Head and Neck Cancer Study Project in the Geriatric Population

NCT06998069 | Recruiting Phase 3 DMC FDA Drug

• 1 other identifier: BrUOG 435
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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

Keywords

Squamous cell carcinoma of the head and neck; Geriatric population

Outcome Measures

Primary Outcomes (1)

• Treatment Completion

  Number of participants who complete 4 cycles of systemic therapy followed by one week of radiation therapy within 14 weeks from start of therapy

  Approximately 14 weeks

Secondary Outcomes (3)

• Assessment of the Overall Response Rate (ORR).

  Approximately 12 weeks after completion of the treatment

• Assessment of the Disease-Free Survival (DFS) and Overall Survival (OS).

  Approximately 3 years

• Toxicity Assessment

  Approximately 30 days post treatment

Study Arms (3)

Arm I PD-L1 CPS 1-19 %

OTHER

Drug: Arm I Carboplatin, Paclitaxel, Pembrolizumab

Arm II PD-L1 CPS 0

OTHER

Drug: Arm II Carboplatin, Paclitaxel, Cetuximab

Arm III PD-L1 CPS > or = 20%

OTHER

Drug: Arm III Pembrolizumab

Interventions

Arm I Carboplatin, Paclitaxel, Pembrolizumab DRUG

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

Also known as: Radiation Therapy

Arm I PD-L1 CPS 1-19 %

Arm II Carboplatin, Paclitaxel, Cetuximab DRUG

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

Also known as: Radiation Therapy

Arm II PD-L1 CPS 0

Arm III Pembrolizumab DRUG

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

Also known as: Radiation Therapy

Arm III PD-L1 CPS > or = 20%

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• The Miriam Hospital: collaborator
• Rhode Island Hospital: collaborator
• Brown University: lead

Study Sites (1)

Rhode Island and The Miriam Hospitals

Providence, Rhode Island, 02903/02906, United States

RECRUITING

MeSH Terms

Conditions

Head and Neck Neoplasms; Squamous Cell Carcinoma of Head and Neck

Interventions

Paclitaxel; pembrolizumab; Radiotherapy; Cetuximab

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Therapeutics; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Central Study Contacts

BrUOG

CONTACT

401-863-3000; BrUOG@brown.edu

Iole Ribizzi-Akhtar, MD

CONTACT

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 7, 2025
• First Posted: May 31, 2025
• Study Start: August 27, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2027
• Last Updated: December 30, 2025

Record last verified: 2025-12

Locations

US (1)