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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT03347123
Other study ID # INCB 24360-208 (ECHO-208)
Secondary ID 2017-001743-12
Status Terminated
Phase Phase 1/Phase 2
First received
Last updated
Start date March 21, 2018
Est. completion date January 29, 2021

Study information

Verified date February 2022
Source Incyte Corporation
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to determine the safety, tolerability, and efficacy of epacadostat when given in combination with nivolumab and ipilimumab, and in combination with nivolumab and lirilumab, in participant with advanced or metastatic malignancies.


Recruitment information / eligibility

Status Terminated
Enrollment 11
Est. completion date January 29, 2021
Est. primary completion date January 29, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - During Phase 1, participant with locally advanced or metastatic solid tumors with disease progression on or after treatment with available therapies, or who are intolerant to treatment, or who refuse standard treatment. - During Phase 2, participant with advanced cancer who have received at least one prior therapy or are treatment naive, depending on the specified tumor type. - Presence of measurable disease per RECIST v1.1. - Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. - Expected survival of = 12 weeks. Exclusion Criteria: - Laboratory and medical history parameters not within the Protocol-defined range. - Receipt of anticancer medications or investigational drugs within Protocol-defined time frames. - Previous radiotherapy within 7 days of Cycle 1 Day 1. - Known active central nervous system metastases and/or carcinomatous meningitis. - Prior treatment with any immune checkpoint inhibitor and/or an IDO inhibitor. - Active infection requiring systemic therapy. - Any active or inactive autoimmune disease or syndrome

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Epacadostat
Phase 1: Epacadostat at the protocol-defined dose twice daily. Phase 2: Epacadostat at the recommended dose from Phase 1.
Nivolumab
Nivolumab at the protocol-specified dose and schedule.
Ipilimumab
Ipilimumab at the protocol-specified dose and schedule.
Lirilumab
Lirilumab at the protocol-specified dose and schedule.

Locations

Country Name City State
United States University of Alabama at Birmingham Birmingham Alabama
United States Duke University Medical Center Durham North Carolina
United States The Angeles Clinic and Research Institute Los Angeles California
United States Vanderbilt University Medical Center Nashville Tennessee
United States John Wayne Cancer Institute Santa Monica California

Sponsors (1)

Lead Sponsor Collaborator
Incyte Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Phase 1: Percentage of Participants With At Least One Treatment Emergent Adverse Events (TEAEs) A TEAE is any AE either reported for the first time or worsening of a pre-existing event after first dose of study treatment. AE is defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related, that occurs after a participant provides informed consent. Screening through up to 100 days after end of treatment, up to approximately 24 months
Primary Phase 2: Objective Response Rate (ORR) Based on Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) ORR was defined as the percentage of participants with confirmed objective response (OR). Confirmed OR is defined as complete response (CR) or partial response (PR) on two consecutive occasions = 4 weeks apart, as determined by the investigator according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. CR is defined as disappearance of all target lesions. PR is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. Every 8 weeks for the first 12 months and then every 12 weeks thereafter up to end of treatment (Up to Month 24)
Secondary Phase 1: Objective Response Rate (ORR) Based on RECIST v1.1 ORR was defined as the percentage of participants with confirmed objective response (OR). Confirmed OR is defined as complete response (CR) or partial response (PR) on two consecutive occasions = 4 weeks apart, as determined by the investigator according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. CR is defined as disappearance of all target lesions. PR is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. Every 8 weeks for the first 12 months and then every 12 weeks thereafter up to end of treatment (Up to Month 24)
Secondary Phase 1: Duration of Response (DOR) DOR was defined as the time from the earliest date of CR or PR until the earliest date at which progression criteria are met as determined by investigator evaluation of radiographic disease assessment per RECIST v1.1, or date of death due to any cause. Disease progression is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study including baseline; or the appearance of one or more new lesions. Every 8 weeks for the first 12 months and then every 12 weeks thereafter up to end of treatment (Up to Month 24)
Secondary Phase 1: Progression-free Survival (PFS) PFS was defined as the time from the start of combination therapy until the earliest date at which progression criteria are met as determined by investigator evaluation of radiographic disease assessment per RECIST v1.1, or date of death due to any cause. Disease progression is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study including baseline; or the appearance of one or more new lesions. Every 8 weeks for the first 12 months and then every 12 weeks thereafter up to end of treatment (Up to Month 24)
Secondary Phase 2: Duration of Response (DOR) DOR was defined as the time from the earliest date of CR or PR until the earliest date at which progression criteria are met as determined by investigator evaluation of radiographic disease assessment per RECIST v1.1, or date of death due to any cause. Disease progression is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study including baseline; or the appearance of one or more new lesions. Every 8 weeks for the first 12 months and then every 12 weeks thereafter up to end of treatment (Up to Month 24)
Secondary Phase 2: Progression-free Survival (PFS) PFS was defined as the time from the start of combination therapy until the earliest date at which progression criteria are met as determined by investigator evaluation of radiographic disease assessment per RECIST v1.1, or date of death due to any cause. Disease progression is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study including baseline; or the appearance of one or more new lesions. Every 8 weeks for the first 12 months and then every 12 weeks thereafter up to end of treatment (Up to Month 24)
Secondary Phase 2: Percentage of Participants With Treatment Emergent Adverse Events (TEAEs) A TEAE was any AE either reported for the first time or worsening of a pre-existing event after first dose of study treatment. AE is defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related, that occurs after a participant provides informed consent. Screening through up to 100 days for treatment Group A and 150 days for treatment Group B after end of treatment, up to approximately 24 months
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