NCI9673 part B: randomised phase 2 study of nivolumab with or without ipilimumab in refractory metastatic anal cancer
Adding ipilimumab to nivolumab for metastatic anal cancer after chemotherapy did not improve response, progression-free survival or overall survival and doubled severe side effects.
Overview
Randomised phase 2 part of the ETCTN trial NCI9673: patients with refractory metastatic squamous cell carcinoma of the anal canal were randomised to nivolumab alone or nivolumab with ipilimumab.
Median progression-free survival was 2.9 months with nivolumab and 3.7 months with the combination (hazard ratio 0.86, p 0.25); response rates were 17.4 and 21.5 percent and median overall survival 15.9 and 20.0 months (hazard ratio 0.98). Grade 3 or worse treatment-related adverse events occurred in 12 percent with nivolumab and 25 percent with the combination. Circulating TIGIT-positive CD8 T cells rose with dual blockade.
- Median progression-free survival 2.9 months (90% CI 1.9 to 3.8) with nivolumab versus 3.7 months (2.0 to 5.6) with nivolumab plus ipilimumab; hazard ratio 0.86 (0.60 to 1.23), p 0.25.
- Response rates 17.4 versus 21.5 percent (p 0.89); median overall survival 15.9 versus 20.0 months (hazard ratio 0.98).
- Grade 3 or worse treatment-related adverse events 12 versus 25 percent.
Single-agent PD-1 blockade remains the immunotherapy standard after chemotherapy in metastatic anal cancer; CTLA-4 blockade adds toxicity without benefit.
- Phase 2 powered for progression-free survival with wide confidence intervals.
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