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)

STATUS

Recruiting
End date

Feb 10, 2027
participants needed

636
sponsor

Merck Sharp & Dohme Corp.

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Updated on 19 February 2024

See if I qualify

cancer

bladder cancer

gemcitabine

pembrolizumab

metastatic bladder cancer

invasive bladder cancer

bladder tumor

chemoradiotherapy

fluorouracil

cancer chemotherapy

mitomycin

metastatic bladder carcinoma

cisplatin

Summary

This study is designed to assess the antitumor efficacy and safety of pembrolizumab in combination with chemoradiotherapy (CRT) versus CRT alone in participants with muscle-invasive bladder cancer (MIBC). The primary hypothesis is that pembrolizumab + chemoradiotherapy is superior to placebo + chemoradiotherapy with respect to bladder intact event-free survival.

Details

Condition	urinary tract neoplasm, bladder cancer, bladder cancer, bladder disorder
Age	18-100 years
Treatment	Pembrolizumab, Gemcitabine, Cisplatin, Conventional Radiotherapy (Bladder only), Conventional Radiotherapy (Bladder and pelvic nodes), Hypofractionated Radiotherapy (Bladder only), Fluorouracil (5-FU), Mitomycin C (MMC), Placebo to Pembrolizumab
Clinical Study Identifier	NCT04241185
Sponsor	Merck Sharp & Dohme Corp.
Last Modified on	19 February 2024

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Eligibility		Yes	No	Not Sure
Inclusion Criteria
	Has a histologically confirmed diagnosis of MIBC with predominant urothelial histology
	Has clinically non-metastatic 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 180 days after the last dose of study
	intervention
	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 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
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 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 co-inhibitory 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 prior to the first dose of study drug
	Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study intervention
	Has severe hypersensitivity (Grade 3) to pembrolizumab and/or the selected chemotherapy regimen, and/or any of their excipients
	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 prior to the first dose of study drug
	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

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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)