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IDO1 Inhibitor

Pre-Surgery Epacadostat for Ovarian Cancer

Phase < 1
Waitlist Available
Led By Kunle Odunsi
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
Pre-surgery tumor deemed amenable to core biopsy (with at least 100 mm^3 tumor volume per biopsy)
Eastern Cooperative Oncology Group (ECOG) performance status of 0-1 (Karnofsky > 70%)
Must not have
Patients who have had prior systemic therapy or radiotherapy for stage III or IV epithelial ovarian, fallopian or primary peritoneal carcinoma
Cardiovascular disease that meets one of the following: congestive heart failure (New York Heart Association class III or IV), active angina pectoris, or recent myocardial infarction (within the last 6 months)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to day 15
Awards & highlights

Summary

This trial will study epacadostat, a drug that may stop the growth of ovarian cancer cells, before surgery in patients with newly diagnosed ovarian cancer.

Who is the study for?
This trial is for women with newly diagnosed stage III-IV epithelial ovarian, fallopian tube, or primary peritoneal cancer. Participants must be able to undergo surgery and a biopsy, have not received prior systemic therapy or radiotherapy for their condition, and should not have certain health conditions that could interfere with the study.
What is being tested?
The trial is testing epacadostat before surgery to see if it can stop tumor growth by blocking enzymes needed for cell growth. It's an Early Phase I pilot study where participants will take epacadostat before undergoing standard debulking surgery.
What are the potential side effects?
While specific side effects of epacadostat are not listed here, similar medications may cause immune-related reactions, fatigue, digestive issues, skin problems and potential risks during surgery due to pre-treatment with the drug.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My tumor can be biopsied and is large enough for the procedure.
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I am fully active or can carry out light work.
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I have been newly diagnosed with advanced ovarian, fallopian, or peritoneal cancer and agree to surgery.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have received treatment for advanced ovarian, fallopian, or peritoneal cancer.
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I have serious heart issues, including recent heart attack or severe heart failure.
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I have had a stroke or am at high risk for blood clots due to severe artery disease in the past 6 months.
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I cannot or do not want to take pills twice a day.
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I have active brain cancer or cancer spread to the lining of my brain.
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I have an autoimmune disorder that needs strong medication.
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I have had a blood clot in my lung or deep veins.
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I have not been on steroids or immunosuppressive therapy for more than a week in the last month.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to day 15
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to day 15 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Number of participants with an increase in CD8+ T cells

Side effects data

From 2020 Phase 3 trial • 93 Patients • NCT03361865
33%
Anaemia
23%
Diarrhoea
23%
Rash
23%
Pruritus
21%
Asthenia
19%
Malignant neoplasm progression
16%
Back pain
16%
Constipation
14%
Nausea
14%
Fatigue
12%
Dyspnoea
12%
Blood creatinine increased
12%
Decreased appetite
12%
Hypoalbuminaemia
12%
Urinary tract infection
12%
Pyrexia
9%
Amylase increased
9%
Aspartate aminotransferase increased
9%
Cough
9%
Hypocalcaemia
9%
Lipase increased
9%
Pneumonitis
9%
Haematuria
9%
Vomiting
9%
Alanine aminotransferase increased
7%
Arthralgia
7%
Creatinine renal clearance decreased
7%
Dysuria
7%
Hyperuricaemia
7%
Insomnia
7%
Oedema peripheral
7%
Hyperkalaemia
7%
Hypothyroidism
7%
Pneumonia
7%
Weight decreased
5%
Abdominal pain
5%
Urosepsis
5%
Blood alkaline phosphatase increased
5%
Device occlusion
5%
Pain in extremity
2%
Lymph gland infection
2%
Urinary tract stoma complication
2%
Septic shock
2%
Encephalitis
2%
Hepatitis
2%
Herpes zoster
2%
Death
2%
Hypophysitis
2%
Renal failure
2%
Left ventricular dysfunction
2%
Nephropathy toxic
2%
Small intestinal obstruction
2%
Somnolence
2%
Pneumocystis jirovecii pneumonia
2%
Renal impairment
2%
Supraventricular tachycardia
2%
Urticaria
2%
Flank pain
2%
Musculoskeletal pain
2%
Gastroenteritis
2%
Hypercalcaemia
2%
Lung neoplasm malignant
2%
Pneumothorax
100%
80%
60%
40%
20%
0%
Study treatment Arm
Pembrolizumab 200 mg + Epacadostat 100 mg BID
Pembrolizumab 200 mg + Placebo BID
Total

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment (IDO1 inhibitor INCB024360)Experimental Treatment3 Interventions
Patients receive IDO1 inhibitor INCB024360 PO BID on days 1-14 and undergo surgery on day 15. Treatment continues in the absence of disease progression or unacceptable toxicity. In circumstances where there are medical or administrative reasons for delaying surgery, treatment with IDO1 inhibitor INCB024360 may continue for up to 3 weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Therapeutic Conventional Surgery
2005
Completed Phase 3
~9870
Epacadostat
2018
Completed Phase 3
~1100

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,842 Previous Clinical Trials
41,002,983 Total Patients Enrolled
291 Trials studying Ovarian Cancer
74,941 Patients Enrolled for Ovarian Cancer
Kunle OdunsiPrincipal InvestigatorCancer Immunotherapy Trials Network
7 Previous Clinical Trials
118 Total Patients Enrolled

Media Library

Ovarian Cancer Research Study Groups: Treatment (IDO1 inhibitor INCB024360)
~2 spots leftby Sep 2025
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