OncoMatch/Clinical Trials/NCT03406247
Adjuvant Immunotherapy After Salvage Surgery in Head and Neck Squamous Cell Carcinoma
Is NCT03406247 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Nivolumab and Ipilimumab for head and neck squamous cell carcinoma.
Treatment: Nivolumab · Ipilimumab — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Head and Neck Squamous Cell Carcinoma
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: radiation therapy — prior
Recurrence or second primary of HNSCC in a previously irradiated area at a dose ≥ 50 Gys
Must have received: salvage surgery — prior
Patient who has received salvage surgery with curative intent and macroscopic complete resection
Cannot have received: anti-PD-1 therapy
Patients having received prior therapy with anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-CTLA-4 antibody (or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways)
Cannot have received: anti-PD-L1 therapy
Patients having received prior therapy with anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-CTLA-4 antibody (or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways)
Cannot have received: anti-PD-L2 therapy
Patients having received prior therapy with anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-CTLA-4 antibody (or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways)
Cannot have received: anti-CD137 therapy
Patients having received prior therapy with anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-CTLA-4 antibody (or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways)
Cannot have received: anti-CTLA-4 therapy
Patients having received prior therapy with anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-CTLA-4 antibody (or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways)
Lab requirements
Blood counts
wbc > 2,000/μl; polynuclear neutrophils >1.5 x 10^9/l; platelets > 75 x 10^9/l; hemoglobin > 8.0 g/dl
Kidney function
creatinine clearance > 40 ml/min (measured or calculated by cockroft and gault formula) or serum creatinine < 2.0 x uln
Liver function
alat/asat < 3.0 x uln; bilirubin < 1.5 x uln (except gilbert syndrome: < 3.0 mg/dl)
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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