{"entity":{"id":"paper-nci9673-part-b-nivolumab-ipilimumab-anal-cancer-morris-jco-2026","kind":"paper","name":"NCI9673 part B: randomised phase 2 study of nivolumab with or without ipilimumab in refractory metastatic anal cancer","aka":[],"tldr":"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.","summary":"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.\n\nMedian 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.","asOf":"2026-09-22","links":[{"label":"J Clin Oncol 2026","url":"https://doi.org/10.1200/JCO-25-00929"},{"label":"PubMed","url":"https://pubmed.ncbi.nlm.nih.gov/41499716/"}],"tags":[],"related":[],"cancers":["metastatic-anal-cancer","anal"],"sections":[],"technologies":[],"targets":[],"drugs":["nivolumab","ipilimumab"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":["nci9673"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":["jco"],"dependsOn":[],"notes":[],"journal":"Journal of Clinical Oncology","year":2026,"doi":"10.1200/JCO-25-00929","pmid":"41499716","authors":"Morris VK, Ciombor KK, Xiao L, et al.","paperType":"rct","findings":["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."],"whatItMeans":"Single-agent PD-1 blockade remains the immunotherapy standard after chemotherapy in metastatic anal cancer; CTLA-4 blockade adds toxicity without benefit.","caveats":["Phase 2 powered for progression-free survival with wide confidence intervals."],"changedPractice":false,"participants":106},"route":"/key-papers/paper-nci9673-part-b-nivolumab-ipilimumab-anal-cancer-morris-jco-2026/","neighbours":{"cancer":[{"id":"anal","kind":"cancer","name":"Anal cancer (squamous cell carcinoma)","route":"/cancers/anal/"},{"id":"metastatic-anal-cancer","kind":"cancer","name":"Metastatic and recurrent anal squamous cell carcinoma","route":"/cancers/metastatic-anal-cancer/"}],"drug":[{"id":"ipilimumab","kind":"drug","name":"Ipilimumab","route":"/drugs/ipilimumab/"},{"id":"nivolumab","kind":"drug","name":"Nivolumab","route":"/drugs/nivolumab/"}],"trial":[{"id":"nci9673","kind":"trial","name":"NCI9673","route":"/trials/nci9673/"}],"journal":[{"id":"jco","kind":"journal","name":"Journal of Clinical Oncology","route":"/journals/jco/"}]}}