drugset / Trial / NCT03406247
Adjuvant Immunotherapy After Salvage Surgery in Head and Neck Squamous Cell Carcinoma
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Ipilimumab | Monoclonal antibody | 1 mg/kg | Intravenous |
| Subject | Nivolumab | Monoclonal antibody | 480 mg | — |