Combination Immunotherapy for Ovarian Cancer
Trial Summary
What is the purpose of this trial?
This is a phase 2 study whose purpose is to see whether the combination of of pembrolizumab, DPX-Survivac vaccine and low-dose cyclophosphamide has anti-tumor activity in patients with advanced epithelial ovarian, fallopian tube or primary peritoneal cancer. DPX-Survivac is an investigational vaccine. A vaccine is a substance that is often given to stimulate the body's immune system (the structure and processes in the body that protects against harmful substances) to help prevent against certain diseases. DPX-Survivac is a vaccine that may teach the immune system to recognize cancer cells and to kill them. Pembrolizumab is a drug that is approved for the treatment of a certain type of melanoma (a type of skin cancer) and non-small cell lung cancer. Pembrolizumab blocks the function of a protein called programmed cell death receptor-1 (PD-1). PD-1 works by keeping the immune system from destroying cancer cells. Stopping PD-1 from working may help the immune system to fight cancer cells. Cyclophosphamide is chemotherapy drug that is approved for the treatment of various cancers alone and in combination with other drugs.
Research Team
Amit Oza, MD
Principal Investigator
Princess Margaret Cancer Centre
Eligibility Criteria
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
Treatment Details
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