OncoMatch/Clinical Trials/NCT07195734
Testing the Addition of Chemotherapy or Chemo-Immunotherapy to the Usual Surgery for Advanced Head and Neck Cancer
Is NCT07195734 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Cemiplimab and Carboplatin for clinical stage ii hpv-mediated (p16-positive) oropharyngeal carcinoma ajcc v8.
Treatment: Carboplatin · Cemiplimab · Cisplatin · Paclitaxel — This phase II trial tests the addition of chemotherapy, with carboplatin and paclitaxel, or chemo-immunotherapy, with carboplatin, paclitaxel and cemiplimab to standard salvage surgery followed by post operative radiation therapy and cisplatin for high risk patients, for the treatment of patients with PD-L1 positive head and neck squamous cell carcinoma that has come back and spread to nearby tissue or lymph nodes after a period of improvement (locally recurrent) or is persistent. Carboplatin is in a class of medications known as platinum-containing compounds. It works in a way similar to the anticancer drug cisplatin, but may be better tolerated than cisplatin. Carboplatin works by killing, stopping or slowing the growth of cancer cells. Paclitaxel is in a class of medications called antimicrotubule agents. It stops cancer cells from growing and dividing and may kill them. Immunotherapy with monoclonal antibodies, such as cemiplimab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Salvage surgery is surgery that takes place to remove tumor tissue after a failure of other treatment. High risk patients also receive radiation therapy uses high energy x-rays, particles, or radioactive seeds to kill cancer cells and shrink tumors. Cisplatin is in a class of medications known as platinum-containing compounds. It works by killing, stopping or slowing the growth of cancer cells. Adding chemotherapy or chemo-immunotherapy to standard salvage surgery may kill more tumor cells than salvage surgery alone in patients with PD-L1 positive locally recurrent or persistent head and neck squamous cell carcinoma.
Check if I qualifyExtracted eligibility criteria
Cancer type
Head and Neck Squamous Cell Carcinoma
Biomarker criteria
Required: PD-L1 (CD274) combined positive score (CPS) ≥ 1 (CPS ≥ 1)
PD-L1 combined positive score (CPS) ≥ 1 using a Clinical Laboratory Improvement Amendments (CLIA) certified laboratory
Allowed: CDKN2A p16 positive
P16 positive oropharynx patients with T2, T3, T4, N0, N1, N2
Disease stage
Required: Stage N2A, N2B, N2C, N3A (AJCC v8)
P16 positive oropharynx patients with T2, T3, T4, N0, N1, N2 and all other patients with T2, T3, T4a, N0, N1, N2a, N2b, N2c, N3a are eligible.
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: radiation therapy — definitive or post-operative
Only patients who received prior radiation therapy in the definitive or post-operative setting (limited to one course) are eligible. Prior radiation therapy must have been completed at least 6 months prior to registration with the majority of the index persistent/recurrent cancer volume (> 50%) irradiated to ≥ 40 Gy at the time
Cannot have received: systemic therapy for recurrent or metastatic SCCHN
Prior systemic therapy including immunotherapy for treatment of recurrent or metastatic SCCHN is not permitted
Cannot have received: investigational anti-cancer agents
No investigational anti-cancer agents received within 4 weeks prior to registration
Lab requirements
Blood counts
ANC ≥ 1,500 cells/mm^3; Platelets ≥ 100,000 cells/mm^3; Hemoglobin ≥ 8.0 g/dL (transfusion/intervention allowed to achieve this)
Kidney function
creatinine clearance (CrCL) > 50 mL/min by the Cockcroft-Gault formula
Liver function
Total bilirubin ≤ 1.5 x institutional ULN (not applicable to patients with known Gilbert's syndrome); AST and ALT ≤ 3 x institutional ULN
ANC ≥ 1,500 cells/mm^3; Platelets ≥ 100,000 cells/mm^3; Hemoglobin ≥ 8.0 g/dL; creatinine clearance (CrCL) > 50 mL/min; Total bilirubin ≤ 1.5 x institutional ULN; AST and ALT ≤ 3 x institutional ULN
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Sutter Medical Center Sacramento · Sacramento, California
- Methodist Jennie Edmundson Hospital · Council Bluffs, Iowa
- University of Kansas Cancer Center · Kansas City, Kansas
- University of Kansas Cancer Center-Overland Park · Overland Park, Kansas
- University of Kansas Hospital-Westwood Cancer Center · Westwood, Kansas
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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