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Immunotherapy Combo for Ovarian Cancer

Phase 2

Waitlist Available

Led By Lilian T Gien

Research Sponsored by National Cancer Institute (NCI)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

Prior platinum-based chemotherapy for management of primary disease

Must not have

History or evidence of central nervous system disease

Prior therapy with specific medications

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trialtests a combo of immunotherapy & enzyme blocking to treat ovarian carcinoma. May be better than usual treatments.

Who is the study for?

This trial is for women with recurrent or progressive clear cell ovarian cancer who have had one prior platinum-based chemotherapy. They must show measurable disease, be in good physical condition (ECOG 0-1), and have recovered from previous treatments. Exclusions include a history of certain cancers, prior treatment with the study drugs or similar immunotherapies, uncontrolled illnesses, CNS disease, HIV/AIDS not well-managed, hepatitis B/C not resolved, recent steroid/immunosuppressant use, and pregnancy.

What is being tested?

The trial tests pembrolizumab plus epacadostat against usual treatments like surgery or chemo. Pembrolizumab is an antibody that may help the immune system attack cancer cells; epacadostat blocks enzymes tumors need to grow. The combination's effectiveness on ovarian clear cell carcinoma will be studied.

What are the potential side effects?

Potential side effects include immune-related reactions such as inflammation in organs (like colitis), skin rashes, hormone gland problems (thyroid dysfunction), fatigue, liver enzyme changes which could indicate liver injury and infusion-related reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am fully active or can carry out light work.

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I have received platinum-based chemotherapy for my initial cancer treatment.

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I am a woman with recurring or worsening clear cell ovarian cancer.

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My tumor is mostly made up of clear cells.

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I have stopped any previous cancer treatments.

Exclusion Criteria

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

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I have a history of brain or spinal cord disease.

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I have previously been treated with specific medications.

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I do not have any uncontrolled illnesses.

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I have received treatment for hepatitis.

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I am on steroids or other drugs that affect my immune system.

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I have a diagnosed gastrointestinal condition.

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I have not had any other cancer besides this one in the last 3 years.

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

Complete or Partial Objective Tumor Response

Secondary study objectives

Number of Participants With Adverse Events of Grade 3 or Higher

Overall Survival (OS)

Progression-free Survival (PFS)

Other study objectives

Presence of PD-L1, IDO-1, Tumor-infiltrating Regulatory T Cells (Tregs), CD8 Tumor-infiltrating Lymphocytes (TILs), and Human Leukocyte Antigen (HLA) Class I in the Tumor Microenvironment

Ratio of Plasma Tryptophan to Kynurenine (T:K)

Soluble PD-L1 (sPD-L1) Levels in Plasma

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 (epacadostat, pembrolizumab)Experimental Treatment2 Interventions

Patients receive epacadostat PO BID and pembrolizumab IV over 30 minutes Q3W. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Pembrolizumab

FDA approved

Epacadostat

Not yet FDA approved

0 / 12Eligibility criteria met