drugset / Trial / NCT03406247

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

NCT03406247 ↗

Phase 2 Recruiting 140 enrolled Gustave Roussy, Cancer Campus, Grand Paris
Non-randomizedSequentialOpen-labelTreatment

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.

Timeline

Start
2018-02-12
Primary completion
2027-11
Completion
2027-11

Drugs

EvaluationDrugModalityDoseRoute
Subject Ipilimumab Monoclonal antibody 1 mg/kg Intravenous
Subject Nivolumab Monoclonal antibody 480 mg —