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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%)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 1 year

Awards & highlights

Study 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.Check my eligibility

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.See study design

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

Select...

My tumor can be biopsied and is large enough for the procedure.

Select...

I am fully active or can carry out light work.

Select...

I have been newly diagnosed with advanced ovarian, fallopian, or peritoneal cancer and agree to surgery.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 1 year for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Number of participants with an increase in CD8+ T cells

Secondary outcome measures

Change in character of the cellular content of PBMCs and ascites fluid, determined by multiparameter flow cytometry

Change in chronic viral responses, including cytomegalovirus

Change in fluid transcriptomes in PBMC and ascites

+7 more

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%

Urinary tract infection

12%

Blood creatinine increased

12%

Decreased appetite

12%

Hypoalbuminaemia

12%

Pyrexia

Lipase increased

Amylase increased

Aspartate aminotransferase increased

Cough

Hypocalcaemia

Pneumonitis

Haematuria

Vomiting

Alanine aminotransferase increased

Arthralgia

Creatinine renal clearance decreased

Hyperuricaemia

Insomnia

Oedema peripheral

Dysuria

Hyperkalaemia

Hypothyroidism

Pneumonia

Weight decreased

Urosepsis

Abdominal pain

Blood alkaline phosphatase increased

Device occlusion

Pain in extremity

Hypophysitis

Renal impairment

Urticaria

Musculoskeletal pain

Death

Encephalitis

Hepatitis

Left ventricular dysfunction

Lymph gland infection

Nephropathy toxic

Pneumocystis jirovecii pneumonia

Renal failure

Small intestinal obstruction

Somnolence

Supraventricular tachycardia

Urinary tract stoma complication

Herpes zoster

Flank pain

Septic shock

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

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

~9850

Epacadostat

2018

Completed Phase 3

~1080

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor

13,654 Previous Clinical Trials

40,932,306 Total Patients Enrolled

286 Trials studying Ovarian Cancer

73,738 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)

Frequently Asked Questions

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

How many participants are being accepted into this research project?

"Unfortunately, this research study is not presently recruiting. It was first uploaded on August 25th 2014 and last modified July 27th 2022. Those looking for alternative clinical trials can find 622 studies actively enrolling patients with stage iiib primary peritoneal cancer ajcc v7 and 13 studies admitting participants to evaluate Epacadostat."

Answered by AI

Has Epacadostat been previously tested in medical research?

"Epacadostat first saw the light of day at University of Minnesota/Masonic Cancer Center back in 2014, and since then there have been 599 completed studies. As for now, 13 clinical trials are currently enrolling patients; most notably in Buffalo, New york."

Answered by AI

Are there vacancies available for individuals to participate in this trial?

"At present, the clinical trial is no longer accepting applications. The listing was initially published on August 25th 2014 and amended as recently as July 27th 2022. For those seeking alternative studies instead, 622 trials are presently recruiting for stage iiib primary peritoneal cancer ajcc v7 while 13 research projects centred around Epacadostat require volunteers."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Epacadostat Before Surgery in Treating Patients With Newly Diagnosed Stage III-IV Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

2014. "Epacadostat Before Surgery in Treating Patients With Newly Diagnosed Stage III-IV Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02042430.

All > Peritoneal Carcinomatosis > Ovarian Cancer