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

A Randomized, Global, Open-label Study of Nivolumab in Combination With BMS-986205 vs Standard of Care EXTREME Regimen in First-line Recurrent/Metastatic Squamous Cell Carcinoma of Head and Neck

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.

Study Overview

• Status: Withdrawn
• Conditions: Head and Neck Cancer
• Intervention / Treatment: Biological: Nivolumab; Drug: BMS-986205; Biological: Cetuximab; Drug: Cisplatin; Drug: Carboplatin; Drug: Fluorouracil

• Study Type: Interventional
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15212-0000
      • Allegheny General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Nivolumab and BMS-986205; Nivolumab administered in combination with BMS-986205	Biological: Nivolumab; Specified dose on specified days; Other Names: BMS-936558; Opdivo; Drug: BMS-986205; Administered 100mg orally once daily for a maximum of 104 weeks
Active Comparator: EXTREME study regimen; Cetuximab + Cisplatin/Carboplatin + Fluorouracil	Biological: Cetuximab; 400 mg/m² intravenous administration once only, then 250 mg/m² weekly maintenance until disease progression, unacceptable toxicity, withdrawal of informed consent, or other reason; Drug: Cisplatin; Cisplatin (100 mg/m2) every 3 weeks (Up to 6 cycles); Drug: Carboplatin; Carboplatin (AUC of 5 mg per milliliter per minute) every 3 weeks (Up to 6 cycles); Drug: Fluorouracil; 1000 mg/m² per day for 4 days, every 3 weeks (Up to 6 cycles)

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Bristol-Myers Squibb

Publications and helpful links

Helpful Links

• BMS Clinical Trial Patient Recruiting

Study record dates

Study Major Dates

• Study Start (Actual): March 28, 2018
• Primary Completion (Actual): April 19, 2018
• Study Completion (Actual): April 19, 2018

Study Registration Dates

• First Submitted: December 22, 2017
• First Submitted That Met QC Criteria: December 22, 2017
• First Posted (Actual): December 29, 2017

Study Record Updates

• Last Update Posted (Actual): April 18, 2019
• Last Update Submitted That Met QC Criteria: April 16, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Carcinoma; Neoplasms, Glandular and Epithelial; Head and Neck Neoplasms; Neoplasms, Squamous Cell; Carcinoma, Squamous Cell; Squamous Cell Carcinoma of Head and Neck; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antimetabolites, Antineoplastic; Antimetabolites; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Antineoplastic Agents, Immunological; Immune Checkpoint Inhibitors; Carboplatin; Fluorouracil; Nivolumab; Cetuximab; Linrodostat
• Other Study ID Numbers: CA017-063; 2017-003059-46 (EudraCT Number)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No