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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NCT03386838 · Status: WITHDRAWN · Phase: PHASE3 · Type: INTERVENTIONAL

Last updated 2019-04-18

No results posted yet for this study

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

Interventions

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)

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)

Sponsors & Collaborators

Principal Investigators

  • Bristol-Myers Squibb · Bristol-Myers Squibb

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-03-28
Primary Completion
2018-04-19
Completion
2018-04-19
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03386838 on ClinicalTrials.gov