VRP-HER2 Vaccine + Pembrolizumab for Breast Cancer
Trial Summary
Do I need to stop my current medications to join the trial?
The trial requires that you stop taking certain medications, such as cytotoxic chemotherapy, anti-estrogen therapy, targeted small molecule therapy, or radiation therapy, at least 3 weeks before starting the trial. Additionally, you should not be on systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the trial.
What data supports the effectiveness of the VRP-HER2 Vaccine + Pembrolizumab treatment for breast cancer?
Pembrolizumab, a part of the treatment, has shown clinical activity in various solid tumors, including breast cancer, and is approved for certain types of lung cancer and melanoma. Additionally, vaccines targeting the HER2 protein, like the VRP-HER2 vaccine, are being actively researched for their potential to boost the immune response against breast cancer.12345
Is the VRP-HER2 Vaccine + Pembrolizumab treatment generally safe for humans?
Pembrolizumab (also known as Keytruda or MK-3475) has been used in various cancer treatments and is generally considered safe, but it can cause side effects. Common side effects include fatigue, cough, nausea, and rash, while more serious immune-related side effects can include lung inflammation (pneumonitis) and thyroid issues. In rare cases, it can cause type 1 diabetes.16789
How is the VRP-HER2 Vaccine + Pembrolizumab treatment different from other breast cancer treatments?
This treatment is unique because it combines a vaccine targeting the HER2 protein, which helps the immune system recognize and attack cancer cells, with Pembrolizumab, a drug that boosts the immune response by blocking a protein that prevents T-cells from attacking cancer. This combination aims to enhance the body's ability to fight breast cancer more effectively than traditional treatments.35101112
What is the purpose of this trial?
In this phase II study, participants will receive the VRP-HER2 immunizations plus pembrolizumab. Subjects will be randomized into 3 arms. They will undergo a biopsy of their tumor and peripheral blood draw for immune cell analyses and be assigned to the applicable arm of the study. Arm A will consist of the the VRP-HER2 immunizations; Arm B will consist of pembrolizumab; Arm C will consist of the VRP-HER2 immunizations plus pembrolizumab.
Eligibility Criteria
Adults over 18 with breast cancer, who've had prior treatment with trastuzumab and pertuzumab, can join this trial. They must have a tumor biopsy available, resolved side effects from previous treatments to mild levels, normal heart function, and be able to use contraception. Exclusions include active brain metastases, certain infections or conditions that could affect the study's outcome or patient safety.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive VRP-HER2 immunizations and/or pembrolizumab based on randomization into one of three arms
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Pembrolizumab
- VRP-HER2
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?
Herbert Lyerly
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