Head and Neck Cancer Study Project in the Geriatric Population

Phase 3

Not yet recruiting

• Conditions: Head and Neck Neoplasms
• Interventions: Drug: Arm II Carboplatin, Paclitaxel, Cetuximab; Drug: Arm I Carboplatin, Paclitaxel, Pembrolizumab; Drug: Arm III Pembrolizumab

• Registration Number: NCT06998069
• Lead Sponsor: Brown University

Brief Summary

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.

Detailed Description

See above summary.

Study Timeline

• Study First Submitted: 2025-05-07
• Study First Submitted QC: 2025-05-28
• Study First Posted: 2025-05-31
• Status Verified: 2025-06
• Last Update Submitted: 2025-06-14
• Last Update Posted: 2025-06-17
• Study Start: 2025-06-30
• Primary Completion: 2026-06-01
• Study Completion: 2027-06-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Patients must have the following
• Pathology confirmed squamous cell carcinoma of the head and neck (unknown primary is excluded).
• Confirmed stage of disease between IB and IVA, based on imaging studies.
• CGA score of 3-5
• Evaluation by medical oncology and radiation oncology.
• Patients in the experimental group must be eligible for systemic treatment with chemoimmunotherapy followed by radiation treatment as determined by the geriatric oncology team.
• Age ≥ 65 years.
• ECOG performance status ≤ 2
• Adequate organ and marrow function as defined below:

Absolute neutrophil count ≥1.0 x 109/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

Males:

CLcr (mL/min) = "[140 - age (years)] × weight (kg)" /"72 × serum creatinine (mg/dL)"

Females:

(CLcr (mL/min) = "[140 - age (years)] × weight (kg)" /"72 × serum creatinine (mg/dL)" × 0.85

• Patients receiving pembrolizumab must meet standard institutional criteria for immunotherapy including no history of severe autoimmune disease.
• Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial.
• For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated.
• Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load.
• Patients with metastases, including treated brain metastases, are not eligible for enrollment.
• Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial.
• 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.
• Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria

• Patients who have previously received systemic chemoimmunotherapy for H/N cancer.
• Patients with uncontrolled intercurrent illness.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm II PD-L1 CPS 0	Arm II Carboplatin, Paclitaxel, Cetuximab	-
Arm I PD-L1 CPS 1-19 %	Arm I Carboplatin, Paclitaxel, Pembrolizumab	-
Arm III PD-L1 CPS > or = 20%	Arm III Pembrolizumab	-

Primary Outcome Measures

Name	Time	Method
Treatment Completion	Approximately 14 weeks	Number of participants who complete 4 cycles of systemic therapy followed by one week of radiation therapy within 14 weeks from start of therapy

Secondary Outcome Measures

Name	Time	Method
Assessment of the Disease-Free Survival (DFS) and Overall Survival (OS).	Approximately 3 years	Number of participants who have no evidence of disease and/or who are alive
Assessment of the Overall Response Rate (ORR).	Approximately 12 weeks after completion of the treatment	Number of participants who achieve a complete or partial response rate per RECIST criteria
Toxicity Assessment	Approximately 30 days post treatment	Participants toxicity assessment (side effects) will be graded per the National Cancer Institute's (NCI) common terminology criteria for adverse events (CTCAE v5.0) reporting.

Trial Locations

Locations (1)

Rhode Island and The Miriam Hospitals; 🇺🇸 Providence, Rhode Island, United States