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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

No Placebo-Only Group

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to day 15

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

Amylase increased

Aspartate aminotransferase increased

Cough

Hypocalcaemia

Lipase increased

Pneumonitis

Haematuria

Vomiting

Alanine aminotransferase increased

Arthralgia

Creatinine renal clearance decreased

Dysuria

Hyperuricaemia

Insomnia

Oedema peripheral

Hyperkalaemia

Hypothyroidism

Pneumonia

Weight decreased

Abdominal pain

Urosepsis

Blood alkaline phosphatase increased

Device occlusion

Pain in extremity

Lymph gland infection

Urinary tract stoma complication

Septic shock

Encephalitis

Hepatitis

Herpes zoster

Death

Hypophysitis

Renal failure

Left ventricular dysfunction

Nephropathy toxic

Small intestinal obstruction

Somnolence

Pneumocystis jirovecii pneumonia

Renal impairment

Supraventricular tachycardia

Urticaria

Flank pain

Musculoskeletal pain

Gastroenteritis

Hypercalcaemia

Lung neoplasm malignant

Pneumothorax

100%

80%

60%

40%

20%

Study treatment Arm

Pembrolizumab 200 mg + Epacadostat 100 mg BID

Pembrolizumab 200 mg + Placebo BID

Total

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 (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

~9890

Epacadostat

2018

Completed Phase 3

~1140