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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

NCT03126110

Description:

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.

Related Conditions:
  • Adenocarcinoma of the Gastroesophageal Junction
  • Cervical Carcinoma
  • Esophageal Carcinoma
  • Gastric Carcinoma
  • Head and Neck Squamous Cell Carcinoma
  • Malignant Solid Tumor
  • Melanoma
Recruiting Status:

Recruiting

Phase:

Phase 1/Phase 2

Trial Eligibility

Document

Title

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

Clinical Trial IDs

  • ORG STUDY ID: INCAGN 1876-201
  • NCT ID: NCT03126110

Conditions

  • Advanced Malignancies
  • Metastatic Cancer

Interventions

DrugSynonymsArms
INCAGN01876INCAGN01876 + Nivolumab
NivolumabINCAGN01876 + Nivolumab
IpilimumabINCAGN01876 + Ipilimumab

Purpose

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.

Trial Arms

NameTypeDescriptionInterventions
INCAGN01876 + NivolumabExperimentalINCAGN01876 combined with nivolumab.
  • INCAGN01876
  • Nivolumab
INCAGN01876 + IpilimumabExperimentalINCAGN01876 combined with ipilimumab.
  • INCAGN01876
  • Ipilimumab
INCAGN01876 + Nivolumab + IpilimumabExperimentalINCAGN01876 combined with nivolumab and ipilimumab.
  • INCAGN01876
  • Nivolumab
  • Ipilimumab

Eligibility Criteria

        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).
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure: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
Safety Issue:
Description: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.

Secondary Outcome Measures

Measure: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
Safety Issue:
Description:Defined as the percentage of subjects having CR or PR
Measure: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
Safety Issue:
Description: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.
Measure: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
Safety Issue:
Description: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.
Measure: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
Safety Issue:
Description: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.
Measure:Phase 1 & Phase 2: Overall survival
Time Frame:1 year, 2 years, and end of study, up to 24 months
Safety Issue:
Description:Determined from the start of combination therapy until death due to any cause.
Measure: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
Safety Issue:
Description: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.

Details

Phase:Phase 1/Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Incyte Biosciences International Sàrl

Trial Keywords

  • cervical cancer
  • endometrial cancer
  • gastric cancer (stomach, esophageal, and gastroesophageal junction [GEJ])
  • hepatocellular carcinoma (HCC)
  • melanoma
  • Merkel cell carcinoma
  • mesothelioma
  • microsatellite instability-high (MSI-H) colorectal cancer (CRC)
  • non-small cell lung cancer (NSCLC)
  • ovarian cancer
  • squamous cell carcinoma of the head and neck (SCCHN)
  • small cell lung cancer (SCLC)
  • renal cell carcinoma (RCC)
  • triple-negative breast cancer (TNBC)
  • urothelial carcinoma
  • glucocorticoid-induced tumor necrosis factor receptor (GITR)

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