Combination Immunotherapy for Ovarian Cancer

Overseen By Amit Oza, MD

Age: 18+

Sex: Female

Trial Phase: Phase 2

Sponsor: University Health Network, Toronto

Must not be taking: Immunosuppressants, Steroids, Live vaccines

Disqualifiers: Autoimmune disease, CNS metastases, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 29

47 Participants Needed

What You Need to Know Before You Apply

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.

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

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.

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.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

4 weeks

1 visit (in-person)

Dose Escalation

Participants receive one of two dose levels of study drugs to determine the best dose level for further testing

8 weeks

8 visits (in-person)

Dose Expansion

Additional participants are enrolled to further test the safety, tolerability, and efficacy of the study drugs at the determined dose level

24 weeks

8 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

52 weeks

Every 12 weeks for the first year, then every 24 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Cyclophosphamide
• DPX-Survivac
• Pembrolizumab

Trial Overview 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.

How Is the Trial Designed?

Group I: Dose Expansion - Cohort C Experimental Treatment 3 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 B Experimental Treatment 3 Interventions

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

Group III: Dose Expansion - Cohort A Experimental Treatment 3 Interventions

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

Group IV: Dose Escalation Experimental Treatment 3 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:

• Breast cancer
• Ovarian cancer
• Multiple myeloma
• Leukemia
• Lymphoma
• Rheumatoid arthritis

Approved in European Union as Endoxan for:

• Breast cancer
• Ovarian cancer
• Multiple myeloma
• Leukemia
• Lymphoma
• Rheumatoid arthritis

Approved in Canada as Neosar for:

• Breast cancer
• Ovarian cancer
• Multiple myeloma
• Leukemia
• Lymphoma
• Rheumatoid arthritis

Approved in Japan as Endoxan for:

• Breast cancer
• Ovarian cancer
• Multiple myeloma
• Leukemia
• Lymphoma

Who Is Running the Clinical Trial?

University Health Network, Toronto

Lead Sponsor

Trials

1,555

Recruited

526,000+

Merck Sharp & Dohme LLC

Industry Sponsor

Trials

4,096

Recruited

5,232,000+

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

Trials

11

Recruited

580+