8 Participants Needed

VRP-HER2 Vaccine + Pembrolizumab for Breast Cancer

Pl
AH
Overseen ByAmy Hobeika
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: Herbert Lyerly
Must be taking: Trastuzumab, Pertuzumab
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial
Breakthrough TherapyThis drug has been fast-tracked for approval by the FDA given its high promise

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

All side effects from my previous cancer treatments are mild, except for possible hair loss, nerve pain, and tiredness.
Be willing and able to provide written informed consent/assent for the trial.
Ability to return to Duke University Medical Center for adequate follow-up as required by this protocol.
See 9 more

Exclusion Criteria

You are allergic to pembrolizumab or any of the substances it contains.
I have had pneumonitis treated with steroids or currently have it.
Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
See 16 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive VRP-HER2 immunizations and/or pembrolizumab based on randomization into one of three arms

15 weeks
Injections every 2 weeks and infusions every 3 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

  • Pembrolizumab
  • VRP-HER2
Trial Overview This phase II trial tests VRP-HER2 vaccinations combined with pembrolizumab in patients with breast cancer. Initially there's a Safety Arm; if safe, participants are randomized into three groups: one receiving just the vaccine (Arm A), another getting only pembrolizumab (Arm B), and the third both treatments (Arm C).
Participant Groups
3Treatment groups
Experimental Treatment
Active Control
Group I: VRP-HER2 Vaccine + PembrolizumabExperimental Treatment2 Interventions
VRP-HER2 Vaccine 4 x 10EE8 IU given as a single injection every 2 weeks for 3 injections total (Cycle 1: Day 1 and Day 15 Cycle 2: Day 8)+ 5 administrations of Pembrolizumab 200 mg every 3 weeks for 5 total IV infusions (Day 1 of each 3 week cycle x 5 cycles)
Group II: VRP-HER2 VaccineActive Control1 Intervention
VRP-HER2 Vaccine 4 x 10EE8 IU given as a single injection every 2 weeks for 3 injections total (Cycle 1: Day 1 and Day 15 Cycle 2: Day 8)
Group III: PembrolizumabActive Control1 Intervention
5 administrations of Pembrolizumab 200 mg every 3 weeks for 5 total IV infusions (Day 1 of each 3 week cycle x 5 cycles)

Pembrolizumab is already approved in United States, European Union, United Kingdom for the following indications:

🇺🇸
Approved in United States as KEYTRUDA for:
  • 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
🇪🇺
Approved in European Union as KEYTRUDA for:
  • 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
🇬🇧
Approved in United Kingdom as KEYTRUDA for:
  • 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

Trials
5
Recruited
60+

Merck Sharp & Dohme LLC

Industry Sponsor

Trials
4,096
Recruited
5,232,000+
Chirfi Guindo profile image

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 profile image

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

Findings from Research

In a phase II trial involving 15 patients with resectable non-small cell lung cancer (NSCLC), neoadjuvant treatment with pembrolizumab showed a major pathologic response in 27% of patients, indicating promising antitumor activity before surgery.
The treatment was found to be feasible and safe, with only 33% of patients experiencing moderate adverse events, and no postoperative mortality, suggesting that pembrolizumab does not compromise surgical outcomes.
Neoadjuvant anti-programmed death-1 immunotherapy by pembrolizumab in resectable non-small cell lung cancer: First clinical experience.Eichhorn, F., Klotz, LV., Kriegsmann, M., et al.[2022]
Pembrolizumab, a PD-1 inhibitor, has demonstrated clinical effectiveness in treating various solid tumors, particularly in patients with PD-L1-positive non-small-cell lung cancer and unresectable/metastatic melanoma.
Early-phase trials and ongoing studies are focused on further confirming the clinical benefits of pembrolizumab in thoracic malignancies, highlighting its potential as a significant treatment option in cancer therapy.
Pembrolizumab for the treatment of thoracic malignancies: current landscape and future directions.Karim, S., Leighl, N.[2017]
In patients with hormone receptor-positive metastatic breast cancer, higher levels of specific immune cells (effector memory CD8+ and CD4+ T cells) before treatment were associated with better responses to the combination therapy of palbociclib, pembrolizumab, and letrozole, compared to those receiving only pembrolizumab and letrozole.
The combination therapy also led to significant changes in myeloid cell composition, including increased mature dendritic cells and decreased classical monocytes, which may enhance the immune response against the cancer.
Pre-existing effector T-cell levels and augmented myeloid cell composition denote response to CDK4/6 inhibitor palbociclib and pembrolizumab in hormone receptor-positive metastatic breast cancer.Egelston, C., Guo, W., Yost, S., et al.[2021]

References

Neoadjuvant anti-programmed death-1 immunotherapy by pembrolizumab in resectable non-small cell lung cancer: First clinical experience. [2022]
Pembrolizumab for the treatment of thoracic malignancies: current landscape and future directions. [2017]
Levels of circulating regulatory CD4+CD25+ T cells are decreased in breast cancer patients after vaccination with a HER2/neu peptide (E75) and GM-CSF vaccine. [2017]
Pre-existing effector T-cell levels and augmented myeloid cell composition denote response to CDK4/6 inhibitor palbociclib and pembrolizumab in hormone receptor-positive metastatic breast cancer. [2021]
AE37: a novel T-cell-eliciting vaccine for breast cancer. [2014]
FDA Approval Summary: Accelerated Approval of Pembrolizumab for Second-Line Treatment of Metastatic Melanoma. [2021]
Recurrent and atypical immune checkpoint inhibitor-induced pneumonitis. [2023]
Biophysical and Immunological Characterization and In Vivo Pharmacokinetics and Toxicology in Nonhuman Primates of the Anti-PD-1 Antibody Pembrolizumab. [2021]
Programmed Cell Death-1 Inhibitor-Induced Type 1 Diabetes Mellitus. [2022]
10.United Statespubmed.ncbi.nlm.nih.gov
Vaccine-Induced Memory CD8+ T Cells Provide Clinical Benefit in HER2 Expressing Breast Cancer: A Mouse to Human Translational Study. [2020]
Application of HER2 peptide vaccines in patients with breast cancer: a systematic review and meta-analysis. [2021]
Assessment of immunologic response and recurrence patterns among patients with clinical recurrence after vaccination with a preventive HER2/neu peptide vaccine: from US Military Cancer Institute Clinical Trials Group Study I-01 and I-02. [2020]
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