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CheckMate 141

Nivolumab versus investigator's choice of single-agent systemic therapy in recurrent squamous-cell carcinoma of the head and neck progressing within 6 months of platinum-based chemotherapy

Phase 3N = 361NCT02105636

Population
Recurrent squamous-cell carcinoma of the head and neck with progression within 6 months after platinum-based chemotherapy
Design
Randomised, open-label phase 3 trial. 361 patients with recurrent squamous-cell carcinoma of the head and neck whose disease progressed within 6 months after platinum-based chemotherapy were assigned 2:1 to nivolumab 3 mg per kilogram every 2 weeks or standard single-agent therapy (methotrexate, docetaxel or cetuximab).
Primary endpoint
OS
Arms
  • Nivolumab (experimental): Nivolumab 3 mg per kilogram every 2 weeks
  • Investigator's choice (control): Single-agent methotrexate, docetaxel or cetuximab
People
Ferris RL, senior author Gillison ML
OSHR 0.7Δ median OS+2.4 monthsΔ 12-month OS+19.4 pointsPFSHR 0.89 (95% CI 0.70–1.13)Δ median PFS−0.3 monthsΔ 6-month PFS+9.8 points
Show the numbers
Results reported for CheckMate 141
EndpointAnalysisNivolumabInvestigator's choiceEffect
OSRandomised patients (N = 361)primaryFerris 2016median 7.5 months (5.5–9.1); 36% at 12 momedian 5.1 months (4–6); 16.6% at 12 moHR 0.7P=0.01Primary endpoint. The abstract reports the hazard ratio for death with a 97.73% CI of 0.51 to 0.96, so no ci95 is entered; the 1-year survival figures are described in the abstract as estimates.
PFSRandomised patients (N = 361)primaryFerris 2016median 2 months (1.9–2.1); 19.7% at 6 momedian 2.3 months (1.9–3.1); 9.9% at 6 moHR 0.89 (95% CI 0.70–1.13)P=0.32Additional (non-primary) endpoint.
ORRRandomised patients (N = 361)primaryFerris 201613.3%5.8%Additional (non-primary) endpoint; no p value in the abstract.
Results reported for CheckMate 141
EndpointAnalysisNivolumabInvestigator's choiceEffect
OSRandomised patients (N = 361)primaryFerris 2016median 7.5 months (5.5–9.1); 36% at 12 momedian 5.1 months (4–6); 16.6% at 12 moHR 0.7P=0.01Primary endpoint. The abstract reports the hazard ratio for death with a 97.73% CI of 0.51 to 0.96, so no ci95 is entered; the 1-year survival figures are described in the abstract as estimates.
PFSRandomised patients (N = 361)primaryFerris 2016median 2 months (1.9–2.1); 19.7% at 6 momedian 2.3 months (1.9–3.1); 9.9% at 6 moHR 0.89 (95% CI 0.70–1.13)P=0.32Additional (non-primary) endpoint.
ORRRandomised patients (N = 361)primaryFerris 201613.3%5.8%Additional (non-primary) endpoint; no p value in the abstract.
Hazard ratio (95% CI) by endpoint. Values below 1 favour the experimental arm.
PFS0.512◀ experimentalcontrol ▶
Data table
EndpointHR95% CI
PFS0.890.7–1.13
Illustrative — modelled from reported values, not trial data. OS, primary.
0%25%50%75%100%051015Months (modelled)
  • Nivolumab (experimental)
  • Investigator's choice (control)

Median-only curves assume a constant hazard (exponential) and fit plateaus, as seen with some immunotherapies, poorly.

Data table (modelled values)
MonthsNivolumabInvestigator's choice
0100.0%100.0%
563.0%50.7%
943.5%29.4%
1427.4%14.9%
1917.3%7.6%
Illustrative — modelled from reported values, not trial data. PFS, primary.
0%25%50%75%100%012345Months (modelled)
  • Nivolumab (experimental)
  • Investigator's choice (control)

Median-only curves assume a constant hazard (exponential) and fit plateaus, as seen with some immunotherapies, poorly.

Data table (modelled values)
MonthsNivolumabInvestigator's choice
0100.0%100.0%
170.7%74.0%
335.4%40.5%
425.0%30.0%
612.5%16.4%
Primary publication: Ferris RL, Blumenschein G Jr, Fayette J, Guigay J, Colevas AD, Licitra L, et al. Nivolumab for Recurrent Squamous-Cell Carcinoma of the Head and Neck. N Engl J Med. 2016;375(19):1856-1867. PubMedDOI

Appears in

Sources

  1. Ferris RL, Blumenschein G Jr, Fayette J, Guigay J, Colevas AD, Licitra L, et al. Nivolumab for Recurrent Squamous-Cell Carcinoma of the Head and Neck. N Engl J Med. 2016;375(19):1856-1867.

    PubMedDOI