A Trial Evaluating the Addition of Nivolumab to Cisplatin-RT for Treatment of Cancers of the Head and Neck

Sponsor
Groupe Oncologie Radiotherapie Tete et Cou
Study ID
NCT03576417
Phase
PHASE3
Status
Active Not Recruiting

Conditions

  • Squamous Cell Carcinoma of Head and Neck

Eligibility Criteria

Sex
ALL
Age
18 Years - 74 Years
Healthy Volunteers
Not accepted

Interventions

  • Cisplatin — DRUG
    Intravenous
  • Nivolumab — DRUG
    Intravenous
  • RT — RADIATION
    IMRT 66 Gy / 6.5 weeks

Study Details

The purpose of this study is to determine the efficacy of nivolumab + cisplatin-RT relative to standard of care (SOC) cisplatin-RT alone, using the disease-free survival (DFS by investigator imaging assessment) as primary endpoint )

Key Dates

Start date
Oct 10, 2018
Status verified
May 2025
Primary completion
Aug 31, 2027
Completion
Sep 30, 2027

Study Design

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

Arms

  • Active Comparator: RT+ cisplatin
    100 mg/m2 of cisplatin on days 1, 22,43 of RT
  • Experimental: RT+ cisplatin + nivolumab
    * 240 mg of nivolumab 3 weeks before RT-Cisplatin * 360 mg of nivolumab on days 1, 22,43 of -RT-cisplatin * 480 mg of nivolumab for maintenance

Primary Outcome Measure

Disease free survival [ Time Frame: 3 years after the end of RT ]

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