Phase 2
Completed N=176
A Study of Epacadostat (INCB024360) in Combination With Durvalumab (MEDI4736) in Subjects With Selected Advanced Solid Tumors (ECHO-203)
Source: ClinicalTrials.gov NCT02318277 ↗Enrolled (actual)
176
Serious AEs
48.3%
Results posted
Dec 2020
Primary outcomePrimary: Phase 1 : Number of Treatment-Emergent Adverse Events (TEAE) — 6; 3; 4; 4 Participants
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Phase 1 : Number of Treatment-Emergent Adverse Events (TEAE) |
6; 3; 4; 4; 8; 9 | — |
| PRIMARY Phase 2: Objective Response Rate (ORR) as Determined by Radiographic Disease Assessments Per Modified Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 |
6; 12 | — |
| SECONDARY Phase 1: Objective Response Rate (ORR) as Determined by Radiographic Disease Assessments Per Modified RECIST v1.1 |
1; 0; 1; 0; 1; 2 | — |
| SECONDARY Phase 2: Number of Treatment-Emergent Adverse Events |
49; 93 | — |
| SECONDARY 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 |
1.9; NA; NA; NA; 13.8; NA | — |
| SECONDARY 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 |
2.4; 12.0; 1.9; 1.7; 4.1; 2.5 | — |
| SECONDARY Phase 1 and 2: Pharmacokinetics (PK) of INCB024360 as Measured by Peak Concentration |
273; 248; 604; 727; 2660; 960 | — |
| SECONDARY Phase 1 and 2: Pharmacokinetics (PK) of INCB024360 as Measured by Time to Maximal Observed Concentration |
2.0; 2.0; 1.9; 2.0; 3.3; 2.0 | — |
| SECONDARY Phase 1 and 2: Pharmacokinetics (PK) of INCB024360 as Area Under the Concentration-time Curve |
1040; 1580; 3090; 3650; 15400; 4130 | — |
| SECONDARY Phase 1 and 2: Immunogenicity of MEDI4736 as Measured by the Number and Percentage of Subjects Who Develop Detectable Anti-drug Antibodies (ADAs) |
0; 0; 0; 0; 0; 1 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT02318277). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.