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INCMGA00012 Plus Chemotherapy in Participants With Advanced Solid Tumors (POD1UM-105)

Primary Purpose

Advanced and/or Metastatic Solid Tumors, Stage IIIB Not Amenable to Curative Therapy to Stage IV Non-small Cell Lung Cancer, Advanced/Metastatic Unresectable Malignant Pleural Mesothelioma

Status
Withdrawn
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Retifanlimab
Gemcitabine
Cisplatin
Pemetrexed
Carboplatin
Paclitaxel
Sponsored by
Incyte Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Advanced and/or Metastatic Solid Tumors focused on measuring solid tumors, non-small cell lung cancer, malignant pleural mesothelioma, chemotherapy, programmed cell death protein 1 (PD-1) inhibitor

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Advanced and/or metastatic solid tumors including the following: histologically or cytologically confirmed diagnosis of Stage IIIB not amenable to curative treatment or Stage IV non-small cell lung cancer (pemetrexed-platinum treatment groups must have nonsquamous histology type); and histologically or cytologically confirmed diagnosis of advanced/metastatic unresectable malignant pleural mesothelioma.
  • No prior systemic treatment with the following exceptions: participants with a known sensitizing mutation (eg, BRAF, EGFR, ALK, or ROS1) should have had disease progression on or following an approved targeted tyrosine kinase inhibitor; and participants who received adjuvant or neoadjuvant chemotherapy are eligible if the adjuvant/neoadjuvant therapy was completed at least 6 months before the date of enrollment.
  • Measurable or nonmeasurable tumor lesions per RECIST v1.1.
  • Eastern Cooperative Oncology Group performance status 0 to 1.

Exclusion Criteria:

  • Received prior treatment with checkpoint inhibitor agents (such as anti-PD-1, anti-PD-L1, anti-PD-L2, or anti-CTLA-4).
  • Had major surgery within 3 weeks before the first dose of study treatment.
  • Received radiation therapy to the lung(s) that is > 30 Gy within 6 months of the first dose of study treatment.
  • Received palliative radiotherapy within 7 days before the first dose of study treatment.
  • Has ≥ Grade 2 residual toxicities from the most recent prior therapy (except alopecia).
  • Organ function (renal, hepatic), bone marrow reserve, and coagulation panel outside the protocol-defined laboratory values.
  • Is currently participating and receiving investigational therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks before the first dose of study treatment.
  • Has active autoimmune disease requiring systemic immunosuppression with corticosteroids (> 10 mg once daily of prednisone or equivalent) or immunosuppressive drugs within 2 years before the first dose of study treatment.
  • Is on chronic systemic steroids (> 10 mg once daily of prednisone or equivalent).
  • Known active central nervous system metastases and/or carcinomatous meningitis (patients with previously-treated and clinically stable brain metastases are eligible and a washout period of ≥ 4 weeks since radiation therapy is required).
  • Known additional malignancy that is progressing or requires active treatment.
  • Evidence of interstitial lung disease or active, noninfectious pneumonitis.
  • History of organ transplant, including allogeneic stem cell transplantation.
  • Active infections requiring systemic antibiotics.
  • Known active hepatitis B or C.
  • Has a diagnosis of immunodeficiency, including participants known to be HIV positive (positive for HIV 1/2 antibodies).
  • Significant cardiac event within 6 months before Cycle 1 Day 1.
  • Has received a live vaccine within 28 days of the planned start of study treatment.
  • Known hypersensitivity to any component of the study drugs, excipients, or another monoclonal antibody which cannot be controlled with standard measures (eg, antihistamines and corticosteroids).

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    Experimental

    Experimental

    Experimental

    Experimental

    Arm Label

    INCMGA00012 + gemcitabine/cisplatin

    INCMGA00012 + pemetrexed/cisplatin

    INCMGA00012 + pemetrexed/carboplatin

    INCMGA00012 + paclitaxel/carboplatin

    Arm Description

    Outcomes

    Primary Outcome Measures

    Number of treatment-emergent adverse events with INCMGA00012 in combination with chemotherapy
    Adverse events reported for the first time or worsening of a pre-existing event after the first dose of study treatment.

    Secondary Outcome Measures

    Objective response rate (ORR)
    Defined as the percentage of participants having complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 as determined by investigator assessment.
    Duration of response (DOR)
    Defined as the time from an initial objective response (CR or PR) according to RECIST v1.1 until disease progression as determined by investigator assessment or death due to any cause.
    Disease control rate (DCR)
    Defined as the number of participants with CR or PR as best response or stable disease that was maintained for at least 12 weeks.
    Cmax of INCMGA00012 when given in combination with chemotherapy agents
    Maximum observed plasma or serum concentration.
    Tmax of INCMGA00012 when given in combination with chemotherapy agents
    Time to maximum concentration.
    Cmin of INCMGA00012 when given in combination with chemotherapy agents
    Minimum observed plasma or serum concentration over the dose interval.
    AUC0-t of INCMGA00012 when given in combination with chemotherapy agents
    Area under the plasma or serum concentration-time curve from time = 0 to the last measurable concentration at time = t.

    Full Information

    First Posted
    April 17, 2019
    Last Updated
    April 21, 2020
    Sponsor
    Incyte Corporation
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03920839
    Brief Title
    INCMGA00012 Plus Chemotherapy in Participants With Advanced Solid Tumors (POD1UM-105)
    Official Title
    A Phase 1b Combination Study of INCMGA00012 Plus Chemotherapy in Participants With Advanced Solid Tumors (POD1UM-105)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2020
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    As of November 4, 2019 the study was halted prematurely and will not resume.
    Study Start Date
    July 15, 2019 (Actual)
    Primary Completion Date
    November 4, 2019 (Actual)
    Study Completion Date
    November 4, 2019 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Incyte Corporation

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    Yes
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The purpose of this study is to assess the safety and tolerability and to determine the recommended Phase 2 dose of INCMGA00012 in combination with common standard-of-care chemotherapy regimens in participants with advanced solid tumors.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Advanced and/or Metastatic Solid Tumors, Stage IIIB Not Amenable to Curative Therapy to Stage IV Non-small Cell Lung Cancer, Advanced/Metastatic Unresectable Malignant Pleural Mesothelioma
    Keywords
    solid tumors, non-small cell lung cancer, malignant pleural mesothelioma, chemotherapy, programmed cell death protein 1 (PD-1) inhibitor

