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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
Study 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.Check my eligibility
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.See study design
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
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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%
Urinary tract infection
12%
Blood creatinine increased
12%
Decreased appetite
12%
Hypoalbuminaemia
12%
Pyrexia
9%
Lipase increased
9%
Amylase increased
9%
Aspartate aminotransferase increased
9%
Cough
9%
Hypocalcaemia
9%
Pneumonitis
9%
Haematuria
9%
Vomiting
9%
Alanine aminotransferase increased
7%
Arthralgia
7%
Creatinine renal clearance decreased
7%
Hyperuricaemia
7%
Insomnia
7%
Oedema peripheral
7%
Dysuria
7%
Hyperkalaemia
7%
Hypothyroidism
7%
Pneumonia
7%
Weight decreased
5%
Urosepsis
5%
Abdominal pain
5%
Blood alkaline phosphatase increased
5%
Device occlusion
5%
Pain in extremity
2%
Hypophysitis
2%
Renal impairment
2%
Urticaria
2%
Musculoskeletal pain
2%
Death
2%
Encephalitis
2%
Hepatitis
2%
Left ventricular dysfunction
2%
Lymph gland infection
2%
Nephropathy toxic
2%
Pneumocystis jirovecii pneumonia
2%
Renal failure
2%
Small intestinal obstruction
2%
Somnolence
2%
Supraventricular tachycardia
2%
Urinary tract stoma complication
2%
Herpes zoster
2%
Flank pain
2%
Septic shock
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
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 2
~2010
Epacadostat
2018
Completed Phase 3
~1080
Find a Location
Who is running the clinical trial?
Memorial Sloan Kettering Cancer CenterLead Sponsor
1,933 Previous Clinical Trials
585,592 Total Patients Enrolled
70 Trials studying Sarcoma
13,737 Patients Enrolled for Sarcoma
Incyte CorporationIndustry Sponsor
364 Previous Clinical Trials
55,135 Total Patients Enrolled
3 Trials studying Sarcoma
126 Patients Enrolled for Sarcoma
Merck Sharp & Dohme LLCIndustry Sponsor
3,886 Previous Clinical Trials
5,054,523 Total Patients Enrolled
31 Trials studying Sarcoma
3,897 Patients Enrolled for Sarcoma
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is enrollment still available to individuals interested in participating in this research?
"Recruitment for this clinical trial has concluded. The study was first launched in January 23, 2018 and the data was last edited on April 18, 2022. Currently, 443 trials are accepting individuals with sarcoma and 971 studies admit patients taking Epacadostat."
Answered by AI
Has the FDA endorsed Epacadostat for clinical application?
"We assign Epacadostat a safety score of 2, as it is in the Phase 2 trial stage and has evidence to support its security but not yet any data backing up its effectiveness."
Answered by AI
Are there additional investigations into the applications of Epacadostat?
"Presently, Epacadostat is being tested in 971 active clinical trials with 122 studies at the Phase 3 stage. Most of these experiments are occurring in Houston, Texas yet there are 35882 sites conducting research on this medication."
Answered by AI
What medical conditions are usually treated with Epacadostat?
"Epacadostat is frequently prescribed to manage malignant neoplasms, yet it can also be used to treat additional conditions such as unresectable melanoma, microsatellite instablity high and the spread of cancer after chemotherapy."
Answered by AI
How many participants is the research trial accommodating?
"At this point, no further applicants are being accepted for this clinical trial. The study began on January 23rd 2018 and was last amended April 18th 2022. However, there are 443 sarcoma trials and 971 Epacadostat studies actively recruiting patients if you're interested in other opportunities."
Answered by AI
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