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 (Sep 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
Treatments studied
Immunotherapy
Chemotherapy
Cancer type
Head and Neck Squamous Cell Carcinoma
Biomarker criteria
Required: PD-L1 (CD274) expression (cps ≥ 1)
Required: CDKN2A expression (p16 positive)
Disease stage
Required: Stage N2A, N2B, N2C, N3A
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: radiation therapy — definitive or post-operative
Cannot have received: systemic therapy for recurrent or metastatic scchn
Lab requirements
Blood counts
anc ≥ 1,500 cells/mm^3; platelets ≥ 100,000 cells/mm^3; hemoglobin ≥ 8.0 g/dl (transfusion or other intervention to achieve hgb ≥ 8.0 g/dl is acceptable)
Kidney function
creatinine clearance (crcl) > 50 ml/min by the cockcroft-gault formula
Liver function
total bilirubin ≤ 1.5 x institutional upper limit of normal (uln) (not applicable to patients with known gilbert's syndrome); ast and alt ≤ 3 x institutional uln
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Banner University Medical Center - Tucson · Tucson, Arizona
- University of Arizona Cancer Center-North Campus · Tucson, Arizona
- USC / Norris Comprehensive Cancer Center · Los Angeles, California
- Sutter Medical Center Sacramento · Sacramento, California
- University of California Davis Comprehensive Cancer Center · Sacramento, California
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT07195734 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior systemic therapy for recurrent or metastatic scchn disqualifies patients from enrollment.
Does this trial require CD274?
Yes, CD274 expression is a required biomarker for enrollment.
Does this trial require CDKN2A?
Yes, CDKN2A expression is a required biomarker for enrollment.
What disease stage is eligible?
Stage N2A or N2B or N2C or N3A is required.
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