Clinical trial · Interventional
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)
NCT02318277CI-TRIAL-00055956completedPhase 1 / Phase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Head and Neck Cancer | Malignant Head and Neck Neoplasm | ALIAS | 0.90 |
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
| Solid Tumors | Solid Neoplasm | CURATED_BROADER | 0.80 |
| UC (Urothelial Cancer) | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| INCB024360 | Drug | — | UNRESOLVED |
| MEDI4736 | Drug | Durvalumab | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- MEDI4736 + INCB024360
- 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
- interventionNames
- Drug: MEDI4736
- Drug: INCB024360
Primary outcomes (2)
- measure
- Phase 1 : Number of Treatment-Emergent Adverse Events (TEAE)
- timeFrame
- Duration of study treatment and up to 90 days after the last dose [approximately 3 years]
- description
- Adverse events reported for the first time or worsening of a pre-existing event after first dose of study drug/treatment
- measure
- Phase 2: Objective Response Rate (ORR) as Determined by Radiographic Disease Assessments Per Modified Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDNaing A, Algazi AP, Falchook GS, Creelan BC, Powderly J, Rosen S, Barve M, Mettu NB, Triozzi PL, Hamm J, Zhou G, Walker C, Dong Z, Patel MR. Phase 1/2 study of epacadostat in combination with durvalumab in patients with metastatic solid tumors. Cancer. 2023 Jan 1;129(1):71-81. doi: 10.1002/cncr.34512. Epub 2022 Oct 30. PMID 36309837