HPV Vaccine + M7824 for HPV-Associated Cancers
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial investigates whether an HPV vaccine combined with the drug M7824 (also known as PRGN-2009 AdenoVerse Immunotherapy) can effectively treat certain cancers linked to the human papillomavirus (HPV). The researchers aim to find a safe dose and determine if the combination treatment elicits a stronger immune response than the vaccine or drug alone. Those who might benefit from joining include individuals with advanced HPV-related cancers or specific types of oropharyngeal (throat) cancer planning for major treatment. Participants will receive either the HPV vaccine alone or with M7824, with treatment lasting up to a year. As a Phase 1, Phase 2 trial, this research seeks to understand how the treatment works in people and measure its effectiveness in an initial, smaller group, offering participants a chance to contribute to groundbreaking cancer treatment advancements.
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 systemic corticosteroids or other immunosuppressive drugs, you may need to stop them at least 1 to 4 weeks before joining the trial, depending on the duration of use.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that the HPV vaccine PRGN-2009 and the drug M7824 have been tested for safety in people with HPV-related cancers. Early results suggest that PRGN-2009, whether used alone or with another experimental drug, is generally safe and well-tolerated by most patients, even those with extensive previous treatments.
For M7824, studies have demonstrated that it works well and is generally safe for patients with advanced cancer when used alone. Trials found no major safety issues.
Overall, past studies have shown both the HPV vaccine and M7824 to be safe. However, joining a new trial always involves some risk. Discuss any concerns with the trial team.12345Why are researchers excited about this trial's treatments?
Researchers are excited about these treatments for HPV-associated cancers because they combine innovative approaches to tackle the disease. Unlike traditional treatments like chemotherapy and radiation, the investigational treatments use a Human Papillomavirus (HPV) vaccine, PRGN-2009, designed to train the immune system to recognize and attack HPV-related cancer cells. Additionally, M7824 is a unique bifunctional fusion protein that targets both the PD-L1 and TGF-β pathways, which are often used by cancer cells to evade the immune system. This dual-action approach could potentially improve the immune response against cancer cells, offering a novel strategy compared to existing therapies.
What evidence suggests that the HPV vaccine combined with M7824 could be effective for HPV-associated cancers?
Research has shown that the HPV vaccine, PRGN-2009, combined with a checkpoint inhibitor, helped about 30% of patients with heavily treated HPV-related cancers achieve significant tumor reduction. Nearly one-third of these patients experienced noticeable tumor shrinkage. In this trial, some participants will receive the HPV vaccine alone, while others will receive it with M7824. Other studies have found that M7824 alone can lead to a 35-40% reduction in tumors for patients with advanced HPV-related cancers. This suggests that both treatments are promising individually. Combining PRGN-2009 with M7824 might enhance these results by boosting the body's immune response.12345
Who Is on the Research Team?
Charalampos Floudas, M.D.
Principal Investigator
National Cancer Institute (NCI)
Are You a Good Fit for This Trial?
Adults (18+) with advanced or metastatic HPV-associated cancers, including cervical, anal, and p16-positive oropharyngeal cancers. Participants must have measurable disease and an ECOG performance status of <=2. Prior treatments are allowed under specific conditions. Adequate organ function is required, and effective contraception must be used.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive the HPV vaccine alone or with M7824. Phase I participants receive the vaccine 2-3 times in the first month, then a booster every 4 weeks. M7824 is given every 2 weeks. Phase II participants receive two doses of the vaccine two weeks apart before planned chemoradiation or surgery.
Follow-up
Participants are monitored for safety and effectiveness after treatment. A visit occurs within 4 weeks after stopping treatment, followed by annual long-term follow-up.
What Are the Treatments Tested in This Trial?
Interventions
- PRGN-2009
- PRGN-2009, M7824
Find a Clinic Near You
Who Is Running the Clinical Trial?
National Cancer Institute (NCI)
Lead Sponsor