Pembrolizumab + Cesium-131 for Head and Neck Cancer

Not currently recruiting at 2 trial locations

Overseen By UCCC Clinical Trials Office

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: University of Cincinnati

Must not be taking: Immune-based anticancer

Disqualifiers: Exposed carotid, Active pharyngo-cutaneous, Multiple metastases, others

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

Breakthrough Therapy This drug has been fast-tracked for approval by the FDA given its high promise

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 13

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new combination treatment for individuals with a specific type of head and neck cancer that has returned after initial treatment. It evaluates the effectiveness of pembrolizumab, a medication that aids the immune system in fighting cancer, in conjunction with a special type of radiation therapy called Cesium-131. The trial seeks participants whose tumors can be surgically removed and who have recovered from the immediate side effects of any previous radiation therapy. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this innovative combination therapy.

Do I need to stop taking my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. However, if you have had immune-based anticancer therapy in the last six months, you cannot participate.

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

Research has shown that using pembrolizumab with Cesium-131 is generally safe. In earlier studies, patients who received pembrolizumab, surgery, and Cesium-131 experienced manageable side effects, indicating that the treatment is usually well-tolerated. Additionally, pembrolizumab alone has proven effective in treating head and neck cancer and has a known safety record. This combination aims to harness the benefits of both treatments while maintaining patient safety. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about the combination of pembrolizumab and Cesium-131 for head and neck cancer because it offers a unique two-pronged approach. Pembrolizumab is an immunotherapy that helps the body's immune system recognize and attack cancer cells, while Cesium-131 provides targeted radiation directly to the tumor site during surgery. This combination could potentially enhance the effectiveness of treatment by directly attacking the cancer and boosting the immune response simultaneously. Unlike standard treatments that often involve separate chemotherapy and radiation sessions over several weeks, this approach aims to optimize cancer control with fewer sessions and potentially fewer side effects.

What evidence suggests that Pembrolizumab and Cesium-131 could be effective for head and neck cancer?

In this trial, participants will receive a combination of pembrolizumab and cesium-131. Studies have shown that pembrolizumab effectively treats head and neck squamous cell carcinoma (HNSCC), especially when the cancer recurs or spreads. Research indicates that pembrolizumab, alone or with chemotherapy, can extend patients' lives. Cesium-131, a type of radiation therapy, targets tumors directly, minimizing harm to nearby healthy tissue. Early findings suggest that combining pembrolizumab with cesium-131 may improve treatment outcomes when administered before and after surgery. This combination could offer new hope for patients with recurring head and neck cancer. ^{1 4 5 6 7}

Who Is on the Research Team?

Chad Zender, MD

Principal Investigator

University of Cincinnati

Are You a Good Fit for This Trial?

This trial is for individuals with a type of throat cancer called HNSCC that has come back and can be removed by surgery. They should have recovered from any serious side effects if they've had radiation before. People with exposed arteries in the neck, ongoing skin-throat connections, or more than one area of cancer spread far away can't join.

Inclusion Criteria

My head or neck cancer has returned and I can undergo another surgery.

My tumor can be surgically removed.

I have recovered from any major side effects of past radiation therapy.

Exclusion Criteria

I have not had immune-based cancer therapy in the last 6 months.

I have an active throat and skin condition.

My surgery involves working around or replacing a major neck artery.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-surgery Treatment

Participants receive one 200mg IV dose of pembrolizumab 14 days before salvage surgery

2 weeks

1 visit (in-person)

Surgery and Brachytherapy

Participants undergo salvage surgery with implantation of Cesium-131 seeds

Single day

1 visit (in-person)

Adjuvant Treatment

Participants receive 200 mg IV of pembrolizumab every 3 weeks for 6 months

6 months

8 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

27 months

Monthly for 3 months, then every 3 months for 24 months

What Are the Treatments Tested in This Trial?

