Phase 2 Study of Pembrolizumab, DPX-Survivac Vaccine and Cyclophosphamide in Advanced Ovarian, Primary Peritoneal or Fallopian Tube Cancer

NCT03029403 | Active Not Recruiting Phase 2 DMC

• 1 other identifier: PESCO
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Advanced Cancer; Ovarian Cancer; Primary Peritoneal Carcinoma; Fallopian Tube Cancer

Outcome Measures

Primary Outcomes (1)

• Overall response rate (ORR)

  ORR will be used to evaluate the clinical anti-tumor activity of Pembrolizumab, DPX Survivac and oral cyclophosphamide combination.

  5 years

Secondary Outcomes (3)

• Progression free survival (PFS) rate

  5 years

• Overall survival (OS) rate

  5 years

• Number of side effects

  5 years

Study Arms (4)

Dose Escalation

EXPERIMENTAL

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

Drug: Pembrolizumab; Biological: DPX-Survivac; Drug: Cyclophosphamide

Dose Expansion - Cohort A

EXPERIMENTAL

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

Drug: Pembrolizumab; Biological: DPX-Survivac; Drug: Cyclophosphamide

Dose Expansion - Cohort B

EXPERIMENTAL

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

Drug: Pembrolizumab; Biological: DPX-Survivac; Drug: Cyclophosphamide

Dose Expansion - Cohort C

EXPERIMENTAL

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.

Drug: Pembrolizumab; Biological: DPX-Survivac; Drug: Cyclophosphamide

Interventions

Pembrolizumab DRUG

Given intravenously in clinic, at 200 mg, on Day 1 of every 21-day cycle.

Also known as: Keytruda

Dose Escalation; Dose Expansion - Cohort A; Dose Expansion - Cohort B; Dose Expansion - Cohort C

DPX-Survivac BIOLOGICAL

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.

Dose Escalation; Dose Expansion - Cohort A; Dose Expansion - Cohort B; Dose Expansion - Cohort C

Cyclophosphamide DRUG

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.

Also known as: Procytox

Dose Escalation; Dose Expansion - Cohort A; Dose Expansion - Cohort B; Dose Expansion - Cohort C

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Health Network, Toronto: lead
• Merck Sharp & Dohme LLC: collaborator
• ImmunoVaccine Technologies, Inc. (IMV Inc.): collaborator

Study Sites (1)

Princess Margaret Cancer Centre

Toronto, Ontario, M5G 2M9, Canada

Location

MeSH Terms

Conditions

Ovarian Neoplasms; Fallopian Tube Neoplasms

Interventions

pembrolizumab; Cyclophosphamide

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Fallopian Tube Diseases

Intervention Hierarchy (Ancestors)

Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds

Study Officials

• Amit Oza, M.D.

  Princess Margaret Cancer Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 20, 2017
• First Posted: January 24, 2017
• Study Start: February 12, 2018
• Primary Completion: December 12, 2025
• Study Completion: April 12, 2026
• Last Updated: September 19, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)