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

July 1, 2021 updated by: Incyte Biosciences International Sàrl

A Phase 1/2 Safety and Efficacy Study of INCAGN01876 in Combination With Immune Therapies in Subjects With Advanced or Metastatic Malignancies

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

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90025
        • The Angeles Clinic and Research Institute
    • New Jersey
      • Hackensack, New Jersey, United States, 07601
        • Hackensack University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: INCAGN01876 + Pembrolizumab + Epacadostat
INCAGN01876 in combination with pembrolizumab and epacadostat
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.
Drug: Epacadostat
Epacadostat will be self-administered orally at the protocol-defined dose.
Other Names:
  • INCB024360
Drug: Pembrolizumab
Pembrolizumab will be administered IV at the protocol-defined dose.
Other Names:
  • Keytruda®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Phase 1 and Phase 2: Participants With Treatment-Emergent Adverse Events (TEAEs) [Safety and Tolerability]
Time Frame: 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.
Screening through 60 days after end of treatment, up to approximately 18 months
Phase 1 and Phase 2 : ORR Based on RECIST v1.1 and mRECIST
Time Frame: 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.
Assessed every 9 weeks for 12 months, then every 12 weeks, up to 18 months
Phase 2: Complete Response Rate (CRR) Based on RECIST v1.1
Time Frame: 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
Assessed every 9 weeks for 12 months, then every 12 weeks, up to 18 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Phase 1 & Phase 2: Disease Control Rate Based on RECIST v1.1 and mRECIST
Time Frame: 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.
Assessed every 9 weeks for 12 months, then every 12 weeks, up to 18 months.
Phase 1 & Phase 2: Duration of Response Based on RECIST v1.1 and mRECIST
Time Frame: 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.
Assessed every 9 weeks for 12 months, then every 12 weeks, up to 18 months
Phase 1 & Phase 2: Duration of Disease Control Based on RECIST v1.1 and mRECIST
Time Frame: 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.
Assessed every 9 weeks for 12 months, then every 12 weeks, up to 18 months
Phase 1 & Phase 2: Progression-free Survival Based on RECIST v1.1 and mRECIST
Time Frame: 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.
Assessed every 9 weeks for 12 months, then every 12 weeks, up to 18 months
Phase 1 & Phase 2: Overall Survival
Time Frame: At 1 year and 2 years.
Defined as the time from the start of combination therapy until death due to any cause.
At 1 year and 2 years.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Incyte Biosciences International Sàrl

Investigators

  • Study Director: John N. Janik, MD, Incyte Corporation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 21, 2017

Primary Completion (Actual)

July 1, 2020

Study Completion (Actual)

July 1, 2020

Study Registration Dates

First Submitted

August 14, 2017

First Submitted That Met QC Criteria

September 8, 2017

First Posted (Actual)

September 11, 2017

Study Record Updates

Last Update Posted (Actual)

July 22, 2021

Last Update Submitted That Met QC Criteria

July 1, 2021

Last Verified

June 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • INCAGN 1876-202

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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