use of inhaled corticosteroids and mineralocorticoids (e.g., fludrocortisone) for patients with orthostatic hypotension or adrenocortical insufficiency is allowed - Patients must not have received of a live, attenuated vaccine within 4 weeks before cycle 1, day 1 or anticipation that such a live, attenuated vaccine will be required during the study and up to 5 months after the last dose of atezolizumab - Influenza vaccination should be given during influenza season only (approximately October to March); patients must not receive live, attenuated influenza vaccine within 4 weeks prior to cycle 1, day 1 or at any time during the study - Patients must not require treatment with a RANKL inhibitor (e.g. denosumab) who cannot discontinue it before treatment with atezolizumab - Absolute neutrophil count (ANC) >= 1,500 microliter (mcL) (within 42 days prior to
registration)

– Platelets >= 100,000/mcL (within 42 days prior to registration)

– Hemoglobin >= 9 g/dL (within 42 days prior to registration)

– Total bilirubin =< 1.5 x institutional upper limit of normal (IULN) (except Gilbert's syndrome, who must have a total bilirubin < 3.0 mg/dL) (within 42 days prior to registration) - Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) =< 2 x IULN (within 42 days prior to registration) - Alkaline phosphatase =< 2 x IULN (within 42 days prior to registration) - Serum creatinine =< 1.5 ULN OR measured or calculated creatinine clearance >= 30
mL/min (within 42 days prior to registration)

– Patients must have Zubrod performance status =< 2 - Patients must have a baseline electrocardiograph (ECG) performed within 42 days prior to registration - Patient must not have history of idiopathic pulmonary fibrosis, pneumonitis (including drug induced), organizing pneumonia (i.e., bronchiolitis obliterans, cryptogenic organizing pneumonia, etc.), or evidence of active pneumonitis - Patients must not have an active infection requiring oral or IV antibiotics within 14 days prior to registration; patients receiving prophylactic antibiotics (e.g., for prevention of a urinary tract infection or chronic obstructive pulmonary disease) are eligible - Patients must not have severe infections within 28 days prior to registration, including but not limited to hospitalization for complications of infection, bacteremia, or severe pneumonia - Patients must not have active autoimmune disease that has required systemic treatment in past two years (i.e., with use of disease modifying agents, corticosteroids or immunosuppressive drugs); replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment; autoimmune diseases include, but are not limited to, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener's granulomatosis, Sjogren's syndrome, Bell's palsy, Guillain-Barre syndrome, multiple sclerosis, autoimmune thyroid disease, vasculitis, or glomerulonephritis - Patients must not have undergone prior allogeneic bone marrow transplantation or prior solid organ transplantation - Patient must not have active tuberculosis - Patients must not have active hepatitis B (chronic or acute) or active hepatitis C infection - Patients with past or resolved hepatitis B infection (defined as having a negative hepatitis B surface antigen [HBsAg] test and a positive anti-HBc [antibody to hepatitis B core antigen] antibody test) are eligible - Patients positive for hepatitis C virus (HCV) antibody are eligible only if polymerase chain reaction (PCR) is negative for HCV RNA - Patients positive for human immunodeficiency virus (HIV) are eligible only if they have all of the following: - A stable regimen of highly active anti-retroviral therapy (HAART) - No requirement for concurrent antibiotics or antifungal agents for the prevention of opportunistic infections - A CD4 count above 250 cells/mcL and an undetectable HIV viral load on standard PCR-based tests - No other prior malignancy is allowed except, for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease free for five years - Patients must not be pregnant or nursing due to the potential teratogenic side effects of the protocol treatment; administration of atezolizumab may have an adverse effect on pregnancy and poses a risk to the human fetus, including embryo-lethality; women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 5 months (150 days) after the last dose of study agent; a woman is considered to be of "reproductive potential" if she has had menses at any time in the preceding 12 consecutive months; should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately - Due to the potential drug reaction with atezolizumab, patients must not be known to be allergic to Chinese hamster egg or ovaries - Patients must be offered the opportunity to participate in specimen banking for future studies, to include translational medicine studies - Patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines - As a part of the oncology patient enrollment network (OPEN) registration process the treating institution's identity is provided in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered in the system [/toggle][/accordian] Click here to be directed to the clinicaltrials.gov website for complete and detailed information about this trial.

Recruiting

S1314, Co-expression Extrapolation (COXEN) Program to Predict Chemotherapy Response in Patients With Bladder Cancer

The primary focus of this study is to see if looking at tumor biomarkers using a program
called coexpression extrapolation or “COXEN” may predict a patient’s response to chemotherapy
before surgery.

For information about this clinical trial here at USC or to see if you qualify, contact Ileana Aldana by email at ileana.aldana@med.usc.edu or by phone at (323) 865-0702 for more information.

Inclusion Criteria:

– Histologically proven bladder cancer (pure small cell carcinoma, pure adenocarcinoma,
and pure squamous cell carcinoma histologies are excluded).

– Stage cT2-T4a N0 M0 disease.

– Documented muscle invasive disease with at least one of the following: disease
measuring at least 10 mm on cross-sectional imaging OR the presence of
tumor-associated hydronephrosis.

– Staging scans with abdominal/pelvic CT or MRI scan and CT scan or x-ray of the chest
within 56 days prior to registration. If alkaline phosphatase is above the treating
institution’s upper limit of normal (ULN), presence of suspicious bone pain, or if
other clinical suspicion, a whole body bone scan is required within 56 days prior to
registration.

– Performance status = 0 or 1

– 18 years of age or older

– Must have tumor tissue from transurethral resection of the bladder tumor (TURBT)
available for submission that is sufficient for COXEN testing and must agree to
submission of 20 (10 micron) slides plus 2 (5 micron) slides from the start and end of
the 20 slides for a total of 22 unstained slides.

– Must agree to collection of tissue (if residual disease is present), urine, and whole
blood.

– Must agree to participate in the translational medicine studies outlined in the
protocol

Exclusion Criteria:

– Prior systemic cytotoxic chemotherapy or systemic anthracycline

– Peripheral neuropathy >/= Grade 2

– Class III/IV heart failure or known left ventricular ejection fraction (LVEF) < 50% - Clinically relevant hearing impairment > Grade 2

– Renal function, calculated creatinine clearance < 60 mL/min - Hepatic function, total bilirubin > 1.5 x institutional upper limit of normal (IULN)
(or > 2.5 x IULN with Gilbert’s disease); AST & ALT > 2 X IULN

– Hematologic function, absolute neutrophil count (ANC) < 1,500/mcL, hemoglobin < 9 g/dL, and platelets < 100,000/mcL - Hypersensitivity to cisplatin, gemcitabine, doxorubicin, vinblastine, methotrexate, or filgrastim/pegfilgrastim - Incidence of or uncontrolled medical illness (e.g. active cardiac symptoms, active systemic infection, etc.) - Pregnant or nursing females - No other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated Stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease free for five years. However, patients with localized prostate cancer who are being followed by an active surveillance program are eligible. [/toggle][/accordian] Click here to be directed to the clinicaltrials.gov website for complete and detailed information about this trial.

