Vanderbilt Clinical Trials

A Study of the Safety, Tolerability, and Efficacy of Epacadostat Administered in Combination With Nivolumab in Select Advanced Cancers (ECHO-204)

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).

Conditions

B-cell Malignancies
Colorectal Cancer (CRC)
Head and Neck Cancer
Lung Cancer
Lymphoma
Melanoma
Ovarian Cancer
Glioblastoma

Eligibility

Eligible Ages: Over 18 Years
Eligible Genders: All
Accepts Healthy Volunteers: No

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

Study Design

Phase: Phase 1/Phase 2
Study Type: Interventional
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
Masking: None (Open Label)

Arm Groups

Arm	Description	Assigned Intervention
Experimental Phase 1 Part 1 Epacadostat 25mg BID +Nivolumab	Epacadostat 25mg oral twice daily (BID) continuous daily dosing in combination with Nivolumab administered intravenously (IV) at 3mg/kg Q2W	Drug: Nivolumab specified dose and dosing schedule Drug: Epacadostat oral twice daily continuous at the protocol-defined dose
Experimental Phase 1 Part 1 Epacadostat 50mg BID +Nivolumab	Epacadostat 50mg oral twice daily (BID) continuous daily dosing in combination with Nivolumab administered intravenously (IV) at 3mg/kg Q2W	Drug: Nivolumab specified dose and dosing schedule Drug: Epacadostat oral twice daily continuous at the protocol-defined dose
Experimental Phase 1 Part 1 Epacadostat 100mg BID +Nivolumab	Epacadostat 100mg oral twice daily (BID) continuous daily dosing in combination with Nivolumab administered intravenously (IV) at 3mg/kg Q2W.	Drug: Nivolumab specified dose and dosing schedule Drug: Epacadostat oral twice daily continuous at the protocol-defined dose
Experimental Phase 1 Part 1 Epacadostat 300mg BID +Nivolumab	Epacadostat 300mg oral twice daily (BID) continuous daily dosing in combination with Nivolumab administered intravenously (IV) at 3mg/kg Q2W.	Drug: Nivolumab specified dose and dosing schedule Drug: Epacadostat oral twice daily continuous at the protocol-defined dose
Experimental Phase 1 Part 2 Epacadostat 100mg BID +Nivolumab +5-FU/Platinum	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).	Drug: Nivolumab specified dose and dosing schedule Drug: Epacadostat oral twice daily continuous at the protocol-defined dose Drug: Chemotherapy Specified dose on specified days
Experimental Phase 1 Part 2 Epacadostat 100mg BID +Pemetrexed/Platinum	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).	Drug: Epacadostat oral twice daily continuous at the protocol-defined dose Drug: Chemotherapy Specified dose on specified days
Experimental Phase 1 Part 2 Epacadostat 100mg BID +Paclitaxel/Platinum	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).	Drug: Epacadostat oral twice daily continuous at the protocol-defined dose Drug: Chemotherapy Specified dose on specified days
Experimental Phase 2 Epacadostat 100mg BID + Nivolumab	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).	Drug: Nivolumab specified dose and dosing schedule Drug: Epacadostat oral twice daily continuous at the protocol-defined dose
Experimental Phase 2 Epacadostat 300mg BID + Nivolumab	Epacadostat 300mg oral twice daily (BID) continuous daily dosing in combination with Nivolumab 240mg Q2W administered intravenously (IV).	Drug: Nivolumab specified dose and dosing schedule Drug: Epacadostat oral twice daily continuous at the protocol-defined dose

More Details

Status: Completed
Sponsor: Incyte Corporation

Study Contact

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.