20 Participants Needed

PVX-410 + Pembrolizumab for Advanced Breast Cancer

Recruiting at 2 trial locations
Age: 18+
Sex: Female
Trial Phase: Phase 1
Sponsor: Massachusetts General Hospital
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
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 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

Member Detail - DF/HCC

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

My DNA test shows I am HLA A2 positive.
I am fully active or can carry out light work.
My organs and bone marrow are functioning well.
See 10 more

Exclusion Criteria

I have cancer that has spread to my brain or spinal cord.
I have an immune system disorder or have been on steroids or other immune-weakening medicines in the last week.
Currently participating or has participated in a study of an investigational agent within 4 weeks of the first dose of study treatment
See 15 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

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.

28 weeks
Weekly visits for the first 6 weeks, then at weeks 10 and 28

Follow-up

Participants are monitored for safety and effectiveness after treatment, including immune response and adverse events.

3 years

Treatment Details

Interventions

  • Pembrolizumab
  • PVX-410
Trial Overview The study tests a combination of immunotherapies: PVX-410 vaccine plus Pembrolizumab, along with Hiltonol and Montanide as possible treatments for breast cancer. The goal is to see how well these drugs work together in patients who express the HLA-A2+ molecule.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: PVX-410Experimental Treatment2 Interventions
* PVX-410 vaccine at W0, 1, 2, 3, 4, and 5 followed by booster PVX-410 vaccine doses at W10 and 28 * Pembrolizumab will be administered every 3 weeks intravenously starting with week 1

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?

Massachusetts General Hospital

Lead Sponsor

Trials
3,066
Recruited
13,430,000+

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 the KEYNOTE-010 study involving patients with advanced NSCLC, pembrolizumab significantly improved health-related quality of life (HRQoL) scores compared to docetaxel, indicating better overall patient well-being during treatment.
Patients treated with pembrolizumab experienced less deterioration in symptoms like cough and dyspnea, and showed a significant prolongation in time to deterioration for these symptoms, particularly at the 10 mg/kg dose compared to docetaxel.
Health-Related Quality of Life in KEYNOTE-010: a Phase II/III Study of Pembrolizumab Versus Docetaxel in Patients With Previously Treated Advanced, Programmed Death Ligand 1-Expressing NSCLC.Barlesi, F., Garon, EB., Kim, DW., et al.[2020]

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]
Health-Related Quality of Life in KEYNOTE-010: a Phase II/III Study of Pembrolizumab Versus Docetaxel in Patients With Previously Treated Advanced, Programmed Death Ligand 1-Expressing NSCLC. [2020]
Safety and Antitumor Activity of Pembrolizumab in Patients with Estrogen Receptor-Positive/Human Epidermal Growth Factor Receptor 2-Negative Advanced Breast Cancer. [2022]
Evaluation of pembrolizumab for the treatment of advanced non-small cell lung cancer: a retrospective, single-centre, single-arm study. [2022]
FDA Approval Summary: Accelerated Approval of Pembrolizumab for Second-Line Treatment of Metastatic Melanoma. [2021]
Programmed Cell Death-1 Inhibitor-Induced Type 1 Diabetes Mellitus. [2022]
Recurrent and atypical immune checkpoint inhibitor-induced pneumonitis. [2023]
Acute myelomonocytic leukemia during pembrolizumab treatment for non-small cell lung cancer: A case report. [2020]
10.United Statespubmed.ncbi.nlm.nih.gov
New Approved Use for Keytruda. [2022]
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