Testing Chemotherapy or Chemo-Immunotherapy for Head and Neck Cancer
This study is for people with head and neck squamous cell carcinoma that has returned locally or is persistent, and is PD-L1 positive. It's testing if adding chemotherapy (carboplatin and paclitaxel) or chemo-immunotherapy (carboplatin, paclitaxel, and cemiplimab) before standard surgery and radiation improves outcomes. The study aims to see if these additions can help prevent the cancer from coming back or spreading. You might be eligible if you have a specific type of head and neck cancer, are at least 18 years old, and your cancer tests positive for PD-L1. The study is currently unclear on its recruitment status and plans to enroll 180 participants. Success will be measured by how long participants live without the cancer returning or progressing.
- Study design
- This study is interventional and plans to enroll 180 participants. Participants will be randomly assigned to one of three groups: standard surgery, chemotherapy before surgery, or chemo-immunotherapy before surgery.
- What's involved
- Participants will undergo blood sample collection, CT scans, and receive intravenous (IV) medications like carboplatin, cemiplimab, or cisplatin depending on their assigned group. The study does not specify the frequency or duration of visits.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for up to 7 years to track event-free survival, which includes disease progression, recurrence, or death.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT07195734
Testing the Addition of Chemotherapy or Chemo-Immunotherapy to the Usual Surgery for Advanced Head and Neck Cancer
Recruiting
PHASE2Ages 18+InterventionalTreatmentNational Cancer Institute (NCI)Government-funded
~180 participants
Updated 2026-08-27 on ClinicalTrials.gov
What's tested:Biospecimen CollectionCarboplatinCemiplimabCisplatinComputed TomographyPaclitaxel
At a glance
Recruiting sites
107 of 108 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Event free survival (EFS)
Measured over From randomization to disease progression or treatment-related toxicities that precludes surgery, disease progression in the absence of surgery, disease recurrence after surgery, or death due to any cause, up to 7 years
Conditions
Where it's being run
108 sites across 22 statesPennsylvania20
Illinois16
Iowa9
Wisconsin9
Missouri8
Oregon8
New Jersey7
Michigan5
Study leadership
- Nabil F Saba · PRINCIPAL_INVESTIGATOR · NRG Oncology
Who to contact
Site Public Contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
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
Prior systemic therapy including immunotherapy with anti-PD1 or anti-PDL1 within the definitive setting (neo-adjuvant, or adjuvant) is permitted and must have been completed at least 4 months prior to registration
Prior systemic therapy including immunotherapy for treatment of recurrent or metastatic SCCHN is not permitted
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 interstitial lung disease
No active, noninfectious pneumonitis requiring immunosuppressive therapy
No history of a solid organ transplant (other than corneal transplant)
No active autoimmune disease that has required systemic treatment in the past 2 years (i.e., use of disease-modifying agents, corticosteroids \[\> 10 mg prednisone/day or equivalent\] or immunosuppressive drugs)
NOTE: Patients meeting the following criteria are not considered immunosuppressed and are eligible to enroll:
Patients who require a brief course of steroids (e.g., prophylaxis for imaging assessments due to hypersensitivity to contrast agents) are not excluded
Patients with type I diabetes mellitus, and endocrinopathies (including hypothyroidism due to autoimmune thyroiditis) only requiring hormone replacement, or skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll
Physiologic replacement doses ≤ 10 mg prednisone/day or equivalent are allowed. Inhaled or topical steroids are permitted
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)
What this trial measures
- Event free survival (EFS)From randomization to disease progression or treatment-related toxicities that precludes surgery, disease progression in the absence of surgery, disease recurrence after surgery, or death due to any cause, up to 7 years
Will be summarized by treatment arm using standard Kaplan-Meier methods, reporting the estimated 2-year EFS rate with corresponding 95% confidence intervals.