Pembrolizumab + Cesium-131 for Head and Neck Cancer

Recruiting in Palo Alto (17 mi)

+2 other locations

Overseen byChad Zender, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Waitlist Available

Sponsor: University of Cincinnati

No Placebo Group

Breakthrough Therapy

Approved in 3 Jurisdictions

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.

See 1 more

Treatment Details

Interventions

Cesium-131 (Brachytherapy)
Pembrolizumab (PD-1 Inhibitor)
Salvage Surgery (Surgery)

Trial OverviewThe 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

1Treatment groups

Experimental Treatment

Group I: Pembrolizumab & Cesium-131Experimental Treatment2 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: