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 (CheckMate 651)

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 3

Conditions: Head and Neck Cancer

Treatments: Drug: Carboplatin/Paraplatin; Drug: Cisplatin/Platinol; Drug: Cetuximab/Erbitux; Drug: Fluorouracil/Adrucil; Biological: Nivolumab; Biological: Ipilimumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT02741570

CA209-651

2016-000725-39 (EudraCT Number)

Details and patient eligibility

About

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

Enrollment: 947 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Histologically confirmed metastatic or recurrent squamous cell carcinoma of the head and neck (oral cavity, oropharynx, hypopharynx & larynx) that is not amenable to curative therapy.
• No prior systemic cancer therapy for recurrent or metastatic disease (except if chemotherapy was part of multimodal treatment completed 6 months prior to enrolment).
• Measurable disease detected by imaging exam (CT or MRI).
• Have tumor tissue for PD L1 expression testing, and for oropharyngeal cancer have results from testing of HPV p16 status.

Exclusion criteria

• Metastatic or recurrent carcinoma of the nasopharynx, squamous cell carcinoma of unknown primary, squamous cell carcinoma originating from skin and salivary glands or non squamous histologies (eg. mucosal melanoma).
• No prior treatment with anti PD1, anti PD L1, anti CTLA 4 antibody or any other antibody or drugs targeting T cell costimulation or checkpoint pathways, or cetuximab or EGFR inhibitors in any treatment setting.
• Participants with certain diseases such as active autoimmune disease, type I diabetes, hypothyroidism that needs hormone replacement, active infection, psychiatric disorder.
• Inadequate hematologic, renal or hepatic function.

Other protocol defined inclusion/exclusion criteria could apply

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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947 participants in 2 patient groups

Nivolumab and Ipilimumab

Experimental group

Description:

Specified dose on specified days

Treatment:

Biological: Ipilimumab

Biological: Nivolumab

Extreme Regimen

Active Comparator group

Description:

Specified dose on specified days

Treatment:

Drug: Fluorouracil/Adrucil

Drug: Carboplatin/Paraplatin

Drug: Cetuximab/Erbitux

Drug: Cisplatin/Platinol