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PD-1/PD-L1 Inhibitor
NY-ESO-1 Vaccine + Nivolumab for Ovarian Cancer
Phase 2
Waitlist Available
Led By Samir N Khleif, MD
Research Sponsored by Georgetown University
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 2 years
Awards & highlights
Study Summary
This trial is testing a new vaccine for ovarian cancer patients who haven't responded to other treatments.
Who is the study for?
This trial is for women aged 18 or older with stage III/IV platinum-refractory ovarian cancer who have progressed on standard treatment, including those with BRCA mutations. Participants must have recovered from recent surgery or therapy, not be on active infection antibiotics (except simple UTI), and agree to use effective contraception. Exclusions include prior nivolumab or similar therapies, autoimmune diseases within the past 2 years, other concurrent clinical trials, and certain medical conditions.Check my eligibility
What is being tested?
The study tests a combination of NY-ESO-1 Peptide vaccine and Nivolumab in patients with advanced ovarian cancer resistant to platinum-based chemotherapy. It's an open-label phase II trial aiming to prevent resistance to anti-PD-1 therapy by using the vaccine as a priming agent before administering Nivolumab.See study design
What are the potential side effects?
Potential side effects may include typical immune-related reactions such as inflammation in various organs due to immune system activation by Nivolumab. The NY-ESO-1 vaccine could cause injection site reactions, flu-like symptoms including fever and chills, fatigue, muscle pain, and possible allergic responses.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Median Progression Free Survival
Secondary outcome measures
Disease Control Rate
Duration of Response
Incidence of Adverse Events (AE)
+2 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: NY-ESO-1 Peptide vaccine plus NivolumabExperimental Treatment2 Interventions
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nivolumab
2014
Completed Phase 3
~4750
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for ovarian cancer include chemotherapy, targeted therapy, and immunotherapy. Chemotherapy, such as carboplatin and paclitaxel, works by damaging the DNA of rapidly dividing cancer cells, leading to cell death.
Targeted therapies, like PARP inhibitors, exploit specific genetic vulnerabilities in cancer cells, such as BRCA mutations, to prevent DNA repair and induce cell death. Immunotherapy, including anti-PD1 agents like nivolumab, enhances the immune system's ability to recognize and destroy cancer cells.
The NY-ESO-1 peptide vaccine, studied as a priming mechanism, aims to prevent resistance to anti-PD1 therapy by stimulating an immune response against cancer cells expressing the NY-ESO-1 antigen. This is crucial for ovarian cancer patients as it may improve the efficacy of immunotherapy and prolong progression-free survival.
Defining the molecular response to trastuzumab, pertuzumab and combination therapy in ovarian cancer.
Defining the molecular response to trastuzumab, pertuzumab and combination therapy in ovarian cancer.
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Who is running the clinical trial?
Georgetown UniversityLead Sponsor
343 Previous Clinical Trials
136,478 Total Patients Enrolled
2 Trials studying Ovarian Cancer
419 Patients Enrolled for Ovarian Cancer
Bristol-Myers SquibbIndustry Sponsor
2,650 Previous Clinical Trials
4,130,808 Total Patients Enrolled
12 Trials studying Ovarian Cancer
1,217 Patients Enrolled for Ovarian Cancer
United States Department of DefenseFED
868 Previous Clinical Trials
327,676 Total Patients Enrolled
7 Trials studying Ovarian Cancer
1,847 Patients Enrolled for Ovarian Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have had a very severe allergic reaction to any unknown allergens or any components of the study drug formulations.You have had an autoimmune disease like Crohn's disease or lupus in the past 2 years. If you have conditions like asthma or vitiligo, or if your autoimmune disease is stable with hormone or steroid replacement, you are not excluded.You have been treated with certain types of medications that target the immune system in the past.You have received any type of cancer treatment within 28 days before starting the new treatment, or within 5 half-lives if it's a type of medication called monoclonal antibodies.You are currently receiving treatment for cancer with chemotherapy, immunotherapy, or biologic therapy. However, using hormones for non-cancer-related medical conditions is okay.You have fully recovered from any recent surgery, radiotherapy, or chemotherapy.Criterion: You have used immunosuppressive medication in the last 14 days, have certain infections or active diseases, have had major surgery in the past 4 weeks, are pregnant or breastfeeding, have certain heart conditions, or have other serious health issues.Women aged 18 or older with advanced ovarian cancer that has not responded to platinum-based treatment and has progressed within 6 months. This includes all participants, regardless of whether they have previously received FDA-approved treatments.You have side effects from previous cancer treatment that have not gotten better, except for hair loss and specific lab results. If you have a lasting side effect that won't get worse with the new treatment, you may still be able to join the study.
Research Study Groups:
This trial has the following groups:- Group 1: NY-ESO-1 Peptide vaccine plus Nivolumab
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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