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 1
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    INCMGA00012 + gemcitabine/cisplatin
    Arm Type
    Experimental
    Arm Title
    INCMGA00012 + pemetrexed/cisplatin
    Arm Type
    Experimental
    Arm Title
    INCMGA00012 + pemetrexed/carboplatin
    Arm Type
    Experimental
    Arm Title
    INCMGA00012 + paclitaxel/carboplatin
    Arm Type
    Experimental
    Intervention Type
    Drug
    Intervention Name(s)
    Retifanlimab
    Other Intervention Name(s)
    INCMGA00012
    Intervention Description
    INCMGA00012 administered intravenously every 3 weeks.
    Intervention Type
    Drug
    Intervention Name(s)
    Gemcitabine
    Intervention Description
    Gemcitabine administered intravenously on Days 1 and 8 of 21-day cycles.
    Intervention Type
    Drug
    Intervention Name(s)
    Cisplatin
    Intervention Description
    Cisplatin administered intravenously on Day 1 of 21-day cycles.
    Intervention Type
    Drug
    Intervention Name(s)
    Pemetrexed
    Intervention Description
    Pemetrexed administered intravenously on Day 1 of 21-day cycles.
    Intervention Type
    Drug
    Intervention Name(s)
    Carboplatin
    Intervention Description
    Carboplatin AUC5 or AUC6 administered intravenously on Day 1 of 21-day cycles.
    Intervention Type
    Drug
    Intervention Name(s)
    Paclitaxel
    Intervention Description
    Paclitaxel administered intravenously on Day 1 of 21-day cycles.
    Primary Outcome Measure Information:
    Title
    Number of treatment-emergent adverse events with INCMGA00012 in combination with chemotherapy
    Description
    Adverse events reported for the first time or worsening of a pre-existing event after the first dose of study treatment.
    Time Frame
    Up to approximately 27 months
    Secondary Outcome Measure Information:
    Title
    Objective response rate (ORR)
    Description
    Defined as the percentage of participants having complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 as determined by investigator assessment.
    Time Frame
    Through study completion, up to approximately 31 months
    Title
    Duration of response (DOR)
    Description
    Defined as the time from an initial objective response (CR or PR) according to RECIST v1.1 until disease progression as determined by investigator assessment or death due to any cause.
    Time Frame
    Through study completion, up to approximately 31 months
    Title
    Disease control rate (DCR)
    Description
    Defined as the number of participants with CR or PR as best response or stable disease that was maintained for at least 12 weeks.
    Time Frame
    Through study completion, up to approximately 31 months
    Title
    Cmax of INCMGA00012 when given in combination with chemotherapy agents
    Description
    Maximum observed plasma or serum concentration.
    Time Frame
    Through post-induction Cycle 5 Day 1, up to 15 weeks
    Title
    Tmax of INCMGA00012 when given in combination with chemotherapy agents
    Description
    Time to maximum concentration.
    Time Frame
    Through post-induction Cycle 5 Day 1, up to 15 weeks
    Title
    Cmin of INCMGA00012 when given in combination with chemotherapy agents
    Description
    Minimum observed plasma or serum concentration over the dose interval.
    Time Frame
    Through post-induction Cycle 5 Day 1, up to 15 weeks
    Title
    AUC0-t of INCMGA00012 when given in combination with chemotherapy agents
    Description
    Area under the plasma or serum concentration-time curve from time = 0 to the last measurable concentration at time = t.
    Time Frame
    Through post-induction Cycle 5 Day 1, up to 15 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Advanced and/or metastatic solid tumors including the following: histologically or cytologically confirmed diagnosis of Stage IIIB not amenable to curative treatment or Stage IV non-small cell lung cancer (pemetrexed-platinum treatment groups must have nonsquamous histology type); and histologically or cytologically confirmed diagnosis of advanced/metastatic unresectable malignant pleural mesothelioma. No prior systemic treatment with the following exceptions: participants with a known sensitizing mutation (eg, BRAF, EGFR, ALK, or ROS1) should have had disease progression on or following an approved targeted tyrosine kinase inhibitor; and participants who received adjuvant or neoadjuvant chemotherapy are eligible if the adjuvant/neoadjuvant therapy was completed at least 6 months before the date of enrollment. Measurable or nonmeasurable tumor lesions per RECIST v1.1. Eastern Cooperative Oncology Group performance status 0 to 1. Exclusion Criteria: Received prior treatment with checkpoint inhibitor agents (such as anti-PD-1, anti-PD-L1, anti-PD-L2, or anti-CTLA-4). Had major surgery within 3 weeks before the first dose of study treatment. Received radiation therapy to the lung(s) that is > 30 Gy within 6 months of the first dose of study treatment. Received palliative radiotherapy within 7 days before the first dose of study treatment. Has ≥ Grade 2 residual toxicities from the most recent prior therapy (except alopecia). Organ function (renal, hepatic), bone marrow reserve, and coagulation panel outside the protocol-defined laboratory values. Is currently participating and receiving investigational therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks before the first dose of study treatment. Has active autoimmune disease requiring systemic immunosuppression with corticosteroids (> 10 mg once daily of prednisone or equivalent) or immunosuppressive drugs within 2 years before the first dose of study treatment. Is on chronic systemic steroids (> 10 mg once daily of prednisone or equivalent). Known active central nervous system metastases and/or carcinomatous meningitis (patients with previously-treated and clinically stable brain metastases are eligible and a washout period of ≥ 4 weeks since radiation therapy is required). Known additional malignancy that is progressing or requires active treatment. Evidence of interstitial lung disease or active, noninfectious pneumonitis. History of organ transplant, including allogeneic stem cell transplantation. Active infections requiring systemic antibiotics. Known active hepatitis B or C. Has a diagnosis of immunodeficiency, including participants known to be HIV positive (positive for HIV 1/2 antibodies). Significant cardiac event within 6 months before Cycle 1 Day 1. Has received a live vaccine within 28 days of the planned start of study treatment. Known hypersensitivity to any component of the study drugs, excipients, or another monoclonal antibody which cannot be controlled with standard measures (eg, antihistamines and corticosteroids).
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Incyte Medical Monitor
    Organizational Affiliation
    Incyte Corporation
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    INCMGA00012 Plus Chemotherapy in Participants With Advanced Solid Tumors (POD1UM-105)

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