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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)

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 : June 7, 2023
Information provided by (Responsible Party):
Merck Sharp & Dohme LLC

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 or pembrolizumab in combination with other investigational agents. 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 Biological: Pembrolizumab/vibostolimab coformulation Biological: Favezelimab/pembrolizumab coformulation Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 320 participants
Allocation: Randomized
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) 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
Actual Study Start Date : February 10, 2016
Estimated Primary Completion Date : August 30, 2026
Estimated Study Completion Date : August 31, 2030

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
Participants receive pembrolizumab 200mg via IV infusion once every 3 weeks for up to 35 administrations
Other Names:
  • MK-3475

Experimental: Pembrolizumab coformulation
Participants receive either pembrolizumab/vibostolimab or favezelimab/pembrolizumab coformulation intravenously Q3W for up to 24 months
Biological: Pembrolizumab/vibostolimab coformulation
Participants receive pembrolizumab/vibostolimab (coformulation of 200 mg pembrolizumab and 200 mg vibostolimab) via IV infusion once every 3 weeks for up to 35 administrations
Other Name: MK-7684A

Biological: Favezelimab/pembrolizumab coformulation
Participants receive favezelimab/pembrolizumab (coformulation of 800mg favezelimab and 200 mg pembrolizumab) via IV infusion once every 3 weeks for up to 35 administrations
Other Name: MK-4280A

Primary Outcome Measures :
  1. Complete Response Rate [ Time Frame: Up to 3 years ]
  2. Disease Free Survival Rate [ Time Frame: Up to approximately 12 months ]
  3. 12-month Complete Response Rate [ Time Frame: Up to approximately 12 months ]

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:

  • 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 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

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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, 08901
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
United States, South Carolina
Call for Information (Investigational Site 0078) Recruiting
Myrtle Beach, South Carolina, United States, 29572
MSD Australia Recruiting
North Ryde, Australia
Contact: Australian Medical Information Centre    61 2 8988 8428      
MSD Finland Oy Recruiting
Espoo, Finland
Contact: Michael Pasternack    358 20 7570300      
MSD France Recruiting
Paris, France
Contact: Dominique Blazy    33 147548990      
MSD Italia S.r.l. Recruiting
Rome, Italy
Contact: Barbara Capaccetti    39 06361911      
Merck Sharp & Dohme BV Recruiting
Haarlem, Netherlands
Contact: Caroline Doornebos    31 23 515 3362      
Puerto Rico
Call for Information (Investigational Site 2402) Recruiting
Ponce, Puerto Rico, 00717
Merck Sharp and Dohme de Espana S.A. Recruiting
Madrid, Spain
Contact: Lourdes Lopez-Bravo    (0034) 913210654      
Merck Sharp & Dohme Ilaclari Ltd. Sti Recruiting
Istanbul, Turkey
Contact: Alev Eren    90 212 336 12 63      
Sponsors and Collaborators
Merck Sharp & Dohme LLC
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Study Director: Medical Director Merck Sharp & Dohme LLC
Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Merck Sharp & Dohme LLC Identifier: NCT02625961    
Other Study ID Numbers: 3475-057
163236 ( Registry Identifier: JAPAC-CTI )
2014-004026-17 ( EudraCT Number )
First Posted: December 9, 2015    Key Record Dates
Last Update Posted: June 7, 2023
Last Verified: June 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:
Keywords provided by Merck Sharp & Dohme LLC:
Additional relevant MeSH terms:
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Urinary Bladder Neoplasms
Non-Muscle Invasive Bladder Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Female Urogenital Diseases
Female Urogenital Diseases and Pregnancy Complications
Urogenital Diseases
Urinary Bladder Diseases
Urologic Diseases
Male Urogenital Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Antineoplastic Agents, Immunological
Antineoplastic Agents
Immune Checkpoint Inhibitors
Molecular Mechanisms of Pharmacological Action