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FDA places partial clinical hold on three nivolumab trials for multiple myeloma
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The FDA placed partial clinical hold on three trials designed to evaluate nivolumab-based combinations for the treatment of patients with relapsed or refractory multiple myeloma, according to the drug’s manufacturer.
Nivolumab (Opdivo, Bristol-Myers Squibb) is a PD-1 immune checkpoint inhibitor that is designed to uniquely harness the body’s own immune system to help restore anti-tumor immune response.
The agency decided available data from Pembrolizumab (Keytruda, Merck) studies indicated the risks for PD-1/PD-L1 regimens outweigh the potential benefit for patients with multiple myeloma.
As part of the terms of the partial clinical hold, patients enrolled in the trials who are experiencing clinical benefit can continue treatment; however, no new patients will enroll in the studies.
The partial clinical hold includes:
- the open-label, randomized phase 3 CheckMate-602 trial, designed to evaluate nivolumab in combination with elotuzumab (Empliciti, Bristol-Myers Squibb), pomalidomide (Pomalyst, Celgene) and dexamethasone in relapsed and refractory multiple myeloma;
- the phase 1 CheckMate-039 study designed to establish the tolerability of nivolumab in combination with daratumumab (Darzalex, Janssen) — with or without pomalidomide and dexamethasone — in relapsed and refractory multiple myeloma; and
- the phase 2 CA204142 multiple cohort Study of elotuzumab in combination with pomalidomide and low-dose dexamethasone, and in combination with nivolumab to treat patients with relapsed or refractory multiple myeloma, prior to treatment with lenalidomide (Revlimid, Celgene).
Other studies evaluating nivolumab outside of multiple myeloma will continue as planned.