A Phase II Clinical Trial of Pembrolizumab (MK-3475) in Subjects with Advanced/Unresectable or Metastatic Urothelial Cancer - A Phase II Trial of MK-3475 in Subjects with Bladder Cancer

Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.0 sites350 target enrollmentDecember 8, 2014

Conditionsadvanced/unresectable (inoperable) or metastatic urothelial cancer of the renal pelvis, ureter, bladder, or urethra.MedDRA version: 19.0Level: LLTClassification code 10046714Term: Urothelial carcinoma bladderSystem Organ Class: 100000004864 Therapeutic area: Diseases [C] - Cancer [C04]

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: advanced/unresectable (inoperable) or metastatic urothelial cancer of the renal pelvis, ureter, bladder, or urethra.
Sponsor: Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
Enrollment: 350
Status: Active, not recruiting
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

December 8, 2014

End Date

TBD

Last Updated

3 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.

Eligibility Criteria

Inclusion Criteria

•In order to be eligible for participation in this trial, the subject must:
•1\. Be willing and able to provide written informed consent/assent for the trial. The subject may also provide consent/assent for Future Biomedical Research. However, the subject may participate in the main trial without participating in Future Biomedical Research.
•2\. Be \=18 years of age on day of signing informed consent.
•3\. Have histologically or cytologically\-confirmed diagnosis of advanced/unresectable (inoperable) or metastatic urothelial cancer of the renal pelvis, ureter, bladder, or urethra. Both transitional cell and mixed transitional/non\-transitional cell histologies are allowed. Subjects with non\-urothelial cancer of the urinary tract are not allowed.
•4\. Be considered cisplatin\-ineligible to receive cisplatin\-based combination therapy, based on having at least one of the following criteria:
•a. ECOG performance status of 2 (the proportion of ECOG 2 subjects will be limited to approximately 50% of the total population)
•b. Creatinine clearance (calculated or measured) \< 60 mL/min but \>30 mL/min
•Note: Subjects with a creatinine clearance (calculated or measured) \< 30 mL/min or on dialysis are excluded from the trial.
•c. CTCAE v.4, Grade \>2 audiometric hearing loss (25dB in two consecutive wave ranges)
•d. CTCAE v.4, Grade \>2 peripheral neuropathy

Exclusion Criteria

•The subject must be excluded from participating in the trial if the subject:
•1\. Has disease that is suitable for local therapy administered with curative intent.
•2\. 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 prior to the first dose of treatment.
•3\. Has had a prior anti\-cancer monoclonal antibody (mAb) for direct anti\-neoplastic treatment 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.
•4\. 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 neuropathy or \= Grade 2 alopecia 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.
•5\. Has a known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin, squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer. A history of prostate cancer that was identified incidentally following cystoprostatectomy for bladder cancer is acceptable, provided that the following criteria are met: stage T2N0M0 or lower; and Gleason score \= 6, and undetectable PSA.
•6\. 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 (confirmed by CT scan if CT used at prior imaging, or confirmed by MRI if MRI was used at prior 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.
•7\. Has an active autoimmune disease that has required systemic treatment in 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.