A Study of the Safety, Tolerability, and Efficacy of Epacadostat Administered in Combination With Nivolumab in Select Advanced Cancers (ECHO-204)
B-cell Malignancies, Colorectal Cancer (CRC), Head and Neck Cancer
About this trial
This is an interventional treatment trial for B-cell Malignancies
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
Sites / Locations
- UAB Comprehensive Cancer Center
- The Angeles Clinic and Research Institute
- USC Norris Cancer Center
- UCSF - University of California San Francisco
- University of Colorado Anschutz Medical Campus
- The University of Kansas Clinical Research Center
- Johns Hopkins Sidney Kimmel Comprehensive Cancer Center
- Dana Farber Cancer Institute
- Lahey Hospital & Medical Center
- NYU Cancer Center
- Columbia University, Herbert Irving Comprehensive Cancer Center
- Duke University Medical Center
- Wake Forest Medical Center Boulevard
- Sanford Research
- University of Pittsburgh School of Medicine
- Sanford Research
- Vanderbilt University Medical Center
- Texas Oncology Research
- MD Anderson Cancer Center
- Utah Cancer Specialists
- Huntsman Cancer Institute
- Medical College of Wisconsin
- The Christie NHS Foundation Trust
- Oxford University Hospitals NHS Trust
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm 7
Arm 8
Arm 9
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Phase 1 Part 1 Epacadostat 25mg BID +Nivolumab
Phase 1 Part 1 Epacadostat 50mg BID +Nivolumab
Phase 1 Part 1 Epacadostat 100mg BID +Nivolumab
Phase 1 Part 1 Epacadostat 300mg BID +Nivolumab
Phase 1 Part 2 Epacadostat 100mg BID +Nivolumab +5-FU/Platinum
Phase 1 Part 2 Epacadostat 100mg BID +Pemetrexed/Platinum
Phase 1 Part 2 Epacadostat 100mg BID +Paclitaxel/Platinum
Phase 2 Epacadostat 100mg BID + Nivolumab
Phase 2 Epacadostat 300mg BID + Nivolumab
Epacadostat 25mg oral twice daily (BID) continuous daily dosing in combination with Nivolumab administered intravenously (IV) at 3mg/kg Q2W
Epacadostat 50mg oral twice daily (BID) continuous daily dosing in combination with Nivolumab administered intravenously (IV) at 3mg/kg Q2W
Epacadostat 100mg oral twice daily (BID) continuous daily dosing in combination with Nivolumab administered intravenously (IV) at 3mg/kg Q2W.
Epacadostat 300mg oral twice daily (BID) continuous daily dosing in combination with Nivolumab administered intravenously (IV) at 3mg/kg Q2W.
Epacadostat 100mg oral twice daily (BID) continuous daily dosing in combination with Nivolumab 360mg Q3W and 5-FU/Platinum( Carboplatin or Cisplatin+5-Fluorouracil) administered intravenously (IV).
Epacadostat 100mg oral twice daily (BID) continuous daily dosing in combination with Nivolumab 360 mg Q3W and Pemetrexed/Platinum (Carboplatin orCisplatin+Pemetrexed) administered intravenously (IV).
Epacadostat 100mg oral twice daily (BID) continuous daily dosing in combination with Nivolumab 360 mg Q3W and Paclitaxel/Platinum(Carboplatin+Cisplatin+Paclitaxel)administered intravenously (IV).
Epacadostat 100mg oral twice daily (BID) continuous daily dosing in combination with Nivolumab 240mg Q2W or 480 mg Q4W based on tumor type administered intravenously (IV).
Epacadostat 300mg oral twice daily (BID) continuous daily dosing in combination with Nivolumab 240mg Q2W administered intravenously (IV).