Cemiplimab + ISA101b for HPV-Related Throat Cancer

Recruiting in Palo Alto (17 mi)

+66 other locations

Overseen ByBonnie Glisson, MD

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: ISA Pharmaceuticals

Prior Safety Data

Approved in 4 jurisdictions

Trial Summary

What is the purpose of this trial?This trial is testing a combination of a cancer vaccine and a drug to help the immune system fight HPV16 positive oropharyngeal cancer. The vaccine teaches the immune system to attack cancer cells, and the drug keeps the immune system active. The vaccine targets cancers related to HPV, including cervical, oropharyngeal, and anal cancers.

Eligibility Criteria

Adults diagnosed with HPV16 positive recurrent or metastatic OPC (a type of throat cancer), whose tumors express a protein called PD-L1 and are suitable for first-line therapy with PD-1 blocking antibodies, or have progressed after chemotherapy. Participants must be in good physical condition (ECOG 0-1) and not have used certain immunosuppressive drugs recently. Women must test negative for pregnancy.

Inclusion Criteria

I am fully active or can carry out light work.

I have signed the consent form approved by the ethics committee.

I am fully active or can carry out light work.

Exclusion Criteria

I have previously been treated with specific immune-targeting cancer drugs.

I have brain or leptomeningeal metastases.

My cancer is HPV16 positive, has not been treated, cannot be surgically removed, does not respond to PD-1 antibody treatments.

I have had more than one chemotherapy treatment for my advanced oral cancer.

Participant Groups

This phase 2 trial is testing the effectiveness of Cemiplimab combined with ISA101b versus Cemiplimab with a placebo in treating HPV16-positive OPC. Patients will be randomly assigned to one of these two groups without knowing which treatment they receive.

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Active ISA101b and cemiplimab.Experimental Treatment2 Interventions

ISA101b 3 times plus cemiplimab every 3 weeks for up to 24 months

Group II: Placebo and cemiplimabPlacebo Group2 Interventions

Placebo 3 times plus cemiplimab every 3 weeks for up to 24 months

Cemiplimab is already approved in European Union, United States, Canada, Brazil for the following indications:

🇪🇺 Approved in European Union as Libtayo for: