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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Complete or Partial Objective Tumor Response

Secondary outcome measures

Number of Participants With Adverse Events of Grade 3 or Higher

Overall Survival (OS)

Progression-free Survival (PFS)

Other outcome measures

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

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 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

NRG OncologyOTHER

232 Previous Clinical Trials

101,175 Total Patients Enrolled

National Cancer Institute (NCI)Lead Sponsor

13,687 Previous Clinical Trials

40,930,357 Total Patients Enrolled

288 Trials studying Ovarian Cancer

73,832 Patients Enrolled for Ovarian Cancer

Lilian T GienPrincipal InvestigatorNRG Oncology

1 Previous Clinical Trials

35 Total Patients Enrolled

Media Library

Epacadostat (Other) Clinical Trial Eligibility Overview. Trial Name: NCT03602586 — Phase 2

Ovarian Cancer Research Study Groups: Treatment (epacadostat, pembrolizumab)

Ovarian Cancer Clinical Trial 2023: Epacadostat Highlights & Side Effects. Trial Name: NCT03602586 — Phase 2

Epacadostat (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03602586 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

To which ailments is the epacadostat and pembrolizumab treatment regimen typically administered?

"Epacadostat and pembrolizumab are recommended for the treatment of malignant tumours, inoperable melanoma, and cases where microsatellite instability is high."

Answered by AI

How many settings is this research experiment active in?

"This clinical trial has been extended to cover a total of 100 centres, located in cities such as Wheat Ridge, Danville and Chillicothe. To reduce the need for travel during the course of this study, prospective participants should select a clinic close by."

Answered by AI

Is there currently availability for prospective participants in this trial?

"As per clinicaltrials.gov, this medical trial has ceased recruitment at the present moment; initially posted on September 28th 2018 and most recently amended November 30th 2022. However, there are over 4200 other studies actively seeking participants currently."

Answered by AI

Has the combination of epacadostat and pembrolizumab been granted FDA clearance?

"Despite being a Phase 2 trial, our team at Power has assigned Treatment (epacadostat and pembrolizumab) with an estimation of safety rating of 2. This means that there is some evidence supporting its security but none for effectiveness."

Answered by AI

Are there any other studies concerning the combination of epacadostat and pembrolizumab?

"Epacadostat and pembrolizumab were initially trialed in 2010 at City of Hope, leading to 262 completed clinical studies. Presently, 970 live experiments are underway with a significant proportion taking place within Wheat Ridge, Colorado."

Answered by AI

How many participants are enrolled in this trial?

"This particular study is not currently enrolling patients. It was first posted on September 28th 2018 and its status was last modified in November 2022. For those searching for alternative trials, there are presently 3306 medical studies for malignant neoplasms recruiting participants and 970 studies concerning Treatment (epacadostat, pembrolizumab) that are open to new enrollees."

Answered by AI

What is the ultimate purpose of this research?

"This clinical trial aspires to observe a Complete or Partial Objective Tumor Response over the span of 7 months. Secondary endpoints include Overall Survival, Progression-Free Survival and Nature/Degree of Adverse Events; all assessed with empirical criteria such as RECIST v1.1 and CTCAE version 5 respectively. Kaplan-Meier product limit method will be used to graph PFS distributions while descriptive statistics will report on adverse events maximum grade outcomes."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Testing Whether the Combination of Two Immunotherapy Drugs Have Activity in Recurrent or Persistent Clear Cell Ovarian Cancer

2018. "Testing Whether the Combination of Two Immunotherapy Drugs Have Activity in Recurrent or Persistent Clear Cell Ovarian Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03602586.

All > Recurrent Ovarian Cancer