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Chemotherapy

Pembrolizumab for Ovarian Cancer

Princess Margaret Cancer Centre, Toronto, Canada
Targeting 4 different conditionsPembrolizumab +2 morePhase 2Waitlist AvailableLed by Amit Oza, M.D.Research Sponsored by University Health Network, Toronto

Study 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.

Eligible Conditions
  • Cancer
  • Ovarian Cancer
  • Peritoneal Carcinoma

Eligibility Criteria

Inclusion Criteria

You will be eligible if you check “Yes” for the criteria below
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Your previous treatment did not stop the growth of your disease, as shown on medical scans.
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You have already received a platinum-based treatment as the first option after surgery, and your cancer has come back.
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You are expected to live for more than 16 weeks.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Overall response rate (ORR)
Secondary outcome measures
Number of side effects
Overall survival (OS) rate
Progression free survival (PFS) rate

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 20 Other Conditions
This treatment demonstrated efficacy for 20 other conditions.
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
FDA approved
Pembrolizumab
FDA approved
DPX-Survivac
2013
Completed Phase 2
~90

Find a site

Who is running the clinical trial?

University Health Network, TorontoLead Sponsor
1,412 Previous Clinical Trials
481,456 Total Patients Enrolled
13 Trials studying Ovarian Cancer
3,435 Patients Enrolled for Ovarian Cancer
Merck Sharp & Dohme LLCIndustry Sponsor
3,775 Previous Clinical Trials
4,984,985 Total Patients Enrolled
39 Trials studying Ovarian Cancer
6,369 Patients Enrolled for Ovarian Cancer
ImmunoVaccine Technologies, Inc. (IMV Inc.)Industry Sponsor
10 Previous Clinical Trials
535 Total Patients Enrolled
2 Trials studying Ovarian Cancer
203 Patients Enrolled for Ovarian Cancer
Amit Oza, M.D.Principal Investigator
Princess Margaret Cancer Centre
8 Previous Clinical Trials
1,282 Total Patients Enrolled
3 Trials studying Ovarian Cancer
109 Patients Enrolled for Ovarian Cancer

Media Library

Cyclophosphamide (Chemotherapy) Clinical Trial Eligibility Overview. Trial Name: NCT03029403 — Phase 2
Ovarian Cancer Research Study Groups: Dose Expansion - Cohort A, Dose Escalation, Dose Expansion - Cohort B, Dose Expansion - Cohort C
Ovarian Cancer Clinical Trial 2023: Cyclophosphamide Highlights & Side Effects. Trial Name: NCT03029403 — Phase 2
Cyclophosphamide (Chemotherapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03029403 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there currently openings for participation in this research program?

"According to the clinicaltrials.gov records, this experiment is still searching for participants and has been actively doing so since its initial post date of February 12th 2018. The details of the trial were last updated on November 29th 2021."

Answered by AI

How many volunteers are engaging in the trial?

"Affirmative. According to clinicaltrials.gov, this study is actively seeking out individuals as of November 29th 2021. Since it was first posted on February 12th 2018, the clinic has been searching for 42 volunteers at a single site."

Answered by AI

What do doctors typically use Pembrolizumab for?

"Pembrolizumab is the go-to medication for treating a wide range of malignancies, such as melanoma of the skin, cervical cancer that recurs, leukemia and refractory/relapsed mediastinal large B cell lymphoma."

Answered by AI

What safety protocols are in place regarding the administration of Pembrolizumab?

"Even though data on Pembrolizumab's efficacy is currently lacking, its safety has been partially studied and thus receives a score of 2."

Answered by AI

Can you offer a synopsis of prior experiments involving Pembrolizumab?

"As of now, research into pembrolizumab is ongoing with 1746 live studies and 274 Phase 3 trials taking place. Philadelphia, Pennsylvania is the epicentre for many of these assessments but Pembrolimzab clinical trials are also active in 62,797 different locations worldwide."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Phase 2 Study of Pembrolizumab, DPX-Survivac Vaccine and Cyclophosphamide in Advanced Ovarian, Primary Peritoneal or Fallopian Tube Cancer
2018. "Phase 2 Study of Pembrolizumab, DPX-Survivac Vaccine and Cyclophosphamide in Advanced Ovarian, Primary Peritoneal or Fallopian Tube Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03029403.
~1 spots leftby Dec 2023
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