An Investigational Immuno-therapy Study of Nivolumab Combined With Ipilimumab Compared to Nivolumab by Itself After Complete Surgical Removal of Stage IIIb/c/d or Stage IV Melanoma
Summary
The purpose of this study is to determine whether an investigational immunotherapy Nivolumab, when combined with Ipilimumab, is more effective than Nivolumab by itself, in delaying the return of cancer in patients who have had a complete surgical removal of stage IIIb/c/d or stage IV Melanoma
Timeline
- Start
- 2017-04-11
- Primary completion
- 2020-06-12
- Completion
- 2021-02-02
Outcome
Missed primary endpoint
registry analysis (superiority test); Arm A: Nivo + Ipi vs Arm B: Nivo; Hazard Ratio (HR) 0.90 (95% CI 0.78 to 1.04) NCT03068455 ↗
registry analysis (superiority test); Arm A: Nivo + Ipi vs Arm B: Nivo; Hazard Ratio (HR) 0.92 (95% CI 0.75 to 1.14) NCT03068455 ↗
paper there was no significant difference between treatment groups for RFS in the all-randomly assigned patient population PMID 36162037 ↗
Publications
- Long GV, Tang H, Desai K, Wang S, Del Vecchio M, Larkin J, Ritchings C, Huang SP, Baden J, Balli D, Chang H, Fusaro G, Tenney D, Dolfi S, Weber J. Pretreatment and on-treatment ctDNA and tissue biomarkers predict recurrence in patients with stage IIIB-D/IV melanoma treated with adjuvant immunotherapy: CheckMate 915. J Immunother Cancer. 2025 Jul 11;13(7):e012034. doi: 10.1136/jitc-2025-012034.
- Weber JS, Schadendorf D, Del Vecchio M, Larkin J, Atkinson V, Schenker M, Pigozzo J, Gogas H, Dalle S, Meyer N, Ascierto PA, Sandhu S, Eigentler T, Gutzmer R, Hassel JC, Robert C, Carlino MS, Di Giacomo AM, Butler MO, Munoz-Couselo E, Brown MP, Rutkowski P, Haydon A, Grob JJ, Schachter J, Queirolo P, de la Cruz-Merino L, van der Westhuizen A, Menzies AM, Re S, Bas T, de Pril V, Braverman J, Tenney DJ, Tang H, Long GV. Adjuvant Therapy of Nivolumab Combined With Ipilimumab Versus Nivolumab Alone in Patients With Resected Stage IIIB-D or Stage IV Melanoma (CheckMate 915). J Clin Oncol. 2023 Jan 20;41(3):517-527. doi: 10.1200/JCO.22.00533. Epub 2022 Sep 26.
- Yoshino T, Oki E, Misumi T, Kotaka M, Manaka D, Eto T, Hasegawa J, Takagane A, Nakamura M, Kato T, Munemoto Y, Nakamura F, Bando H, Taniguchi H, Sakamoto Y, Shiozawa M, Nishi M, Horiuchi T, Yamagishi H, Sakamoto J, Mizushima T, Ohtsu A, Mori M. Final Analysis of 3 Versus 6 Months of Adjuvant Oxaliplatin and Fluoropyrimidine-Based Therapy in Patients With Stage III Colon Cancer: The Randomized Phase III ACHIEVE Trial. J Clin Oncol. 2022 Oct 10;40(29):3419-3429. doi: 10.1200/JCO.21.02628. Epub 2022 May 5.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Ipilimumab | Monoclonal antibody | 1 mg/kg | — |
| Subject | Nivolumab | Monoclonal antibody | 240 mg | — |
| Subject | Nivolumab | Monoclonal antibody | 480 mg | — |