A Phase II Clinical Trial to Study the Efficacy and Safety of Pembrolizumab (MK-3475) in Subjects With High Risk Non-muscle Invasive Bladder Cancer (NMIBC) Unresponsive to Bacillus Calmette-Guerin (BCG) Therapy


Condition: Bladder Cancer

Intervention:

  • Biological: pembrolizumab

Purpose: In this study, participants with high risk non-muscle-invasive bladder cancer (NMIBC) unresponsive to Bacillus Calmette Guerin (BCG) therapy and who are considered ineligible for or have refused to undergo radical cystectomy, will receive pembrolizumab therapy. The primary study hypothesis is that treatment with pembrolizumab will result in a clinically meaningful response.

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT02625961

Sponsor: Merck Sharp & Dohme Corp.

Primary Outcome Measures:

  • Measure: Complete Response Rate
  • Time Frame: Up to 3 years
  • Safety Issue:
  • Measure: Disease Free Survival Rate
  • Time Frame: Up to 3 years
  • Safety Issue:

Secondary Outcome Measures:

  • Measure: Duration of Response
  • Time Frame: Up to 3 years
  • Safety Issue:

Estimated Enrollment: 260

Study Start Date: February 10, 2016

Phase: Phase 2

Eligibility:

  • Age: minimum 18 Years maximum N/A
  • Gender: All

Inclusion Criteria:

  • 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 therapy
  • Ineligible for radical cystectomy or refusal of radical cystectomy
  • Available tissue from a newly obtained core biopsy of a tumor lesion not previously irradiated
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
  • 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:

  • Muscle-invasive, locally advanced nonresectable, or metastatic urothelial carcinoma (i.e., T2, T3, T4, and / or stage IV)
  • 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
  • Prior 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 receptor
  • Known human immunodeficiency virus (HIV)
  • Known active Hepatitis B or C infection
  • Received a live virus vaccine within 30 days of planned start of study treatment
  • Has had an allogeneic tissue/solid organ transplant

Contact:

  • Toll Free Number
  • 1-888-577-8839

Locations:

  • Call for Information (Investigational Site 0022)
  • Duarte California 91010 United States
  • Call for Information (Investigational Site 0017)
  • Los Angeles California 90048 United States
  • Call for Information (Investigational Site 0021)
  • Orange California 92868 United States
  • Call for Information (Investigational Site 0032)
  • Santa Monica California 90404 United States
  • Call for Information (Investigational Site 0070)
  • Denver Colorado 80211 United States
  • Call for Information (Investigational Site 0077)
  • Hanover Maryland 21076 United States
  • Call for Information (Investigational Site 0026)
  • Boston Massachusetts 02115 United States
  • Call for Information (Investigational Site 0034)
  • Detroit Michigan 48202 United States
  • Call for Information (Investigational Site 0023)
  • Minneapolis Minnesota 55455 United States
  • Call for Information (Investigational Site 0096)
  • Las Vegas Nevada 89148 United States
  • Call for Information (Investigational Site 0002)
  • Hackensack New Jersey 07601 United States
  • Call for Information (Investigational Site 0018)
  • New Brunswick New Jersey 08903 United States
  • Call for Information (Investigational Site 0073)
  • Voorhees New Jersey 08043 United States
  • Call for Information (Investigational Site 0035)
  • Lake Success New York 11042-1133 United States
  • Call for Information (Investigational Site 0004)
  • New York New York 10016 United States
  • Call for Information (Investigational Site 0025)
  • New York New York 10065 United States
  • Call for Information (Investigational Site 0076)
  • Syracuse New York 13210 United States
  • Call for Information (Investigational Site 0072)
  • Cincinnati Ohio 45212 United States
  • Call for Information (Investigational Site 0009)
  • Cleveland Ohio 44106 United States
  • Call for Information (Investigational Site 0074)
  • Bala-Cynwyd Pennsylvania 19004 United States
  • Call for Information (Investigational Site 0008)
  • Pittsburgh Pennsylvania 15232 United States
  • Call for Information (Investigational Site 0078)
  • Myrtle Beach South Carolina 29572 United States
  • Call for Information (Investigational Site 0092)
  • Houston Texas 77024 United States
  • Call for Information (Investigational Site 0003)
  • Salt Lake City Utah 84112 United States
  • Call for Information (Investigational Site 0079)
  • Virginia Beach Virginia 23462 United States
  • Call for Information (Investigational Site 0031)
  • Seattle Washington 98109 United States
  • Merck Sharp & Dohme
  • North Ryde Australia
  • MSD Brasil
  • Sao Paulo Brazil
  • Merck Canada
  • Kirkland Quebec H9H 4M7 Canada
  • MSD Finland Oy
  • Espoo Finland
  • MSD France
  • Paris France
  • Vianex, S.A. / MSD
  • Alimos Greece
  • MSD Italia S.r.l.
  • Rome Italy
  • MSD K.K.
  • Chiyoda-Ku, Tokyo 102-8667 Japan
  • MSD Korea LTD
  • Seoul 4130 Korea, Republic of
  • Merck Sharp & Dohme BV
  • Haarlem Netherlands
  • Merck Sharp & Dohme IDEA, Inc.
  • Moscow Russian Federation
  • MSD Sweden
  • Stockholm Sweden
  • Merck Sharp & Dohme Ilaclari Ltd. Sti
  • Istanbul Turkey

View trial on ClinicalTrials.gov


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