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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

This trial's timeline: 3 weeks for screening, Varies for treatment, and by 24 weeks 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 patients with best objective response rate

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

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

~3150

Epacadostat

2018

Completed Phase 3

~1190