Pembrolizumab for Oropharyngeal Cancer

Not yet recruiting at 1 trial location

Overseen By Glenn Hanna, MD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Dana-Farber Cancer Institute

Must not be taking: Immunosuppressants, Corticosteroids

Disqualifiers: Stage IV cancer, Autoimmune disease, others

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

Prior Safety Data This treatment has passed at least one previous human trial

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

Compensation: Varies

Number of Visits: 22

Duration: 54 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

The purpose of this study is to assess risk for HPV driven oropharyngeal cancers by using HPV blood tests and clinical features (such as tumor stage and smoking status) to determine appropriate treatment to improve survival outcomes in participants with stage I, II, or III, HPV-associated oropharyngeal (tongue base or tonsil) squamous cell carcinoma,.

Who Is on the Research Team?

Glenn Hanna, MD

Principal Investigator

Dana-Farber Cancer Institute

Are You a Good Fit for This Trial?

Inclusion Criteria

HPV status should be confirmed on tissue biopsy or cytologic sample

I have HPV-related cancer, but the original tumor site is unknown.

My organs and bone marrow work well enough for immunotherapy.

Exclusion Criteria

My cancer is stage IV according to the AJCC 2017 guidelines.

Pregnant or lactating women

I have previously received immunotherapy targeting PD-1, PD-L1, or T-cell receptors.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants receive Pembrolizumab every 6 weeks for up to 9 cycles or undergo observation

54 weeks

9 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 years

Visits every 12 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Pembrolizumab

How Is the Trial Designed?

Group I: Adjuvant Pembroluzimab Experimental Treatment 1 Intervention

* Cycle 1 through Cycle 9 (42-day cycles) * Days 1-378: Predetermined dose of Pembrolizumab once every 6 weeks, up to 9 cycles * Follow up for up to 2 years

Group II: Observation Active Control 1 Intervention

Cycle 1 through Cycle 9 (42-day cycles) Days 1-378: Standard of care observation Device: NavDx® TTMV-HPV DNA testing (used for risk stratification and treatment assignment) Follow up for up to 2 years

Who Is Running the Clinical Trial?

Dana-Farber Cancer Institute

Lead Sponsor

Trials

1,128

Recruited

382,000+

Merck Sharp & Dohme LLC

Industry Sponsor

Trials

4,096

Recruited

5,232,000+

Chirfi Guindo

Merck Sharp & Dohme LLC

Chief Marketing Officer since 2022

Degree in Engineering from Ecole Centrale de Paris, MBA from New York University Stern School of Business

Robert M. Davis

Merck Sharp & Dohme LLC

Chief Executive Officer since 2021

JD from Northwestern University Pritzker School of Law, MBA from Northwestern University Kellogg Graduate School of Management, Bachelor's in Finance from Miami University