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T cell activating therapy
Immunotherapy for Ovarian Cancer
Phase 1 & 2
Waitlist Available
Research Sponsored by ImmunoVaccine Technologies, Inc. (IMV Inc.)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Must have evidence of progressive disease with either biochemical (i.e. rising CA-125) and/or radiologic progression
Must have measurable disease by RECIST v1.1, a successful pre-treatment tumor biopsy, and be willing to undergo tumor biopsy during treatment
Must not have
Prior receipt of survivin based vaccines or immune checkpoint inhibitors (e.g. anti-CTLA-4, anti-PD-1, anti-PD-L1, or any other antibody or drug specifically targeting T cell co-stimulation) or an IDO inhibitor
Receipt of live attenuated vaccines
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 13 months
Awards & highlights
Approved for 20 Other Conditions
No Placebo-Only Group
Summary
This trial will test the safety and potential effectiveness of combining three immunotherapy treatments for ovarian cancer.
Who is the study for?
This trial is for patients with recurrent ovarian, fallopian tube, or peritoneal cancer who have completed first-line treatment and may have had subsequent chemotherapy. They should be able to perform daily activities (ECOG 0-1), have a life expectancy of at least 6 months, measurable disease, and no history of certain autoimmune diseases or other serious conditions.
What is being tested?
The study tests the combination of DPX-Survivac therapy with low dose oral cyclophosphamide and IDO1 inhibitor epacadostat in patients. It aims to assess safety and how well these treatments can modulate the immune system against cancer cells.
What are the potential side effects?
Potential side effects include reactions related to immune activation such as inflammation, possible infection risks due to immunosuppression from cyclophosphamide, gastrointestinal issues from oral agents' absorption problems, and any specific side effects related to epacadostat.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My cancer is getting worse, shown by tests or scans.
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My cancer can be measured and I agree to have tumor biopsies before and during treatment.
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I can carry out all my daily activities without help.
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My cancer is in the ovary, fallopian tube, or peritoneum and is advanced.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have not received vaccines or drugs targeting immune checkpoints or IDO inhibitors.
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I have received a live vaccine recently.
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I have a skin or blood vessel disorder.
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I have fluid buildup in my abdomen.
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I have a blockage in my intestine caused by cancer.
Select...
I have recently had thyroid inflammation.
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I have severe swelling in my legs.
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I have a digestive condition that affects how my body absorbs medication taken by mouth.
Select...
My cancer has spread to my brain or its coverings.
Select...
I am currently taking or have recently taken MAOIs or UGT1A9 inhibitors.
Select...
I am currently dealing with a serious infection.
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I am currently on steroids or other drugs that weaken my immune system.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 13 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 13 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Objective Response Rate (Phase 2 only)
Secondary study objectives
Objective Response Rate (for each treatment group)
Awards & Highlights
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
2Treatment groups
Experimental Treatment
Group I: Arm 2Experimental Treatment2 Interventions
DPX-Survivac, Cyclophosphamide (in Phase 2 only)
Group II: Arm 1Experimental Treatment3 Interventions
DPX-Survivac, Cyclophosphamide, Epacadostat (Phase 1 and initially Phase 2)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cyclophosphamide
FDA approved
Find a Location
Who is running the clinical trial?
ImmunoVaccine Technologies, Inc. (IMV Inc.)Lead Sponsor
10 Previous Clinical Trials
497 Total Patients Enrolled
3 Trials studying Ovarian Cancer
250 Patients Enrolled for Ovarian Cancer
Incyte CorporationIndustry Sponsor
393 Previous Clinical Trials
63,881 Total Patients Enrolled
8 Trials studying Ovarian Cancer
1,104 Patients Enrolled for Ovarian Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You meet the specific lab test requirements outlined in the study.I have not received vaccines or drugs targeting immune checkpoints or IDO inhibitors.I have received a live vaccine recently.I have a skin or blood vessel disorder.My cancer is getting worse, shown by tests or scans.My cancer can be measured and I agree to have tumor biopsies before and during treatment.I can carry out all my daily activities without help.I have completed first-line treatment for my cancer, including surgery and chemotherapy.I have fluid buildup in my abdomen.You have a tumor that is 4 centimeters or larger.I have a blockage in my intestine caused by cancer.I have recently had thyroid inflammation.I have severe swelling in my legs.My cancer is in the ovary, fallopian tube, or peritoneum and is advanced.I have a digestive condition that affects how my body absorbs medication taken by mouth.My cancer has spread to my brain or its coverings.I do not have any cancer other than non-serious skin, cervical, or controlled bladder cancer.I am eligible for or currently receiving treatment aimed at curing my condition.I am currently taking or have recently taken MAOIs or UGT1A9 inhibitors.I am currently dealing with a serious infection.I have not been treated for an autoimmune disease in the last 2 years, except for vitiligo or diabetes.You are expected to live for at least 6 more months.I haven't had a heart attack or stroke in the last 6 months.I am currently on steroids or other drugs that weaken my immune system.
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.
Awards:
This trial has 2 awards, including:- 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.
Research Study Groups:
This trial has the following groups:- Group 1: Arm 1
- Group 2: Arm 2