~27 spots leftby Mar 2026

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:
  • Cutaneous squamous cell carcinoma (CSCC)
  • Non-small cell lung cancer (NSCLC)
🇺🇸 Approved in United States as Libtayo for:
  • Cutaneous squamous cell carcinoma (CSCC)
  • Basal cell carcinoma (BCC)
  • Non-small cell lung cancer (NSCLC)
🇨🇦 Approved in Canada as Libtayo for:
  • Cutaneous squamous cell carcinoma (CSCC)
  • Non-small cell lung cancer (NSCLC)
🇧🇷 Approved in Brazil as Libtayo for:
  • Cutaneous squamous cell carcinoma (CSCC)

Find A Clinic Near You

Research locations nearbySelect from list below to view details:
Revive Research Institute, Inc. - Farmington HillsFarmington Hills, MI
Revive Research Institute, Inc.Sterling Heights, MI
University of California San FranciscoSan Francisco, CA
Robert H. Lurie Comprehensive Cancer CenterChicago, IL
More Trial Locations
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Who is running the clinical trial?

ISA PharmaceuticalsLead Sponsor
Regeneron PharmaceuticalsIndustry Sponsor

References