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Cancer Vaccine
Dendritic Cell Vaccine + Pembrolizumab for Ovarian Cancer
Phase 1 & 2
Recruiting
Led By Matthew S. Block, M.D., Ph.D.
Research Sponsored by Mayo Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age >= 18 years
Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Study Summary
This trial is testing if a vaccine made from a person's own cells can help fight advanced ovarian, fallopian tube or primary peritoneal cancer.
Who is the study for?
This trial is for adults with certain types of advanced ovarian, fallopian tube, or primary peritoneal cancer that has come back. Participants must be in good physical condition (ECOG PS 0 or 1), not pregnant, willing to use contraception if they can have children, and able to provide tissue samples. They should not have had prior anti-PD-1/L1 therapy for ovarian cancer or recent anticancer treatment and must not have other serious illnesses.Check my eligibility
What is being tested?
The study tests a vaccine made from the patient's own white blood cells treated with peptides (FRaDCs) combined with pembrolizumab, an immunotherapy drug. The goal is to see if this combo helps the immune system destroy tumor cells in patients with recurrent cancers mentioned above.See study design
What are the potential side effects?
Possible side effects include reactions at the injection site from the vaccine and typical immunotherapy-related issues like inflammation in organs due to an overactive immune response, fatigue, digestive problems, skin rash, and potential complications related to infusions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
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I am fully active or can carry out light work.
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My ovarian cancer has come back and reacts to platinum-based treatment.
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My cancer is a confirmed case of ovarian, fallopian tube, or peritoneal cancer.
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My cancer can be measured by scans or a specific blood test.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Confirm objective response rate (ORR)
Determine whether the combination of FRαDCs and pembrolizumab has an acceptable toxicity profile.
Secondary outcome measures
Duration of response
Incidence of adverse events
Overall survival (OS)
+1 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (apheresis, FRalphaDC, pembrolizumab)Experimental Treatment7 Interventions
Patients undergo apheresis for multi-epitope folate receptor alpha-loaded dendritic cell vaccine manufacturing on study. Patients then receive multi-epitope folate receptor alpha-loaded dendritic cell vaccine ID and pembrolizumab IV on study. Patients also undergo CT and/or MRI as well as blood sample collection throughout the trial. Patients undergo biopsy on study.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Biopsy
2014
Completed Phase 4
~1090
Biospecimen Collection
2004
Completed Phase 2
~1700
Computed Tomography
2017
Completed Phase 2
~2720
Magnetic Resonance Imaging
2017
Completed Phase 3
~1190
Pembrolizumab
2017
Completed Phase 2
~2010
Find a Location
Who is running the clinical trial?
Mayo ClinicLead Sponsor
3,215 Previous Clinical Trials
3,767,203 Total Patients Enrolled
2 Trials studying Fallopian Tube Carcinosarcoma
139 Patients Enrolled for Fallopian Tube Carcinosarcoma
Matthew S. Block, M.D., Ph.D.Principal InvestigatorMayo Clinic in Rochester
5 Previous Clinical Trials
159 Total Patients Enrolled
1 Trials studying Fallopian Tube Carcinosarcoma
73 Patients Enrolled for Fallopian Tube Carcinosarcoma
Matthew S BlockPrincipal InvestigatorMayo Clinic in Rochester
4 Previous Clinical Trials
163 Total Patients Enrolled
1 Trials studying Fallopian Tube Carcinosarcoma
73 Patients Enrolled for Fallopian Tube Carcinosarcoma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am 18 years old or older.My blood, kidney, liver, and clotting tests are normal.I do not have any severe illnesses besides my current condition.I have another cancer that hasn't needed serious treatment in the last 3 years.I am willing to have a central line placed if needed.I have been treated for ovarian cancer with specific immune therapy.I have been diagnosed with HIV.My condition is getting worse quickly or causing symptoms.I have recently undergone treatment for cancer.I do not have any serious infections, lung issues, autoimmune diseases, or mental health/social situations that would prevent me from following the study's requirements.I have an active hepatitis B or C infection.I have had a stem cell transplant from a donor.I have not had a heart attack in the last 6 months and do not need ongoing therapy for severe heart rhythm problems.I am willing to give a sample of my previous biopsy for research.Women who could become pregnant must have a negative pregnancy test within a week before joining the study.I am fully active or can carry out light work.I am willing to get a tetanus shot if I haven't had one in the last year.My ovarian cancer has come back and reacts to platinum-based treatment.I haven't taken immunosuppressive drugs in the last week and don't expect to need them during the study.My cancer is a confirmed case of ovarian, fallopian tube, or peritoneal cancer.My cancer can be measured by scans or a specific blood test.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (apheresis, FRalphaDC, pembrolizumab)
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 people still able to enroll in this experiment?
"Clinicaltrials.gov states that this trial is no longer seeking participants, having been last updated on June 26th 2023 after initially posted in July 1st 2023. However, 3953 other studies are recruiting patients at the moment."
Answered by AI
What is the primary objective of this trial?
"The primary aim of this trial, which will be assessed over a period of 21 days or less, is to ascertain the objective response rate. Secondary endpoints include progression free survival (PFS), overall survival (OS) and adverse events as defined by Common Terminology Criteria for Adverse Events v5.0. PFS will be calculated using Kaplan-Meier methodologies with progressive disease signalling discontinuation from the study while OS measures mortality from any cause since enrolment into the clinical trial."
Answered by AI
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