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Trial record 1 of 20 for:    merck | Recruiting, Not yet recruiting, Available Studies | bladder cancer
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Study of Pembrolizumab (MK-3475) in Participants With High Risk Non-muscle Invasive Bladder Cancer (MK-3475-057/KEYNOTE-057)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02625961
Recruitment Status : Recruiting
First Posted : December 9, 2015
Last Update Posted : April 17, 2020
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Bladder Cancer Biological: pembrolizumab Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 260 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : February 10, 2016
Estimated Primary Completion Date : June 15, 2022
Estimated Study Completion Date : July 30, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bladder Cancer

Arm Intervention/treatment
Experimental: Pembrolizumab
Participants receive pembrolizumab, 200 mg, intravenously, every 3 weeks (Q3W) for up to 24 months.
Biological: pembrolizumab
Other Name: MK-3475

Primary Outcome Measures :
  1. Complete Response Rate [ Time Frame: Up to 3 years ]
  2. Disease Free Survival Rate [ Time Frame: Up to 3 years ]

Secondary Outcome Measures :
  1. Duration of Response [ Time Frame: Up to 3 years ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02625961

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Contact: Toll Free Number 1-888-577-8839

Hide Hide 30 study locations
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United States, California
Call for Information (Investigational Site 0021) Recruiting
Orange, California, United States, 92868
Call for Information (Investigational Site 0032) Recruiting
Santa Monica, California, United States, 90404
United States, Massachusetts
Call for Information (Investigational Site 0026) Recruiting
Boston, Massachusetts, United States, 02115
United States, Michigan
Call for Information (Investigational Site 0034) Recruiting
Detroit, Michigan, United States, 48202
United States, Minnesota
Call for Information (Investigational Site 0023) Recruiting
Minneapolis, Minnesota, United States, 55455
United States, New Jersey
Call for Information (Investigational Site 0002) Recruiting
Hackensack, New Jersey, United States, 07601
Call for Information (Investigational Site 0018) Recruiting
New Brunswick, New Jersey, United States, 08903
Call for Information (Investigational Site 0073) Recruiting
Voorhees, New Jersey, United States, 08043
United States, New York
Call for Information (Investigational Site 0035) Recruiting
Lake Success, New York, United States, 11042-1133
Call for Information (Investigational Site 0004) Recruiting
New York, New York, United States, 10016
Call for Information (Investigational Site 0025) Recruiting
New York, New York, United States, 10065
Call for Information (Investigational Site 0076) Recruiting
Syracuse, New York, United States, 13210
United States, Ohio
Call for Information (Investigational Site 0072) Recruiting
Cincinnati, Ohio, United States, 45212
United States, Pennsylvania
Call for Information (Investigational Site 0074) Recruiting
Bala-Cynwyd, Pennsylvania, United States, 19004
Call for Information (Investigational Site 0008) Recruiting
Pittsburgh, Pennsylvania, United States, 15232
United States, South Carolina
Call for Information (Investigational Site 0078) Recruiting
Myrtle Beach, South Carolina, United States, 29572
United States, Texas
Call for Information (Investigational Site 0092) Recruiting
Houston, Texas, United States, 77024
United States, Washington
Call for Information (Investigational Site 0031) Recruiting
Seattle, Washington, United States, 98109
Merck Sharp & Dohme Recruiting
North Ryde, Australia
Contact: Australian Medical Information Centre    61 2 8988 8428      
Canada, Quebec
Merck Canada Recruiting
Kirkland, Quebec, Canada, H9H 4M7
Contact: Medical Information Centre Centre dinformation medicale Merck Canada Inc.    514-428-8600 / 1-800-567-2594      
MSD Finland Oy Recruiting
Espoo, Finland
Contact: Michael Pasternack    358 20 7570300      
MSD France Recruiting
Paris, France
Contact: Dominique Blazy    33 147548990      
Vianex, S.A. / MSD Recruiting
Alimos, Greece
Contact: Lazaros Poughias    30 2109897322      
MSD Italia S.r.l. Recruiting
Rome, Italy
Contact: Patrizia Nardini    39 06 361911      
MSD K.K. Recruiting
Chiyoda-Ku, Tokyo, Japan, 102-8667
Contact: Japan Call Center    81-3-6272-1957      
Korea, Republic of
MSD Korea LTD Recruiting
Seoul, Korea, Republic of, 4130
Contact: Jongho Ahn    82-2-331-2000 2015      
Merck Sharp & Dohme BV Recruiting
Haarlem, Netherlands
Contact: Caroline Doornebos    31 23 515 3362      
Russian Federation
Merck Sharp & Dohme IDEA, Inc. Recruiting
Moscow, Russian Federation
Contact: Tatiana Serebriakova    74959167100, EXT.366      
MSD Sweden Recruiting
Stockholm, Sweden
Contact: Tryggve Ljung    46 (0)70 545 28 66      
Merck Sharp & Dohme Ilaclari Ltd. Sti Recruiting
Istanbul, Turkey
Contact: Alev Eren    90 212 336 12 63      
Sponsors and Collaborators
Merck Sharp & Dohme Corp.
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Study Director: Medical Director Merck Sharp & Dohme Corp.
Additional Information:
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Responsible Party: Merck Sharp & Dohme Corp. Identifier: NCT02625961    
Other Study ID Numbers: 3475-057
2014-004026-17 ( EudraCT Number )
163236 ( Registry Identifier: JAPAC-CTI )
First Posted: December 9, 2015    Key Record Dates
Last Update Posted: April 17, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:
Keywords provided by Merck Sharp & Dohme Corp.:
Additional relevant MeSH terms:
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Urinary Bladder Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Urinary Bladder Diseases
Urologic Diseases
Antineoplastic Agents, Immunological
Antineoplastic Agents