FDA Places Partial Clinical Hold on Three Opdivo Clinical Trials

The U.S. Food and Drug Administration (FDA) has placed a partial clinical hold on CA209602 (CheckMate-602), CA209039 (CheckMate-039) and CA204142, three clinical trials investigating Opdivo (nivolumab)-based combinations in patients with relapsed or refractory multiple myeloma.

This partial clinical hold is related to risks identified in trials studying another anti-PD-1 agent, pembrolizumab, in patients with multiple myeloma. The FDA determined data currently available from non-Opdivo studies indicate the risks of PD-1/PD-L1 treatment plus pomalidomide or lenalidomide and...