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| Name | Class |
|---|---|
| Merck Sharp & Dohme LLC | INDUSTRY |
| ImmunoVaccine Technologies, Inc. (IMV Inc.) | INDUSTRY |
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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.
This study has two phases: a dose escalation phase and a dose expansion phase.
For the dose escalation part, groups of participants will receive one of two dose levels of study drugs to determine the best dose level for further testing.
Once the best dose level is found, additional participant will be enrolled to the dose expansion to further test the safety, tolerability, and efficacy of the study drugs at that dose level in specific types of cancers. All participants will receive pembrolizumab, DPX-Survivac, and low-dose cyclophosphamide.
Participants will be screened for eligibility by standard safety tests and procedures within 28 days of the start of the study drug. Tests and procedures done for research purposes only during this time include archival tumor tissue collection, fresh research biopsy, and blood sample collection for biomarker/genetic/immune research. Participants will also be asked if they agree to an optional fresh research biopsy at disease progression
Eligible participants will receive the following every 21 day cycle:
While receiving the study treatment, participants will be asked to visit the study site on Day 1 of Cycles 1-8 for tests and procedures. Tests and procedures done for research purposes only include additional blood sample collection and a second fresh research biopsy for biomarker/genetic/immune research.
Participants who benefit from the study treatment may be able to receive additional treatment if they progress after stopping the study treatment.
When participants are taken off the study treatment permanently, they will be asked to return to the study site for an End of Study Treatment visit about 30 days after stopping the study treatment to have tests and procedures done for safety purposes.
Participants who are taken off the study treatment for any reason other than disease progression will continue to have radiological assessments and blood draws every 12 weeks for the first year and every 24 weeks after year 1 until they start a new anti-cancer treatment, disease progression, or the study ends. Participants will continue to be followed for survival and to review any new anti-cancer therapies every 12 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dose Escalation | Experimental | Patients with epithelial ovarian, fallopian tube or primary peritoneal cancer. |
|
| Dose Expansion - Cohort A | Experimental | Patients with platinum-sensitive epithelial ovarian, fallopian tube or primary peritoneal cancer. |
|
| Dose Expansion - Cohort B | Experimental | Patients with platinum-resistant epithelial ovarian, fallopian tube or primary peritoneal cancer. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pembrolizumab | Drug | Given intravenously in clinic, at 200 mg, on Day 1 of every 21-day cycle. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Progression free survival (PFS) rate | PFS rate from start of study treatment to time of progression or death whichever comes first | 5 years |
| Overall survival (OS) rate | OS rate from start of study treatment until death for every cause |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Amit Oza, M.D. | Princess Margaret Cancer Centre | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Princess Margaret Cancer Centre | Toronto | Ontario | M5G 2M9 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42129168 | Derived | Veneziani AC, Lheureux S, Millar DG, Dhani N, Colombo I, Madariaga A, Soberanis Pina P, Atale S, Chan YL, Lee J, Ramsahai J, Quintos J, Wang L, Li X, Bowering V, Ohashi P, Wang B, Oza AM. Maveropepimut-S, pembrolizumab and low dose cyclophosphamide in metastatic ovarian cancer: phase 1/2 PESCO trial. Nat Commun. 2026 May 14. doi: 10.1038/s41467-026-72125-0. Online ahead of print. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Sep 25, 2025 | |
| Reset | Oct 22, 2025 |
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|
| 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. |
|
| 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. |
|
|
| 5 years |
| Number of side effects | Adverse events will be analyzed as safety parameters | 5 years |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Sep 25, 2025 | Oct 22, 2025 | |||
| Jun 17, 2026 |
| ID | Term |
|---|---|
| D010051 | Ovarian Neoplasms |
| D005185 | Fallopian Tube Neoplasms |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
| D005184 | Fallopian Tube Diseases |
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| ID | Term |
|---|---|
| C582435 | pembrolizumab |
| D003520 | Cyclophosphamide |
| ID | Term |
|---|---|
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
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