Interventions

• Cesium-131
• Pembrolizumab
• Salvage Surgery

Trial Overview The study tests combining Pembrolizumab (a drug that helps the immune system fight cancer) and Cesium-131 Brachytherapy (a type of targeted internal radiation therapy) along with salvage surgery to remove recurrent throat cancer.

How Is the Trial Designed?

Group I: Pembrolizumab & Cesium-131 Experimental Treatment 2 Interventions

200 mg Pembrolizumab (Day -14 pre-surgery; Every 3 weeks after surgery) + Cesium-131 Seeds to deliver 60-70Gy of radiation (Single dose at the time of salvage surgery)

Pembrolizumab is already approved in United States, European Union, United Kingdom for the following indications:

Approved in United States as KEYTRUDA for:

• Head and neck squamous cell carcinoma (HNSCC) with PD-L1 CPS ≥1
• Melanoma
• Non-small cell lung cancer (NSCLC)
• Urothelial carcinoma
• Colorectal cancer
• Gastric cancer
• Hepatocellular carcinoma
• Renal cell carcinoma
• Cervical cancer
• Endometrial carcinoma

Approved in European Union as KEYTRUDA for:

• Head and neck squamous cell carcinoma (HNSCC) with PD-L1 CPS ≥1
• Melanoma
• Non-small cell lung cancer (NSCLC)
• Urothelial carcinoma
• Colorectal cancer
• Gastric cancer
• Hepatocellular carcinoma
• Renal cell carcinoma
• Cervical cancer
• Endometrial carcinoma

Approved in United Kingdom as KEYTRUDA for:

• Untreated metastatic or unresectable recurrent head and neck squamous cell carcinoma (HNSCC) with PD-L1 CPS ≥1

Who Is Running the Clinical Trial?

University of Cincinnati

Lead Sponsor

Trials

442

Recruited

639,000+

IsoRay Medical, Inc.

Industry Sponsor

Trials

4

Recruited

50+

Citations

1. ascopubs.org ascopubs.org/doi/10.1200/JCO.2025.43.16_suppl.e18044

Neoadjuvant/adjuvant pembrolizumab and surgery ... Conclusions: This study establishes proof-of-concept showing potential efficacy of neoadjuvant/adjuvant pembrolizumab and surgery + Cs-131, with ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11694497/

Real-World Evidence on the Effectiveness of Pembrolizumab ... The study showed some beneficial effects of pembrolizumab monotherapy in recurrent/metastatic/unresectable HNSCC patients in real-world scenarios.

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/36219809/

Updated Results of the Phase III KEYNOTE-048 Study - PubMed Pembrolizumab and pembrolizumab-chemotherapy demonstrated efficacy in recurrent/metastatic head and neck squamous cell carcinoma in KEYNOTE-048.

4. clinicaltrials.gov clinicaltrials.gov/study/NCT02252042

Study Details | NCT02252042 | Pembrolizumab (MK-3475) ... The primary study hypothesis is that pembrolizumab treatment prolongs Overall Survival (OS) when compared to standard treatment. Official Title. A Phase III ...

5. merck.com merck.com/news/mercks-keytruda-pembrolizumab-met-primary-endpoint-of-event-free-survival-efs-as-perioperative-treatment-regimen-in-patients-with-resected-locally-advanced-head-and-neck-squamous-c/

Merck's KEYTRUDA® (pembrolizumab) Met Primary ... KEYNOTE-689 is the first Phase 3 trial to demonstrate statistically significant and clinically meaningful improvement in EFS in the intent-to-treat population.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8660666/

Multi-Institutional Study Validates Safety of Intraoperative ... We explore the safety and oncologic benefit of intraoperative Cesium-131 (Cs-131) brachytherapy combined with salvage local and/or regional surgical resection.

7. clinicaltrials.gov clinicaltrials.gov/study/NCT02358031

NCT02358031 | A Study of Pembrolizumab (MK-3475) for ... A Phase 3 Clinical Trial of Pembrolizumab (MK-3475) in First Line Treatment of Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma