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NCT03386838 Clinical Trial

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Clinical Trial Details — Status: Withdrawn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Status Withdrawn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
First received
Last updated
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
Health authority
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Status Withdrawn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

Study Design

Related Conditions & MeSH terms

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
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