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Cancer Vaccine

Dendritic Cell Vaccine + Pembrolizumab for Ovarian Cancer (FRAPPE Trial)

Phase 1 & 2

Recruiting

Led By Matthew S. Block, MD, PhD

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

Must not have

Co-morbid systemic illnesses or severe concurrent disease

Prior treatment for ovarian cancer with an anti-PD-1 or anti-PD-L1 monoclonal antibody

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

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.

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.

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 below

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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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have any severe illnesses besides my current condition.

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I have been treated for ovarian cancer with specific immune therapy.

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I have been diagnosed with HIV.

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My condition is getting worse quickly or causing symptoms.

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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.

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I have an active hepatitis B or C infection.

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I have had a stem cell transplant from a donor.

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I have not had a heart attack in the last 6 months and do not need ongoing therapy for severe heart rhythm problems.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Confirm objective response rate (ORR)

Determine whether the combination of FRαDCs and pembrolizumab has an acceptable toxicity profile.

Secondary study objectives

Duration of response

Incidence of adverse events

Overall survival (OS)

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial 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 on day 1 of cycles 1-5 and pembrolizumab IV over 30 minutes on day 1 of cycles 1-8. Cycles repeat every 21 days for up to 8 cycles in the absence of disease progression or unacceptable toxicity. Patient then receive multi-epitope folate receptor alpha-loaded dendritic cell vaccine ID on day 1 of odd cycles and pembrolizumab IV over 30 minutes on day 1 of remaining cycles. Cycles repeat every 42 days for up to cycle 22 in the absence of disease progression or unacceptable toxicity. 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

Pheresis

2017

Completed Phase 2

~10

Biopsy

2014

Completed Phase 4

~1150