Treatment Options for Head and Neck Cancer

Overseen By BrUOG

Age: 65+

Sex: Any

Trial Phase: Phase 3

Sponsor: Brown University

Must be taking: Chemoimmunotherapy

Disqualifiers: Metastases, Uncontrolled illness, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 14 weeks

20 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Eligibility Criteria

This trial is for people aged 65 or older with stage IB-IVA squamous cell carcinoma of the head and neck. They must be somewhat frail (CGA score 3-5), able to undergo chemoimmunotherapy followed by radiation, have decent organ/marrow function, no severe autoimmune diseases, controlled HIV/HBV if present, cured HCV, and manageable cardiac risk (NYHA class ≤2B). Those who've had prior chemoimmunotherapy for this cancer or uncontrolled illnesses can't join.

Inclusion Criteria

CGA score of 3-5

Ability to understand and the willingness to sign a written informed consent document

My cancer is a confirmed squamous cell carcinoma of the head or neck.

Exclusion Criteria

Patients with uncontrolled intercurrent illness

I have had chemoimmunotherapy for head/neck cancer.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Comprehensive Geriatric Assessment

Participants undergo a comprehensive geriatric assessment as part of standard assessments

1 week

Treatment

Participants receive a novel reduced intensity regimen tailored based on PD-L1 CPS, involving 4 cycles of systemic chemotherapy and/or immunotherapy followed by radiation treatment

14 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 weeks

Long-term Follow-up

Participants are assessed for disease-free survival and overall survival

3 years

Treatment Details

Interventions

• Carboplatin
• Cetuximab
• Paclitaxel
• Pembrolizumab

Trial Overview The study tests a reduced intensity treatment tailored based on PD-L1 CPS in elderly patients classified as frail. It includes systemic chemotherapy with Carboplatin and Paclitaxel plus immunotherapy agents Pembrolizumab or Cetuximab in different combinations (Arm I: all three drugs; Arm II: chemo + Cetuximab; Arm III: only Pembrolizumab), followed by radiation therapy.

Participant Groups

Group I: Arm III PD-L1 CPS > or = 20% Experimental Treatment 1 Intervention

Group II: Arm II PD-L1 CPS 0 Experimental Treatment 1 Intervention

Group III: Arm I PD-L1 CPS 1-19 % Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Brown University

Lead Sponsor

Trials

480

Recruited

724,000+

Rhode Island Hospital

Collaborator

Trials

275

Recruited

71,400+

The Miriam Hospital

Collaborator

Trials

252

Recruited

39,200+