OncoMatch/Clinical Trials/NCT07882888
Iparomlimab and Tuvonralimab With With Cetuximab in Resectable OSCC
Official title: A Prospective, Single-arm, Phase II Clinical Study of Iparomlimab and Tuvonralimab With Cetuximab in Patients With Locally Advanced Resectable Oral Squamous Cell Carcinoma
Is NCT07882888 recruiting? Yes, currently enrolling (Oct 2026). This Phase 2 trial studies iparomlimab and tuvonralimab combined with cetuximab for head and neck cancer.
Treatment: iparomlimab and tuvonralimab combined with cetuximab — This is a single-center, single-arm phase II clinical study designed to evaluate the efficacy and safety of Iparomlimab and Tuvonralimab combined with cetuximab in patients with locally advanced resectable oral squamous cell carcinoma. The treatment regimen for the experimental group is as follows: The recommended dose of epalorestivolimab is 5 mg/kg. Cetuximab is administered at an initial dose of 400 mg/m² followed by 250 mg/m² once weekly, or alternatively cetuximab 500 mg/m² once every 2 weeks, via intravenous infusion. Each treatment cycle lasts 21 days, with 3 cycles administered preoperatively. Patients will undergo surgical resection at 3 weeks ± 7 days after completion of neoadjuvant therapy, followed by concurrent radiotherapy or chemoradiotherapy at 6 weeks ± 2 weeks postoperatively. One clinical tumor imaging assessment will be performed preoperatively per RECIST v1.1 (Appendix 4). In addition, clinically required assessments including vital signs, physical examination, complete blood count, urinalysis, liver and renal function tests, serum electrolytes, thyroid function, electrocardiogram, ECOG performance status, and quality-of-life questionnaires will be completed on Day 1 of each treatment cycle (refer to the study flowchart for specific assessments at each visit). Subjects with hepatitis virus carriage will have viral load monitoring every 2 to 4 treatment cycles. If PD is assessed per RECIST v1.1 but the subject remains clinically stable or the investigator judges that continued treatment may still benefit the subject, reassessment may be performed 4 weeks later using irRECIST. Treatment may be continued if no progressive disease is identified on reassessment.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Targeted therapy
Cancer type
Head and Neck Squamous Cell Carcinoma
Biomarker criteria
Required: PD-L1 (CD274) expression (testing required; no eligibility threshold specified)
Disease stage
Required: Stage III, IVA
Excluded: Stage IVB, IVC
Performance status
ECOG 0–1(Restricted strenuous activity)
Demographics
Prior therapy
Cannot have received: anti-PD-1/PD-L1/PD-L2/CTLA-4 antibody or T-cell receptor agonist/antagonist
Prior treatment with anti-PD-1/PD-L1/PD-L2/CTLA-4 antibodies or agonist/antagonist agents targeting T-cell receptors (e.g., OX40, CD137)
Cannot have received: stem cell transplantation
Prior stem cell transplantation
Cannot have received: solid organ transplantation
solid organ transplantation
Lab requirements
Blood counts
absolute neutrophil count (ANC) ≥1.5×10⁹/L, platelets (PLT) ≥100×10⁹/L, hemoglobin (HB) ≥9 g/dL (no blood transfusion or component transfusion within 14 days before testing)
Kidney function
serum creatinine <1.5 × ULN, or creatinine clearance ≥60 mL/min; blood urea nitrogen ≤200 mg/L
Liver function
serum total bilirubin (TBIL) ≤1.5 × ULN; aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5 × ULN (AST and ALT ≤5 × ULN permitted in the presence of liver metastases)
Cardiac function
normal electrocardiogram (ECG) or ECG abnormalities of no clinical significance; left ventricular ejection fraction (LVEF) >50% on echocardiography
Adequate organ function assessed within 14 days prior to the first dose of study drug, defined as: Hematology: ANC ≥1.5×10⁹/L, PLT ≥100×10⁹/L, HB ≥9 g/dL (no blood transfusion or component transfusion within 14 days before testing); Hepatic: TBIL ≤1.5 × ULN; AST and ALT ≤2.5 × ULN (AST and ALT ≤5 × ULN permitted in the presence of liver metastases); Renal: serum creatinine <1.5 × ULN, or creatinine clearance ≥60 mL/min; blood urea nitrogen ≤200 mg/L; Cardiac: normal ECG or ECG abnormalities of no clinical significance; LVEF >50% on echocardiography
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Frequently asked questions
Is NCT07882888 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior anti-PD-1/PD-L1/PD-L2/CTLA-4 antibody or T-cell receptor agonist/antagonist, stem cell transplantation, solid organ transplantation disqualifies patients from enrollment.
Does this trial require CD274?
Yes, CD274 expression is a required biomarker for enrollment.
What disease stage is eligible?
Stage III or IVA is required.
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