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

Head and Neck Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03386838
• Other study ID #: CA017-063
• Secondary ID: 2017-003059-46
• Status: Withdrawn
• Phase: Phase 3
• Start date: March 28, 2018
• Est. completion date: April 19, 2018

Study information

• Verified date: April 2019
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: April 19, 2018
• Est. primary completion date: April 19, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Squamous Cell
• Head and Neck Cancer
• Head and Neck Neoplasms
• Squamous Cell Carcinoma of Head and Neck

Intervention

Biological:
• Nivolumab
Specified dose on specified days

Drug:
• BMS-986205
Administered 100mg orally once daily for a maximum of 104 weeks

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)
• Carboplatin
Carboplatin (AUC of 5 mg per milliliter per minute) every 3 weeks (Up to 6 cycles)
• Fluorouracil
1000 mg/m² per day for 4 days, every 3 weeks (Up to 6 cycles)

Locations

Country	Name	City	State
United States	Allegheny General Hospital	Pittsburgh	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression-free survival (PFS) as determined by Blinded Independent Central Review (BICR) using RECIST 1.1		Approximately 2 years
Primary	Overall survival (OS)		Approximately 40 months
Primary	Objective response rate (ORR) determined by BICR using RECIST 1.1		Approximately 2 years
Secondary	Number of adverse events (AE)		Approximately 2 years
Secondary	Number of serious adverse events (SAE)		Approximately 2 years
Secondary	Time to meaningful symptomatic deterioration (TTSD)		Approximately 2 years

External Links

•   BMS Clinical Trial Patient Recruiting
•   FDA Safety Alerts and Recalls
•   Investigator Inquiry Form