Phase 2
Completed N=307
A Study of the Safety, Tolerability, and Efficacy of Epacadostat Administered in Combination With Nivolumab in Select Advanced Cancers (ECHO-204)
Source: ClinicalTrials.gov NCT02327078 ↗Enrolled (actual)
307
Serious AEs
48.2%
Results posted
Apr 2023
Primary outcomePrimary: Phase 1, Part 1: Number of Participants With Dose Limiting Toxicities (DLTs) — 0; 0; 0; 0 Participants
Summary
This is a Phase 1/2, open label study. Phase 1 consists of 2 parts. Part 1 is a dose-escalation assessment of the safety and tolerability of epacadostat administered with nivolumab in subjects with select advanced solid tumors and lymphomas. Part 2 will evaluate the safety and tolerability of epacadostat in combination with nivolumab and chemotherapy in subjects with squamous cell carcinoma of head and neck (SCCHN) and non-small cell lung cancer (NSCLC).
Phase 2 will include expansion cohorts in 7 tumor types, including melanoma, NSCLC, SCCHN, colorectal cancer, ovarian cancer, glioblastoma and diffuse large B-cell lymphoma (DLBCL).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Phase 1, Part 1: Number of Participants With Dose Limiting Toxicities (DLTs) |
0; 0; 0; 0 | — |
| PRIMARY Phase 1, Part 2: Number of Participants With Dose Limiting Toxicities (DLTs) |
0; 0; 0 | — |
| PRIMARY Phase 1, Parts 1 and 2: Number of Participants With At Least One Treatment-Emergent Adverse Event (TEAE) |
3; 6; 14; 13; 6; 3 | — |
| PRIMARY Phase 2: Objective Response Rate (ORR) in Participants With Select Solid Tumors Per Response Evaluation Criteria in Solid Tumors (RECIST) v 1.1 for Participants With Solid Tumors and Per Cheson Criteria for Participants With DLBCL |
3.8; 0.0; 62.0; 28.6; 28.6; 20.7 | — |
| PRIMARY Phase 2: Progression Free Survival (PFS) |
1.78; 1.64; NA; 1.76; 2.55; 1.88 | — |
| PRIMARY Phase 2: Overall Survival (OS) Rate of Proportion With Glioblastoma |
0.458 | — |
| SECONDARY Phase 1, Part 2: ORR Per RECIST v1.1 and for Participants With Advanced or Metastatic SCCHN and Advanced or Metastatic NSCLC |
50.0; 33.3; 100.0 | — |
| SECONDARY Phase 1, Part 1: ORR Per RECIST v1.1 for Participants With Solid Tumors; Per Cheson Criteria for Participants With B-cell NHL; and Per RANO and mRANO Criteria for Participants With GBM |
0.0; 0.0; 0.0; 23.1 | — |
| SECONDARY Phase 1, Part 2: Duration of Response (DOR) for Participants With Advanced or Metastatic SCCHN and Advanced or Metastatic NSCLC |
3.82; NA; 3.93 | — |
| SECONDARY Phase 1, Part 2: PFS for Participants With Advanced or Metastatic SCCHN and Advanced or Metastatic NSCLC |
5.72; 2.83; 6.10 | — |
| SECONDARY Phase 2: Duration of Response |
NA; NA; NA; NA; NA; 3.93 | — |
| SECONDARY Phase 2: Duration of Disease Control, Defined as CR, PR, and Stable Disease (SD) |
3.72; 4.57; NA; NA; NA; NA | — |
| SECONDARY Phase 2: Safety and Tolerability Measured by the Number of Adverse Events (AEs), Serious Adverse Events (SAEs), and Fatal Treatment Emergent AEs |
82; 176; 40; 89; 4; 5 | — |
Eligibility Criteria
Inclusion Criteria
- Male or female subjects, age 18 years or older
- Subjects with histologically or cytologically confirmed NSCLC, MEL (including I/O relapsed MEL or I/O refractory MEL), CRC, SCCHN, ovarian cancer, recurrent B cell NHL or HL, or glioblastoma
- Presence of measurable disease by RECIST v1.1 for solid tumors or Cheson criteria for B cell NHL (including DLBCL) or HL. For subjects with glioblastoma, presence of measurable disease is not required.
- Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1
- Fresh baseline tumor biopsies (defined as a biopsy specimen taken since completion of the most recent prior chemotherapy regimen) are required for all cohorts except glioblastoma
Exclusion Criteria
- Laboratory and medical history parameters not within Protocol-defined range
- Currently pregnant or breastfeeding
- Subjects who have received prior immune checkpoint inhibitors or an IDO inhibitor (except select Phase 2 cohorts evaluating I/O relapsed or I/O refractory MEL). Subjects who have received experimental vaccines or other immune therapies should be discussed with the medical monitor to confirm eligibility
- Untreated central nervous system (CNS) metastases or CNS metastases that have progressed
- Subjects with any active or inactive autoimmune process
- Evidence of interstitial lung disease or active, noninfectious pneumonitis
- Subjects with any active or inactive autoimmune process
- Ocular MEL
Data sourced from ClinicalTrials.gov (NCT02327078). 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.