A randomized, open-label, phase 3 study of nivolumab in combination with ipilimumab vs extreme regimen (cetuximab + cisplatin/carboplatin + fluorouracil) as first-line therapy in patients with recurrent or metastatic squamous cell carcinoma of the head and neck-CheckMate 651

Background

Patients (pts) with recurrent/metastatic (R/M) SCCHN have a poor prognosis. Addition of cetuximab to platinum and 5-FU (Extreme regimen) improved overall survival (OS) vs platinum-fluorouracil alone as first-line (1L) treatment of pts with R/M SCCHN and is a widely accepted standard of care in this setting. However, treatment results remain disappointing with

Trial design

Pts aged ≥18 yr with histologically confirmed R/M SCCHN not amenable to curative therapy who have received no prior systemic therapy for their disease (except chemotherapy given as part of a multimodal treatment regimen that was completed 6 mo or more before enrollment) will be eligible. Approximately 490 pts will be randomized to receive nivo in combination with ipi or the Extreme regimen until progression or unacceptable toxicity. Primary endpoints are OS and progression-free survival. Secondary endpoints are objective response rate, time to symptomatic deterioration based on the 10-item Functional Assessment of Cancer Therapy-Head & Neck Symptom Index, and PD-L1 expression as a predictive biomarker for efficacy.

Clinical trial identification

NCT02741570

Legal entity responsible for the study

Sponsored by Bristol-Myers Squibb.

Funding

Sponsored by Bristol-Myers Squibb.

Disclosure

A. Argiris: Consultant for BMS. M. Gillison: Consultant and clinical trials contract to OSU with Bristol-Myers Squibb. Consultant for Merck Inc and Lilly. R.L. Ferris: Grant received from VentiRx, Bristol-Myers Squibb, and AZ/Medimmune. Member of ad-hoc advisory board for Merck, Celgene, Bristol-Myers Squibb, AZ/Medimmune. K. Harrington: Advisory Board member for BMS, Astra-Zeneca, Merck and Pfizer. T.K. Sanchez, C. Baudelet, W.J. Geese: Employee of Bristol-Myers Squibb. J. Shaw: Employee and shareholder of Bristol-Myers Squibb. R. Haddad: Grants and personal fees received from BMS during the conduct of the study. Grants received from Astra Zeneca, Celgene, and Venti-Rx. Received personal fees from Merck, Pfizer, Celgene, Eisai.