Combination Immunotherapy for Ovarian Cancer

Recruiting in Palo Alto (17 mi)

Overseen byAmit Oza, MD

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: University Health Network, Toronto

No Placebo Group

Prior Safety Data

Breakthrough Therapy

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.

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

My cancer is in the ovary, peritoneum, or fallopian tube and confirmed by a lab test.

I had platinum-based chemotherapy after surgery and my cancer has come back.

I agree to provide tumor samples before and during treatment.

+6 more

Exclusion Criteria

I have an autoimmune disease but it's not diabetes or vitiligo.

I am not allergic to Pembrolizumab, DPX-Survivac, Cyclophosphamide, or their ingredients.

I have previously been treated with specific immune therapies or a DPX-Survivac vaccine.

+6 more

Participant Groups

The study tests if pembrolizumab (a drug that helps the immune system fight cancer cells by blocking PD-1 protein) combined with DPX-Survivac vaccine (which may teach the immune system to kill cancer cells) and low-dose cyclophosphamide (a chemotherapy drug) can effectively treat these cancers. It's a phase 2 trial focusing on anti-tumor activity.

4Treatment groups

Experimental Treatment

Group I: Dose Expansion - Cohort CExperimental Treatment3 Interventions

Patients with recurrent advanced epithelial ovarian, fallopian tube and primary peritoneal patients with uncommon tumor histologies, including clear cell, mucinous and low grade serous or low grade endometrioid ovarian subtypes.

Group II: Dose Expansion - Cohort BExperimental Treatment3 Interventions

Patients with platinum-resistant epithelial ovarian, fallopian tube or primary peritoneal cancer.

Group III: Dose Expansion - Cohort AExperimental Treatment3 Interventions

Patients with platinum-sensitive epithelial ovarian, fallopian tube or primary peritoneal cancer.

Group IV: Dose EscalationExperimental Treatment3 Interventions

Patients with epithelial ovarian, fallopian tube or primary peritoneal cancer.

Cyclophosphamide is already approved in United States, European Union, Canada, Japan for the following indications:

🇺🇸 Approved in United States as Cytoxan for: