Efficacy and Safety of Pembrolizumab (MK-3475) in Combination With Chemoradiotherapy (CRT) Versus CRT Alone in Muscle-invasive Bladder Cancer (MIBC) (MK-3475-992/KEYNOTE-992)
Pembrolizumab: 400 mg of IV (intravenous) pembrolizumab once every 6 weeks.
Conventional Radiotherapy (Bladder only): 64 Gy of radiation administered to participant's bladder only. Thirty-two fractions will be administered over 6.5 weeks.
Conventional Radiotherapy (Bladder and pelvic nodes): 64 Gy of radiation administered to participant's bladder and pelvic nodes. Thirty-two fractions will be administered over 6.5 weeks.
Hypofractionated Radiotherapy (Bladder only): 55 Gy of radiation administered to participant's bladder only. Twenty fractions will be administered over 4 weeks.
Cisplatin: 35 mg of cisplatin per cubic meter of body volume, administered once weekly via IV infusion.
Fluorouracil (5-FU): 5-FU administered via IV infusion at a dose of 500 mg per cubic meter of body volume on Days 1-5 and 22-26.
Mitomycin C (MMC): MMC administered via IV infusion at a dose of 12 mg per cubic meter of body volume on Day 1.
Gemcitabine: Gemcitabine administered via IV infusion at a dose of 27 mg per cubic meter of body volume twice weekly.
Placebo to Pembrolizumab: Placebo to intravenous (IV) pembrolizumab administered once every 6 weeks.
Study summary
Researchers are looking for new ways to treat muscle-invasive bladder cancer (MIBC). MIBC is a type of cancer that has not spread from the muscles in the bladder to other parts of the body.
MIBC is treated by having surgery to remove the bladder (cystectomy). Not all people choose to have surgery and want to keep their bladder using other treatments.
Chemoradiotherapy (CRT)- is a type of non-surgical treatment for MIBC which combines Chemotherapy (a treatment with medicine to destroy cancer cells or stop them growing) and Radiation therapy (a treatment that uses beams of intense energy \[like X-rays\] to shrink or get rid of tumors).
Pembrolizumab is an immunotherapy, which is a treatment that helps the immune system fight cancer.
A placebo looks like the study medicine but has no study medicine in it. Using a placebo helps researchers better understand if the study medicine works.
The goal of this study is to learn: 1. If a study medicine pembrolizumab given with Chemoradiotherapy (CRT) can help people live longer without their cancer growing, spreading, or coming back compared to placebo given with CRT. 2. About the safety and how well people tolerate CRT alone or in combination with pembrolizumab.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
* Has a histologically confirmed initial diagnosis of muscle-invasive bladder cancer (MIBC) with predominant urothelial histology
* Has clinically nonmetastatic bladder cancer (N0M0)
* Has planned and is eligible to receive chemoradiotherapy (CRT) and one of the protocol-specified radiosensitizing chemotherapy regimens
* Has Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
* Demonstrates adequate organ function
* Male participants are eligible to participate if they agree to the following during the intervention period and for at least 90 days after the last dose of CRT treatment:
* Refrain from donating sperm
* Be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis) and agree to remain abstinent; or must agree to use contraception unless confirmed to be azoospermic
* A female participant is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies:
* Is not a woman of childbearing potential (WOCBP)
* Is a WOCBP and using a contraceptive method that is highly effective (with a failure rate of \<1% per year), with low user dependency or be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis), during the intervention period and for at least 180 days the time needed to eliminate each study intervention after the last dose of study intervention; and agrees not to donate eggs (ova, oocytes) to others or freeze/store for her own use for the purpose of reproduction during this period. The length of time required to continue contraception for each study intervention is as follows: MK-3475 - 120 days and CRT - 180 days
Exclusion Criteria:
* Has the presence of diffuse carcinoma in situ (CIS) (multiple foci of CIS) throughout the bladder
* Has the presence of urothelial carcinoma (UC) at any site outside of the urinary bladder in the previous 2 years except for Ta stage/T1 stage/CIS of the upper tract if the participant has undergone a complete nephroureterectomy
* Has a known additional malignancy that is progressing or has required active therapy within the past 3 years, except basal cell carcinoma of the skin, squamous cell carcinoma of the skin, superficial bladder cancer or other carcinoma in situ that has undergone potentially curative therapy
* Has the presence of bilateral hydronephrosis
* Has limited bladder function with frequency of small amounts of urine (\< 30 mL), urinary incontinence, or requires self-catheterization or a permanent indwelling catheter
* Has received prior pelvic/local radiation therapy for any reason or any antineoplastic treatment for muscle-invasive bladder cancer (MIBC). Treatment for non-muscle invasive bladder cancer (NMIBC) with intravesical instillation therapy that was completed ≥28 days prior to randomization is allowed. Prior systemic treatment of NMIBC is not permitted.
* Received prior therapy with an anti-PD-1 (programmed cell death protein 1), anti-PD-L1 (programmed death-ligand 1), or anti-PD-L2 (programmed cell death 1 ligand 2), or with an agent directed to another stimulatory or coinhibitory T-cell receptor (e.g., CTLA-4 \[cytotoxic T-lymphocyte-associated protein 4\], OX 40, or CD137 \[cluster of differentiation 137\])
* Has received a live vaccine within 30 days before the first dose of study medication
* Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks before the first dose of study medication
* Has known severe hypersensitivity (≥Grade 3) to the selected chemotherapy regimen, and/or any of their excipients and excipients of pembrolizumab
* Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days before the first dose of study medication
* Has an active autoimmune disease that has required systemic treatment in the past 2 years (ie, with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment and is allowed
* Has a history of non-infectious pneumonitis that required steroids or has current pneumonitis
* Has an active infection requiring systemic therapy
* Has a known history of human immunodeficiency virus (HIV) infection
* Has a known history of hepatitis B or known active hepatitis C virus infection
* Has a known history of active tuberculosis (TB; Bacillus tuberculosis)
* Has a known psychiatric or substance abuse disorder that would interfere with the participant's ability to cooperate with the requirements of the study
* Has had an allogenic tissue/solid organ transplant
Primary outcome measure(s)
Bladder Intact Event-Free Survival (BI-EFS) — Up to approximately 76 months BI-EFS is defined as the time from randomization to any of the following events: residual/recurrent MIBC post-chemoradiotherapy (CRT), nodal or distant metastases as assessed by computerized tomography (CT) and CT urography (CTU) or magnetic resonance urography (MRU) per blinded independent central review (BICR) and/or biopsy results assessed by central pathology review, radical cystectomy, or death due to any cause. If biopsy is not feasible due to participant safety, the imaging alone will be sufficient. The BI-EFS for all participants will be presented.
Trial sites (134)
Facility
City
Region
Status
Washington Cancer Institute at MedStar Washington Hospital Center ( Site 0041)
Washington D.C.
District of Columbia
Bay Pines VA Medical Center ( Site 0055)
Bay Pines
Florida
AdventHealth Orlando-AdventHealth Medical Group Hematology & Oncology at Orlandoc ( Site 0004)
Orlando
Florida
Norton Cancer Institute ( Site 0044)
Louisville
Kentucky
Pikeville Medical Center ( Site 0009)
Pikeville
Kentucky
Baltimore VA Medical Center ( Site 0054)
Baltimore
Maryland
Washington University ( Site 0003)
St Louis
Missouri
Summit Medical Group Cancer Center ( Site 6008)
Florham Park
New Jersey
John Theurer Cancer Center at Hackensack University Medical Center ( Site 0005)
Hackensack
New Jersey
New York Oncology Hematology P.C ( Site 0024)
Albany
New York
Roswell Park Cancer Institute ( Site 6009)
Buffalo
New York
Winthrop University Hospital ( Site 0069)
Mineola
New York
New York University Perlmutter Cancer Center ( Site 0001)
New York
New York
Westchester Medical Center ( Site 6014)
Valhalla
New York
Fairview Hospital-Moll Cancer Center ( Site 6013)
Cleveland
Ohio
Cleveland Clinic Main ( Site 0062)
Cleveland
Ohio
Cleveland Clinic - Hillcrest Hospital-Hillcrest Hospital Cancer Center ( Site 6012)
Mayfield Heights
Ohio
MidLantic urology ( Site 0070)
Bala-Cynwyd
Pennsylvania
Saint Francis Cancer Center ( Site 0026)
Greenville
South Carolina
Carolina Urologic Research Center ( Site 0002)
Myrtle Beach
South Carolina
Urology San Antonio Research ( Site 6010)
San Antonio
Texas
Inova Schar Cancer Institute ( Site 6006)
Fairfax
Virginia
West Virginia University - Charleston Area Medical Center ( Site 6003)
Charleston
West Virginia
Froedtert and Medical College of Wisconsin ( Site 0022)
Milwaukee
Wisconsin
Liverpool Hospital ( Site 0220)
Liverpool
New South Wales
GenesisCare North Shore ( Site 0217)
St Leonards
New South Wales
Monash Medical Centre ( Site 0216)
Clayton
Victoria
Austin Health ( Site 0218)
Heidelberg
Victoria
Sir Charles Gairdner Hospital ( Site 0223)
Nedlands
Western Australia
Oncocentro Valdivia ( Site 7055)
Valdivia
Los Ríos Region
FALP ( Site 7056)
Santiago
Region M. de Santiago
Bradfordhill-Clinical Area ( Site 7051)
Santiago
Region M. de Santiago
ONCOCENTRO APYS-ACEREY ( Site 7054)
Viña del Mar
Valparaiso
Bradford Hill Norte ( Site 7052)
Antofagasta
Chile
Fakultni nemocnice Olomouc ( Site 0559)
Olomouc
Czechia
2. LF UK a FN Motol ( Site 0555)
Prague
Czechia
Nemocnice Na Bulovce ( Site 0556)
Prague
Czechia
Herlev og Gentofte Hospital. ( Site 0401)
Herlev
Capital Region
Odense Universitetshospital ( Site 0403)
Odense
Region Syddanmark
North Estonia Medical Centre Foundation ( Site 0081)
Tallinn
Harju
+ 94 more sites — see the full list on the official registry below.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
We use cookies to analyse site traffic and improve your experience. With your consent, we may also use cookies for advertising. You can change your choice at any time.