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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests new treatment options for individuals with squamous cell carcinoma of the head and neck. Researchers aim to evaluate a reduced intensity treatment plan for those classified as frail, using a combination of chemotherapy (including drugs like Carboplatin and Paclitaxel), immunotherapy (such as Pembrolizumab), and radiation. Treatment adjusts based on PD-L1 CPS scores, tailoring therapy to each person's cancer. The trial seeks participants aged 65 and older with stage IB-IVA head and neck cancer who are identified as frail and can handle this specific treatment approach. As a Phase 3 trial, it represents the final step before FDA approval, offering participants a chance to contribute to potentially groundbreaking treatment advancements.

Do I need to stop my current medications to join the trial?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that the combination of pembrolizumab, carboplatin, and paclitaxel is generally well-tolerated, meaning most patients can manage the side effects. Common side effects include fatigue and nausea.

One study found that using pembrolizumab with carboplatin and paclitaxel was safe even for patients with extensive prior treatments, suggesting the treatment's safety for more vulnerable individuals.

The combination of carboplatin, paclitaxel, and cetuximab has also been studied, yielding similar safety results, with few serious side effects reported.

Overall, these treatments have been tested in various studies and are generally well-tolerated. However, discussing personal implications with a doctor is important. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these treatments for head and neck cancer because they combine cutting-edge immunotherapy and targeted therapies that show promise in enhancing patient outcomes. Pembrolizumab, a standout in this trial, is an immunotherapy drug that boosts the body's immune response to fight cancer cells, which is different from the traditional chemotherapy approach. Cetuximab, another treatment in the trial, targets the epidermal growth factor receptor (EGFR) on cancer cells, helping to slow down their growth in a more focused manner compared to standard chemotherapy. This combination of therapies could potentially offer more personalized treatment options with fewer side effects than traditional treatments like surgery and radiation.

What evidence suggests that this trial's treatments could be effective for head and neck cancer?

Research has shown that a combination of carboplatin, paclitaxel, and cetuximab effectively treats frail patients with head and neck cancer, with 43% of patients responding well. Some participants in this trial will receive this combination. Additionally, using pembrolizumab with carboplatin and paclitaxel has shown promising results, particularly for advanced cases. Studies have demonstrated a 49% response rate with this combination, with patients living without cancer progression for an average of 5.6 months and an overall survival time of 13.1 months. Depending on their specific treatment arm, participants in this trial may receive the pembrolizumab combination. These findings suggest that the treatments in this study have been effective in similar patient groups. ^{2 3 6 7 8}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9893993/

High Response Rate to Carboplatin-Paclitaxel-Cetuximab ... Carboplatin, paclitaxel, and CTX have been used on a weekly regimen with a good tolerance in frail patients and a 43% overall response rate [7].

2. ascopubs.org ascopubs.org/doi/10.1200/JCO.23.02625

Pembrolizumab Plus Carboplatin and Paclitaxel as First- ... Pembrolizumab plus carboplatin and paclitaxel showed promising antitumor activity and a manageable safety profile in first-line R/M HNSCC.

3. clinicaltrials.gov clinicaltrials.gov/study/NCT06725368

Carboplatin + Paclitaxel + Cetuximab (PCC) After Failure of ... The median progression-free survival was 4.9 months, and the overall survival was 9.4 months. Finally, in a study investigating the efficacy of ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S1053429625000098

Metastatic Head and Neck Cancer: Immunotherapy and ... KEYNOTE-B10 results showed similar efficacy with a response rate of 49% (95% CI 38.4-58.7), median PFS 5.6 months (95% CI 5.1-6.7), and OS 13.1 months (95% CI ...

5. asco.org asco.org/abstracts-presentations/ABSTRACT446782

Comparative efficacy of pembrolizumab with carboplatin ... Conclusions: This NMA with MAIC suggests patients treated with the KNB10 regimen had improved or comparable ORR outcomes versus other recommended 1L ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40272712/

Pembrolizumab with Carboplatin and Paclitaxel Versus ... This study looked at how well a treatment combination works for patients with a specific type of cancer called recurrent or metastatic head and ...

7. frontiersin.org frontiersin.org/journals/immunology/articles/10.3389/fimmu.2025.1574988/full

A retrospective efficacy and safety study of pembrolizumab ... The primary objective of this study was to retrospectively assess the efficacy and safety profiles of two neoadjuvant regimens combining either pembrolizumab ...

8. spandidos-publications.com spandidos-publications.com/10.3892/ol.2022.13623

Safety and preliminary activity of pembrolizumab ... Safety and preliminary activity of pembrolizumab‑carboplatin‑paclitaxel in heavily pretreated and/or fragile patients with PDL1‑positive ...