INCAGN01876 in Combination With Immune Therapies in Subjects With Advanced or Metastatic Malignancies

Phase 1

Terminated

• Conditions: Advanced Malignancies; Metastatic Cancer
• Interventions: Drug: INCAGN01876; Drug: Epacadostat; Drug: Pembrolizumab

• Registration Number: NCT03277352
• Lead Sponsor: Incyte Biosciences International Sàrl

Brief Summary

The purpose of this study is to determine the safety, tolerability, and efficacy of INCAGN01876 when given in combination with immune therapies.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-08-14
• Study First Submitted QC: 2017-09-08
• Study First Posted: 2017-09-11
• Study Start: 2017-11-21
• Primary Completion: 2020-07-01
• Study Completion: 2020-07-01
• Status Verified: 2021-06
• Results First Submitted: 2021-07-01
• Results First Submitted QC: 2021-07-01
• Last Update Submitted: 2021-07-01
• Results First Posted: 2021-07-22
• Last Update Posted: 2021-07-22

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 10

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
INCAGN01876 + Pembrolizumab + Epacadostat	INCAGN01876	INCAGN01876 in combination with pembrolizumab and epacadostat
INCAGN01876 + Pembrolizumab + Epacadostat	Pembrolizumab	INCAGN01876 in combination with pembrolizumab and epacadostat
INCAGN01876 + Pembrolizumab + Epacadostat	Epacadostat	INCAGN01876 in combination with pembrolizumab and epacadostat

Primary Outcome Measures

Name	Time	Method
Phase 1 and Phase 2: Participants With Treatment-Emergent Adverse Events (TEAEs) [Safety and Tolerability]	Screening through 60 days after end of treatment, up to approximately 18 months	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.
Phase 2: Complete Response Rate (CRR) Based on RECIST v1.1	Assessed every 9 weeks for 12 months, then every 12 weeks, up to 18 months	Defined as the percentage of checkpoint inhibitor-naive melanoma participants who have a CR based on investigator assessment per RECIST v1.1
Phase 1 and Phase 2 : ORR Based on RECIST v1.1 and mRECIST	Assessed every 9 weeks for 12 months, then every 12 weeks, up to 18 months	Defined as the percentage of participants having a CR or PR based on investigator assessment per RECIST v1.1.

Secondary Outcome Measures

Name	Time	Method
Phase 1 & Phase 2: Disease Control Rate Based on RECIST v1.1 and mRECIST	Assessed every 9 weeks for 12 months, then every 12 weeks, up to 18 months.	Defined as the percentage of participants having CR, PR, or stable disease (SD) based on investigator assessment per RECIST v1.1.
Phase 1 & Phase 2: Duration of Response Based on RECIST v1.1 and mRECIST	Assessed every 9 weeks for 12 months, then every 12 weeks, up to 18 months	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.
Phase 1 & Phase 2: Duration of Disease Control Based on RECIST v1.1 and mRECIST	Assessed every 9 weeks for 12 months, then every 12 weeks, up to 18 months	Defined as time from first report of SD or better until disease progression or death from any cause.
Phase 1 & Phase 2: Progression-free Survival Based on RECIST v1.1 and mRECIST	Assessed every 9 weeks for 12 months, then every 12 weeks, up to 18 months	Defined as the time from the start of combination therapy until the earliest date of disease progression or death due to any cause.
Phase 1 & Phase 2: Overall Survival	At 1 year and 2 years.	Defined as the time from the start of combination therapy until death due to any cause.

Trial Locations

Locations (2)

The Angeles Clinic and Research Institute; 🇺🇸 Los Angeles, California, United States

Hackensack University Medical Center; 🇺🇸 Hackensack, New Jersey, United States