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Clinical Trial of Nivolumab (BMS-936558) Combined With Ipilimumab Followed by Nivolumab Monotherapy as First-Line Therapy of Subjects With Histologically Confirmed Stage III (Unresectable) or Stage IV Melanoma CheckMate 401: CHECKpoint Pathway and nivoluMAb Clinical Trial Evaluation 401

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Trial Profile

Clinical Trial of Nivolumab (BMS-936558) Combined With Ipilimumab Followed by Nivolumab Monotherapy as First-Line Therapy of Subjects With Histologically Confirmed Stage III (Unresectable) or Stage IV Melanoma CheckMate 401: CHECKpoint Pathway and nivoluMAb Clinical Trial Evaluation 401

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 20 Jun 2023

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At a glance

  • Drugs Ipilimumab (Primary) ; Nivolumab (Primary)
  • Indications Malignant melanoma; Uveal melanoma
  • Focus Adverse reactions; Registrational
  • Acronyms CheckMate 401
  • Sponsors Bristol-Myers Squibb

    • Most Recent Events

    • 12 Jun 2023 The maintenance phase dosing regimen was changed to nivolumab 240 mg once every 2 weeks because simulated population pharmacokinetic and exposure-response analyses predicted similar activity between nivolumab 240 mg and 3 mg/kg, as per results published in the Journal of Clinical Oncology.
    • 12 Jun 2023 Results assessing the paucity of data in patients with historically poor outcomes for nivolumab plus ipilimumab followed by nivolumab monotherapy in clinically diverse patient populations with advanced melanoma, published in the Journal of Clinical Oncology.
    • 14 Apr 2021 Status changed from active, no longer recruiting to completed.
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