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

NCT03386838 | Withdrawn Phase 3 DMC FDA Drug

• 2 other identifiers: CA017-0632017-003059-46
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Head and Neck Cancer

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (3)

• 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

Study Arms (2)

Nivolumab and BMS-986205

EXPERIMENTAL

Nivolumab administered in combination with BMS-986205

Biological: Nivolumab; Drug: BMS-986205

EXTREME study regimen

ACTIVE COMPARATOR

Cetuximab + Cisplatin/Carboplatin + Fluorouracil

Biological: Cetuximab; Drug: Cisplatin; Drug: Carboplatin; Drug: Fluorouracil

Interventions

Nivolumab BIOLOGICAL

Specified dose on specified days

Also known as: Opdivo, BMS-936558

Nivolumab and BMS-986205

BMS-986205 DRUG

Administered 100mg orally once daily for a maximum of 104 weeks

Nivolumab and BMS-986205

Cetuximab BIOLOGICAL

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

EXTREME study regimen

Cisplatin DRUG

Cisplatin (100 mg/m2) every 3 weeks (Up to 6 cycles)

EXTREME study regimen

Carboplatin DRUG

Carboplatin (AUC of 5 mg per milliliter per minute) every 3 weeks (Up to 6 cycles)

EXTREME study regimen

Fluorouracil DRUG

1000 mg/m² per day for 4 days, every 3 weeks (Up to 6 cycles)

EXTREME study regimen

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (1)

Allegheny General Hospital

Pittsburgh, Pennsylvania, 15212-0000, United States

Location

Related Links

• BMS Clinical Trial Patient Recruiting
• Investigator Inquiry Form

MeSH Terms

Conditions

Head and Neck Neoplasms

Interventions

Nivolumab; linrodostat; Cetuximab; Cisplatin; Carboplatin; Fluorouracil

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Coordination Complexes; Organic Chemicals; Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 22, 2017
• First Posted: December 29, 2017
• Study Start: March 28, 2018
• Primary Completion: April 19, 2018
• Study Completion: April 19, 2018
• Last Updated: April 18, 2019

Record last verified: 2019-04

Locations

US (1)