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

Phase 3

Withdrawn

• Conditions: Head and Neck Cancer
• Interventions: Biological: Nivolumab; Biological: Cetuximab; Drug: BMS-986205; Drug: Cisplatin; Drug: Carboplatin; Drug: Fluorouracil

• Registration Number: NCT03386838
• Lead Sponsor: Bristol-Myers Squibb

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-12-22
• Study First Submitted QC: 2017-12-22
• Study First Posted: 2017-12-29
• Study Start: 2018-03-28
• Primary Completion: 2018-04-19
• Study Completion: 2018-04-19
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-16
• Last Update Posted: 2019-04-18

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Nivolumab and BMS-986205	Nivolumab	Nivolumab administered in combination with BMS-986205
Nivolumab and BMS-986205	BMS-986205	Nivolumab administered in combination with BMS-986205
EXTREME study regimen	Cetuximab	Cetuximab + Cisplatin/Carboplatin + Fluorouracil
EXTREME study regimen	Carboplatin	Cetuximab + Cisplatin/Carboplatin + Fluorouracil
EXTREME study regimen	Fluorouracil	Cetuximab + Cisplatin/Carboplatin + Fluorouracil
EXTREME study regimen	Cisplatin	Cetuximab + Cisplatin/Carboplatin + Fluorouracil

Primary Outcome Measures

Name	Time	Method
Progression-free survival (PFS) as determined by Blinded Independent Central Review (BICR) using RECIST 1.1	Approximately 2 years
Overall survival (OS)	Approximately 40 months
Objective response rate (ORR) determined by BICR using RECIST 1.1	Approximately 2 years

Secondary Outcome Measures

Name	Time	Method
Number of adverse events (AE)	Approximately 2 years
Number of serious adverse events (SAE)	Approximately 2 years
Time to meaningful symptomatic deterioration (TTSD)	Approximately 2 years

Trial Locations

Locations (1)

Allegheny General Hospital; 🇺🇸 Pittsburgh, Pennsylvania, United States