OncoMatch/Clinical Trials/NCT07090317
Iparomlimab and Tuvonralimab in HNSCC
Is NCT07090317 recruiting? Yes, currently enrolling (Jun 2026). This Phase 2 trial studies Iparomlimab and Tuvonralimab for recurrent/metastatic head and neck squamous cell carcinoma.
Treatment: Iparomlimab and Tuvonralimab — This 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.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Other
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)
Demographics
Prior therapy
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.
Frequently asked questions
Is NCT07090317 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior anti-ctla-4 therapy disqualifies patients from enrollment.
Does this trial require CD274?
Yes, CD274 any tested is a required biomarker for enrollment.
Does this trial require CDKN2A?
Yes, CDKN2A P16 detection status is a required biomarker for 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.
Check if I qualify