Status:
NOT_YET_RECRUITING
Testing the Addition of Chemotherapy or Chemo-Immunotherapy to the Usual Surgery for Advanced Head and Neck Cancer
Lead Sponsor:
National Cancer Institute (NCI)
Conditions:
Clinical Stage II HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8
Clinical Stage III HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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 pos...
Detailed Description
PRIMARY OBJECTIVE: I. To assess and compare investigator-assessed event-free survival (EFS) of patients treated with chemotherapy (carboplatin + paclitaxel) or chemo-immunotherapy (carboplatin + pacl...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Pathologically (histologically or cytologically) proven diagnosis of locally recurrent or persistent squamous cell carcinoma of head and neck (SCCHN) arising within the oral cavity, oropharynx, larynx, or hypopharynx
- PD-L1 combined positive score (CPS) ≥ 1 using a Clinical Laboratory Improvement Amendments (CLIA) certified laboratory
- Verify insurance (or other payment) coverage for neoadjuvant chemotherapy
- Measurable Disease as defined by RECIST 1.1
- Patients must have locally recurrent or persistent SCCHN arising within the oral cavity, oropharynx, larynx, or hypopharynx (American Joint Committee on Cancer \[AJCC\] Cancer Staging Manual, 8th Edition) AND are deemed candidates for salvage surgery:
- 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.
- Patients must be deemed surgically resectable without gross residual disease.
- For patients with oral cavity SCCHN, only those with recurrent or persistent disease after prior surgery are eligible.
- Patients who are candidates for salvage laryngectomy to treat recurrent laryngeal cancer and who are having salvage surgery for curative intent are eligible.
- Patients with resectable lymph node-only recurrence are eligible.
- No major vascular involvement (\> 180° involvement of the common carotid or internal carotid artery), jugular foramen involvement, or prevertebral, paraspinous muscle involvement precluding a curative resection
- No evidence of distant metastatic disease
- The following minimum diagnostic workup is required:
- General history and physical examination.
- Diagnostic-quality neck CT and PET/CT of neck (PET with attenuation-correction CT of neck, chest, and abdomen)
- Age ≥ 18
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
- Negative urine or serum pregnancy test (in persons of childbearing potential) within 30 days prior to registration. Childbearing potential is defined as any person who has experienced menarche and who has not undergone surgical sterilization (hysterectomy or bilateral oophorectomy) or who is not postmenopausal
- Absolute neutrophil count (ANC) ≥ 1,500 cells/mm\^3
- Platelets ≥ 100,000 cells/mm\^3
- Hemoglobin ≥ 8.0 g/dL (Note: The use of transfusion or other intervention to achieve hemoglobin \[Hgb\] ≥ 8.0 g/dL is acceptable)
- Adequate renal function defined as creatinine clearance (CrCL) \> 50 mL/min by the Cockcroft-Gault formula
- Total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN) (Not applicable to patients with known Gilbert's syndrome)
- Aspartate aminotransferase (AST)(serum glutamic oxaloacetic transaminase \[SGOT\]) and alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase \[SGPT\]) ≤ 3 x institutional ULN
- 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
- No prior systemic therapy or immunotherapy for treatment of recurrent or metastatic SCCHN.
- Note: Patients who have completed immunotherapy within the definitive setting (neo-adjuvant, or adjuvant) at least 4 months prior to registration are eligible
- No investigational anti-cancer agents received within 4 weeks prior to registration
- No New York Heart Association Functional Classification III or IV (Note: Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification)
- No active infection requiring IV antibiotics, IV antiviral, or IV antifungal treatments
- No peripheral neuropathy grade 3 or 4
- No history of allergic reaction to the study agent, compounds of similar chemical or biologic composition to the study agent, and immune checkpoint inhibitors (or any of its excipients)
Exclusion
Key Trial Info
Start Date :
February 12 2026
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2033
Estimated Enrollment :
180 Patients enrolled
Trial Details
Trial ID
NCT07195734
Start Date
February 12 2026
End Date
February 1 2033
Last Update
January 9 2026
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