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

Part of paid clinical trials in Pittsburgh, Pennsylvania.

Sponsor
Bristol-Myers Squibb
Study ID
NCT03386838
Phase
PHASE3
Status
Withdrawn

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Nivolumab — BIOLOGICAL
    Specified dose on specified days
  • BMS-986205 — DRUG
    Administered 100mg orally once daily for a maximum of 104 weeks
  • 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
  • Cisplatin — DRUG
    Cisplatin (100 mg/m2) every 3 weeks (Up to 6 cycles)
  • Carboplatin — DRUG
    Carboplatin (AUC of 5 mg per milliliter per minute) every 3 weeks (Up to 6 cycles)
  • Fluorouracil — DRUG
    1000 mg/m² per day for 4 days, every 3 weeks (Up to 6 cycles)

Study Details

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.

Key Dates

Start date
Mar 28, 2018
Status verified
Apr 2019
Primary completion
Apr 19, 2018
Completion
Apr 19, 2018

Study Design

Enrollment
0 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Nivolumab and BMS-986205
    Nivolumab administered in combination with BMS-986205
  • Active Comparator: EXTREME study regimen
    Cetuximab + Cisplatin/Carboplatin + Fluorouracil

Primary Outcome Measure

Progression-free survival (PFS) as determined by Blinded Independent Central Review (BICR) using RECIST 1.1 [ Time Frame: Approximately 2 years ]

Locations (1)

FacilityCityStateZIPSite coordinators
Allegheny General HospitalPittsburghPennsylvania15212-0000-

Find similar trials in Pittsburgh, PA

By condition
Head and neck cancer
By specialty
OncologyENT
By research site
Allegheny General Hospital· Pittsburgh, PA

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