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Pembrolizumab + BCG is a combination therapy under investigation for the treatment of high-risk non-muscle-invasive bladder cancer (NMIBC), particularly in patients with persistent, recurrent, or BCG-unresponsive disease. Pembrolizumab is a humanized monoclonal antibody that targets the programmed death 1 (PD-1) receptor on T cells, blocking its interaction with PD-L1 and PD-L2 ligands to enhance anti-tumor immune responses. Bacillus Calmette–Guérin (BCG) is an attenuated live vaccine strain of Mycobacterium bovis used intravesically as immunotherapy for NMIBC; it stimulates local immune activation within the bladder wall. The rationale for combining these agents stems from evidence that aberrant PD-1 signaling may contribute to resistance against BCG therapy and tumor recurrence. Early-phase clinical trials have demonstrated that this combination can be administered safely and may improve complete response rates compared to BCG alone[4][5][6][8]. Ongoing phase III studies are evaluating efficacy and safety in larger patient populations.
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