BMS provides update on RELATIVITY-123 trial evaluating the fixed-dose combination of nivolumab and relatlimab in patients with previously treated metastatic microsatellite stable (MSS) colorectal cancer.
Bristol Myers Squibb announced that the Phase III RELATIVITY-123 trial evaluating the fixed-dose combination of nivolumab and relatlimab for the treatment of microsatellite stable (MSS) metastatic colorectal cancer (mCRC) patients whose disease has progressed following at least one, but no more than four, prior lines of therapy for metastatic disease will be discontinued due to futility based on a planned analysis conducted by an independent data monitoring committee.
It was determined that the trial was unlikely to meet its primary endpoints upon completion.
The recommendation to stop the study was not based on safety concerns. The safety profile was consistent with previously reported studies of the fixed-dose combination of nivolumab and relatlimab.
Investigation of the fixed-dose combination of nivolumab and relatlimab as a treatment for other tumor types will continue as planned. These results do not impact the currently approved indication for patients with unresectable or metastatic melanoma.
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