Trial intelligence / Profile preview

Phase 3 trial of pembrolizumab plus BCG versus BCG alone in high-risk non-muscle invasive bladder cancer

NL-OMON58811Phase 3Active, not recruiting

Sponsor
Merck & Co.
Start
May 2019
Modality
Immune Checkpoint Inhibitors → Monoclonal Antibodies → Antibody-Based Therapeutics, Recombinant Proteins and Enzymes, Vaccines & Immunotherapeutics
Countries
1
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Overview

Phase 3, randomised, open-label trial of pembrolizumab and bcg vaccine in transitional cell carcinoma of the bladder (TCC) and Bladder cancer in situ (CIS) (5 cohorts), sponsored by Merck & Co. Primary endpoints: Complete Response Rate by blinded independent central review and Event-Free Survival. Started May 2019; status: active, not recruiting.

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Drugs

pembrolizumabbcg vaccine
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Conditions

transitional cell carcinoma of the bladder (TCC)Bladder cancer in situ (CIS)

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