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Phase 1/2 Study Exploring the Safety, Tolerability, and Efficacy of INCAGN01876 Combined With Immune Therapies in Advanced or Metastatic Malignancies

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ClinicalTrials.gov Identifier: NCT03126110
Recruitment Status : Active, not recruiting
First Posted : April 24, 2017
Last Update Posted : July 21, 2020
Sponsor:
Information provided by (Responsible Party):
Incyte Corporation ( Incyte Biosciences International Sàrl )

Tracking Information
First Submitted Date  ICMJE April 19, 2017
First Posted Date  ICMJE April 24, 2017
Last Update Posted Date July 21, 2020
Actual Study Start Date  ICMJE April 13, 2017
Estimated Primary Completion Date April 28, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 29, 2018)
  • 1. Phase 1: Safety and tolerability assessed by monitoring frequency, duration, and severity of adverse events (AEs) [ Time Frame: Screening through 60 days after end of treatment, up to 18 months ]
    An 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 subject provides informed consent.
  • Phase 2: Objective response rate (ORR) based on Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. [ Time Frame: Every 8 weeks for 12 months, then every 12 weeks, up to 18 months ]
    Defined as the percentage of subjects having complete response (CR) or partial response (PR)
Original Primary Outcome Measures  ICMJE
 (submitted: April 21, 2017)
  • Phase 1: Safety and tolerability assessed by monitoring frequency, duration, and severity of adverse events (AEs) [ Time Frame: Screening through 60 days after end of treatment, up to 18 months ]
    An 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 subject provides informed consent.
  • Phase 2: Objective response rate (ORR) based on Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. [ Time Frame: Every 8 weeks for 12 months, then every 12 weeks, up to 18 months ]
    Defined as the percentage of subjects having complete response (CR) or partial response (PR)
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 29, 2018)
  • Phase 1: ORR based on RECIST v1.1 and modified RECIST v1.1 (mRECIST v1.1) [ Time Frame: Assessed every 8 weeks for 12 months, then every 12 weeks, up to 18 months ]
    Defined as the percentage of subjects having CR or PR
  • Phase 1 & Phase 2: Duration of response based on RECIST v1.1 and mRECIST v1.1 [ Time Frame: Assessed every 8 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, if occurring sooner than progression.
  • Phase 1 & Phase 2: Duration of disease control based on RECIST v1.1 and mRECIST v1.1 [ Time Frame: Assessed every 8 weeks for 12 months, then every 12 weeks, up to 18 months ]
    Defined as CR, PR, and stable disease (SD) as measured from first report of SD or better until disease progression or death from any cause, if occurring sooner than progression.
  • Phase 1 & Phase 2: Progression-free survival based on RECIST v1.1 and mRECIST v1.1 [ Time Frame: Assessed every 8 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, if occurring sooner than progression.
  • Phase 1 & Phase 2: Overall survival [ Time Frame: 1 year, 2 years, and end of study, up to 24 months ]
    Determined from the start of combination therapy until death due to any cause.
  • Phase 2: Safety and tolerability assessed by monitoring frequency, duration, and severity of adverse events [ Time Frame: Screening through 60 days after end of treatment, up to 18 months ]
    An 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 subject provides informed consent.
Original Secondary Outcome Measures  ICMJE
 (submitted: April 21, 2017)
  • Phase 1 & Phase 2: ORR based on RECIST v1.1 and modified RECIST v1.1 (mRECIST v1.1) [ Time Frame: Assessed every 8 weeks for 12 months, then every 12 weeks, up to 18 months ]
    Defined as the percentage of subjects having CR or PR
  • Phase 1 & Phase 2: Duration of response based on RECIST v1.1 and mRECIST v1.1 [ Time Frame: Assessed every 8 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, if occurring sooner than progression.
  • Phase 1 & Phase 2: Duration of disease control based on RECIST v1.1 and mRECIST v1.1 [ Time Frame: Assessed every 8 weeks for 12 months, then every 12 weeks, up to 18 months ]
    Defined as CR, PR, and stable disease (SD) as measured from first report of SD or better until disease progression or death from any cause, if occurring sooner than progression.
  • Phase 1 & Phase 2: Progression-free survival based on RECIST v1.1 and mRECIST v1.1 [ Time Frame: Assessed every 8 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, if occurring sooner than progression.
  • Phase 1 & Phase 2: Overall survival [ Time Frame: 1 year, 2 years, and end of study, up to 24 months ]
    Determined from the start of combination therapy until death due to any cause.
  • Phase 1 & Phase 2: Safety and tolerability assessed by monitoring frequency, duration, and severity of adverse events [ Time Frame: Screening through 60 days after end of treatment, up to 18 months ]
    An 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 subject provides informed consent.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Phase 1/2 Study Exploring the Safety, Tolerability, and Efficacy of INCAGN01876 Combined With Immune Therapies in Advanced or Metastatic Malignancies
Official Title  ICMJE A Phase 1/2 Study Exploring the Safety, Tolerability, and Efficacy of INCAGN01876 in Combination With Immune Therapies in Subjects With Advanced or Metastatic Malignancies
Brief Summary The purpose of this study is to determine the safety, tolerability, and efficacy of INCAGN01876 when given in combination with immune therapies in subjects with advanced or metastatic malignancies.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Advanced Malignancies
  • Metastatic Cancer
Intervention  ICMJE
  • Drug: INCAGN01876
    In Phase 1 subjects will receive INCAGN01876 administered intravenously (IV) at the protocol-defined dose according to cohort enrollment. In Phase 2, subjects will be administered IV study drug at the recommended dose from Phase 1.
  • Drug: Nivolumab
    Nivolumab will be administered IV at the protocol-defined dose according to assigned treatment group.
  • Drug: Ipilimumab
    Ipilimumab will be administered IV at the protocol-defined dose according to assigned treatment group.
Study Arms  ICMJE
  • Experimental: INCAGN01876 + Nivolumab
    INCAGN01876 combined with nivolumab.
    Interventions:
    • Drug: INCAGN01876
    • Drug: Nivolumab
  • Experimental: INCAGN01876 + Ipilimumab
    INCAGN01876 combined with ipilimumab.
    Interventions:
    • Drug: INCAGN01876
    • Drug: Ipilimumab
  • Experimental: INCAGN01876 + Nivolumab + Ipilimumab
    INCAGN01876 combined with nivolumab and ipilimumab.
    Interventions:
    • Drug: INCAGN01876
    • Drug: Nivolumab
    • Drug: Ipilimumab
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: July 17, 2020)
45
Original Estimated Enrollment  ICMJE
 (submitted: April 21, 2017)
450
Estimated Study Completion Date  ICMJE October 28, 2021
Estimated Primary Completion Date April 28, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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 cervical cancer, gastric cancer (including stomach, esophageal, and GEJ), SCCHN, PD-1 refractory SCCHN and PD-1/PD-L1 relapsed melanoma.
  • Presence of measurable disease based on RECIST v1.1.
  • Eastern Cooperative Oncology Group (ECOG) performance status 0 to 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).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   Belgium,   Italy,   Spain,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03126110
Other Study ID Numbers  ICMJE INCAGN 1876-201
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Incyte Corporation ( Incyte Biosciences International Sàrl )
Study Sponsor  ICMJE Incyte Biosciences International Sàrl
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: John E. Janik, MD Incyte Corporation
PRS Account Incyte Corporation
Verification Date July 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP