Description:
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).
Title
- Brief Title: A Study of the Safety, Tolerability, and Efficacy of Epacadostat Administered in Combination With Nivolumab in Select Advanced Cancers (ECHO-204)
- Official Title: A Phase 1/2 Study of the Safety, Tolerability, and Efficacy of Epacadostat Administered in Combination With Nivolumab in Select Advanced Cancers (ECHO-204)
Clinical Trial IDs
- ORG STUDY ID:
INCB 24360-204 / ECHO-204
- NCT ID:
NCT02327078
Conditions
- B-cell Malignancies
- Colorectal Cancer (CRC)
- Head and Neck Cancer
- Lung Cancer
- Lymphoma
- Melanoma
- Ovarian Cancer
- Glioblastoma
Interventions
Drug | Synonyms | Arms |
---|
Nivolumab (Phase 1) | | (Phase 1, Part 1) : Nivolumab + Epacadostat |
Epacadostat (Phase 1) | | (Phase 1, Part 1) : Nivolumab + Epacadostat |
Chemotherapy (Phase 1) | | (Phase 1, Part 2): Nivolumab + Epacadostat + Chemotherapy |
Nivolumab (Phase 2) | | (Phase 2): Nivolumab + Epacadostat |
Epacadostat (Phase 2) | | (Phase 2): Nivolumab + Epacadostat |
Purpose
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).
Trial Arms
Name | Type | Description | Interventions |
---|
(Phase 1, Part 1) : Nivolumab + Epacadostat | Experimental | | - Nivolumab (Phase 1)
- Epacadostat (Phase 1)
|
(Phase 2): Nivolumab + Epacadostat | Experimental | | - Nivolumab (Phase 2)
- Epacadostat (Phase 2)
|
(Phase 1, Part 2): Nivolumab + Epacadostat + Chemotherapy | Experimental | | - Nivolumab (Phase 1)
- Epacadostat (Phase 1)
- Chemotherapy (Phase 1)
|
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
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Phase 1, Part 1: Safety and tolerability of epacadostat and nivolumab assessed by number of subjects with dose limiting toxicities (DLTs) |
Time Frame: | 42 days |
Safety Issue: | |
Description: | A DLT was defined as the occurrence of any of the toxicities occurring up to and including Day 42 in Phase 1 Parts 1 and 2. |
Secondary Outcome Measures
Measure: | Phase 1, Part 1: ORR per RECIST v1.1 and mRECIST for subjects with solid tumors; per Cheson and mCheson criteria for subjects with B-cell NHL; and per RANO and mRANO criteria for subjects with GBM |
Time Frame: | Response will be assessed every 8 weeks during study participation which is estimated to be a minimum of 6 months. |
Safety Issue: | |
Description: | |
Measure: | Phase 1, Part 2: ORR per RECIST v1.1 and modified RECIST for subjects with advanced or metastatic SCCHN and advanced or metastatic NSCLC |
Time Frame: | Response will be assessed every 8 weeks during study participation which is estimated to be a minimum of 6 months. |
Safety Issue: | |
Description: | |
Measure: | Phase 1, Part 2: Duration of response (DOR) for subjects with advanced or metastatic SCCHN and advanced or metastatic NSCLC |
Time Frame: | Response will be assessed every 8 weeks during study participation which is estimated to be a minimum of 6 months. |
Safety Issue: | |
Description: | |
Measure: | Phase 1, Part 2: PFS for subjects with advanced or metastatic SCCHN and advanced or metastatic NSCLC |
Time Frame: | Response will be assessed every 8 weeks during study participation which is estimated to be a minimum of 6 months. |
Safety Issue: | |
Description: | |
Measure: | Phase 2: Duration of response (DOR) |
Time Frame: | Response will be assessed every 8 weeks during study participation which is estimated to be a minimum of 6 months. |
Safety Issue: | |
Description: | |
Measure: | Phase 2: Duration of disease control, defined as CR, PR, and stable disease (SD) |
Time Frame: | Response will be assessed every 8 weeks during study participation which is estimated to be a minimum of 6 months. |
Safety Issue: | |
Description: | |
Measure: | Phase 2: Safety and tolerability measured by the frequency of adverse events (AEs), serious adverse events (SAEs), and deaths |
Time Frame: | AEs are assessed for the duration of the study participation which is estimated to be a minimum of 27 months (24 months +100 day safety FU). |
Safety Issue: | |
Description: | |
Details
Phase: | Phase 1/Phase 2 |
Primary Purpose: | Interventional |
Overall Status: | Completed |
Lead Sponsor: | Incyte Corporation |
Last Updated
August 28, 2020