OncoMatch/Clinical Trials/NCT06998069
Head and Neck Cancer Study Project in the Geriatric Population
Is NCT06998069 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies multiple treatments including Arm I Carboplatin, Paclitaxel, Pembrolizumab and Arm II Carboplatin, Paclitaxel, Cetuximab for head and neck neoplasms.
Treatment: Arm I Carboplatin, Paclitaxel, Pembrolizumab · Arm II Carboplatin, Paclitaxel, Cetuximab · Arm III Pembrolizumab — This is a study conducted in patients with a diagnosis of stage IB-IVA squamous cell carcinoma of the head and neck. Patients will have a comprehensive geriatric assessment (CGA) as part of standard assessments. The patients classified as frail, with a CGA score of 3-5, will then be treated with a novel reduced intensity regimen. The regimen will be tailored based on the programmed cell death ligand 1 combined positive score (PD-L1 CPS) and will involve 4 cycles of systemic chemotherapy and/or immunotherapy followed by radiation treatment.
Check if I qualifyExtracted eligibility criteria
Cancer type
Head and Neck Squamous Cell Carcinoma
Disease stage
Required: Stage IB, II, III, IVA
Confirmed stage of disease between IB and IVA, based on imaging studies.
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Cannot have received: systemic chemoimmunotherapy
Patients who have previously received systemic chemoimmunotherapy for H/N cancer.
Lab requirements
Blood counts
Absolute neutrophil count ≥1.0 x 10^9/L; Platelets >100,000/mm3
Kidney function
Creatinine clearance ≥ 40 mL/min (Cockcroft Gault) or <1.5 x ULN
Liver function
Total bilirubin <1.5 x ULN; AST/SGOT <3 x ULN; ALT/SGPT <3 x ULN
Cardiac function
NYHA class 2B or better if cardiac history or risk
Adequate organ and marrow function as defined below: Absolute neutrophil count ≥1.0 x 10^9/L Platelets >100,000/mm3 Total bilirubin <1.5 x ULN Aspartate aminotransferase (ast/sgot) <3 x ULN Alanine aminotransferase (alt/sgpt) <3 x ULN Creatinine clearance ≥ 40 mL/min as determined by Cockcroft Gault (using actual body weight) or <1.5 x Upper limit of normal 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. To be eligible for this trial, patients should be class 2B or better.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Rhode Island and The Miriam Hospitals · Providence, Rhode Island
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