Clinical Trials /

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

NCT03920839

Description:

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.

Related Conditions:
  • Malignant Pleural Mesothelioma
  • Malignant Solid Tumor
  • Non-Small Cell Lung Carcinoma
Recruiting Status:

Withdrawn

Phase:

Phase 1

Trial Eligibility

Document

Title

  • 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)

Clinical Trial IDs

  • ORG STUDY ID: INCMGA 0012-105
  • NCT ID: NCT03920839

Conditions

  • 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

Interventions

DrugSynonymsArms
INCMGA00012INCMGA00012 + gemcitabine/cisplatin
GemcitabineINCMGA00012 + gemcitabine/cisplatin
CisplatinINCMGA00012 + gemcitabine/cisplatin
PemetrexedINCMGA00012 + pemetrexed/cisplatin
CarboplatinINCMGA00012 + pemetrexed/carboplatin
PaclitaxelINCMGA00012 + paclitaxel/carboplatin

Purpose

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.

Trial Arms

NameTypeDescriptionInterventions
INCMGA00012 + gemcitabine/cisplatinExperimental
  • INCMGA00012
  • Gemcitabine
  • Cisplatin
INCMGA00012 + pemetrexed/cisplatinExperimental
  • INCMGA00012
  • Cisplatin
  • Pemetrexed
INCMGA00012 + pemetrexed/carboplatinExperimental
  • INCMGA00012
  • Pemetrexed
  • Carboplatin
INCMGA00012 + paclitaxel/carboplatinExperimental
  • INCMGA00012
  • Carboplatin
  • Paclitaxel

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

Primary Outcome Measures

Measure:Number of treatment-emergent adverse events with INCMGA00012 in combination with chemotherapy
Time Frame:Up to approximately 27 months
Safety Issue:
Description:Adverse events reported for the first time or worsening of a pre-existing event after the first dose of study treatment.

Secondary Outcome Measures

Measure:Objective response rate (ORR)
Time Frame:Through study completion, up to approximately 31 months
Safety Issue:
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.
Measure:Duration of response (DOR)
Time Frame:Through study completion, up to approximately 31 months
Safety Issue:
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.
Measure:Disease control rate (DCR)
Time Frame:Through study completion, up to approximately 31 months
Safety Issue:
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.
Measure:Cmax of INCMGA00012 when given in combination with chemotherapy agents
Time Frame:Through post-induction Cycle 5 Day 1, up to 15 weeks
Safety Issue:
Description:Maximum observed plasma or serum concentration.
Measure:Tmax of INCMGA00012 when given in combination with chemotherapy agents
Time Frame:Through post-induction Cycle 5 Day 1, up to 15 weeks
Safety Issue:
Description:Time to maximum concentration.
Measure:Cmin of INCMGA00012 when given in combination with chemotherapy agents
Time Frame:Through post-induction Cycle 5 Day 1, up to 15 weeks
Safety Issue:
Description:Minimum observed plasma or serum concentration over the dose interval.
Measure:AUC0-t of INCMGA00012 when given in combination with chemotherapy agents
Time Frame:Through post-induction Cycle 5 Day 1, up to 15 weeks
Safety Issue:
Description:Area under the plasma or serum concentration-time curve from time = 0 to the last measurable concentration at time = t.

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Not yet recruiting
Lead Sponsor:Incyte Corporation

Trial Keywords

  • solid tumors
  • non-small cell lung cancer
  • malignant pleural mesothelioma
  • chemotherapy
  • programmed cell death protein 1 (PD-1) inhibitor

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