Pembrolizumab + Ultrasound for Head and Neck Cancer

Overseen By Joseph M Curry, MD

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Thomas Jefferson University

Must not be taking: Immunosuppressants, Corticosteroids

Disqualifiers: HPV-positive SCC, Cardiac conditions, Active autoimmune, 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

Compensation: Varies

Number of Visits: 3

Duration: 9 weeks

6 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This is a feasibility trial studying anti-PD-1 therapy (Pembrolizumab) among patients with R/M HNSCC, delivered with ultrasound-induced microbubble cavitation, with the goal of optimizing delivery of Pembrolizumab and tumor response to Pembrolizumab. Patients will undergo 3 infusions of Pembrolizumab plus Definity 3 weeks apart. Following each infusion, ultrasound will be directed at the primary tumor site to induce microbubble cavitation, with the goal of tumor sonoporation. The primary endpoints will be feasibility, measured based on successful recruitment of 6 participants within 1 year of initiating recruitment, with successful completion of trial procedures among at least 80 percent of patients. Secondary endpoints will include proportion of serious adverse events, clinical/radiographic response, overall survival, and progression-free survival.

Who Is on the Research Team?

Joseph M Curry, MD

Principal Investigator

Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University

Are You a Good Fit for This Trial?

Inclusion Criteria

4. Bilirubin less than or equal to 1.5 x the upper limit of normal (except subjects with Gilbert syndrome, who can have total bilirubin \<3 mg/dl);

My head and neck cancer is HPV-negative and has a CPS score above 1.

My tumor can be seen and measured on an ultrasound and can be biopsied.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive 3 cycles of Pembrolizumab plus Definity infusions every 3 weeks, with ultrasound-induced microbubble cavitation directed at the primary tumor site

9 weeks

3 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessment of adverse events and response rates

3 months

Regular follow-up visits

Long-term follow-up

Participants are monitored for overall survival and progression-free survival

90 days after last dose

What Are the Treatments Tested in This Trial?

Interventions

• Pembrolizumab
• Ultrasound-Induced Microbubble Cavitation

How Is the Trial Designed?

Group I: Arm 1: Pembro + Ultrasound-Induced Microbubble Cavitation Experimental Treatment 3 Interventions

Treatment will be administered on an outpatient basis. 200 mg Pembrolizumab + 3 mL Definity infusions will be administered by nurses at Thomas Jefferson University every 3 weeks for up to 3 cycles. The first cycle will take 60 minutes, while the subsequent infusions should take half an hour to complete.

Who Is Running the Clinical Trial?

Thomas Jefferson University

Lead Sponsor

Trials

475

Recruited

189,000+

Lantheus Medical Imaging

Industry Sponsor

Trials

57

Recruited

4,333,000+