pTVG-HP + Nivolumab for Prostate Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
The purpose of this study is to evaluate the safety of an investigational DNA vaccine, pTVG-HP, a plasmid DNA encoding human prostatic acid phosphatase (PAP), in combination with nivolumab, and the efficacy of this combination in decreasing serum Prostate-Specific Antigen (PSA) in patients with non-metastatic, non-castrate prostate cancer (clinical stage D0/M0).
Will I have to stop taking my current medications?
The trial requires that you stop taking medications or supplements with known hormonal effects, such as PC-SPES, megestrol acetate, finasteride, ketoconazole, estradiol, or Saw Palmetto. If you are taking other medications with possible anticancer effects, you must discuss them with the study doctor before joining the trial. Additionally, if you have used certain herbal supplements or experimental therapies for prostate cancer, you must stop them at least 4 weeks before starting the trial.
Is the combination of pTVG-HP and Nivolumab safe for humans?
Nivolumab, used in various cancers, can cause immune-related side effects, which are reactions from the immune system that might affect different parts of the body. These side effects can be serious and include issues with blood cells, but they vary depending on the individual and the type of cancer being treated.12345
What makes the pTVG-HP + Nivolumab treatment unique for prostate cancer?
The pTVG-HP + Nivolumab treatment is unique because it combines a DNA vaccine targeting a prostate-specific antigen with an immune checkpoint inhibitor, aiming to enhance the body's immune response against prostate cancer. This approach is different from standard treatments as it leverages the immune system to specifically target cancer cells, potentially offering a novel strategy for patients with advanced prostate cancer.46789
What data supports the effectiveness of the treatment pTVG-HP + Nivolumab for prostate cancer?
Research suggests that combining nivolumab with other drugs like ipilimumab has shown some effectiveness in treating certain types of prostate cancer, especially in patients with specific genetic mutations. However, the effectiveness of nivolumab alone or in combination with pTVG-HP for prostate cancer is not well-established, and more research is needed.4561011
Who Is on the Research Team?
Hamid Emamekhoo, MD
Principal Investigator
University of Wisconsin, Madison
Are You a Good Fit for This Trial?
Men over 18 with non-metastatic, PSA-recurrent prostate cancer after surgery and possible radiation therapy. They should have a rising PSA level, be in good physical condition (ECOG score < 2), expect to live at least another year, and have normal blood counts and organ function. No recent immunosuppressants or other cancer treatments are allowed, except certain hormone therapies under specific conditions.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive Nivolumab and pTVG-HP with rhGM-CSF as an adjuvant if needed
Follow-up
Participants are monitored for safety and effectiveness after treatment
Long-term follow-up
Participants are monitored for metastasis-free survival and PSA response
What Are the Treatments Tested in This Trial?
Interventions
- Nivolumab
- pTVG-HP
Nivolumab is already approved in United States, European Union, Canada, Switzerland for the following indications:
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Wisconsin, Madison
Lead Sponsor
Madison Vaccines Inc. (MVI)
Collaborator
Bristol-Myers Squibb
Industry Sponsor
Christopher Boerner
Bristol-Myers Squibb
Chief Executive Officer since 2023
PhD in Business Administration from the Haas School of Business, University of California, Berkeley; BA in Economics and History from Washington University in St. Louis
Deepak L. Bhatt
Bristol-Myers Squibb
Chief Medical Officer since 2024
MD from Yale University; MSc in Clinical Epidemiology from the University of Pennsylvania
AIQ Solutions
Industry Sponsor
AIQ Solutions
Collaborator