JPRN-jRCT2080223181
Completed
Phase 2
A Phase II Clinical Trial to Study the Efficacy and Safety of Pembrolizumab (MK-3475) and Pembrolizumab in Combination with Other Investigational Agents in Subjects with High-risk Non-muscle-Invasive Bladder Cancer (NMIBC) Unresponsive to Bacillus Calmette-Guerin (BCG) Therapy
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- High-risk Non-muscle-Invasive Bladder Cancer
- Sponsor
- MSD K.K.
- Enrollment
- 260
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Have a histologically\-confirmed diagnosis of high\-risk non\-muscle\-invasive (T1, High Grade Ta and/or CIS) transitional cell carcinoma of the bladder. Subjects with tumors of mixed transitional/non\-transitional cell histology are allowed, but transitional cell carcinoma must be the predominant histology.
- •\- Fully resected disease at study entry (residual CIS acceptable).
- •\- Have been treated with adequate BCG therapy and have developed high\-risk NMIBC that is unresponsive to BCG therapy.
- •\- Have elected not to undergo, or are considered ineligible for radical cystectomy, as determined by the treating surgeon.
- •\- Have provided tissue for biomarker analysis from the most recent cystoscopy/TURBT procedures from which tumor sample is available.
- •\- Have a performance status of 0, 1 or 2 on the Eastern Cooperative Oncology Group (ECOG) Performance Scale.
- •\- Have adequate organ function.
- •\- Female participants of childbearing potential have a negative urine or serum pregnancy test and must be willing to use an adequate method of contraception.
- •\- Male participants must be willing to use an adequate method of contraception.
Exclusion Criteria
- •\- Has muscle\-invasive, locally advanced nonresectable, or metastatic urothelial carcinoma (i.e., T2, T3, T4, and / or stage IV).
- •\- Has concurrent extra\-vesical (i.e., urethra, ureter, or renal pelvis) non\-muscle invasive transitional cell carcinoma of the urothelium.
- •\- Currently participating or has participated in a study of an investigational agent and received study therapy or received investigational device within 4 weeks prior to the first dose of study treatment.
- •\- Received intervening intravesical chemotherapy or immunotherapy from the time of most recent cystoscopy / Transurethral Resection of Bladder Tumor (TURBT) to starting study treatment.
- •\- Received prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to starting study treatment or not recovered from adverse events due to a previously administered agent.
- •\- Known additional malignancy that is progressing or requires active treatment excepting 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 treated with definitive intent (surgically or through radiation therapy) is acceptable provided that the following criteria are met: Stage T2N0M0 or lower; Gleason score \<\=7 and prostatic\-specific antigen (PSA) undetectable for at least 1 year while off androgen deprivation therapy that was either treated with definitive intent or untreated in active surveillance that has been stable for the past year prior to study allocation.
- •\- Active autoimmune disease that has required systemic treatment in the past 2 years.
- •\- Evidence of interstitial lung disease or active non\-infectious pneumonitis.
- •\- Active infection requiring systemic therapy.
- •\- Pregnant or breastfeeding, or expecting to conceive within the projected duration of the trial through 120 days after the last dose of study treatment.
Outcomes
Primary Outcomes
Not specified
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