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NCI9673 was the first completed immunotherapy trial in anal cancer: nivolumab on its own shrank tumours in a quarter of heavily treated patients, which made PD-1 blockade a standard later option, but the follow-on randomisation showed that adding ipilimumab did not help and added toxicity.
NCI9673 was a multi-institutional phase 2 trial of the NCI Experimental Therapeutics Clinical Trials Network. Part A gave nivolumab to 37 patients with previously treated metastatic anal squamous cell carcinoma; part B randomised further patients to nivolumab alone or nivolumab with ipilimumab, with progression-free survival as the primary endpoint.
In part A nine of 37 patients responded (24 percent), including two complete responses, with few grade 3 events and no serious adverse events, which established PD-1 blockade as an option after chemotherapy. In part B 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 similar (17.4 against 21.5 percent), and grade 3 or worse treatment-related adverse events doubled with ipilimumab (25 against 12 percent). The corpus's metastatic anal cancer page cites NCI9673 for nivolumab after chemotherapy.
Numbers are from the trial as recorded here; see the source links in the table below. This is orientation, not medical advice: ask your team how closely the trial population matches you.
143 enrolled.
95% CI 15 to 33; 2 complete and 7 partial responses
Source90% CI 2.0 to 5.6 · 90% CI 1.9 to 3.8
Source12 patients · 6 patients
Source| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Objective response rate, part Aprimary | Nivolumab | 37 | 24% | - | - | link |
| Progression-free survival, part Bprimary | Nivolumab + ipilimumab | - | 3.7 months | 0.86 (0.6 to 1.23) | 0.25 | link |
| Nivolumab | - | 2.9 months | ||||
| Objective response rate, part B | Nivolumab + ipilimumab | - | 21.5% | - | 0.89 | link |
| Nivolumab | - | 17.4% | ||||
| Overall survival, part B | Nivolumab + ipilimumab | - | 20 months | 0.98 | - | link |
| Nivolumab | - | 15.9 months | ||||
| Grade 3 or worse treatment-related adverse events, part B | Nivolumab + ipilimumab | - | 25% | - | - | link |
| Nivolumab | - | 12% |
Single-agent PD-1 blockade remains the immunotherapy standard after chemotherapy in metastatic anal cancer; CTLA-4 blockade adds toxicity without benefit.
PD-1 blockade is an option for metastatic anal cancer after chemotherapy, and the basis for later immunotherapy combinations in the disease.
Shares Metastatic and recurrent anal squamous cell carcinoma, Anal cancer (squamous cell carcinoma), Immune checkpoint inhibitors and the tag soc-trials.
Shares Metastatic and recurrent anal squamous cell carcinoma, Anal cancer (squamous cell carcinoma) and the tag soc-trials.
Shares MD Anderson Cancer Center and the tag soc-trials.
Shares Anal cancer (squamous cell carcinoma) and the tag soc-trials.
Shares MD Anderson Cancer Center and the tag soc-trials.
Shares Immune checkpoint inhibitors and the tag soc-trials.
Shares Immune checkpoint inhibitors and the tag soc-trials.
Shares MD Anderson Cancer Center, Ipilimumab, Nivolumab, Immune checkpoint inhibitors.