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Chemotherapy

Combination Immunotherapy for Ovarian Cancer

Phase 2

Waitlist Available

Led By Amit Oza, M.D.

Research Sponsored by University Health Network, Toronto

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients must have histologically or cytologically confirmed advanced epithelial ovarian, primary peritoneal or fallopian tube carcinomas.

Have received a front line platinum-based regimen (administered via either IV or IP) following primary or interval debulking surgery with documented disease recurrence.

Must not have

Hypersensitivity to Pembrolizumab, DPX-Survivac immunovaccine, Cyclophosphamide or any of their excipients.

Prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2 agent or DPX-Survivac vaccine.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial will test whether the combination 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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects include typical reactions from immune therapies such as fatigue, skin reactions, inflammation of organs; from vaccines like soreness at injection site; and from chemotherapy including nausea, hair loss and increased risk of infections.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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

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I am fully active and can carry on all pre-disease activities without restriction.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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

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I have an active tuberculosis infection.

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I have active brain metastases or carcinomatous meningitis.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Overall response rate (ORR)

Secondary study objectives

Number of side effects

Overall survival (OS) rate

Progression free survival (PFS) rate

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Cyclophosphamide

2010