Combination Immunotherapy for Ovarian Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new combination of treatments to combat advanced ovarian, fallopian tube, or primary peritoneal cancer. The treatments include a vaccine called DPX-Survivac, which trains the immune system to attack cancer cells, a drug called pembrolizumab that aids the immune system in targeting cancer, and a chemotherapy drug called cyclophosphamide. This study suits individuals whose cancer has returned after initial treatment and who have experienced disease progression. Participants must have specific types of these cancers and be willing to provide tumor samples for research. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.
Do I have to stop taking my current medications for the trial?
The trial does not specify if you need to stop taking your current medications, but you cannot be on any investigational drugs or immunosuppressive therapy within 7 days before starting the trial treatment.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Previous studies have shown that pembrolizumab, when combined with other treatments, is well-tolerated by patients with ovarian cancer. This drug, already approved for certain skin and lung cancers, has a strong safety record.
Cyclophosphamide, another treatment in this study, is also well-tolerated. Past research has demonstrated its effectiveness and safety when used with other drugs for various types of cancer.
The DPX-Survivac vaccine has been tested in ovarian cancer patients and found to be well-tolerated. It aids the immune system in fighting cancer cells.
Together, these treatments have shown promising safety results in other studies. Although this current trial is still in the early stages, available evidence suggests these treatments are generally well-tolerated.12345Why are researchers excited about this trial's treatments?
Researchers are excited about the combination of cyclophosphamide, DPX-Survivac, and pembrolizumab for ovarian cancer because it offers a novel approach compared to standard treatments like surgery and chemotherapy. Unlike traditional therapies, this combination leverages immunotherapy to stimulate the body's immune system to recognize and attack cancer cells more effectively. DPX-Survivac is particularly unique as it targets the survivin protein, which is often overexpressed in cancer cells and helps them survive. Pembrolizumab, known as a checkpoint inhibitor, works by unleashing the immune system to fight cancer cells, adding an extra layer of defense. This combination could potentially lead to more targeted and durable responses in patients, especially those with platinum-sensitive or resistant types of ovarian cancer.
What evidence suggests that this trial's treatments could be effective for ovarian cancer?
This trial will evaluate the combination of pembrolizumab, DPX-Survivac, and cyclophosphamide for treating ovarian cancer. Studies have shown that pembrolizumab, when combined with other drugs, helps patients with recurrent ovarian cancer live longer without disease progression. DPX-Survivac, an experimental vaccine, has proven safe and beneficial for these patients. Cyclophosphamide, a chemotherapy drug, has been effective when used regularly for recurrent ovarian cancer. These treatments aim to strengthen the immune system to fight cancer cells, and early research shows promising results. Participants in this trial will receive these treatments in different cohorts based on their specific cancer characteristics.34678
Who Is on the Research Team?
Amit Oza, MD
Principal Investigator
Princess Margaret Cancer Centre
Are You a Good Fit for This Trial?
This trial is for patients with advanced ovarian, fallopian tube, or primary peritoneal cancer who've had disease progression after platinum-based chemotherapy. They must have measurable disease and a good performance status (ECOG <=1), be willing to provide tumor tissue samples, and have a life expectancy over 16 weeks. Those with immunodeficiency, recent immunosuppressive therapy, autoimmune diseases requiring treatment in the last two years (except vitiligo or diabetes), active TB, CNS metastases, or allergies to the drugs are excluded.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Dose Escalation
Participants receive one of two dose levels of study drugs to determine the best dose level for further testing
Dose Expansion
Additional participants are enrolled to further test the safety, tolerability, and efficacy of the study drugs at the determined dose level
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Cyclophosphamide
- DPX-Survivac
- Pembrolizumab
Cyclophosphamide is already approved in United States, European Union, Canada, Japan for the following indications:
- Breast cancer
- Ovarian cancer
- Multiple myeloma
- Leukemia
- Lymphoma
- Rheumatoid arthritis
- Breast cancer
- Ovarian cancer
- Multiple myeloma
- Leukemia
- Lymphoma
- Rheumatoid arthritis
- Breast cancer
- Ovarian cancer
- Multiple myeloma
- Leukemia
- Lymphoma
- Rheumatoid arthritis
- Breast cancer
- Ovarian cancer
- Multiple myeloma
- Leukemia
- Lymphoma
Find a Clinic Near You
Who Is Running the Clinical Trial?
University Health Network, Toronto
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
ImmunoVaccine Technologies, Inc. (IMV Inc.)
Industry Sponsor