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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT03277352
Other study ID # INCAGN 1876-202
Secondary ID
Status Terminated
Phase Phase 1/Phase 2
First received
Last updated
Start date November 21, 2017
Est. completion date July 1, 2020

Study information

Verified date June 2021
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 INCAGN01876 when given in combination with immune therapies.


Recruitment information / eligibility

Status Terminated
Enrollment 10
Est. completion date July 1, 2020
Est. primary completion date July 1, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Locally advanced or metastatic disease; locally advanced disease must not be amenable to resection with curative intent. - Phase 1: Subjects with advanced or metastatic solid tumors. - Phase 1: Subjects who have disease progression after treatment with available therapies. - Phase 2: Subjects with advanced or metastatic melanoma, RCC, and urothelial carcinoma. - Presence of measurable disease based on RECIST v1.1. - Eastern Cooperative Oncology Group performance status of 0 or 1. Exclusion Criteria: - Laboratory and medical history parameters not within the Protocol-defined range - Prior treatment with any tumor necrosis factor super family agonist. - Receipt of anticancer medications or investigational drugs within protocol-defined intervals before the first administration of study drug. - Has not recovered to = Grade 1 from toxic effects of prior therapy. - Active autoimmune disease. - Known active central nervous system metastases and/or carcinomatous meningitis. - Evidence of active, noninfectious pneumonitis or history of interstitial lung disease. - Evidence of hepatitis B virus or hepatitis C virus infection or risk of reactivation. - Known history of human immunodeficiency virus (HIV; HIV 1/2 antibodies).

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
INCAGN01876
In Phase 1 subjects will receive INCAGN01876 administered intravenously (IV) at the protocol-defined dose and schedule according to cohort and treatment group enrollment. In Phase 2, subjects will be administered IV study drug at the recommended dose from Phase 1.
Epacadostat
Epacadostat will be self-administered orally at the protocol-defined dose.
Pembrolizumab
Pembrolizumab will be administered IV at the protocol-defined dose.

Locations

Country Name City State
United States Hackensack University Medical Center Hackensack New Jersey
United States The Angeles Clinic and Research Institute Los Angeles California

Sponsors (1)

Lead Sponsor Collaborator
Incyte Biosciences International Sàrl

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Phase 1 and Phase 2: Participants With Treatment-Emergent Adverse Events (TEAEs) [Safety and Tolerability] A TEAE is any adverse event (AE) either reported for the first time or worsening of a pre-existing event after the first dose of study treatment. Screening through 60 days after end of treatment, up to approximately 18 months
Primary Phase 1 and Phase 2 : ORR Based on RECIST v1.1 and mRECIST Defined as the percentage of participants having a CR or PR based on investigator assessment per RECIST v1.1. Assessed every 9 weeks for 12 months, then every 12 weeks, up to 18 months
Primary Phase 2: Complete Response Rate (CRR) Based on RECIST v1.1 Defined as the percentage of checkpoint inhibitor-naive melanoma participants who have a CR based on investigator assessment per RECIST v1.1 Assessed every 9 weeks for 12 months, then every 12 weeks, up to 18 months
Secondary Phase 1 & Phase 2: Disease Control Rate Based on RECIST v1.1 and mRECIST Defined as the percentage of participants having CR, PR, or stable disease (SD) based on investigator assessment per RECIST v1.1. Assessed every 9 weeks for 12 months, then every 12 weeks, up to 18 months.
Secondary Phase 1 & Phase 2: Duration of Response Based on RECIST v1.1 and mRECIST Defined as the time from the earliest date of disease response (CR or PR) until earliest date of disease progression or death due to any cause. Assessed every 9 weeks for 12 months, then every 12 weeks, up to 18 months
Secondary Phase 1 & Phase 2: Duration of Disease Control Based on RECIST v1.1 and mRECIST Defined as time from first report of SD or better until disease progression or death from any cause. Assessed every 9 weeks for 12 months, then every 12 weeks, up to 18 months
Secondary Phase 1 & Phase 2: Progression-free Survival Based on RECIST v1.1 and mRECIST Defined as the time from the start of combination therapy until the earliest date of disease progression or death due to any cause. Assessed every 9 weeks for 12 months, then every 12 weeks, up to 18 months
Secondary Phase 1 & Phase 2: Overall Survival Defined as the time from the start of combination therapy until death due to any cause. At 1 year and 2 years.
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