Neoplasms

All Conditions

Respiratory Tract (Lung and Bronchial) Diseases

Head and Neck Neoplasms

Lung Neoplasms

Antineoplastic Agents

All Drugs and Chemicals

Durvalumab

Antineoplastic Agents, Immunological

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

MEDI4736 administered intravenously (IV) every two weeks (q2w)

MEDI4736

INCB024360

Lance Leopold, MD

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.

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

A Phase 1/2 Study Exploring the Safety, Tolerability, and Efficacy of Epacadostat (INCB024360) in Combination With Durvalumab (MEDI4736) in Subjects With Selected Advanced Solid Tumors (ECHO-203)

Adverse events reported for the first time or worsening of a pre-existing event after first dose of study drug/treatment

ORR was defined as the percentage of participants having a complete response (CR) or partial response (PR) as determined by investigator assessment of radiographic disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.

ORR was defined as the percentage of participants having a complete response (CR) or partial response (PR) as determined by investigator assessment of radiographic disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1

Defined as the time from earliest date of disease response until the earliest date of disease progression per RECIST v1.1, or death due to any cause, if occurring sooner than progression.

AstraZeneca

Incyte Corporation

Epacadostat (25 mg) oral twice-daily (BID) dosing in combination with durvalumab (3 mg/kg) administered intravenously (IV) on Day 1 of each 14 day cycle.

Phase I : Epacadostat (25 mg) + Durvalumab (3 mg/kg)

Epacadostat (25 mg) oral twice-daily (BID) dosing in combination with durvalumab (10 mg/kg) administered intravenously (IV) on Day 1 of each 14 day cycle.

Phase I : Epacadostat (25 mg) + Durvalumab (10 mg/kg)

Epacadostat (50 mg) oral twice-daily (BID) dosing in combination with durvalumab (10 mg/kg) administered intravenously (IV) on Day 1 of each 14 day cycle.

Phase I : Epacadostat (50 mg) + Durvalumab (10 mg/kg)

Epacadostat (75 mg) oral twice-daily (BID) dosing in combination with durvalumab (10 mg/kg) administered intravenously (IV) on Day 1 of each 14 day cycle.

Phase I : Epacadostat (75 mg) + Durvalumab (10 mg/kg)

Epacadostat (100 mg) oral twice-daily (BID) dosing in combination with durvalumab (10 mg/kg) administered intravenously (IV) on Day 1 of each 14 day cycle.

Phase I : Epacadostat (100 mg) + Durvalumab (10 mg/kg)

Epacadostat (300 mg) oral twice-daily (BID) dosing in combination with durvalumab (10 mg/kg) administered intravenously (IV) on Day 1 of each 14 day cycle.

Phase I : Epacadostat (300 mg) + Durvalumab (10 mg/kg)

Epacadostat (100 mg) oral twice-daily (BID) dosing in combination with durvalumab (10 mg/kg) administered intravenously (IV) on Day 1 of each 14 day cycle in select tumor types.

Phase II : Epacadostat (100 mg) + Durvalumab (10 mg/kg)

Epacadostat (300 mg) oral twice-daily (BID) dosing in combination with durvalumab (10 mg/kg) administered intravenously (IV) on Day 1 of each 14 day cycle in select tumor types.

Phase II : Epacadostat (300 mg) + Durvalumab (10 mg/kg)

Total

Age, Continuous

Sex: Female, Male

Race/Ethnicity, Customized

Intent-to-Treat Population who are enrolled in Phase 1 and 2 part of the study

Study Director

The Phase 1 safety population includes all subjects enrolled in the Phase 1 portion of the study who received at least 1 dose of INCB024360 or MEDI4736. Treatment groups were determined according to the actual treatment the subject received on Day 1 regardless of the actual study drug the subject received during participation in the study.

Phase 1 : Number of Treatment-Emergent Adverse Events (TEAE)

Intent-to-Treat Population : All subjects who are enrolled in the Phase 2 portion of the study.

Phase 2: Objective Response Rate (ORR) as Determined by Radiographic Disease Assessments Per Modified Response Evaluation Criteria in Solid Tumors (RECIST) v1.1

Intent-to-Treat Population: All subjects who are enrolled in the Phase 1 portion of the study. Treatment groups for this population were defined according to the treatment assignment at the time of enrollment on Day 1 regardless of the actual study drug the subject received during his/her continued participation in the study.

Phase 1: Objective Response Rate (ORR) as Determined by Radiographic Disease Assessments Per Modified RECIST v1.1

The Phase 2 safety population includes all subjects enrolled in the Phase 2 portion of the study who received at least 1 dose of INCB024360 or MEDI4736.

Phase 2: Number of Treatment-Emergent Adverse Events

Intent-to-Treat Population: All subjects who are enrolled in the Phase 1 \& 2 portion of the study. Treatment groups were defined at the time of enrollment on Day 1 according to the treatment assignment for Phase 1 and according to the tumor type for phase 2.

Phase 1 and 2: Durability of Response as Measured by the Time From the Earliest Date of Disease Response Until Earliest Date of Disease Progression

Phase 1 and 2: Progression-free Survival as Measured by the Duration From the Date of Enrollment Until the Earliest Date of Disease Progression or Death

Epacadostat (25 mg) oral twice-daily (BID) dosing in combination with durvalumab (3 or 10 mg/kg) administered intravenously (IV) on Day 1 of each 14 day cycle.

Phase I : Epacadostat (25 mg) + Durvalumab

The PK evaluable population will include all subjects who received at least 1 dose of INCB024360 and provided at least 1 post dose plasma sample (1 PK/PD measurement). Phase I : Epacadostat (25 mg) + Durvalumab (3 mg/kg)" Arm/Group were combined with the data collected from participants in the "Phase I : Epacadostat (25 mg) + Durvalumab (10 mg/kg)" Arm/Group for PK Analysis.

Phase 1 and 2: Pharmacokinetics (PK) of INCB024360 as Measured by Peak Concentration

Phase 1 and 2: Pharmacokinetics (PK) of INCB024360 as Measured by Time to Maximal Observed Concentration

Phase 1 and 2: Pharmacokinetics (PK) of INCB024360 as Area Under the Concentration-time Curve

Phase I : Epacadostat (75 mg) + Durvalumab (10 mg/kg)Edit

Epacadostat (100 mg) oral twice-daily (BID) dosing in combination with durvalumab (10 mg/kg) administered intravenously (IV) on Day 1 of each 14 day cycle

Phase I : Epacadostat (300 mg) + Durvalumab (10 mg/kg)Edit

Epacadostat (100 mg) oral twice-daily (BID) dosing in combination with durvalumab (10 mg/kg) administered intravenously (IV) on Day 1 of each 14 day cycle to determine maximum Tolerated dose (MTD) or pharmacologically active dose (PAD).

Phase 2 Stage 1: Epacadostat (100 mg) + Durvalumab (10 mg/kg)

Epacadostat (300 mg) oral twice-daily (BID) dosing in combination with durvalumab (10 mg/kg) administered intravenously (IV) on Day 1 of each 14 day cycle to determine maximum Tolerated dose (MTD) or pharmacologically active dose (PAD).

Phase 2 Stage 2: Epacadostat (300 mg) + Durvalumab (10 mg/kg)

Evaluable Patients Post-Baseline: Treatment-Induced ADA - Patients who had baseline negative ADA result who developed anti-drug antibodies at any time after initial drug administration.

Spots Global Cancer Trial Database for A Study of Epacadostat (INCB024360) in Combination With Durvalumab (MEDI4736) in Subjects With Selected Advanced Solid Tumors (ECHO-203)

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

Useful links and downloads for this trial