Last updated 27 days ago
Study of Pembrolizumab (MK-3475) and Pembrolizumab With Other Investigational Agents in Participants With High Risk Non-muscle Invasive Bladder Cancer (MK-3475-057/KEYNOTE-057)
320 patients around the world
Available in Puerto Rico, Spain, United States, Brazil
Merck Sharp & Dohme LLC
320Patients around the world
This study is for people with
Bladder Cancer
Non-muscle-invasive bladder cancer
Requirements for the patient
From 18 Years
All Gender
Medical requirements
- Histologically-confirmed diagnosis of high risk non-muscle-invasive (T1, high grade Ta and / or carcinoma in situ [CIS]) transitional cell carcinoma of the bladder (mixed histology tumors allowed if transitional cell histology is predominant histology).Fully resected disease at study entry (residual CIS acceptable)BCG-unresponsive high risk non-muscle-invasive bladder cancer after treatment with adequate BCG therapyIneligible for radical cystectomy or refusal of radical cystectomyAvailable tissue from a newly obtained core biopsy of a tumor lesion not previously irradiatedEastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2Adequate organ functionFemale participants of childbearing potential have a negative urine or serum pregnancy test and must be willing to use an adequate method of contraceptionMale participants must be willing to use an adequate method of contraception
- Centrally assessed muscle-invasive, locally advanced nonresectable, or metastatic urothelial carcinoma (i.e., T2, T3, T4, and / or stage IV)Centrally assessed concurrent extra-vesical (i.e., urethra, ureter, or renal pelvis) non-muscle invasive transitional cell carcinoma of the urotheliumCurrently 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 treatmentReceived intervening intravesical chemotherapy or immunotherapy from the time of most recent cystoscopy / Transurethral Resection of Bladder Tumor (TURBT) to starting study treatmentReceived 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 agentKnown 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 allocationActive autoimmune disease that has required systemic treatment in the past 2 yearsEvidence of interstitial lung disease or active non-infectious pneumonitisActive infection requiring systemic therapyPregnant or breastfeeding, or expecting to conceive within the projected duration of the trial through 120 days after the last dose of study treatmentPrior therapy with an anti-programmed cell death 1 (PD-1), anti-PD-ligand 2 (L2) agent, or with an agent directed to another co-inhibitory T-cell receptorKnown human immunodeficiency virus (HIV)Known active Hepatitis B or C infectionReceived a live virus vaccine within 30 days of planned start of study treatmentHas had an allogeneic tissue/solid organ transplant
SponsorMerck Sharp & Dohme LLC
Conditions
Non-muscle-invasive bladder cancer
Requirements
From 18 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT02625961
