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NCI9673

Needs review

Nivolumab for previously treated unresectable metastatic anal cancer (NCI9673): a multicentre, single-arm, phase 2 study

Phase 2N = 37NCT02314169

Population
Patients with treatment-refractory metastatic squamous cell carcinoma of the anal canal; 39 screened, 37 enrolled and given at least one dose.
Design
Single-arm, multicentre phase 2 trial at ten US academic centres (Part A of NCI9673). Nivolumab 3 mg/kg every 2 weeks in treatment-refractory metastatic squamous cell carcinoma of the anal canal. Primary endpoint: response per RECIST 1.1 in the intention-to-treat population. The study was ongoing at the data cutoff. The randomised Part B of the same registration is recorded separately.
Primary endpoint
ORR
Arms
  • Nivolumab (experimental, n = 37): Nivolumab 3 mg/kg every 2 weeks
People
Morris VK, senior author Eng C
Show the numbers
Results reported for NCI9673
EndpointAnalysisNivolumabControlEffect
ORRIntention-to-treat population (37 enrolled and treated)primaryMorris 201724% (15–33%)—Nine responders among 37: two complete and seven partial responses. The abstract and Results print the response rate as 24% with a 95% CI of 15-33%. The Methods state that 95% CIs around proportions were calculated with an exact binomial calculation, but an exact (Clopper-Pearson) 95% interval for 9 of 37 is about 12-41%, so the printed interval does not match the method described. No correction to the paper is listed in PubMed; the interval is recorded as published. 34 of the 37 were response-evaluable; the primary analysis is by intention to treat (37).
Results reported for NCI9673
EndpointAnalysisNivolumabControlEffect
ORRIntention-to-treat population (37 enrolled and treated)primaryMorris 201724% (15–33%)—Nine responders among 37: two complete and seven partial responses. The abstract and Results print the response rate as 24% with a 95% CI of 15-33%. The Methods state that 95% CIs around proportions were calculated with an exact binomial calculation, but an exact (Clopper-Pearson) 95% interval for 9 of 37 is about 12-41%, so the printed interval does not match the method described. No correction to the paper is listed in PubMed; the interval is recorded as published. 34 of the 37 were response-evaluable; the primary analysis is by intention to treat (37).
Primary publication: Morris VK, Salem ME, Nimeiri H, Iqbal S, Singh P, Ciombor K, et al. Nivolumab for previously treated unresectable metastatic anal cancer (NCI9673): a multicentre, single-arm, phase 2 study. Lancet Oncol. 2017;18(4):446-453. PubMedDOI

Appears in

Sources

  1. Morris VK, Salem ME, Nimeiri H, Iqbal S, Singh P, Ciombor K, et al. Nivolumab for previously treated unresectable metastatic anal cancer (NCI9673): a multicentre, single-arm, phase 2 study. Lancet Oncol. 2017;18(4):446-453.

    PubMedDOI