An Immuno-therapy Study of Nivolumab in Combination With Experimental Medication BMS-986205 Compared to Standard of Care EXTREME Regimen in First-line Recurrent/Metastatic Squamous Cell Carcinoma of Head and Neck

Bristol-Myers Squibb (BMS)

Status and phase: Withdrawn; Phase 3

Conditions: Head and Neck Cancer

Treatments: Biological: Cetuximab; Drug: Carboplatin; Drug: BMS-986205; Drug: Cisplatin; Biological: Nivolumab; Drug: Fluorouracil

Study type: Interventional

Funder types: Industry

Identifiers

NCT03386838

2017-003059-46 (EudraCT Number)

CA017-063

Details and patient eligibility

About

This is a study of Nivolumab in combination with experimental medication BMS-986205 compared to the standard of care EXTREME regimen in head and neck cancer that has come back after initial treatment, or is widespread when first diagnosed.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

• Histologically confirmed squamous cell carcinoma of the head and neck (SCCHN), from any of the following primary sites only: oral cavity, oropharynx, hypopharynx, and larynx.
• Recurrent or metastatic disease that is not amenable to therapy with curative intent (surgery or radiation therapy with or without chemotherapy)
• No prior treatment with systemic anti-cancer therapy for SCCHN, unless protocol specified criteria are met
• ECOG Performance Status of 0-1
• Measurable disease by CT or MRI per RECIST 1.1 criteria

Exclusion Criteria:

• Women who are pregnant or breastfeeding
• Recurrent or metastatic carcinoma of the nasopharynx, squamous cell carcinoma of unknown primary, squamous cell carcinoma that originated from the skin and salivary gland or paranasal sinus, non-squamous histologies (eg, mucosal melanoma)
• Participants with untreated CNS metastases are excluded
• Participants with carcinomatous meningitis
• Prior malignancy active within the previous 3 years except for locally curable cancers that have been apparently cured, such as basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the prostate, cervix, or breast

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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0 participants in 2 patient groups

Nivolumab and BMS-986205

Experimental group

Description:

Nivolumab administered in combination with BMS-986205

Treatment:

Drug: BMS-986205

Biological: Nivolumab

EXTREME study regimen

Active Comparator group

Description:

Cetuximab + Cisplatin/Carboplatin + Fluorouracil

Treatment:

Drug: Carboplatin

Biological: Cetuximab

Drug: Fluorouracil

Drug: Cisplatin