The U.S. Food and Drug Administration (FDA) has removed the partial clinical holds placed on several clinical trials investigating checkpoint inhibitors in combination with immunomodulatory drugs for myeloma patients.
The Roche trial (NCT02431208) investigating atezolizumab (Tecentriq®) in combination with pomalidomide or lenalidomide for relapsed and refractory myeloma patients will now continue with protocol amendments as agreed by the FDA. The original article is available here.
In addition, two Bristol-Myers Squibb trials (CA204142 and CA209039) that are investigating nivolumab (Opdivo®) combinations for the treatment of relapsed and refractory myeloma have also had the partial clinical holds removed, and are open to patient recruitment again. Further information is available here.
These trials were placed on clinical hold earlier this year, due to safety concerns that arose from trials involving pembrolizumab (Keytruda®), another checkpoint inhibitor, in combination with immunomodulatory drugs in myeloma patients. Several trials investigating pembrolizumab, nivolumab and durvaluamab (Imfinzi™) remain under partial or full clinical hold by the FDA.