Adjuvant Immunotherapy After Salvage Surgery in Head and Neck Squamous Cell Carcinoma

Sponsor
Gustave Roussy, Cancer Campus, Grand Paris
Study ID
NCT03406247
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

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

Interventions

  • Nivolumab — DRUG
    Patients in cohorts 1 and 1bis will be administered Nivolumab 240 mg every 2 weeks during 3 first months and then 480 mg every 4 weeks during 3 months Patients in cohorts 2 and 2bis will be administered \- nivolumab 240 mg every 2 weeks during 6 months
  • Ipilimumab — DRUG
    Patients in cohorts 2 and 2bis will be administered \- ipilimumab 1mg/kg IV every 6 weeks during 6 months

Study Details

Two randomized trials of reirradiation after salvage surgery have been conducted by the GETTEC and GORTEC collaborative groups, both members of the French HN Intergroup: The first trial compared reirradiation and a "wait and see attitude" and was published in 2008 \[1\]. The second trial compared two modalities of reirradiation. Our hypothesis is that adjuvant treatment with immunotherapy will lead to a DFS similar to that observed in previous trials of post-operative reirradiation with possibly lower toxicity.

Key Dates

Start date
Feb 12, 2018
Status verified
May 2025
Primary completion
Nov 30, 2027
Completion
Nov 30, 2027

Study Design

Enrollment
140 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Nivolumab
    Patients in cohorts 1 and 1bis will be administered Nivolumab 240 mg every 2 weeks during 3 first months and then 480 mg every 4 weeks during 3 months
  • Experimental: Nivolumab + Ipilimumab
    Patients in cohorts 2 and 2bis will be administered * nivolumab 240 mg every 2 weeks during 6 months * ipilimumab 1mg/kg IV every 6 weeks during 6 months

Primary Outcome Measure

Two Years Disease Free Survival [ Time Frame: Two years ]

Central Contacts

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