Study of Nivolumab in Combination With Ipilimumab Compared to the Standard of Care (Extreme Regimen) as First Line Treatment in Patients With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck
Summary
The main purpose of this study is to compare nivolumab and ipilimumab with the extreme regimen as first line treatment in patients with recurrent or metastatic squamous cell of the head and neck cancer
Timeline
- Start
- 2016-10-05
- Primary completion
- 2021-05-10
- Completion
- 2022-09-22
Outcome
Mixed primary results
registry MEDIAN Nivolumab + Ipilimumab: 17.58 (13.77 to 21.98) Months NCT02741570 ↗
registry analysis (superiority test); Nivolumab + Ipilimumab vs EXTREME Regimen; p = 0.0469; Hazard Ratio (HR) 0.78 (97.51% CI 0.59 to 1.03); Log Rank NCT02741570 ↗
registry MEDIAN Nivolumab + Ipilimumab: 13.90 (12.12 to 15.77) Months NCT02741570 ↗
registry analysis (superiority test); Nivolumab + Ipilimumab vs EXTREME Regimen; p = 0.4951; Cox Proportional Hazard 0.95 (97.9% CI 0.80 to 1.13); Log Rank NCT02741570 ↗
Publications
- Haddad RI, Harrington K, Tahara M, Ferris RL, Gillison M, Fayette J, Daste A, Koralewski P, Zurawski B, Taberna M, Saba NF, Mak M, Kawecki A, Girotto G, Alvarez Avitia MA, Even C, Toledo JGR, Guminski A, Muller-Richter U, Kiyota N, Roberts M, Khan TA, Miller-Moslin K, Wei L, Argiris A. Nivolumab Plus Ipilimumab Versus EXTREME Regimen as First-Line Treatment for Recurrent/Metastatic Squamous Cell Carcinoma of the Head and Neck: The Final Results of CheckMate 651. J Clin Oncol. 2023 Apr 20;41(12):2166-2180. doi: 10.1200/JCO.22.00332. Epub 2022 Dec 6.
- Hwang M, Seiwert TY. Are taxanes the future for head and neck cancer? Pragmatism in the immunotherapy era. Lancet Oncol. 2021 Apr;22(4):413-415. doi: 10.1016/S1470-2045(21)00121-2. Epub 2021 Mar 5. No abstract available.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Carboplatin | Small molecule | — | — |
| Comparator | Cetuximab | Monoclonal antibody | — | — |
| Comparator | Cisplatin | Other / unclassified | — | — |
| Subject | Ipilimumab | Monoclonal antibody | — | — |
| Subject | Nivolumab | Monoclonal antibody | — | — |
| Comparator | fluorouracil | Small molecule | — | — |