PVX-410 + Pembrolizumab for Advanced Breast Cancer
Trial Summary
Do I need to stop my current medications to join the trial?
The trial protocol does not specify if you need to stop taking your current medications. However, it mentions that ongoing or planned systemic anti-cancer therapy or radiation therapy is not allowed, and there are specific time frames for stopping certain treatments before starting the trial. It's best to discuss your current medications with the study team to get a clear answer.
What data supports the effectiveness of the drug pembrolizumab for advanced breast cancer?
Research shows that pembrolizumab, when used for certain types of advanced breast cancer, was well tolerated and provided a modest but lasting response in some patients. In a study, 12% of patients experienced a partial response, and 20% had a clinical benefit, indicating potential effectiveness in this context.12345
Is the combination of PVX-410 and Pembrolizumab safe for humans?
Pembrolizumab (also known as Keytruda) has been used in various cancer treatments and is generally considered safe, but it can cause side effects. Common side effects include fatigue, nausea, and rash, while more serious immune-related side effects can affect organs like the lungs (pneumonitis) and endocrine organs, sometimes leading to conditions like type 1 diabetes. These side effects are rare but important to consider.12678
What makes the drug PVX-410 + Pembrolizumab unique for advanced breast cancer?
This treatment combines PVX-410, a cancer vaccine, with Pembrolizumab, an immune checkpoint inhibitor that helps the immune system attack cancer cells. Pembrolizumab has shown success in treating other cancers by targeting the PD-1 pathway, making this combination a novel approach for advanced breast cancer.125910
What is the purpose of this trial?
This research study is studying immunotherapy as a possible treatment for metastatic Triple Negative Breast Cancer (TNBC) in participants who are HLA-A2+.The drugs involved in this study are:* PVX-410* Pembrolizumab* Hiltonol* Montanide
Research Team
Steven Isakoff, MD, PhD
Principal Investigator
Massachusetts General Hospital
Eligibility Criteria
This trial is for women over 18 with metastatic Triple Negative Breast Cancer who are HLA-A2+. They must have had at least one prior systemic therapy, not be pregnant or breastfeeding, agree to use birth control if of childbearing potential, and have no active infections like HIV or hepatitis. Participants should not have received certain vaccines or cancer treatments recently and must be in good health with proper organ function.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive PVX-410 vaccine at weeks 0, 1, 2, 3, 4, and 5, followed by booster doses at weeks 10 and 28. Pembrolizumab is administered every 3 weeks starting at week 1.
Follow-up
Participants are monitored for safety and effectiveness after treatment, including immune response and adverse events.
Treatment Details
Interventions
- Pembrolizumab
- PVX-410
Pembrolizumab is already approved in United States, European Union, United Kingdom for the following indications:
- Head and neck squamous cell carcinoma (HNSCC) with PD-L1 CPS ≥1
- Melanoma
- Non-small cell lung cancer (NSCLC)
- Urothelial carcinoma
- Colorectal cancer
- Gastric cancer
- Hepatocellular carcinoma
- Renal cell carcinoma
- Cervical cancer
- Endometrial carcinoma
- Head and neck squamous cell carcinoma (HNSCC) with PD-L1 CPS ≥1
- Melanoma
- Non-small cell lung cancer (NSCLC)
- Urothelial carcinoma
- Colorectal cancer
- Gastric cancer
- Hepatocellular carcinoma
- Renal cell carcinoma
- Cervical cancer
- Endometrial carcinoma
- Untreated metastatic or unresectable recurrent head and neck squamous cell carcinoma (HNSCC) with PD-L1 CPS ≥1
Find a Clinic Near You
Who Is Running the Clinical Trial?
Massachusetts General Hospital
Lead Sponsor
Merck Sharp & Dohme LLC
Industry Sponsor
Chirfi Guindo
Merck Sharp & Dohme LLC
Chief Marketing Officer since 2022
Degree in Engineering from Ecole Centrale de Paris, MBA from New York University Stern School of Business
Robert M. Davis
Merck Sharp & Dohme LLC
Chief Executive Officer since 2021
JD from Northwestern University Pritzker School of Law, MBA from Northwestern University Kellogg Graduate School of Management, Bachelor's in Finance from Miami University