Study of Nivolumab in Combination With Ipilimumab Versus Nivolumab in Combination With Ipilimumab Placebo in Patients With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck

Summary

A study in patients with metastatic or recurrent squamous cell cancer of the head and neck to evaluate the effectiveness of Nivolumab plus Ipilumumab vs. Nivolumab alone (CheckMate 714)

Timeline

Start

2016-11-08

Primary completion

2019-01-23

Completion

2022-04-21

Outcome

Missed primary endpoint

paper did not meet its primary end point of ORR benefit with first-line nivolumab plus ipilimumab vs nivolumab alone PMID 37022706 ↗

registry NUMBER Treatment A - Platinum Refractory Subgroup: 13.2 (8.4 to 19.5) percentage of participants NCT02823574 ↗

registry NUMBER Treatment B - Platinum Refractory Subgroup: 18.3 (10.6 to 28.4) percentage of participants NCT02823574 ↗

registry p = 0.2897; Odds Ratio (OR) 0.68 (95.5% CI 0.33 to 1.43) NCT02823574 ↗

Publications

• Harrington KJ, Ferris RL, Gillison M, Tahara M, Argiris A, Fayette J, Schenker M, Bratland A, Walker JWT, Grell P, Even C, Chung CH, Redman R, Coutte A, Salas S, Grant C, de Azevedo S, Soulieres D, Hansen AR, Wei L, Khan TA, Miller-Moslin K, Roberts M, Haddad R. Efficacy and Safety of Nivolumab Plus Ipilimumab vs Nivolumab Alone for Treatment of Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck: The Phase 2 CheckMate 714 Randomized Clinical Trial. JAMA Oncol. 2023 Jun 1;9(6):779-789. doi: 10.1001/jamaoncol.2023.0147.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Ipilimumab	Monoclonal antibody	1 mg/kg	Intravenous
Subject	Nivolumab	Monoclonal antibody	3 mg/kg	Intravenous

Indications