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CheckMate 204

An Investigational Immuno-therapy Study to Evaluate Safety and Effectiveness in Patients With Melanoma That Has Spread to the Brain, Treated With Nivolumab in Combination With Ipilimumab, Followed by Nivolumab by Itself

Phase 2N = 94NCT02320058

Population
Metastatic melanoma with at least one measurable, nonirradiated brain metastasis (0.5 to 3 cm) and no neurologic symptoms; 94 patients analysed
Design
Open-label multicentre single-arm phase 2 study of nivolumab 1 mg per kilogram plus ipilimumab 3 mg per kilogram every 3 weeks for up to four doses, then nivolumab 3 mg per kilogram every 2 weeks until progression or unacceptable toxic effects. Primary end point intracranial clinical benefit: stable disease for at least 6 months, complete response or partial response. The registry record lists 119 enrolled; the paper analysed 94 patients with asymptomatic brain metastases, and the sources read do not explain the difference.
Primary endpoint
Intracranial clinical benefit rate
Arms
  • Nivolumab plus ipilimumab (experimental, n = 94): Nivolumab 1 mg per kilogram plus ipilimumab 3 mg per kilogram every 3 weeks for up to four doses, then nivolumab 3 mg per kilogram every 2 weeks
People
Tawbi HA, senior author Margolin K
Show the numbers
Results reported for CheckMate 204
EndpointAnalysisNivolumab plus ipilimumabControlEffect
Intracranial clinical benefit rate94 patients, median follow-up 14.0 monthsprimarymedian follow-up 14 monthsTawbi 201857% (47–68%)—Complete response in 26%, partial response in 30% and stable disease for at least 6 months in 2%. Extracranial clinical benefit 56% (95% CI 46 to 67). Grade 3 or 4 treatment-related adverse events in 55%; one patient died from immune-related myocarditis.
Results reported for CheckMate 204
EndpointAnalysisNivolumab plus ipilimumabControlEffect
Intracranial clinical benefit rate94 patients, median follow-up 14.0 monthsprimarymedian follow-up 14 monthsTawbi 201857% (47–68%)—Complete response in 26%, partial response in 30% and stable disease for at least 6 months in 2%. Extracranial clinical benefit 56% (95% CI 46 to 67). Grade 3 or 4 treatment-related adverse events in 55%; one patient died from immune-related myocarditis.
Primary publication: Tawbi HA, Forsyth PA, Algazi A, Hamid O, Hodi FS, Moschos SJ, et al. Combined Nivolumab and Ipilimumab in Melanoma Metastatic to the Brain. N Engl J Med. 2018;379(8):722-730. PubMedDOI

Appears in

Sources

  1. Tawbi HA, Forsyth PA, Algazi A, Hamid O, Hodi FS, Moschos SJ, et al. Combined Nivolumab and Ipilimumab in Melanoma Metastatic to the Brain. N Engl J Med. 2018;379(8):722-730.

    PubMedDOI