NCT03406247

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

Adjuvant Immunotherapy After Salvage Surgery in Head and Neck Squamous Cell Carcinoma : Phase 2 Trial Evaluating the Efficacy and the Toxicity of Nivolumab Alone, and of the Combination Nivolumab and Ipilimumab

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 140 (estimated)
• Sponsor: Gustave Roussy, Cancer Campus, Grand Paris · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Head and Neck Squamous Cell Carcinoma

Interventions

Type	Name	Description
DRUG	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 Patients in cohorts 2 and 2bis will be administered \- nivolumab 240 mg every 2 weeks during 6 months
DRUG	Ipilimumab	Patients in cohorts 2 and 2bis will be administered \- ipilimumab 1mg/kg IV every 6 weeks during 6 months

Timeline

• Start date: 2018-02-12
• Primary completion: 2027-11-01
• Completion: 2027-11-01
• First posted: 2018-01-23
• Last updated: 2025-05-08

Locations

1 site across 1 country: France