Clinical Trials /

A Study of INCMGA00012 in Participants With Selected Solid Tumors (POD1UM-203)

NCT03679767

Description:

The purpose of this study is to assess the clinical activity and safety of INCMGA00012 in participants with advanced solid tumors where the efficacy of PD-1 inhibitors has previously been established.

Related Conditions:
  • Clear Cell Renal Cell Carcinoma
  • Melanoma
  • Non-Small Cell Lung Carcinoma
  • Urothelial Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: A Study of INCMGA00012 in Participants With Selected Solid Tumors (POD1UM-203)
  • Official Title: A Phase 2 Study of INCMGA00012 (PD-1 Inhibitor) in Participants With Selected Solid Tumors (POD1UM-203)

Clinical Trial IDs

  • ORG STUDY ID: INCMGA 0012-203
  • NCT ID: NCT03679767

Conditions

  • Metastatic Non-small Cell Lung Cancer
  • Locally Advanced Urothelial Cancer
  • Metastatic Urothelial Cancer
  • Unresectable Melanoma
  • Metastatic Melanoma
  • Locally Advanced Renal Cell Carcinoma
  • Metastatic Clear-Cell Renal Cell Carcinoma

Interventions

DrugSynonymsArms
INCMGA00012INCMGA00012

Purpose

The purpose of this study is to assess the clinical activity and safety of INCMGA00012 in participants with advanced solid tumors where the efficacy of PD-1 inhibitors has previously been established.

Trial Arms

NameTypeDescriptionInterventions
INCMGA00012ExperimentalINCMGA00012 administered to cohorts of specific tumor types.
  • INCMGA00012

Eligibility Criteria

        Inclusion Criteria:

          -  Confirmed diagnosis of one of the following: treatment-naïve metastatic non-small cell
             lung cancer with high PD-L1 expression (tumor proportion score ≥ 50%) and no epidermal
             growth factor receptor (EGFR), alkaline phosphatase (ALK), or ROS activating genomic
             tumor aberrations; locally advanced or metastatic urothelial carcinoma in participants
             who are not eligible for cisplatin therapy and whose tumors express PD-L1 with a
             combined positive score ≥ 10; unresectable or metastatic melanoma; locally advanced or
             metastatic renal cell carcinoma with clear cell component (with or without sarcomatoid
             features) and having received no prior systemic therapy.

          -  Measurable disease per RECIST v1.1.

          -  Eastern Cooperative Oncology Group performance status 0 to 1.

          -  Willingness to avoid pregnancy or fathering children.

        Exclusion Criteria:

          -  Receipt of anticancer therapy or participation in another interventional clinical
             study within 21 days before the first administration of study drug.

          -  Prior treatment with PD-1 or PD-L1 directed therapy (other immunotherapies may be
             acceptable with prior approval from the medical monitor).

          -  Radiotherapy within 14 days of first dose of study treatment with the following
             caveats: 28 days for pelvic radiotherapy; 6 months for thoracic region radiotherapy
             that is > 30 Gy.

          -  Toxicity of prior therapy that has not recovered to ≤ Grade 1 or baseline (with the
             exception of anemia not requiring transfusion support and any grade of alopecia).
             Endocrinopathy, if well-managed, is not exclusionary and should be discussed with
             sponsor medical monitor.

          -  Has not recovered adequately from toxicities and/or complications from surgical
             intervention before starting study drug.

          -  Laboratory values outside the protocol-defined range at screening.

          -  Active malignancy requiring treatment of a type not included in the study population.

          -  Active autoimmune disease requiring systemic immunosuppression in excess of
             physiologic maintenance doses of corticosteroids (> 10 mg of prednisone or
             equivalent).

          -  Evidence of interstitial lung disease or active noninfectious pneumonitis.

          -  Known active central nervous system metastases and/or carcinomatous meningitis.

          -  Known active hepatitis B antigen, hepatitis B virus, or hepatitis C virus infection.

          -  Active infections requiring systemic therapy.

          -  Known to be HIV-positive, unless all of the following criteria are met: CD4+ count ≥
             300/μL, undetectable viral load, receiving highly active antiretroviral therapy.

          -  Known hypersensitivity to another monoclonal antibody that cannot be controlled with
             standard measures (eg, antihistamines and corticosteroids).

          -  Impaired cardiac function or clinically significant cardiac disease.

          -  Is pregnant or breastfeeding.

          -  Has received a live vaccine within 28 days of the planned start of study drug.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Overall response rate
Time Frame:Up to at least 6 months from the start of treatment
Safety Issue:
Description:Defined as the percentage of participants having a complete response (CR) or partial response (PR), according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 as determined by the investigator.

Secondary Outcome Measures

Measure:Duration of response
Time Frame:Up to approximately 3 years
Safety Issue:
Description:Defined as the time from an initial objective response (CR or PR) according to RECIST v1.1 until first observation of documented disease progression as determined by investigator or death due to any cause.
Measure:Disease control rate
Time Frame:Up to approximately 3 years
Safety Issue:
Description:Defined as the proportion of participants with either an objective response (CR and PR) or stable disease, according to RECIST v1.1.
Measure:Progression-free survival
Time Frame:Up to approximately 3 years
Safety Issue:
Description:Defined as the time from the start of therapy until disease progression, as determined by investigator or death due to any cause.
Measure:Overall survival
Time Frame:Up to approximately 3 years
Safety Issue:
Description:Defined as the time from the start of therapy until death due to any cause.
Measure:Number of treatment-emergent adverse events
Time Frame:Up to approximately 3 years
Safety Issue:
Description:Defined as adverse events reported for the first time or worsening of a pre-existing event after first dose of study drug.
Measure:Cmax of INCMGA00012
Time Frame:Up to approximately 2 years
Safety Issue:
Description:Maximum observed plasma or serum concentration.
Measure:Tmax of INCMGA00012
Time Frame:Up to approximately 2 years
Safety Issue:
Description:Time to maximum concentration.
Measure:Cmin of INCMGA00012
Time Frame:Up to approximately 2 years
Safety Issue:
Description:Minimum observed plasma or serum concentration over the dose interval.
Measure:AUC0-t of INCMGA00012
Time Frame:Up to approximately 2 years
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 2
Primary Purpose:Interventional
Overall Status:Not yet recruiting
Lead Sponsor:Incyte Corporation

Trial Keywords

  • PD-1inhibitor
  • non-small cell lung cancer
  • urothelial cancer
  • melanoma
  • renal cell carcinoma

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