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IDO1 Inhibitor
Epacadostat + Pembrolizumab for Sarcoma
Phase 2
Waitlist Available
Led By Sandra D'Angelo, MD
Research Sponsored by Memorial Sloan Kettering Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up by 24 weeks
Awards & highlights
No Placebo-Only Group
Summary
This trial will test the efficacy of epacadostat + pembrolizumab in sarcoma patients to see if the combo has good and bad effects and how well it works.
Who is the study for?
Adults with advanced sarcoma who have tried at least one other treatment can join this trial. They must be in good health otherwise, able to consent, and willing to follow the study plan. A biopsy is needed unless it's too risky. Those without standard treatment options or refusing standard chemo are also eligible.
What is being tested?
The trial tests a combo of two drugs: Epacadostat, which blocks an enzyme that cancers use to hide from the immune system, and Pembrolizumab, an immunotherapy drug already used for some cancers. The goal is to see if together they work better for sarcoma.
What are the potential side effects?
Possible side effects include immune-related issues like inflammation in various organs (colitis, hepatitis), skin problems (rash), endocrine disorders (thyroid dysfunction), fatigue, flu-like symptoms and potential infusion reactions.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ by 24 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~by 24 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
number of patients with best objective response rate
Side effects data
From 2020 Phase 3 trial • 93 Patients • NCT0336186533%
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
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
4Treatment groups
Experimental Treatment
Group I: Vascular Sarcoma SubtypesExperimental Treatment2 Interventions
Including angiosarcoma and Epithelioid Hemangioendothelioma (EHE). Epacadostat 100mg Twice daily Continuously days 1-21 of each 3 week cycle Oral Pembrolizumab 200mg Every 3 weeks Day 1 of each 3 week cycle IV infusion
Group II: UPS, Liposarcoma or pleomorphic liposarcomaExperimental Treatment2 Interventions
Undifferentiated Pleomorphic Sarcoma (UPS) or Liposarcoma (dedifferentiated or pleomorphic liposarcoma) Epacadostat 100mg Twice daily Continuously days 1-21 of each 3 week cycle Oral Pembrolizumab 200mg Every 3 weeks Day 1 of each 3 week cycle IV infusion
Group III: OtherExperimental Treatment2 Interventions
Epacadostat 100mg Twice daily Continuously days 1-21 of each 3 week cycle Oral Pembrolizumab 200mg Every 3 weeks Day 1 of each 3 week cycle IV infusion
Group IV: LeiomyosarcomaExperimental Treatment2 Interventions
Epacadostat 100mg Twice daily Continuously days 1-21 of each 3 week cycle Oral Pembrolizumab 200mg Every 3 weeks Day 1 of each 3 week cycle IV infusion
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
2017
Completed Phase 3
~3130
Epacadostat
2018
Completed Phase 3
~1210
Find a Location
Who is running the clinical trial?
M.D. Anderson Cancer CenterOTHER
3,074 Previous Clinical Trials
1,803,317 Total Patients Enrolled
Memorial Sloan Kettering Cancer CenterLead Sponsor
1,979 Previous Clinical Trials
599,808 Total Patients Enrolled
Incyte CorporationIndustry Sponsor
393 Previous Clinical Trials
63,936 Total Patients Enrolled
Merck Sharp & Dohme LLCIndustry Sponsor
4,032 Previous Clinical Trials
5,189,770 Total Patients Enrolled
Sandra D'Angelo, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
4 Previous Clinical Trials
187 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am 18 years old or older.My organs are working well enough for treatment.You need to agree to have a tissue sample taken from your tumor before treatment begins. If it's too risky or impossible to do so, the principal investigator may decide to exempt you from this requirement.I am fully active or able to carry out light work.My cancer can be measured and hasn't been treated with radiation, or if it has, it's gotten worse.I have had at least one treatment for my sarcoma, or there is no standard treatment for my type.You agree to sign a paper saying you want to take part in the trial and you understand what it involves.My blood counts are within normal ranges.You agree to follow the treatment plan.My sarcoma is confirmed to be advanced or has spread.
Research Study Groups:
This trial has the following groups:- Group 1: Vascular Sarcoma Subtypes
- Group 2: UPS, Liposarcoma or pleomorphic liposarcoma
- Group 3: Leiomyosarcoma
- Group 4: Other
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.