OncoMatch/Clinical Trials/NCT03406247
Adjuvant Immunotherapy After Salvage Surgery in Head and Neck Squamous Cell Carcinoma
Is NCT03406247 recruiting? Yes, currently enrolling (Jun 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
Treatments studied
Immunotherapy
Cancer type
Head and Neck Squamous Cell Carcinoma
Performance status
ECOG 0–1(Restricted strenuous activity)
Demographics
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.
Frequently asked questions
Is NCT03406247 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior anti-PD-1 therapy, anti-PD-L1 therapy, anti-PD-L2 therapy disqualifies patients from enrollment.
Is there an age limit?
Yes. Patients must be 75 years or younger.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
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