Clinical Trials /

A Study of INCMGA00012 in Metastatic Merkel Cell Carcinoma (POD1UM-201)

NCT03599713

Description:

The purpose of this study is to assess the clinical activity and safety of INCMGA00012 in participants with advanced/metastatic Merkel cell carcinoma (MCC).

Related Conditions:
  • Merkel Cell Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: A Study of INCMGA00012 in Metastatic Merkel Cell Carcinoma
  • Official Title: A Phase 2 Study of INCMGA00012 in Participants With Metastatic Merkel Cell Carcinoma

Clinical Trial IDs

  • ORG STUDY ID: INCMGA 0012-201
  • NCT ID: NCT03599713

Conditions

  • Metastatic Merkel Cell Carcinoma

Interventions

DrugSynonymsArms
INCMGA00012MGA012INCMGA00012

Purpose

The purpose of this study is to assess the clinical activity and safety of INCMGA00012 in participants with metastatic merkel cell carcinoma (MCC).

Trial Arms

NameTypeDescriptionInterventions
INCMGA00012Experimental
  • INCMGA00012

Eligibility Criteria

        Inclusion Criteria:

          -  Signed informed consent.

          -  Diagnosis of MCC with distant metastatic disease as a component of tumor burden and no
             more than 3 prior systemic treatments, inclusive of systemic adjuvant therapy.

          -  Eastern Cooperative Oncology Group performance status of 0 to 1.

          -  Measurable disease according to RECIST v1.1.

          -  Availability of tumor tissue (fresh or archival) for central pathology review.

          -  Willingness to avoid pregnancy or fathering children based on protocol-defined
             criteria.

        Exclusion Criteria:

          -  Prior programmed cell death protein 1 (PD-1) or programmed cell death ligand protein 1
             (PD-L1)-directed therapy.

          -  Treatment with anticancer drugs or participation in another interventional clinical
             study within 21 days before the first administration of study drug.

          -  Has not recovered to ≤ Grade 1 or baseline from toxic effects of prior therapy (with
             the exceptions for anemia not requiring transfusion support and any grade of alopecia)
             and/or complications from prior surgical intervention within 7 days before starting
             study treatment.

          -  Radiation therapy administered within 2 weeks of first dose of study treatment or
             radiation therapy in the thoracic region that is > 30 Gy within 6 months of the first
             dose of study treatment.

          -  Known central nervous system (CNS) metastases and/or carcinomatous meningitis.

          -  History of second malignancy within 3 years (with exceptions).

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

          -  Clinically significant pulmonary, cardiac, gastrointestinal or autoimmune disorders.

          -  Active bacterial, fungal, or viral infections, including hepatitis A, B, and C.

          -  Receipt of a live vaccine within 90 days of planned start of study therapy.

          -  Current use of protocol-defined prohibited medication.

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

          -  Inability or unlikely, in the opinion of the investigator, to comply with the Protocol
             requirements.

          -  Participant who is pregnant or breastfeeding.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Overall response rate in chemotherapy-naive participants
Time Frame:Up to approximately 3 years
Safety Issue:
Description:Defined as the percentage of participants with an objective response (complete response [CR] or partial response [PR]) according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) as determined by independent central radiographic review (ICR).

Secondary Outcome Measures

Measure:Overall response rate in the full study population (chemotherapy-naive and chemotherapy-refractory participants)
Time Frame:Up to approximately 3 years
Safety Issue:
Description:Defined as the percentage of participants with an objective response (CR or PR) according to RECIST v1.1 as determined by ICR.
Measure:Duration of response in the chemotherapy-naive and full study populations
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 disease progression as determined by ICR or death due to any cause.
Measure:Disease control rate in the chemotherapy-naive and full study populations
Time Frame:Up to approximately 3 years
Safety Issue:
Description:Defined as the proportion of participants with either an objective response or stable disease lasting at least 6 months.
Measure:Progression-free survival in the chemotherapy-naive and full study populations
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 the ICR or death due to any cause.
Measure:Overall survival in the chemotherapy-naive and full study populations
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 27 months
Safety Issue:
Description:Adverse events reported for the first time or worsening of a pre-existing event after first dose of study treatment.
Measure:Cmax of INCMGA00012
Time Frame:Up to approximately 6 months
Safety Issue:
Description:Maximum observed serum concentration.
Measure:tmax of INCMGA00012
Time Frame:Up to approximately 6 months
Safety Issue:
Description:Time to maximum concentration.
Measure:Cmin of INCMGA00012
Time Frame:Up to approximately 6 months
Safety Issue:
Description:Minimum observed serum concentration over the dose interval.
Measure:AUCt of INCMGA00012
Time Frame:Up to approximately 6 months
Safety Issue:
Description:Area under the serum concentration-time curve.

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Incyte Corporation

Trial Keywords

  • Metastatic merkel cell carcinoma
  • anti-PD-1 antibody
  • immunoglobulin G4 (IgG4) monoclonal antibody
  • INCMGA00012

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