Clinical Trials /

A Study Exploring the Safety and Efficacy of INCAGN01949 in Combination With Immune Therapies in Advanced or Metastatic Malignancies

NCT03241173

Description:

The purpose of this study is to determine the safety, tolerability, and efficacy of INCAGN01949 when given in combination with immune therapies in participants with advanced or metastatic malignancies.

Related Conditions:
  • Malignant Solid Tumor
  • Renal Cell Carcinoma
  • Urothelial Carcinoma
Recruiting Status:

Active, not recruiting

Phase:

Phase 1/Phase 2

Trial Eligibility

Document

Title

  • Brief Title: A Study Exploring the Safety and Efficacy of INCAGN01949 in Combination With Immune Therapies in Advanced or Metastatic Malignancies
  • Official Title: A Phase 1/2 Study Exploring the Safety, Tolerability, and Efficacy of INCAGN01949 in Combination With Immune Therapies in Subjects With Advanced or Metastatic Malignancies

Clinical Trial IDs

  • ORG STUDY ID: INCAGN 1949-201
  • NCT ID: NCT03241173

Conditions

  • Advanced or Metastatic Malignancies

Interventions

DrugSynonymsArms
INCAGN01949INCAGN01949 + Ipilimumab
NivolumabINCAGN01949 + Nivolumab
IpilimumabINCAGN01949 + Ipilimumab
INCAGN01949INCAGN01949 + Nivolumab

Purpose

The purpose of this study is to determine the safety, tolerability, and efficacy of INCAGN01949 when given in combination with immune therapies in participants with advanced or metastatic malignancies.

Trial Arms

NameTypeDescriptionInterventions
INCAGN01949 + NivolumabExperimentalINCAGN01949 combined with nivolumab.
  • Nivolumab
  • INCAGN01949
INCAGN01949 + IpilimumabExperimentalINCAGN01949 combined with ipilimumab.
  • INCAGN01949
  • Ipilimumab
INCAGN01949 + Nivolumab + IpilimumabExperimentalINCAGN01949 combined with nivolumab and ipilimumab.
  • Nivolumab
  • Ipilimumab
  • INCAGN01949

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 urothelial carcinoma or RCC.

          -  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

          -  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:Phase 1: Participants With Treatment-Emergent Adverse Events (TEAEs) [Safety and Tolerability]
Time Frame:Screening through 60 days after end of treatment, up to 18 months
Safety Issue:
Description:TEAEs 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 & Phase 2: ORR based on RECIST v1.1 and modified RECIST (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 a 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: Disease control rate 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 percentage of subjects having a CR, PR, or stable disease (SD).
Measure:Phase 1 & Phase 2: Duration of disease control based on RECIST v1.1 and mRECIST v1.
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 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:At 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 1 & Phase 2: Participants With Treatment-Emergent Adverse Events (TEAEs) [Safety and Tolerability]
Time Frame:Screening through 60 days after end of treatment, up to 18 months
Safety Issue:
Description:TEAEs 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

  • advanced or metastatic cervical cancer
  • endometrial cancer
  • esophageal cancer
  • hepatocellular carcinoma (HCC)
  • melanoma
  • Merkel cell carcinoma
  • mesothelioma
  • microsatellite instability-high colorectal cancer
  • non-small cell lung cancer (NSCLC)
  • ovarian cancer
  • squamous cell carcinoma of the head and neck
  • small cell lung cancer (SLCL)
  • renal cell carcinoma (RCC)
  • triple-negative breast cancer
  • TNBC
  • urothelial carcinoma
  • OX40 ligand (OX40)
  • SCCHN
  • MSI-H CRC
  • gastric cancer (including stomach and gastroesophageal junction [GEJ])

Last Updated

January 17, 2018