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Alkylating agents
DPX-Survivac + Immunotherapy for Advanced Cancers
Phase 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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up approximately 24 months
Awards & highlights
No Placebo-Only Group
Summary
This trial will test a new cancer treatment involving two drugs and immunotherapy. The goal is to see if it is safe and effective for treating certain types of advanced and recurrent solid tumors.
Who is the study for?
This trial is for adults with certain advanced cancers (ovarian, liver, lung, bladder or those with high microsatellite instability) who've finished first-line therapy. They must have a life expectancy of at least 6 months and be relatively mobile (ECOG 0-1). People can't join if they're on steroids/immunosuppressants, had recent radiotherapy or certain cancer mutations, serious infections/transplants, other malignancies or conditions that could interfere with the treatment.
What is being tested?
The study tests DPX-Survivac combined with low dose Cyclophosphamide and Pembrolizumab to see how safe and effective it is against selected advanced solid tumors. Participants will receive this combination therapy to evaluate its impact on their cancer's progression.
What are the potential side effects?
Possible side effects include immune-related reactions such as inflammation in organs; infusion reactions; fatigue; blood disorders; increased risk of infection; allergic responses to pembrolizumab; digestive issues possibly affecting absorption of oral medications.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ approximately 24 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~approximately 24 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Efficacy as measured by objective response rate
Safety as measured by the rate of adverse events
Secondary study objectives
Objective response rate
Other study objectives
Cell mediated immunology
Changes in immune cell infiltration
Awards & Highlights
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 2 (Ovarian cohort only)Experimental Treatment2 Interventions
DPX-Survivac, Pembrolizumab
Group II: Arm 1 (All cohorts)Experimental Treatment3 Interventions
DPX-Survivac, Cyclophosphamide, Pembrolizumab
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cyclophosphamide
2010
Completed Phase 4
~2310
Pembrolizumab
2017
Completed Phase 3
~3150
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Who is running the clinical trial?
Merck Sharp & Dohme LLCIndustry Sponsor
4,010 Previous Clinical Trials
5,185,059 Total Patients Enrolled
6 Trials studying Microsatellite Instability
1,763 Patients Enrolled for Microsatellite Instability
ImmunoVaccine Technologies, Inc. (IMV Inc.)Lead Sponsor
10 Previous Clinical Trials
398 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have received a transplanted organ or tissue from another person.You recently received vaccines that contain weakened viruses.You are expected to live for at least 6 more months.You have current or ongoing skin or blood vessel problems.You have significant swelling in your legs or feet.You have received a vaccine or other treatments that target survivin or boost the immune system in the past.You have another type of cancer, except for non-melanoma skin cancer, early-stage cervical cancer, or controlled bladder cancer.You have a buildup of fluid in your abdomen or chest that cannot be treated or controlled.You have a blockage in your intestines that is caused by cancer or a recent history of such a blockage.You have an autoimmune disease that needed treatment within the past two years (except for replacement therapy).You have recently had thyroid inflammation.You have a history of lung inflammation or currently have lung inflammation that needs treatment with steroids.You have cancer that has spread to your brain or the membranes surrounding your brain.You have a stomach or intestinal condition that may make it difficult for your body to absorb medicine taken by mouth.You have recently had a heart attack or stroke, or you have other serious ongoing health problems.You have a severe allergic reaction (Grade 3 or higher) to pembrolizumab.You have received chemotherapy or immunotherapy within the past 28 days before the study.You have previously been treated with a medication that affects the immune system and had severe side effects (Grade 3 or higher).You have advanced or spreading solid tumors and have already finished your initial treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Arm 1 (All cohorts)
- Group 2: Arm 2 (Ovarian cohort only)
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.
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