OncoMatch/Clinical Trials/NCT07447570
Iparomlimab and Tuvonralimab Plus Hypofractionated Radiotherapy and Chemotherapy for HAHNSCC
Is NCT07447570 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Iparomlimab and Tuvonralimab and Chemotherapy for head and neck cancer.
Treatment: Iparomlimab and Tuvonralimab · Chemotherapy — Head and neck squamous cell carcinoma (HNSCC) is often diagnosed at a locally advanced stage, where cisplatin-based chemoradiotherapy is standard but still results in high recurrence rates. Immunotherapy is promising for HNSCC due to its high mutational burden, and adding PD-1 inhibitors to induction chemotherapy has improved responses without added toxicity. Radiotherapy can further stimulate antitumor immunity. Iparomlimab and Tuvonralimab, a dual anti-PD-1/CTLA-4 antibody, has shown strong activity across several solid tumors, and early studies suggest synergy with hypofractionated radiotherapy. However, evidence in locally advanced HNSCC is lacking. The investigators therefore propose a multicenter, single-arm phase II trial to assess the efficacy and safety of combining Iparomlimab and Tuvonralimab injection with chemoradiotherapy in locoregionally advanced HNSCC.
Check if I qualifyExtracted eligibility criteria
Cancer type
Head and Neck Squamous Cell Carcinoma
Disease stage
Required: Stage III, IVB
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: chemotherapy
No prior systemic therapy for head and neck squamous cell carcinoma (including chemotherapy, EGFR monoclonal antibodies, anti-PD-1 or anti-PD-L1 antibodies, anti-CTLA-4 antibodies, or other immune checkpoint inhibitors)
Cannot have received: EGFR-targeted therapy
No prior systemic therapy for head and neck squamous cell carcinoma (including chemotherapy, EGFR monoclonal antibodies, anti-PD-1 or anti-PD-L1 antibodies, anti-CTLA-4 antibodies, or other immune checkpoint inhibitors)
Cannot have received: anti-PD-1 therapy
No prior systemic therapy for head and neck squamous cell carcinoma (including chemotherapy, EGFR monoclonal antibodies, anti-PD-1 or anti-PD-L1 antibodies, anti-CTLA-4 antibodies, or other immune checkpoint inhibitors)
Cannot have received: anti-PD-L1 therapy
No prior systemic therapy for head and neck squamous cell carcinoma (including chemotherapy, EGFR monoclonal antibodies, anti-PD-1 or anti-PD-L1 antibodies, anti-CTLA-4 antibodies, or other immune checkpoint inhibitors)
Cannot have received: anti-CTLA-4 therapy
No prior systemic therapy for head and neck squamous cell carcinoma (including chemotherapy, EGFR monoclonal antibodies, anti-PD-1 or anti-PD-L1 antibodies, anti-CTLA-4 antibodies, or other immune checkpoint inhibitors)
Cannot have received: immune checkpoint inhibitor
No prior systemic therapy for head and neck squamous cell carcinoma (including chemotherapy, EGFR monoclonal antibodies, anti-PD-1 or anti-PD-L1 antibodies, anti-CTLA-4 antibodies, or other immune checkpoint inhibitors)
Cannot have received: anti-PD-1 therapy
Previous treatment with anti-PD-1, anti-PD-L1, or anti-CTLA-4 antibodies
Cannot have received: anti-PD-L1 therapy
Previous treatment with anti-PD-1, anti-PD-L1, or anti-CTLA-4 antibodies
Cannot have received: anti-CTLA-4 therapy
Previous treatment with anti-PD-1, anti-PD-L1, or anti-CTLA-4 antibodies
Lab requirements
Blood counts
ANC ≥1.5 × 10⁹/L or within normal range; platelet count ≥100 × 10⁹/L; hemoglobin ≥90 g/L.
Kidney function
Serum creatinine ≤1.5 × ULN, or creatinine clearance (CCR) ≥60 mL/min; urine dipstick protein <2+. For subjects with baseline ≥2+ proteinuria, a 24-hour urine test must show <1 g of protein.
Liver function
Total bilirubin ≤1.5 × ULN; for Gilbert's syndrome, TBIL ≤3 × ULN; AST and ALT ≤2.5 × ULN in patients without liver metastasis, or ≤5 × ULN in those with liver metastasis; albumin ≥28 g/L.
Adequate bone marrow and organ function (without receiving any cellular products, blood components, colony-stimulating factors, or cytokine therapy within 14 days prior to laboratory testing): Hematology: ANC ≥1.5 × 10⁹/L or within normal range; platelet count ≥100 × 10⁹/L; hemoglobin ≥90 g/L. Liver function: Total bilirubin ≤1.5 × ULN; for Gilbert's syndrome, TBIL ≤3 × ULN; AST and ALT ≤2.5 × ULN in patients without liver metastasis, or ≤5 × ULN in those with liver metastasis; albumin ≥28 g/L. Renal function: Serum creatinine ≤1.5 × ULN, or creatinine clearance (CCR) ≥60 mL/min; urine dipstick protein <2+. For subjects with baseline ≥2+ proteinuria, a 24-hour urine test must show <1 g of protein. Coagulation: INR ≤1.5; APTT ≤1.5 × ULN.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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