Recruiting

Blue Light Cystoscopy With Cysview® Registry

Registry study to gather more information on the current use of Blue Light Cystoscopy with
Cysview (BLCC) in urologists’ practices.

For information about this clinical trial here at USC or to see if you qualify, contact Ileana Aldana by email at ileana.aldana@med.usc.edu or by phone at (323) 865-0702 for more information.

Inclusion Criteria:

– Adult >18 years old

– Suspected or known non-muscle invasive bladder cancer on the basis of a prior
cystoscopy

Exclusion Criteria:

– Porphyria

– Gross hematuria

– Known hypersensitivity to hexaminolevulinate or aminolevulinate derivatives

Click here to be directed to the clinicaltrials.gov website for complete and detailed information about this trial.

Recruiting

Retroperitoneal Lymph Node Dissection in Treating Patients With Testicular Seminoma

This phase II trial studies how well retroperitoneal lymph node dissection (RPLND) works in
treating patients with stage I-IIa testicular seminoma. The retroperitoneum is the space in
the body behind the intestines that is typically the first place that seminoma spreads. RPLND
is a surgery that removes lymph nodes in this area to treat testicular seminoma and may
experience fewer long-term toxicities, such as a second cancer, cardiovascular disease,
metabolic syndrome (pre-diabetes), or lung disease.

For information about this clinical trial here at USC or to see if you qualify, contact Ileana Aldana by email at ileana.aldana@med.usc.edu or by phone at (323) 865-0702 for more information.

Inclusion Criteria:

– Pure seminoma after orchiectomy presenting with isolated retropreritoneal
lymphadenopathy OR stage I pure seminoma with isolated retroperitoneal relapse.
Relapse should be within 3 years

– Lymphadenopathy in the retroperitoneum: at least one lymph node 1-3 cm in greatest
dimension, no lymph node > 3 cm in greatest dimension, no more than 2 lymph nodes 1-3
cm in greatest dimension

– Axial imaging of lymphadenopathy within 6 weeks of the date of RPLND

– Retroperitoneal lymphadenopathy must be within the RPLND template

– If there is borderline lymphadenopathy, defined as the largest retroperitoneal lymph
node measuring 0.90 – 0.99 cm in the greatest dimension, an abdominal computed
tomography (CT) scan should be repeated (recommend interval of 6 – 8 weeks); the same
lymph node must demonstrate growth to >= 1.0 cm in the greatest dimension

– Biopsy is not required, though if biopsy of the retroperitoneal node(s) was obtained,
pathology must be consistent with pure seminoma

– Chest imaging (x-ray, CT or magnetic resonance imaging [MRI]) negative for metastasis
no more than 6 weeks prior to the date of RPLND

– Primary tumor excised by radical inguinal orchiectomy and pathology consistent with
pure seminoma

– Serum alpha fetoprotein (AFP) not more than 1.5 times upper limit of normal,
beta-human chorionic gonadotropin (HCG), lactate dehydrogenase (LDH) (per the local
laboratory assay) within 14 days of RPLND

– Eastern Cooperative Oncology Group (ECOG) performance status =< 1 - Ability to understand and the willingness to sign a written informed consent - Serum coagulation studies (INR/PTT) and platelet counts suitable for surgery per surgeon discretion. Exclusion Criteria: - Second primary malignancy - History of receiving chemotherapy or radiotherapy - Patients receiving any other investigational agent (s) - Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements [/toggle][/accordian] Click here to be directed to the clinicaltrials.gov website for complete and detailed information about this trial.

Recruiting

Prospective Validation of Prostate Biomarkers for Repeat Biopsy

Target enrollment is 1000 prospectively enrolled subjects with an initial negative biopsy
scheduled for repeat biopsy.

Subjects must have had their negative index prostate biopsy procedure within 30 months of
being scheduled for their repeat biopsy.

All enrolled subjects will have all core tissues from the initial negative biopsy blinded and
tested with the assay.

All subjects will have serum and plasma samples obtained prior to DRE, and a urine sample
collected immediately following DRE but in advance of the repeat biopsy; samples will be
blinded and sent to MDxHealth for evaluation.

For information about this clinical trial here at USC or to see if you qualify, contact Ileana Aldana by email at ileana.aldana@med.usc.edu or by phone at (323) 865-0702 for more information.

Inclusion Criteria:

– Males, aged 40 years to 85, who underwent a previous cancer-negative prostate biopsy
within 30 months of being scheduled for a repeat biopsy.

– The initial TRUS guided negative prostate biopsy must have collected a minimum of 10
tissue cores and sections from all prostate biopsy cores collected by the physician
must be submitted to MDxHealth in order to allow for full comprehensive
testing/evaluation of all the sections of the patient’s prostate prior to the
scheduled repeat biopsy.

– Minimum tissue volume criteria of 20 microns of prostate biopsy core tissue is
available (40 microns preferable).

– Previous biopsy histology may include the presence of high-grade prostatic
intraepithelial neoplasia (HGPIN), proliferative inflammatory atrophy (PIA), glandular
inflammation, atypical small acinar proliferation (ASAP) or atypical cells.

– Tissue was extracted using standard TRUS guided biopsy core extraction (and not
transurethral resection of the prostate (TURP).

– Pre-DRE serum sample, pre-DRE plasma sample, and Post-DRE urine sample to be collected
in advance of the repeat biopsy. Samples can be collected within three months of the
scheduled repeat biopsy, up until the day of, but prior to, the procedure.

Exclusion Criteria:

– Patient who has undergone previously testing by ConfirmMDx from the same biopsy

– Patients with prior diagnosis of prostate cancer in any previous biopsy.

– Patients with a limited life expectancy and generally not considered for a repeat
Tissue extracted using transurethral resection of the prostate (TURP) procedures

– Patients with a history of cancer (except basal cell carcinoma)

Click here to be directed to the clinicaltrials.gov website for complete and detailed information about this trial.

The OLYMPUS Study – Optimized DeLivery of Mitomycin for Primary UTUC Study

The study is investigating the ability of UroGen’s MitoGel™ procedure to treat urothelial
carcinoma tumors from the upper urinary tract. If this treatment will prove to be effective
this will lead to the development of a new treatment approach for patients suffering from Low
Grade Upper Urinary Urothelial Carcinoma (UTUC).

For information about this clinical trial here at USC or to see if you qualify, contact Ileana Aldana by email at ileana.aldana@med.usc.edu or by phone at (323) 865-0702 for more information.

Main Inclusion Criteria:

1. Patient is at least 18 years of age.

2. Naive or recurrent patients with LG, non-invasive UTUC in the pyelocalyceal system.

3. Patient has at least one (1) measurable papillary LG tumor, evaluated visually, ≤ 15
mm. The largest lesion should not exceed 15mm.

4. Biopsy taken from one or more tumors located above the ureteropelvic junction (UPJ)
showing LG urothelial carcinoma. Diagnosed not more than 2 months prior to the
screening.

5. Patient should have at least one remaining papillary LG tumor evaluated visually with
a diameter of at least 5 mm.

6. Wash urine cytology sampled from the pyelocalyceal system documenting the absence of
HG urothelial cancer, diagnosed not more than 2 months prior to the screening.

7. Patient with bilateral LG UTUC may be enrolled if at least one side meets the
inclusion criteria for the trial and if the other kidney does not require further
treatments (The other kidney can be treated prior to the beginning of the study).

Main Exclusion Criteria:

1. Patient received BCG treatment for UC during the 6 months prior to Visit 1.

2. The patient has untreated concurrent urothelial cancer in other locations other than
the target area (unless treated during screening)

3. Carcinoma in situ (CIS) in the past in the urinary tract.

4. Patient has a history of invasive urothelial carcinoma in the urinary tract during the
past 5 (Five) years.

5. Patient has a history of high grade papillary urothelial carcinoma in the urinary
tract during the past 2 (Two) years.

6. Patient is actively being treated or intends to be treated with systemic chemotherapy
during the duration of the trial.

Click here to be directed to the clinicaltrials.gov website for complete and detailed information about this trial.

Recruiting

Continuous Infusion of Ropivacaine Hydrochloride in Reducing Pain After Surgery in Patients With Bladder Cancer

This randomized phase IV trial studies how well the continuous infusion of ropivacaine
hydrochloride works in reducing pain after surgery in patients with bladder cancer.
Ropivacaine hydrochloride is an anesthetic drug used to decrease pain by numbing an area of
the body without putting the patient to sleep. Continuous infusion of ropivacaine
hydrochloride may reduce pain and improve the quality of life for patients after bladder
surgery.

For information about this clinical trial here at USC or to see if you qualify, contact Ileana Aldana by email at ileana.aldana@med.usc.edu or by phone at (323) 865-0702 for more information.

Inclusion Criteria:

– Undergoing elective open radical cystectomy

– Ability to understand and the willingness to sign a written informed consent

Exclusion Criteria:

– Allergy or adverse reaction to ropivacaine (ropivacaine hydrochloride) or any amide
type of local anesthesia

– Allergy or adverse reaction to local anesthesia catheter

– Additional surgery at the same time as RC (e.g. nephroureterectomy)

– Coagulopathy

– Thrombocytopenia

– Local or systemic infection

– Pregnancy

– Chronic hepatic disease

– Use of type III antiarrhythmics (e.g. amiodarone)

– History of chronic pain and/or daily opioid use

Click here to be directed to the clinicaltrials.gov website for complete and detailed information about this trial.

Robotic or Open Radical Cystectomy in Treating Patients With Bladder Cancer

This randomized phase II trial studies how well robotic radical cystectomy (RRC) or open
radical cystectomy (ORC) works in treating patients with bladder cancer. Cystectomy is a
surgical procedure to remove all or part of the bladder (the organ that holds urine) or to
remove a cyst (a sac or capsule in the body). In RRC, the the surgeon makes small cuts in the
abdomen and uses a thin, lighted instrument with a camera attached called a scope. With the
help of a robot, the surgeon removes the bladder and other nearby structures. In ORC, the
surgeon makes a cut into the lower abdomen to expose the urinary tract in order to remove the
bladder and nearby structures. It is not yet known whether RRC or ORC has fewer
complications, better quality of life, and faster recovery time in treating patients with
bladder cancer.

For information about this clinical trial here at USC or to see if you qualify, contact Ileana Aldana by email at ileana.aldana@med.usc.edu or by phone at (323) 865-0702 for more information.

Inclusion Criteria:

– Indication for radical cystectomy for urothelial cancer

– All types of urinary diversions

– Tis-T3 Urothelial cancer; patients will be stratified according to clinical stage

– Ability to consent

– Patient meets criteria to be a surgical candidate

Exclusion Criteria:

– Inability to give consent or adhere to follow-up schedule

– T4 tumor

– Bulky lymphadenopathy (> 2 cm)

– Prior pelvic radiation

– Not surgical candidate because of significant co-morbidity

– Uncontrolled coagulopathy

Click here to be directed to the clinicaltrials.gov website for complete and detailed information about this trial.

Recruiting

Biologic Mesh in Preventing Hernia in Patients With Bladder Cancer Undergoing Radical Cystectomy With Ileal Conduit Diversion

This randomized phase III trial studies how well biologic mesh works in preventing parastomal
hernia in patients with bladder cancer who are undergoing radical cystectomy, or removal of
the bladder, and ileal conduit diversion. An ileal conduit is a tube created from your small
intestine that will be used as a tube for urine to flow out of your body. Parastomal hernia
is a type of hernia that can occur in the stomach area where the ileal conduit is placed.
Biologic mesh may help prevent parastomal hernia following surgery and ileal conduit
diversion.

For information about this clinical trial here at USC or to see if you qualify, contact Ileana Aldana by email at ileana.aldana@med.usc.edu or by phone at (323) 865-0702 for more information.

Inclusion Criteria:

– Bladder cancer, undergoing radical cystectomy and ileal conduit diversion

– Ability to understand and the willingness to sign a written informed consent

– Follow-up either here at University of Southern California (USC) or centers that are
available to transfer the requested clinical and radiological data

Exclusion Criteria:

– Previous scar or mesh at the level of ileal conduit

– Survival less than 12 months after surgery (either predicted survival before surgery
or actual survival after surgery < 12 months) - History of allergic reactions attributed to compounds of similar chemical or biologic composition to cadaveric component, i.e. Flex HD [/toggle][/accordian] Click here to be directed to the clinicaltrials.gov website for complete and detailed information about this trial.

Recruiting

Dysport® Treatment of Urinary Incontinence in Adults Subjects With Neurogenic Detrusor Overactivity (NDO) Due to Spinal Cord Injury or Multiple Sclerosis – Study 1

The purpose of this study is to provide confirmatory evidence of the safety and efficacy of
two Dysport® (AbobotulinumtoxinA) doses (600 units [U] and 800 U), compared to placebo in
reducing urinary incontinence (UI) in adult subjects treated for neurogenic detrusor
overactivity (NDO) due to spinal cord injury (SCI) or multiple sclerosis (MS).

For information about this clinical trial here at USC or to see if you qualify, contact Ileana Aldana by email at ileana.aldana@med.usc.edu or by phone at (323) 865-0702 for more information.

Key Inclusion Criteria:

– Urinary Incontinence for at least 3 months prior to Screening as a result of
Neurogenic Detrusor Overactivity due to Spinal Cord Injury or Multiple Sclerosis.

– Subjects with Spinal Cord Injury must have a stable neurological injury at T1 level or
below which occurred at least 6 months prior to Screening.

– Subjects with Multiple Sclerosis must be clinically stable in the investigator’s
opinion, with no exacerbation (relapse) of MS for at least 3 months prior to
Screening.

– Subjects must have had an inadequate response after at least 4 weeks of oral
medications used in the treatment of NDO (e.g. anticholinergics, beta-3 agonists)
and/or have intolerable side-effects.

– Routinely performing Clean Intermittent Catheterization (CIC) to ensure adequate
bladder emptying.

– An average of at least two episodes per day of Urinary Incontinence recorded on the
screening bladder diary.

Key Exclusion Criteria:

– Any current condition (other than NDO) that may impact on bladder function.

– Previous or current, tumour or malignancy affecting the spinal column or spinal cord,
or any other unstable cause of SCI.

– Any condition that will prevent cystoscopic treatment administration or CIC usage,
e.g. urethral strictures.

– Current indwelling bladder catheter, or removal of indwelling bladder catheter less
than 4 weeks prior to Screening.

– BTX-A treatment within 9 months prior to Screening for any urological condition (e.g.
detrusor or urethral sphincter treatments).

– Any neuromodulation/electrostimulation usage for urinary symptoms/incontinence within
4 weeks prior to Screening. Any implanted neuromodulation device must be switched off
at least 4 weeks prior to Screening.

Click here to be directed to the clinicaltrials.gov website for complete and detailed information about this trial.

Recruiting

Trial of NanoPac® Focal Therapy in Subjects With Prostate Cancer

Open-label, dose rising, Phase IIa trial of intratumorally-injected NanoPac® 6, 10, or 15
mg/mL in subjects with prostate cancer scheduled for prostatectomy.

For information about this clinical trial here at USC or to see if you qualify, contact Ileana Aldana by email at ileana.aldana@med.usc.edu or by phone at (323) 865-0702 for more information.

Inclusion Criteria:

– Male; 18 years of age and older

– Histopathologically proven adenocarcinoma, Gleason grade ≥ 7 of the prostate planned
radical prostatectomy; appropriate for treatment with paclitaxel therapy

– ECOG of 0 or 1

– Laboratory requirements:

– WBC >2500/mm3

– Neutrophil >1500/mm3

– Hemoglobin >10 mg/dL

– Platelet >100,000/ mm3

– AST and ALT <2.5 x ULN - Total bilirubin <1.5 x ULN - Creatinine <2 mg/dL - Normal PT/INR and PTT; - Willing to use appropriate contraception from time of NanoPac® injection until prostatectomy - Willing to receive an mpMRI Exclusion Criteria: - Evidence of locally advanced or metastatic disease; - Prostate size ≥ 50 cc - Prior prostatectomy - Anticipated use of concomitant chemotherapy (other than the protocol specified agents), immunotherapy, or systemic use of hormonal therapy (such as GnRH analogs, antiandrogens, androgen receptor inhibitors, and 5-α reductase inhibitors) prior to surgery - Treatment with a prior investigational agent within 30 days of first dose of investigational medication - Any previous local treatment of the prostate (i.e. radiation) - Any other condition (e.g. psychiatric disorder) that, in the opinion of the Investigator, may interfere with the patient's ability to comply with the study requirements or visit schedule - Known sensitivity to any of the study medication components - History of prior malignancy that has not been in remission for >5 years, with the
exception of basal cell or squamous cell carcinoma.

Click here to be directed to the clinicaltrials.gov website for complete and detailed information about this trial.

Recruiting

Diagnosing Clinically Significant Prostate Cancer In African American and White Men With Elevated PSA

This randomized phase II trial studies how well systematic random biopsy or magnetic
resonance imaging (MRI)-ultrasound image (US) fusion biopsy work in diagnosing prostate
cancer in patients with elevated prostate specific antigen. Systematic random biopsy and
MRI-US fusion biopsy may work better in improving the accuracy of prostate cancer detection.

For information about this clinical trial here at USC or to see if you qualify, contact Ileana Aldana by email at ileana.aldana@med.usc.edu or by phone at (323) 865-0702 for more information.

Inclusion Criteria:

– Written informed consent and Health Insurance Portability and Accountability Act
(HIPAA) authorization for release of personal health information

– Note: HIPAA authorization may be included in the informed consent or obtained
separately

– Eastern Cooperative Oncology Group (ECOG) performance status of =< 1 within 3 months (93 days) prior to being registered for protocol - African-American or white men (Hispanic or non-Hispanic) - Prostate biopsy-naive or a single negative biopsy - Having elevated prostate specific antigen (PSA) (> 2.5 ng/ml) and no palpable nodule
on digital rectal exam (DRE)

– Ability to understand the willingness to sign a written informed consent

– Patients must be willing to undergo a radiologic imaging before and after biopsy of
the prostate

– Patients must be willing to undergo a biopsy of the prostate

Exclusion Criteria:

– Patients who have had chemotherapy or radiotherapy within 12 months of the study for
other diagnoses not related to prostate cancer

– Patients receiving any other investigational agents

– Uncontrolled intercurrent illness including, but not limited to, ongoing or active
infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac
arrhythmia, or psychiatric illness/social situations that would limit compliance with
study requirements

– Patients with active inflammatory bowel disease

– Patients who are unable to undergo MRI

– Patients who had any surgery of the prostate including TURP (transurethral resection
of the prostate)

– Patients who had > 1 prior prostate biopsy

Click here to be directed to the clinicaltrials.gov website for complete and detailed information about this trial.

Recruiting

High-Intensity Focused Ultrasound in Treating Participants With Intermediate and High-risk Prostate Cancer

This phase II trial studies how well high-intensity focused ultrasound works in treating
participants with intermediate and high-risk prostate cancer. High-intensity focused
ultrasound uses high frequency sound waves to deliver a strong beam which may target and
destroy a specific part of the prostate, while minimizing damage to surrounding structures
and tissue.

For information about this clinical trial here at USC or to see if you qualify, contact Ileana Aldana by email at ileana.aldana@med.usc.edu or by phone at (323) 865-0702 for more information.

Inclusion Criteria:

– Male having a diagnosis of clinically-significant prostate cancer (CsPCa) made within
the past 12 months (Gleason 7-9) with no evidence of metastatic disease; all outside
pathology will be re-reviewed at University of Southern California (USC) to verify
diagnosis

– Patients have elected to undergo radical prostatectomy (RP) as treatment of choice and
have to be a surgical candidate for RP; this determination will be made by the patient
in conjunction with their treating urologist and is current standard of practice

– Standard preoperative evaluation is performed and deemed satisfactory to proceed to
surgery as per their treating urologist

– Ability to understand AND willingness to sign a written informed consent

– Patients must be willing to undergo HIFU, CEUS, MRI and prostate biopsy pre-RP for
research purposes

Exclusion Criteria:

– Patients may not be receiving any other investigational agents or have received any
definitive prostate cancer (PCa)-specific treatment (en-bloc resection of bladder
tumors [EBRT], Brachytherapy etc) prior

– Patients with known metastases would be excluded from this clinical trial

– Uncontrolled inter-current illness including, but not limited to, ongoing or active
infection, symptomatic congestive heart failure, unstable angina pectoris, clinical
significant cardiac arrhythmia (rate controlled atrial fibrillation allowed), or
psychiatric illness/social situations that would limit compliance with study
requirements

– Patients with active autoimmune diseases or active immune suppressive therapy or
inflammatory bowel disease; a low dose steroid daily administration (equivalent
dexamethasone < 10mg/day) is acceptable - Patients with rectal disease - Patients who are unable to undergo MRI - Patients with convincing evidence of extraprostatic extension or T4 disease on digital rectal examination (DRE) [/toggle][/accordian] Click here to be directed to the clinicaltrials.gov website for complete and detailed information about this trial.

High-Intensity Focused Ultrasound in Treating Participants With Intermediate and High-risk Prostate Cancer

This phase II trial studies how well high-intensity focused ultrasound works in treating
participants with intermediate and high-risk prostate cancer. High-intensity focused
ultrasound uses high frequency sound waves to deliver a strong beam which may target and
destroy a specific part of the prostate, while minimizing damage to surrounding structures
and tissue.

For information about this clinical trial here at USC or to see if you qualify, contact Ileana Aldana by email at ileana.aldana@med.usc.edu or by phone at (323) 865-0702 for more information.

Inclusion Criteria:

– Male having a diagnosis of clinically-significant prostate cancer (CsPCa) made within
the past 12 months (Gleason 7-9) with no evidence of metastatic disease; all outside
pathology will be re-reviewed at University of Southern California (USC) to verify
diagnosis

– Patients have elected to undergo radical prostatectomy (RP) as treatment of choice and
have to be a surgical candidate for RP; this determination will be made by the patient
in conjunction with their treating urologist and is current standard of practice

– Standard preoperative evaluation is performed and deemed satisfactory to proceed to
surgery as per their treating urologist

– Ability to understand AND willingness to sign a written informed consent

– Patients must be willing to undergo HIFU, CEUS, MRI and prostate biopsy pre-RP for
research purposes

Exclusion Criteria:

– Patients may not be receiving any other investigational agents or have received any
definitive prostate cancer (PCa)-specific treatment (en-bloc resection of bladder
tumors [EBRT], Brachytherapy etc) prior

– Patients with known metastases would be excluded from this clinical trial

– Uncontrolled inter-current illness including, but not limited to, ongoing or active
infection, symptomatic congestive heart failure, unstable angina pectoris, clinical
significant cardiac arrhythmia (rate controlled atrial fibrillation allowed), or
psychiatric illness/social situations that would limit compliance with study
requirements

– Patients with active autoimmune diseases or active immune suppressive therapy or
inflammatory bowel disease; a low dose steroid daily administration (equivalent
dexamethasone < 10mg/day) is acceptable - Patients with rectal disease - Patients who are unable to undergo MRI - Patients with convincing evidence of extraprostatic extension or T4 disease on digital rectal examination (DRE) [/toggle][/accordian] Click here to be directed to the clinicaltrials.gov website for complete and detailed information about this trial.

MDSC Clinical Assay in Finding and Monitoring Cancer Cells in Blood and Urine Samples From Patients With or Without Localized or Metastatic Bladder Cancer

This pilot research trial studies how well myeloid derived suppressor cells (MDSC) clinical
assay works in finding and monitoring cancer cells in blood and urine samples from patients
with or without localized or metastatic bladder cancer. Studying samples of blood and urine
from patients with or without bladder cancer in the laboratory may help doctors identify and
learn more about biomarkers related to cancer and may help doctors improve ways to diagnose
and treat patients.

For information about this clinical trial here at USC or to see if you qualify, contact Ileana Aldana by email at ileana.aldana@med.usc.edu or by phone at (323) 865-0702 for more information.

Inclusion Criteria:

– Subjects must meet the criteria for one of the three following groups:

– Normal patients- aged 40 years and older with no evidence of hematuria or cancer

– Patients with localized bladder cancer diagnosed by cystoscopy and pathology:
T2N0M0 or T3N0M0 who have not received neoadjuvant chemotherapy

– Patients with metastatic bladder cancer: newly diagnosed with no previous
treatment for metastatic disease

– Ability to understand and the willingness to sign a written informed consent

Exclusion Criteria:

– For normal subject arm: evidence of cancer or hematuria

– For localized bladder cancer: evidence of metastatic disease, second cancer, prior
chemotherapy or radiotherapy within 4 weeks prior to entering the study or those who
have not recovered from adverse events due to agents administered more than 4 weeks
earlier

– For metastatic bladder cancer: prior therapy for metastatic disease

– Uncontrolled intercurrent illness including, but not limited to previous or current
history of second malignancy unrelated to bladder cancer; autoimmune disease or immune
deficiency, chronic treatment with immunomodulatory therapies (e.g. glucocorticoids);
significant trauma, surgery, or infection in the past two weeks or psychiatric
illness/social situations that would limit compliance with study requirements

Click here to be directed to the clinicaltrials.gov website for complete and detailed information about this trial.

Recruiting

Myeloid Derived Suppressor Cells Clinical Assay in Finding Kidney Cancer

This pilot research trial studies the use of the Myeloid Derived Suppressor Cells Clinical
Assay in finding and monitoring kidney cancer. Studying samples of blood and urine from
patients with kidney cancer in the laboratory may aid doctors in the early detection of
cancer, monitor tumor response to therapy, detect the presence of occult spreading of
disease, and identify early return of disease.

For information about this clinical trial here at USC or to see if you qualify, contact Ileana Aldana by email at ileana.aldana@med.usc.edu or by phone at (323) 865-0702 for more information.

Inclusion Criteria:

– Subjects enrolled in this study must meet one of the 3 following criteria:

– Group 1: Healthy individual with no history of cancer or hematuria

– Group 2: Subject with a diagnosis of localized renal cell carcinoma (by imaging
and eventual pathology) scheduled to undergo nephrectomy

– Group 3: Subject with a diagnosis of metastatic renal cell cancer(by imaging and
eventual pathology) who is scheduled to begin a new systemic therapy

– Any type of renal cell carcinoma (RCC); any prior therapy

– Performance status: 0-3

– Leukocytes >= 3,000/mcL (frequently used – numbers listed are examples, investigator
should modify as needed)

– Absolute neutrophil count >= 1,500/mcL (frequently used – numbers listed are examples,
investigator should modify as needed)

– Ability to understand and the willingness to sign a written informed consent

Exclusion Criteria:

– For normal subject arm: no evidence of cancer or hematuria

– For localized RCC arm: no evidence of metastatic disease, second cancer, prior
chemotherapy or radiotherapy within 4 weeks prior to entering the study or those who
have not recovered from adverse events due to agents administered more than 4 weeks
earlier

– For metastatic RCC arm: no evidence of second cancer, prior chemotherapy or
radiotherapy within 4 weeks prior to entering the study or those who have not
recovered from adverse events due to agents administered more than 4 weeks earlier

– For all subjects: uncontrolled intercurrent illness including, but not limited to
previous or current history of second malignancy unrelated to renal cell carcinoma;
autoimmune disease or immune deficiency, chronic treatment with immunomodulatory
therapies (e.g. glucocorticoids); significant trauma, surgery, or infection in the
past two weeks or psychiatric illness/social situations that would limit compliance
with study requirements

Click here to be directed to the clinicaltrials.gov website for complete and detailed information about this trial.

