Advanced CancerPhase 2NCT03029403
Phase 2 Study of Pembrolizumab, DPX-Survivac Vaccine and Cyclophosphamide in Advanced Ovarian, Primary Peritoneal or Fallopian Tube Cancer
A Phase 2 study testing Pembrolizumab, DPX-Survivac and Cyclophosphamide in people with Advanced Cancer and Ovarian Cancer, run by University Health Network, Toronto at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Advanced Cancer, Ovarian Cancer, Primary Peritoneal Carcinoma
- What is being tested?
- Pembrolizumab, DPX-Survivac and Cyclophosphamide
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 1 siteCanada
- Study dates
- 12 Feb 2018to 12 Apr 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 2 Study of Pembrolizumab (MK-3475), DPX-Survivac Vaccine and Low Dose of Cyclophosphamide Combination in Patients With Advanced Ovarian, Primary Peritoneal or Fallopian Tube Cancer
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.
Read more
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.
Read the detailed description
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:
- Pembrolizumab, intravenously, at 200 mg, on Day 1 of every cycle.
- DPX-Survivac, 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 depending on the assigned dose level.
- Cyclophosphamide, orally, at 50 mg, twice a day, starting about 7 days before Cycle 1 Day 1, then continue 7 days off, 7 days on.
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.
- Being tested
- Pembrolizumab, DPX-Survivac, Cyclophosphamide
- Medical subject headings
- Ovarian Neoplasms, Fallopian Tube Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PembrolizumabDrug
Also called Keytruda
Given intravenously in clinic, at 200 mg, on Day 1 of every 21-day cycle.
DPX-SurvivacBiological
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.
CyclophosphamideDrug
Also called Procytox
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.
| Study group | Role | What they receive |
|---|---|---|
| Dose Escalation | Experimental | Patients with epithelial ovarian, fallopian tube or primary peritoneal cancer. Receives: Drug: Pembrolizumab; Biological: DPX-Survivac; Drug: Cyclophosphamide |
| Dose Expansion - Cohort A | Experimental | Patients with platinum-sensitive epithelial ovarian, fallopian tube or primary peritoneal cancer. Receives: Drug: Pembrolizumab; Biological: DPX-Survivac; Drug: Cyclophosphamide |
| Dose Expansion - Cohort B | Experimental | Patients with platinum-resistant epithelial ovarian, fallopian tube or primary peritoneal cancer. Receives: 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. Receives: Drug: Pembrolizumab; Biological: DPX-Survivac; Drug: Cyclophosphamide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall response rate (ORR)
ORR will be used to evaluate the clinical anti-tumor activity of Pembrolizumab, DPX Survivac and oral cyclophosphamide combination.
Measured: 5 years
Secondary outcomes (3)
Progression free survival (PFS) rate
PFS rate from start of study treatment to time of progression or death whichever comes first
Measured: 5 years
Overall survival (OS) rate
OS rate from start of study treatment until death for every cause
Measured: 5 years
Number of side effects
Adverse events will be analyzed as safety parameters
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2017 (estimated)
- Study start12 Feb 2018
- Primary completion12 Dec 2025 (estimated)
- Study completion12 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Advanced CancerStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC, ImmunoVaccine Technologies, Inc. (IMV Inc.)
- Responsible party
- Sponsor
- Investigators
- Amit Oza, M.D., Principal investigator, Princess Margaret Cancer Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03029403
- Sponsor's protocol ID
- PESCO
- Status last verified
- Sep 2025
- First submitted
- 20 Jan 2017
- Last updated
- 19 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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;17(1):6416. doi: 10.1038/s41467-026-72125-0.
PubMed 42129168
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Study of Pembrolizumab (MK-3475), DPX-Survivac Vaccine and Low Dose of Cyclophosphamide Combination in Patients With Advanced Ovarian, Primary Peritoneal or Fallopian Tube Cancer
- ClinicalTrials.gov ID
- NCT03029403
- Acronym / sponsor ID
- PESCO
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 47 participants (actual)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC, ImmunoVaccine Technologies, Inc. (IMV Inc.)
- Study start
- 12 Feb 2018 (actual)
- Primary completion
- 12 Dec 2025 (estimated)
- Study completion
- 12 Apr 2026 (estimated)
- First posted
- 24 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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:
- Pembrolizumab, intravenously, at 200 mg, on Day 1 of every cycle.
- DPX-Survivac, 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 depending on the assigned dose level.
- Cyclophosphamide, orally, at 50 mg, twice a day, starting about 7 days before Cycle 1 Day 1, then continue 7 days off, 7 days on.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Dose Escalation | Experimental | Drug: Pembrolizumab, Biological: DPX-Survivac, Drug: CyclophosphamidePatients with epithelial ovarian, fallopian tube or primary peritoneal cancer. |
| Dose Expansion - Cohort A | Experimental | Drug: Pembrolizumab, Biological: DPX-Survivac, Drug: CyclophosphamidePatients with platinum-sensitive epithelial ovarian, fallopian tube or primary peritoneal cancer. |
| Dose Expansion - Cohort B | Experimental | Drug: Pembrolizumab, Biological: DPX-Survivac, Drug: CyclophosphamidePatients with platinum-resistant epithelial ovarian, fallopian tube or primary peritoneal cancer. |
| Dose Expansion - Cohort C | Experimental | Drug: Pembrolizumab, Biological: DPX-Survivac, Drug: CyclophosphamidePatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (9 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PembrolizumabAlso: KeytrudaGiven intravenously in clinic, at 200 mg, on Day 1 of every 21-day cycle. | Drug | Dose Escalation, Dose Expansion - Cohort A, Dose Expansion - Cohort B, Dose Expansion - Cohort C |
| DPX-SurvivacGiven 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. | Biological | Dose Escalation, Dose Expansion - Cohort A, Dose Expansion - Cohort B, Dose Expansion - Cohort C |
| CyclophosphamideAlso: ProcytoxGiven orally, at 50 mg, twice a day, starting about 7 days before Cycle 1 Day 1, then continue 7 days off, 7 days on. | Drug | Dose Escalation, Dose Expansion - Cohort A, Dose Expansion - Cohort B, Dose Expansion - Cohort C |
Primary outcome
Overall response rate (ORR)
Time frame: 5 years
ORR will be used to evaluate the clinical anti-tumor activity of Pembrolizumab, DPX Survivac and oral cyclophosphamide combination.
3 secondary outcomes
Progression free survival (PFS) rate
Time frame: 5 years
Overall survival (OS) rate
Time frame: 5 years
Number of side effects
Time frame: 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2025.
- Derived from this study: PubMed 42129168Veneziani 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;17(1):6416. doi: 10.1038/s41467-026-72125-0.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amit Oza, M.D. principal investigator
Princess Margaret Cancer Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Pembrolizumab, DPX-Survivac and Cyclophosphamide in people with Advanced Cancer and Ovarian Cancer, run by University Health Network, Toronto at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 19 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall response rate (ORR) (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03029403, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2025.