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 (CheckMate 714)

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 2

Conditions: Head and Neck Cancer

Treatments: Biological: Nivolumab; Biological: Ipilimumab; Other: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT02823574

CA209-714

2016-001645-64 (EudraCT Number)

Details and patient eligibility

About

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)

Enrollment: 425 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Confirmed squamous cell head and neck cancer
• Widespread (metastatic) disease, or returned after previous treatment (recurrent)
• Tumor sample must be available for analysis of PDL1 (Programmed death-ligand 1) and HPV [Human Papilloma Virus (oropharynx only)]
• Performance status ECOG 0-1 (Eastern Cooperative Oncology Group)

Exclusion criteria

• Previous treatment for metastatic or recurrent disease
• Cancer arising from one of the following primary sites: paranasal sinus, nasopharynx, salivary gland, skin
• Any non-squamous subtype
• Active autoimmune disease
• Positive test for hepatitis B, C or HIV (Human Immunodeficiency Virus) virus
• Previous treatment with checkpoint inhibitor drugs
• Active CNS metastases or carcinomatous meningitis

Other protocol-defined inclusion/exclusion criteria apply

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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425 participants in 2 patient groups

Nivolumab and Ipilimumab

Experimental group

Description:

Specified dose on specified days

Treatment:

Biological: Ipilimumab

Biological: Nivolumab

Nivolumab and Ipilimumab-placebo

Active Comparator group

Description:

Specified dose on specified days

Treatment:

Other: Placebo

Biological: Nivolumab