Cemiplimab + ISA101b for HPV-Related Throat Cancer
Trial Summary
Will I have to stop taking my current medications?
The trial protocol does not specify if you need to stop taking your current medications. However, if you are on immunosuppressive medications like steroids, you may need to stop them 14 days before starting the study drug.
What data supports the effectiveness of the drug Cemiplimab + ISA101b for HPV-related throat cancer?
Is the combination of Cemiplimab and ISA101b generally safe for humans?
Cemiplimab, also known as Libtayo, has been studied for various cancers and is generally considered to have an acceptable safety profile. Common side effects are manageable, and no new safety concerns were observed in combination therapies. However, specific safety data for the combination with ISA101b is not provided in the available research.678910
How is the drug cemiplimab unique for treating HPV-related throat cancer?
Cemiplimab is unique because it is an immunotherapy drug that works by blocking the PD-1 receptor, which helps the immune system attack cancer cells more effectively. This approach is different from traditional chemotherapy, which directly targets and kills cancer cells, and it represents a novel option for treating cancers that are sensitive to immune system modulation.4681011
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.
Research Team
Bonnie Glisson, MD
Principal Investigator
M.D. Anderson Cancer Center
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
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive cemiplimab plus placebo or cemiplimab plus ISA101b every 3 weeks for up to 24 months
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Cemiplimab
- ISA101b
- Placebo
Cemiplimab is already approved in European Union, United States, Canada, Brazil for the following indications:
- Cutaneous squamous cell carcinoma (CSCC)
- Non-small cell lung cancer (NSCLC)
- Cutaneous squamous cell carcinoma (CSCC)
- Basal cell carcinoma (BCC)
- Non-small cell lung cancer (NSCLC)
- Cutaneous squamous cell carcinoma (CSCC)
- Non-small cell lung cancer (NSCLC)
- Cutaneous squamous cell carcinoma (CSCC)
Find a Clinic Near You
Who Is Running the Clinical Trial?
ISA Pharmaceuticals
Lead Sponsor
Regeneron Pharmaceuticals
Industry Sponsor
Leonard Schleifer
Regeneron Pharmaceuticals
Chief Executive Officer since 1988
MD and PhD in Medicine
George Yancopoulos
Regeneron Pharmaceuticals
Chief Medical Officer since 1997
MD from Harvard Medical School