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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.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years
Awards & highlights
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.
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.Check my eligibility
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.See study design
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 belowSelect...
My cancer is in the ovary, peritoneum, or fallopian tube and confirmed by a lab test.
Select...
I had platinum-based chemotherapy after surgery and my cancer has come back.
Select...
I am fully active and can carry on all pre-disease activities without restriction.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 years
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
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
1995
Completed Phase 3
~3780
Pembrolizumab
2017
Completed Phase 2
~2010
DPX-Survivac
2013
Completed Phase 2
~90
Find a Location
Who is running the clinical trial?
University Health Network, TorontoLead Sponsor
1,468 Previous Clinical Trials
484,472 Total Patients Enrolled
14 Trials studying Ovarian Cancer
3,436 Patients Enrolled for Ovarian Cancer
Merck Sharp & Dohme LLCIndustry Sponsor
3,886 Previous Clinical Trials
5,054,524 Total Patients Enrolled
41 Trials studying Ovarian Cancer
6,553 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
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My cancer is in the ovary, peritoneum, or fallopian tube and confirmed by a lab test.I had platinum-based chemotherapy after surgery and my cancer has come back.I have an autoimmune disease but it's not diabetes or vitiligo.I am not allergic to Pembrolizumab, DPX-Survivac, Cyclophosphamide, or their ingredients.I have previously been treated with specific immune therapies or a DPX-Survivac vaccine.I have an active tuberculosis infection.I agree to provide tumor samples before and during treatment.I can provide samples of my tumor for testing.I have not received a live vaccine in the last 30 days.I have had thyroiditis in the last 5 years.I have active brain metastases or carcinomatous meningitis.I haven't taken steroids or immunosuppressants in the last 7 days.I am fully active and can carry on all pre-disease activities without restriction.
Research Study Groups:
This trial has the following groups:- Group 1: Dose Escalation
- Group 2: Dose Expansion - Cohort A
- Group 3: Dose Expansion - Cohort B
- Group 4: Dose Expansion - Cohort C
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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
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