A Study of Epacadostat (INCB024360) in Combination With Durvalumab (MEDI4736) in Subjects With Selected Advanced Solid Tumors (ECHO-203)

Incyte

Status and phase: Completed; Phase 2; Phase 1

Conditions: UC (Urothelial Cancer); Lung Cancer; Head and Neck Cancer; Solid Tumors

Treatments: Drug: MEDI4736; Drug: INCB024360

Study type: Interventional

Funder types: Industry

Identifiers

NCT02318277

INCB 24360-203 / ECHO-203

Details and patient eligibility

About

The purpose of this study is to explore the safety, tolerability, pharmacokinetics, immunogenicity and preliminary efficacy of INCB024360 administered in combination with MEDI4736 in subjects with selected advanced solid tumors.

Enrollment: 176 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male or female subjects, age 18 years or older
• Histologically or cytologically confirmed diagnosis of selected locally advanced or metastatic solid tumors
• Must have failed at least 1 prior treatment regimen for locally advanced or metastatic disease or be intolerant to treatment or refuse standard treatment

Exclusion criteria

• Laboratory and medical history parameters not within protocol-defined range
• Participation in any other study in which receipt of an investigational study drug occurred within 28 days or 5 half-lives (whichever is longer) prior to first dose
• Prior treatment with immune checkpoint inhibitors (eg, anti-CTLA-4, anti-PD-1, anti-PD-L1, and any other antibody or drug specifically targeting T-cell co-stimulation) or an IDO inhibitor (exception is tumor types in which a PD-1 pathway targeted agent is approved, e.g. melanoma, non-small cell lung cancer.)
• Receipt of any anticancer medication in the 21 days prior to receiving the first dose of study medication
• Has an active or inactive autoimmune process
• Evidence of interstitial lung disease or active, non-infectious pneumonitis
• Prior radiotherapy within 2 weeks of initiating treatment; Must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis
• Untreated central nervous system (CNS) metastases or CNS metastases that have progressed
• Currently pregnant or breastfeeding

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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176 participants in 1 patient group

MEDI4736 + INCB024360

Experimental group

Description:

MEDI4736 at selected dose levels every 2 weeks + INCB024360 25 mg BID as starting dose, followed by dose escalations until MTD or PAD is identified

Treatment:

Drug: INCB024360

Drug: MEDI4736