Cisplatin + Pembrolizumab for Head and Neck Cancer

Recruiting in Palo Alto (17 mi)

+5 other locations

Overseen byTrisha Wise-Draper, MD,PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Trisha Wise-Draper

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?The purpose of this research study is to test the safety and the benefit of adding pembrolizumab (a therapy that activates the immune system to fight cancer) to standard of care treatment for head and neck cancer. The standard of care treatment will include surgery followed by radiation for 6 weeks. Some patients may also receive cisplatin as standard of care once a week for 6 weeks if the cancer is found to be "high risk". High risk includes cancer that was not completely removed (positive margins) or cancer that has invaded through the outer lining of your lymph nodes.

Eligibility Criteria

This trial is for adults with head and neck squamous cell carcinoma who are fit enough for surgery, have certain high-risk cancer features, and can handle standard treatments. They must not have immune deficiencies, be on recent immunosuppressants, or have specific other cancers or infections like TB or hepatitis.

Inclusion Criteria

I am willing to have surgery to remove a tumor and neck lymph nodes.

Adequate labs

I can carry out all my usual activities without help.

+2 more

Exclusion Criteria

My throat cancer is caused by HPV.

I have an immune system disorder or have been on steroids or immune-suppressing drugs within the last week.

My cancer is located in the nasopharynx or sinonasal region.

+2 more

Participant Groups

The study tests adding pembrolizumab to the usual care (surgery plus radiation) for head and neck cancer. Some patients may also get cisplatin if their cancer is 'high risk'. The goal is to see if pembrolizumab improves outcomes when combined with these standard therapies.

1Treatment groups

Experimental Treatment

Group I: PembrolizumabExperimental Treatment4 Interventions

Pembrolizumab in combination with standard of care surgery followed by radiation therapy with or without cisplatin

Cisplatin is already approved in European Union, United States, Canada, Japan for the following indications:

🇪🇺 Approved in European Union as Platinol for: