Head and Neck NeoplasmsPhase 3NCT06998069
Head and Neck Cancer Study Project in the Geriatric Population
A Phase 3 study testing Arm I Carboplatin, Paclitaxel, Pembrolizumab, Arm II Carboplatin, Paclitaxel, Cetuximab and Arm III Pembrolizumab in people with Head and Neck Neoplasms, run by Brown University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Head and Neck Neoplasms
- What is being tested?
- Arm I Carboplatin, Paclitaxel, Pembrolizumab, Arm II Carboplatin, Paclitaxel, Cetuximab and Arm III Pembrolizumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Aug 2025to 1 Jun 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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.
Show all 22Show fewer
- 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.
Who cannot join
- Patients who have previously received systemic chemoimmunotherapy for H/N cancer.
- Patients with uncontrolled intercurrent illness.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Iole Ribizzi-Akhtar, MD contact
United States1 site, 1 recruiting
- Recruiting
Rhode Island and The Miriam Hospitals
Providence, Rhode Island, 02903/02906
BrUOG, 401-863-3000, BrUOG@brown.edu
Iole Ribizzi-Akhtar, MD
About this study
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.
Read the detailed description
See above summary.
- Conditions
- Head and Neck Neoplasms
- Being tested
- Arm I Carboplatin, Paclitaxel, Pembrolizumab, Arm II Carboplatin, Paclitaxel, Cetuximab, Arm III Pembrolizumab
- Keywords
- Squamous cell carcinoma of the head and neck, Geriatric population
- Medical subject headings
- Head and Neck Neoplasms, Squamous Cell Carcinoma of Head and Neck
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Arm I Carboplatin, Paclitaxel, PembrolizumabDrug
Also called Radiation Therapy
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, CetuximabDrug
Also called Radiation Therapy
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 PembrolizumabDrug
Also called Radiation Therapy
Pembrolizumab, 200 mg, day 1 of each cycle, each cycle every 21 days for 4 cycles Radiation Therapy 30Gy 1 week
| Study group | Role | What they receive |
|---|---|---|
| Arm I PD-L1 CPS 1-19 % | Other | Not described Receives: Drug: Arm I Carboplatin, Paclitaxel, Pembrolizumab |
| Arm II PD-L1 CPS 0 | Other | Not described Receives: Drug: Arm II Carboplatin, Paclitaxel, Cetuximab |
| Arm III PD-L1 CPS > or = 20% | Other | Not described Receives: Drug: Arm III Pembrolizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Approximately 14 weeks
Secondary outcomes (3)
Assessment of the Overall Response Rate (ORR).
Number of participants who achieve a complete or partial response rate per RECIST criteria
Measured: Approximately 12 weeks after completion of the treatment
Assessment of the Disease-Free Survival (DFS) and Overall Survival (OS).
Number of participants who have no evidence of disease and/or who are alive
Measured: Approximately 3 years
Toxicity Assessment
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.
Measured: Approximately 30 days post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2025
- Study start27 Aug 2025
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Brown University
- Sponsor type
- University, hospital or other
- Collaborators
- The Miriam Hospital, Rhode Island Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06998069
- Sponsor's protocol ID
- BrUOG 435
- Status last verified
- Aug 2026
- First submitted
- 7 May 2025
- Last updated
- 20 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Head and Neck Cancer Study Project in the Geriatric Population
- ClinicalTrials.gov ID
- NCT06998069
- Acronym / sponsor ID
- BrUOG 435
- Conditions
- Head and Neck Neoplasms
- Keywords
- Squamous cell carcinoma of the head and neck, Geriatric population
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Brown UniversityUniversity, hospital or other
- Collaborators
- The Miriam Hospital, Rhode Island Hospital
- Study start
- 27 Aug 2025 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Jun 2027 (estimated)
- First posted
- 31 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (22 listed)
- 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.
Key exclusion criteria (2 listed)
- Patients who have previously received systemic chemoimmunotherapy for H/N cancer.
- Patients with uncontrolled intercurrent illness.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Arm I Carboplatin, Paclitaxel, PembrolizumabAlso: Radiation TherapyCarboplatin, 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 | Drug | Arm I PD-L1 CPS 1-19 % |
| Arm II Carboplatin, Paclitaxel, CetuximabAlso: Radiation TherapyCarboplatin, 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 | Drug | Arm II PD-L1 CPS 0 |
| Arm III PembrolizumabAlso: Radiation TherapyPembrolizumab, 200 mg, day 1 of each cycle, each cycle every 21 days for 4 cycles Radiation Therapy 30Gy 1 week | Drug | Arm III PD-L1 CPS > or = 20% |
Primary outcome
Treatment Completion
Time frame: 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
3 secondary outcomes
Assessment of the Overall Response Rate (ORR).
Time frame: Approximately 12 weeks after completion of the treatment
Assessment of the Disease-Free Survival (DFS) and Overall Survival (OS).
Time frame: Approximately 3 years
Toxicity Assessment
Time frame: Approximately 30 days post treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2026.
Related trials for Head and Neck Neoplasms
RecruitingPhase 2
Adebrelimab ±Induction Chemotherapy Followed by Concurrent Chemoradiotherapy for Unresectable Locally Advanced ESCC
Esophageal Squamous Cell Carcinoma, Immunotherapy
RecruitingPhase 1/2
Docetaxel and SX-682 in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma, Salivary Gland Carcinoma, and Advanced Prostate Cancer
Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma
RecruitingPhase 2
Testing the Addition of Chemotherapy or Chemo-Immunotherapy to the Usual Surgery for Advanced Head and Neck Cancer
Clinical Stage II HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8, Clinical Stage III HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8
RecruitingPhase 1
A Study of LY4257496 in Participants With Cancer (OMNIRAY)
Breast Neoplasms, Colorectal Neoplasms
Active, not recruitingPhase 3
Testing Immunotherapy Versus Observation in Patients With HPV Throat Cancer
Clinical Stage II HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8, Clinical Stage III HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Iole Ribizzi-Akhtar, MD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Arm I Carboplatin, Paclitaxel, Pembrolizumab, Arm II Carboplatin, Paclitaxel, Cetuximab and Arm III Pembrolizumab in people with Head and Neck Neoplasms, run by Brown University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 22 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact BrUOG (401-863-3000, BrUOG@brown.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment Completion (time frame: Approximately 14 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2026.