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Bending the Curve Trial by Trial
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CheckMate 066

Study of Nivolumab (BMS-936558) Compared With Dacarbazine in Untreated, Unresectable, or Metastatic Melanoma

Phase 3N = 418NCT01721772

Population
Previously untreated metastatic melanoma without a BRAF mutation
Design
Double-blind randomised phase 3 trial of nivolumab 3 mg per kilogram every 2 weeks with dacarbazine-matched placebo versus dacarbazine 1,000 mg per square metre every 3 weeks with nivolumab-matched placebo. Primary end point overall survival.
Primary endpoint
OS
Arms
  • Nivolumab (experimental): Nivolumab 3 mg per kilogram every 2 weeks plus dacarbazine-matched placebo every 3 weeks
  • Dacarbazine (control): Dacarbazine 1,000 mg per square metre every 3 weeks plus nivolumab-matched placebo every 2 weeks
People
Robert C, senior author Ascierto PA
OSHR 0.42Δ 12-month OS+30.8 pointsPFSHR 0.43 (95% CI 0.34–0.56)Δ median PFS+2.9 monthsΔ ORR+26.1 points
Show the numbers
Results reported for CheckMate 066
EndpointAnalysisNivolumabDacarbazineEffect
OSRandomised population as described in the abstract (analysis population not stated there)primaryRobert 201572.9% at 12 mo (65.5–78.9%)42.1% at 12 mo (33.0–50.9%)HR 0.42P<0.001Hazard ratio for death with a 99.79% confidence interval of 0.25 to 0.73, as published.
PFSRandomised population as described in the abstract (analysis population not stated there)primaryRobert 2015median 5.1 monthsmedian 2.2 monthsHR 0.43 (95% CI 0.34–0.56)P<0.001
ORRRandomised population as described in the abstract (analysis population not stated there)primaryRobert 201540% (33.3–47.0%)13.9% (9.5–19.4%)P<0.001Odds ratio 4.06.
Results reported for CheckMate 066
EndpointAnalysisNivolumabDacarbazineEffect
OSRandomised population as described in the abstract (analysis population not stated there)primaryRobert 201572.9% at 12 mo (65.5–78.9%)42.1% at 12 mo (33.0–50.9%)HR 0.42P<0.001Hazard ratio for death with a 99.79% confidence interval of 0.25 to 0.73, as published.
PFSRandomised population as described in the abstract (analysis population not stated there)primaryRobert 2015median 5.1 monthsmedian 2.2 monthsHR 0.43 (95% CI 0.34–0.56)P<0.001
ORRRandomised population as described in the abstract (analysis population not stated there)primaryRobert 201540% (33.3–47.0%)13.9% (9.5–19.4%)P<0.001Odds ratio 4.06.
Hazard ratio (95% CI) by endpoint. Values below 1 favour the experimental arm.
PFS0.512◀ experimentalcontrol ▶
Data table
EndpointHR95% CI
PFS0.430.34–0.56
Illustrative — modelled from reported values, not trial data. PFS, primary.
0%25%50%75%100%024681012Months (modelled)
  • Nivolumab (experimental)
  • Dacarbazine (control)

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

Data table (modelled values)
MonthsNivolumabDacarbazine
0100.0%100.0%
366.5%38.9%
644.2%15.1%
1025.7%4.3%
1317.1%1.7%
Primary publication: Robert C, Long GV, Brady B, Dutriaux C, Maio M, Mortier L, et al. Nivolumab in previously untreated melanoma without BRAF mutation. N Engl J Med. 2015;372(4):320-30. PubMedDOI

Appears in

Sources

  1. Robert C, Long GV, Brady B, Dutriaux C, Maio M, Mortier L, et al. Nivolumab in previously untreated melanoma without BRAF mutation. N Engl J Med. 2015;372(4):320-30.

    PubMedDOI