Pembrolizumab: Given intravenously in clinic, at 200 mg, on Day 1 of every 21-day cycle.
DPX-Survivac: Given by injection under the skin of the upper thigh in clinic. Participants will receive one priming dose of 0.25 mL of DPX-Survivac on Cycle 1 Day 1. After about 6 weeks, participants will receive an additional boosting dose of 0.25 or 0.5 mL DPX-Survivac.
Cyclophosphamide: Given orally, at 50 mg, twice a day, starting about 7 days before Cycle 1 Day 1, then continue 7 days off, 7 days on.
Study summary
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.
Eligibility
Sex
FEMALE
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
* Patients must have histologically or cytologically confirmed advanced epithelial ovarian, primary peritoneal or fallopian tube carcinomas.
* Patients must have radiologically documented disease progression from their prior line of therapy.
* Patients must have measurable disease based on RECIST 1.1.
* Have received a front line platinum-based regimen (administered via either IV or IP) following primary or interval debulking surgery with documented disease recurrence.
* Have fulfilled the following additional requirements regarding prior treatments depending on the cohort that the patient is to be enrolled in.
* Eastern Cooperative Group (ECOG) performance status \<=1.
* Life expectancy greater than 16 weeks.
* Availability of archival tumor tissue samples. Additional samples may be requested if tumor tissue provided is not adequate for quality and/or quantity as assessed by the laboratory.
* Be willing to provide tumor tissue from a newly obtained core or excisional biopsy prior to start treatment and on day 15 of cycle 1.
Exclusion Criteria:
* Patients who are receiving any other investigational agents.
* Diagnosis of immunodeficiency or therapy with systemic steroid or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment.
* History of autoimmune disease, such as but not restricted to, rheumatoid arthritis, inflammatory bowel disease, systemic lupus erythematous, ankylosing spondylitis, scleroderma, or multiple sclerosis requiring treatment within the last two years. Patients with vitiligo or diabetes are not excluded.
* Patients with history of thyroiditis within 5 years.
* Patients with known history of active TB (Bacillus Tuberculosis).
* Patients with known active central nervous system (CNS) metastases and/or carcinomatous meningitis.
* Hypersensitivity to Pembrolizumab, DPX-Survivac immunovaccine, Cyclophosphamide or any of their excipients.
* Patients that have received a live vaccine within 30 days of planned start of study therapy.
* Prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2 agent or DPX-Survivac vaccine.
Primary outcome measure(s)
Overall response rate (ORR) — 5 years ORR will be used to evaluate the clinical anti-tumor activity of Pembrolizumab, DPX Survivac and oral cyclophosphamide combination.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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