Recruiting
Phase 3

Chemotherapy & Immunotherapy

Sponsor:

Brown University

Code:

NCT06998069

Conditions

Head and Neck Neoplasms

Eligibility Criteria

Sex: All

Age: 65+

Healthy Volunteers: Not accepted

Interventions

Arm I Carboplatin, Paclitaxel, Pembrolizumab

Arm II Carboplatin, Paclitaxel, Cetuximab

Arm III Pembrolizumab

Study Details

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.

Conditions

Head and Neck Neoplasms

Study ID

NCT06998069

Start date

Aug 27, 2025

Status verified date

Aug, 2026

Completion date

Jun 1, 2027

Anticipated

Primary completion date

Dec 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 65+

Healthy Volunteers: Not accepted

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

Enrollment

20 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

other: Arm I PD-L1 CPS 1-19 %

other: Arm II PD-L1 CPS 0

other: Arm III PD-L1 CPS > or = 20%

Interventions

Arm I Carboplatin, Paclitaxel, Pembrolizumab

Carboplatin, AUC 5, day 1 of each cycle, each cycle every 21 days for 4 cycles Paclitaxel, 175 mg/m2, day 1 of each cycle, each cycle every 21 days for 4 cycles Pembrolizumab, 200 mg, day 1 of each cycle, each cycle every 21 days for 4 cycles Radiation Therapy 30Gy 1 week

Arm II Carboplatin, Paclitaxel, Cetuximab

Carboplatin, AUC 5, day 1 of each cycle, each cycle every 21 days for 4 cycles Paclitaxel, 175 mg/m2, day 1 of each cycle, each cycle every 21 days for 4 cycles Cetuximab 400 mg/m2, day 1 of the first cycle and then 250 mg/m2 days 1, 8, 15 every 21 days for 4 cycles Radiation Therapy 30Gy 1 week

Arm III Pembrolizumab

Pembrolizumab, 200 mg, day 1 of each cycle, each cycle every 21 days for 4 cycles Radiation Therapy 30Gy 1 week

Primary outcome measure

  • Treatment Completion [ Time Frame: Approximately 14 weeks ]

Central Contacts and Locations

Central contacts

BrUOG

401-863-3000BrUOG@brown.edu

Locations

Rhode Island and The Miriam Hospitals

Recruiting

Providence, Rhode Island, United States, 02903/02906

Contacts

BrUOG

401-863-3000BrUOG@brown.edu

Principal Investigator:

Iole Ribizzi-Akhtar, MD

More Information

Sponsor

Brown University

Last update posted

Aug 20, 2026

Last verified

Aug, 2026

Keywords

  • Squamous cell carcinoma of the head and neck
  • Geriatric population

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-05. This information was provided to ClinicalTrials.gov by Brown University on 2026-08-20.