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OncoMatch/Clinical Trials/NCT07090317

Iparomlimab and Tuvonralimab in HNSCC

Is NCT07090317 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Iparomlimab and Tuvonralimab for recurrent/metastatic head and neck squamous cell carcinoma.

Phase 2RecruitingShanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong UniversityNCT07090317Data as of May 2026

Treatment: Iparomlimab and TuvonralimabThis study is a single center, non-randomized, prospective phase II clinical trial to evaluate the efficacy and safety of Iparomlimab and Tuvonralimab in patients with with recurrent/metastatic head and neck squamous cell carcinoma failed second-line treatment. The participants would receive cetuximab combined with Iparomlimab and Tuvonralimab until termination criteria are met.

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Extracted eligibility criteria

Cancer type

Head and Neck Squamous Cell Carcinoma

Biomarker criteria

Required: PD-L1 (CD274) any tested (testing required; no eligibility threshold specified)

Availability of tumor tissue for PD-L1 detection (paraffin-embedded specimens within 2 years or fresh tumor tissue)

Required: CDKN2A P16 detection status (testing required; no eligibility threshold specified)

For patients with oropharyngeal cancer, the P16 detection status, determined by IHC method

Disease stage

Metastatic disease required

Performance status

ECOG 0–1(Restricted strenuous activity)

Prior therapy

Min 2 prior lines

Cannot have received: anti-ctla-4 therapy

Lab requirements

Blood counts

hemoglobin ≥ 100g/l, white blood cell count ≥ 4.0×10^9/l or neutrophil count ≥ 2.0×10^9/l, and platelet count ≥ 100×10^9/l without blood transfusion or colony-stimulating factor support

Kidney function

serum creatinine level < 1.5 times the upper limit of normal or creatinine clearance rate ≥ 60ml/min, and blood urea nitrogen ≤ 200mg/l; urinary protein < +; if urinary protein is +, the 24-hour total protein must be < 500mg

Liver function

serum total bilirubin level ≤ 1.5 times the upper limit of normal, aspartate transaminase (ast) and alanine transaminase (alt) ≤ 1.5 times the upper limit of normal

Cardiac function

no myocardial infarction within 1 year; no unstable angina; no symptomatic severe arrhythmia; no cardiac insufficiency

Structured fields extracted by AI. May contain errors — verify against the official protocol.

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