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Study of Pembrolizumab (MK-3475) in Participants With High Risk Non-muscle Invasive Bladder Cancer (MK-3475-057/KEYNOTE-057)

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ClinicalTrials.gov Identifier: NCT02625961
Recruitment Status : Recruiting
First Posted : December 9, 2015
Last Update Posted : October 12, 2018
Sponsor:
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

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 260 participants
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 : February 15, 2019
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 ]


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

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 ClinicalTrials.gov identifier (NCT number): NCT02625961


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

  Hide Study Locations
Locations
United States, California
Call for Information (Investigational Site 0022) Recruiting
Duarte, California, United States, 91010
Call for Information (Investigational Site 0017) Recruiting
Los Angeles, California, United States, 90048
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, Colorado
Call for Information (Investigational Site 0070) Recruiting
Denver, Colorado, United States, 80211
United States, Maryland
Call for Information (Investigational Site 0077) Recruiting
Hanover, Maryland, United States, 21076
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, Nevada
Call for Information (Investigational Site 0096) Recruiting
Las Vegas, Nevada, United States, 89148
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
Call for Information (Investigational Site 0009) Recruiting
Cleveland, Ohio, United States, 44106
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, Utah
Call for Information (Investigational Site 0003) Recruiting
Salt Lake City, Utah, United States, 84112
United States, Virginia
Call for Information (Investigational Site 0079) Recruiting
Virginia Beach, Virginia, United States, 23462
United States, Washington
Call for Information (Investigational Site 0031) Recruiting
Seattle, Washington, United States, 98109
Australia
Merck Sharp & Dohme Recruiting
North Ryde, Australia
Contact: Australian Medical Information Centre    61 2 8988 8428      
Brazil
MSD Brasil Recruiting
Sao Paulo, Brazil
Contact: MSD Online    0800 012 22 32      
Canada, Quebec
Merck Canada Recruiting
Kirkland, Quebec, Canada, H9H 4M7
Contact: Medical Information Centre Centre d'information medicale Merck Canada Inc.    514-428-8600 / 1-800-567-2594      
Finland
MSD Finland Oy Recruiting
Espoo, Finland
Contact: Katrin Moeschlin    460857813500      
France
MSD France Recruiting
Paris, France
Contact: Valerie Bouchara    33 180464417      
Greece
Vianex, S.A. / MSD Recruiting
Alimos, Greece
Contact: Anna Aletra    30 2109897318      
Italy
MSD Italia S.r.l. Recruiting
Rome, Italy
Contact: Paola Chiaretta Fattore    39 0636191739      
Japan
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: TaeYoun Jo    8223312313      
Netherlands
Merck Sharp & Dohme BV Recruiting
Haarlem, Netherlands
Contact: Arjan Ooms    31235153306      
Russian Federation
Merck Sharp & Dohme IDEA, Inc. Recruiting
Moscow, Russian Federation
Contact: Tatiana Serebriakova    74959167100, EXT.366      
Sweden
MSD Sweden Recruiting
Stockholm, Sweden
Contact: Katrin Moeschlin    46857813545      
Turkey
Merck Sharp & Dohme Ilaclari Ltd. Sti Recruiting
Istanbul, Turkey
Contact: Betul Erdogan    2123361232      
Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Director Merck Sharp & Dohme Corp.

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT02625961     History of Changes
Other Study ID Numbers: 3475-057
2014-004026-17 ( EudraCT Number )
First Posted: December 9, 2015    Key Record Dates
Last Update Posted: October 12, 2018
Last Verified: October 2018

Keywords provided by Merck Sharp & Dohme Corp.:
PD1
PDL1
PD-L1
PD-1

Additional relevant MeSH terms:
Urinary Bladder Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Urinary Bladder Diseases
Urologic Diseases
Pembrolizumab
Antineoplastic Agents