Pembrolizumab + Cesium-131 for Head and Neck Cancer

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

50 Participants Needed

Trial Summary

What is the purpose of this trial?

To Study Perioperative PD-1 Inhibitor and Cesium-131 Interstitial Brachytherapy in patients with locally recurrent HNSCC eligible for salvage surgery.

Research Team

Chad Zender, MD

Principal Investigator

University of Cincinnati

Eligibility Criteria

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.

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

I have an active throat and skin condition.

Timeline

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

Treatment Details

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.

Participant Groups

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+