Recruiting

Cell-Free DNA and RNA in Blood fromMetastatic Prostate Cancer Patients

This research trial studies cell-free deoxyribonucleic acid (DNA) and ribonucleic acid (RNA)
in blood from patients with prostate cancer that does not respond to hormone therapy and has
spread to other places in the body. Studying samples of blood from patients with prostate
cancer may help doctors to learn more about the changes that occur in tumor cells over time
and how they become resistant to anti-cancer drugs.

For information about this clinical trial here at USC or to see if you qualify, contact Ileana Aldana by email at ileana.aldana@med.usc.edu or by phone at (323) 865-0702 for more information.

Inclusion Criteria:

– A diagnosis of histologically confirmed prostate adenocarcinoma and falling into one
of the following 5 groups:

– Currently receiving ADT (previously untreated for metastatic disease)

– These patients will be grouped into 3 cohorts: having received ADT for 3-6
months; for 1-2 years; and for > 3 years

– Scheduled to begin treatment with ADT (previously untreated for metastatic
disease)

– Scheduled to begin treatment with enzalutamide (castration resistant / has
received ADT / may have received abiraterone)

– Scheduled to begin treatment with abiraterone (castration resistant / has
received ADT / may have received enzalutamide)

– Scheduled to begin treatment with docetaxel (castration resistant / has received
ADT / has received enzalutamide and/or abiraterone)

– Have been diagnosed with either hormone-naive or castrate-resistant metastatic disease

– Ability and willingness to provide written and informed consent

Exclusion Criteria:

– Patients who receive combined ADT with docetaxel for hormone-naive metastatic prostate
cancer

– Patients on intermittent ADT

Click here to be directed to the clinicaltrials.gov website for complete and detailed information about this trial.

Recruiting

Nivolumab in Treating Patients With Localized Kidney Cancer Undergoing Nephrectomy

This randomized phase III trial compares nephrectomy (surgery to remove a kidney or part of a
kidney) with or without nivolumab in treating patients with kidney cancer that is limited to
a certain part of the body (localized). Monoclonal antibodies, such as nivolumab, may
interfere with the ability of tumor cells to grow and spread. Giving nivolumab before
nephrectomy may make the tumor smaller and reduce the amount of normal tissue that needs to
be removed, and after nephrectomy to increase survival. It is not yet known whether nivolumab
and nephrectomy is more effective than nephrectomy alone in treating patients with kidney
cancer.

For information about this clinical trial here at USC or to see if you qualify, contact Ileana Aldana by email at ileana.aldana@med.usc.edu or by phone at (323) 865-0702 for more information.

Inclusion Criteria:

– ELIGIBILITY CRITERIA FOR PREREGISTRATION (STEP 0):

– Preoperative biopsy for confirmation of renal cell carcinoma (RCC) must be performed
within four (4) months prior to randomization

– If biopsy was performed as part of patients standard care, and will not be
performed during step 0 proceed directly to randomization

– ELIGIBILITY CRITERIA FOR RANDOMIZATION (STEP 1):

– Patients with newly diagnosed higher risk RCC of any histology including sarcomatoid
or (if preoperative biopsy was uninformative) – “unknown” histology; RCC must have
been confirmed by biopsy within 4 months prior to randomization; if the biopsy clearly
demonstrated a benign condition or a different type of cancer, the patient is not
eligible to be randomized

– Clinical stage >= T2NxM0 or TanyN+ disease for which radical or partial nephrectomy is
planned

– Patients must have no clinical or radiological evidence of distant metastases (M0)

– No concurrent or prior systemic or local anti-cancer therapy for RCC is permitted;
examples of these prohibited therapies include:

– Radical or partial nephrectomy for prior RCC

– Metastectomy for RCC

– Radiation therapy to the renal bed or any distant metastatic sites

– Antineoplastic systemic therapies for RCC: i.e., chemotherapy, hormonal therapy,
immunotherapy, or standard or investigational agents for treatment of RCC

– Prior treatment with an anti-programmed cell death 1 (PD-1), anti-programmed cell
death-ligand 1 (PD-L1), anti-PD-L2, anti-cluster of differentiation (CD)137, or
anti-cytotoxic T-lymphocyte protein 4 (CTLA-4) antibody, or any other antibody or
drug specifically targeting T-cell co-stimulation or checkpoint pathways

– Eastern Cooperative Oncology Group (ECOG) performance status: 0 or 1

– Women must not be pregnant or breast-feeding; all females of childbearing potential
must have a blood test or urine study within 2 weeks prior to registration to rule out
pregnancy; a female of childbearing potential is any woman, regardless of sexual
orientation or whether they have undergone tubal ligation, who meets the following
criteria:

– Has not undergone a hysterectomy or bilateral oophorectomy, or

– Has not been naturally postmenopausal for at least 24 consecutive months (i.e.,
has had menses at any time in the preceding 24 consecutive months)

– Women of childbearing potential and sexually active males must be strongly advised to
use accepted and effective methods of contraception, as described in the informed
consent form (ICF), or to abstain from sexual intercourse for the duration of their
participation in the study; women of childbearing potential should use adequate
methods to avoid pregnancy for 23 weeks after the last dose of nivolumab; sexually
active males should use adequate methods to avoid pregnancy for 31 weeks after the
last dose of nivolumab

– Patient must have no prior history of RCC that was resected with curative intent
within the past 5 years

– Patients must not have other current malignancies:

– Adequately treated basal cell or squamous cell skin cancer, in situ cervical
cancer, adequately treated stage I or II cancer from which the patient is
currently in complete remission, or any other cancer from which the patient has
been disease-free for 3 years prior to the time of registration and they are not
receiving any current treatment

– Prior or current prostate cancer is excluded

– A history of superficial Ta urothelial cancer is permitted (not being
currently treated) but T1 or greater disease is excluded

– No active known or suspected autoimmune disease; the following are permitted: patients
with vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune or
non-autoimmune condition requiring hormone replacement, asymptomatic hypothyroidism
not requiring treatment, psoriasis not requiring systemic treatment, or conditions not
expected to recur

– No ongoing condition requiring systemic treatment with either corticosteroids (> 10 mg
daily prednisone equivalent) or other immunosuppressive medications; no treatment with
other immunosuppressive agents within 14 days prior to the first dose of study drug;
topical, ocular, intra-articular, intranasal, inhaled steroids and adrenal replacement
steroid doses > 10 mg daily prednisone equivalent are permitted in the absence of
active autoimmune disease.; a brief (less than 3 weeks) course of corticosteroids (any
amount) for prophylaxis (for example: contrast dye allergy) or for treatment of
non-autoimmune conditions (for example: delayed-type hypersensitivity reaction caused
by a contact allergen) is permitted if > 14 days since last dose

– No uncontrolled adrenal insufficiency

– No known chronic active liver disease or evidence of acute or chronic hepatitis B
virus (HBV) or hepatitis C (HCV)

– Patients must not have a serious intercurrent illness, including ongoing or active
infection requiring parental antibiotics

– No known evidence of human immunodeficiency virus (HIV) infection

– No known medical condition (e.g. a condition associated with uncontrolled diarrhea
such as ulcerative colitis or acute diverticulitis) that, in the investigator’s
opinion, would increase the risk associated with study participation or interfere with
the interpretation of safety results

– No major surgery within 28 days prior to randomization

– Patients currently enrolled in other clinical trials testing a therapeutic
intervention

– White blood cells >= 2000/uL, within 4 weeks of randomization

– Absolute granulocyte count (AGC) >= 1,500/mm^3, within 4 weeks of randomization

– Platelet count >= 100,000/mm^3, within 4 weeks of randomization

– Hemoglobin >= 9.0 g/dL, within 4 weeks of randomization

– Serum creatinine =< 1.5 x upper limit of normal (ULN) or calculated creatinine clearance (CrCl) >= 40 mL/min, within 4 weeks of randomization

– Total bilirubin =< 1.5 x ULN (except subjects with Gilbert syndrome, who can have total bilirubin < 3.0 x ULN), within 4 weeks of randomization - Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 2.5 x ULN, within 4 weeks of randomization - No history of severe hypersensitivity to a monoclonal antibody - Signed, dated informed consent [/toggle][/accordian] Click here to be directed to the clinicaltrials.gov website for complete and detailed information about this trial.

Recruiting

Trial of Pembrolizumab for Advanced Penile Squamous Cell Carcinoma

Penile squamous cell carcinoma (PSCC) is relatively rare but exhibits higher incidences in
less developed countries. PSCC is a highly aggressive malignancy characterized by early
spread. Pembrolizumab has recently been FDA-approved for the treatment of melanoma but will
serve as the investigational agent for this penile cancer study.

For information about this clinical trial here at USC or to see if you qualify, contact Ileana Aldana by email at ileana.aldana@med.usc.edu or by phone at (323) 865-0702 for more information.

Inclusion Criteria:

1. Locally advanced unresectable or metastatic stage 4 (i.e. T4 or N3 or M1) PSCC

2. Radiologic evidence for progressive disease after ≥1 prior chemotherapy regimen

3. Be at least 18 years of age on day of signing informed consent.

4. Have measurable disease based on RECIST 1.1.

5. Have a performance status of 0-2 on the ECOG (Eastern Cooperative Oncology Group)
Performance Scale.

6. Demonstrate adequate organ function with all screening labs being performed within 14
days of treatment initiation.

– Absolute neutrophil count (ANC) ≥1,500 /mcL

– Platelets ≥100,000/mcL

– Hemoglobin ≥9 g/dL or ≥5.6 mmol/L without transfusion or erythropoietin
dependency (within 7 days of assessment)

– Serum creatinine ≤1.5 X upper limit of normal (ULN); alternately measured or
calculated creatinine clearance ≥30 mL/min with creatinine levels >1.5 X
institutional ULN (GFR can also be used in place of creatinine or CrCl)

– Serum total bilirubin ≤1.5 X ULN or direct bilirubin ≤ ULN for subjects with
total bilirubin levels >1.5 ULN

– AST (SGOT) and ALT (SGPT) ≤ 2.5 X ULN or ≤ 5 X ULN for subjects with liver
metastases

– Albumin >2.5 mg/dL

– International Normalized Ratio (INR) or Prothrombin Time (PT) ≤1.5 X ULN unless
subject is receiving anticoagulant therapy as long as PT or PTT is within
therapeutic range of intended use of anticoagulants

– Activated Partial Thromboplastin Time (aPTT) ≤1.5 X ULN unless subject is
receiving anticoagulant therapy as long as PT or PTT is within therapeutic range
of intended use of anticoagulants

7. Subjects should agree to use an adequate method of contraception starting with the
first dose of study therapy through 120 days after the last dose of study therapy

8. Formalin-fixed paraffin embedded (FFPE) tumor tissue from previous biopsy is
requested, but not mandatory.

9. Be willing and able to provide written informed consent/assent for the trial.

Exclusion Criteria:

1. Is currently participating and receiving study therapy or has participated in a study
of an investigational agent and received study therapy or used an investigational
device within 4 weeks of the first dose of treatment.

2. Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any
other form of immunosuppressive therapy within 7 days prior to the first dose of trial
treatment.

3. Has a known history of active TB (Bacillus Tuberculosis)

4. Hypersensitivity to Pembrolizumab or any of its excipients.

5. Has had a prior anti-cancer monoclonal antibody (mAb) within 4 weeks prior to study
Day 1 or who has not recovered (i.e., ≤ Grade 1 or at baseline) from adverse events
due to agents administered more than 4 weeks earlier.

6. Has had prior chemotherapy, targeted small molecule therapy, or radiation therapy
within 2 weeks prior to study Day 1 or who has not recovered (i.e., ≤ Grade 1 or at
baseline) from adverse events due to a previously administered agent.

– Note: Subjects with ≤ Grade 2 neuropathy are an exception to this criterion and
may qualify for the study.

– Note: If subject received major surgery, they must have recovered adequately from
the toxicity and/or complications from the intervention prior to starting
therapy.

7. Has a known additional malignancy that is progressing or requires active treatment.
Exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the
skin that has undergone potentially curative therapy or in situ cervical cancer.

8. Has known active central nervous system (CNS) metastases and/or carcinomatous
meningitis. Subjects with previously treated brain metastases may participate provided
they are stable (without evidence of progression by imaging for at least four weeks
prior to the first dose of trial treatment and any neurologic symptoms have returned
to baseline), have no evidence of new or enlarging brain metastases, and are not using
steroids for at least 7 days prior to trial treatment. This exception does not include
carcinomatous meningitis which is excluded regardless of clinical stability.

9. Has active autoimmune disease that has required systemic treatment in the past 2 years
(i.e. with use of disease modifying agents, corticosteroids or immunosuppressive
drugs). Replacement therapy (e.g. thyroxine, insulin, or physiologic corticosteroid
replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a
form of systemic treatment.

10. Has known history of, or any evidence of active, non-infectious pneumonitis.

11. Has an active infection requiring systemic therapy.

12. Has a history or current evidence of any condition, therapy, or laboratory abnormality
that might confound the results of the trial, interfere with the subject’s
participation for the full duration of the trial, or is not in the best interest of
the subject to participate, in the opinion of the treating investigator.

13. Has known psychiatric or substance abuse disorders that would interfere with
cooperation with the requirements of the trial.

14. Is pregnant expecting to father children within the projected duration of the trial,
starting with the pre-screening or screening visit through 120 days after the last
dose of trial treatment.

15. Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent.

16. Has a known history of Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies).

17. Has known active Hepatitis B (e.g., HBsAg reactive) or Hepatitis C (e.g., HCV RNA
[qualitative] is detected).

18. Has known active Tuberculosis infection.

19. Has received a live vaccine within 30 days of planned start of study therapy. Note:
Seasonal influenza vaccines for injection are generally inactivated flu vaccines and
are allowed; however intranasal influenza vaccines (e.g., Flu-Mist®) are live
attenuated vaccines, and are not allowed.

Click here to be directed to the clinicaltrials.gov website for complete and detailed information about this trial.

Recruiting

Combination Therapy With Pembrolizumab and sEphB4-HSA in Previously Treated Urothelial Carcinoma

This phase II trial studies how well recombinant EphB4-HSA fusion protein and pembrolizumab
work in treating patients with urothelial (bladder) cancer that has spread from the primary
site to other places in the body or has come back and does not respond to certain
chemotherapy drugs. Combinations of biological substances in recombinant EphB4-HSA fusion
protein may be able to carry tumor-killing substances directly to urothelial cancer cells.
Monoclonal antibodies, such as pembrolizumab, may interfere with the ability of cancer cells
to grow and spread. Giving recombinant EphB4-HSA fusion protein and pembrolizumab together
may be a better treatment for patients with urothelial cancer.

For information about this clinical trial here at USC or to see if you qualify, contact Ileana Aldana by email at ileana.aldana@med.usc.edu or by phone at (323) 865-0702 for more information.

Inclusion Criteria:

– Be willing and able to provide written informed consent/assent for the trial

– Advanced (metastatic or recurrent) pathologically proven urothelial carcinoma which is
refractory to platinum based due to disease progression on a platinum containing
regimen; patients progressing within 12 months of their last dose of platinum-based
neoadjuvant or adjuvant chemotherapy will be considered platinum refractory

– Have measurable disease based on RECIST 1.1

– Be willing to provide tissue from a newly obtained core or excisional biopsy of a
tumor lesion; newly-obtained is defined as a specimen obtained for up to 6 weeks (42
days) prior to initiation of treatment on day 1; subjects for whom newly-obtained
samples cannot be provided (e.g. inaccessible or subject safety concern) may submit an
archived specimen only upon agreement from the Sponsor; an optional core biopsy will
be requested from an accessible metastatic site after 2 cycles of treatment

– Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG)
performance scale

– Absolute neutrophil count (ANC) >= 1,500/mcL

– Platelets >= 100,000/mcL

– Hemoglobin >= 9 g/dL or >= 5.6 mmol/L without transfusion or erythropoietin (EPO)
dependency (within 7 days of assessment)

– Measured or calculated creatinine clearance (glomerular filtration rate [GFR] can also
be used in place of creatinine or creatinine clearance [CrCl]) >= 30mL/min for subject
with creatinine levels > 1.5 X institutional upper limit of normal (ULN)

– Serum total bilirubin =< 1.5 X ULN or direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULN

– Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT]) and
alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 2.5 X ULN or =< 5 X ULN for subjects with liver metastases - Albumin >= 2.5 mg/dL

– International normalized ratio (INR) or prothrombin time (PT) =< 1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants - Activated partial thromboplastin time (aPTT) =< 1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants - Recovered to grade 1 from the effects (excluding alopecia) of any prior therapy for their malignancies - Female subject of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication; if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required - Female subjects of childbearing potential should be willing to use 2 methods of birth control or be surgically sterile, or abstain from heterosexual activity for the course of the study through 120 days after the last dose of study medication; subjects of childbearing potential are those who have not been surgically sterilized or have not been free from menses for > 1 year

– Male subjects should agree to use an adequate method of contraception starting with
the first dose of study therapy through 120 days after the last dose of study therapy

Exclusion Criteria:

– Is currently participating and receiving study therapy or has participated in a study
of an investigational agent and received study therapy or used an investigational
device within 4 weeks of the first dose of treatment

– Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any
other form of immunosuppressive therapy within 7 days prior to the first dose of trial
treatment

– Has a known history of active TB (bacillus tuberculosis)

– Hypersensitivity to pembrolizumab or any of its excipients

– Has had a prior anti-cancer monoclonal antibody (mAb) within 4 weeks prior to study
day 1 or who has not recovered (ie, =< grade 1 or at baseline) from adverse events due to agents administered more than 4 weeks earlier - Has had prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to study day 1 or who has not recovered (ie, =< grade 1 or at baseline) from adverse events due to a previously administered agent; Note: subjects with =< grade 2 neuropathy are an exception to this criterion and may qualify for the study; Note: if subject received major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting therapy - Has a known additional malignancy that is progressing or requires active treatment; exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the skin or early stage carcinoma of the cervix that has undergone potentially curative therapy or in situ cervical cancer; patients with incidental prostate cancer diagnosed at cystectomy or deemed appropriate for surveillance based on national guidelines will be allowed to enroll - Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis; subjects with previously treated brain metastases may participate provided they are stable (without evidence of progression by imaging for at least four weeks prior to the first dose of trial treatment and any neurologic symptoms have returned to baseline), have no evidence of new or enlarging brain metastases, and are not using steroids for at least 7 days prior to trial treatment; this exception does not include carcinomatous meningitis which is excluded regardless of clinical stability - Has active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs); replacement therapy (eg., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc) is not considered a form of systemic treatment - Has known history of, or any evidence of active, non-infectious pneumonitis - Has an active infection requiring systemic therapy - Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator - Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial - Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the pre-screening or screening visit through 120 days after the last dose of trial treatment - Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent, or sEsphB4-HSA - Has a known history of human immunodeficiency virus (HIV) (HIV 1/2 antibodies) - Has known active Hepatitis B (eg, hepatitis B surface antigen [HBsAg] reactive) or Hepatitis C (eg, hepatitis C virus [HCV] ribonucleic acid [RNA] [qualitative] is detected) - Major systemic infection requiring antibiotics 72 hours or less prior to first dose of study drug - Has New York Heart Association (NYHA) class 3 or 4, myocardial infarction, acute coronary syndrome, diabetes mellitus with ketoacidosis or chronic obstructive pulmonary disease (COPD) requiring hospitalization in the preceding 6 months; or any other intercurrent medical condition that contraindicates treatment with sEphB4HSA or pembrolizumab (MK-3475) or places the patient at undue risk for treatment related complications - Any other condition, including mental illness or substance abuse, deemed by the investigator to be likely to interfere with a patient's ability to sign informed consent, cooperate and participate in the study, or interferes with the interpretation of the results - Any active bleeding in the last =< 4 weeks or have an otherwise known bleeding diathesis - Has received a live vaccine within 30 days of planned start of study therapy; Note: seasonal influenza vaccines for injection are generally inactivated flu vaccines and are allowed; however intranasal influenza vaccines (eg, flu-mist) are live attenuated vaccines, and are not allowed [/toggle][/accordian] Click here to be directed to the clinicaltrials.gov website for complete and detailed information about this trial.

Recruiting