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 (POD1UM-201)
  • Official Title: A Phase 2 Study of INCMGA00012 in Participants With Metastatic Merkel Cell Carcinoma (POD1UM-201)

Clinical Trial IDs

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

Conditions

  • Metastatic Merkel Cell Carcinoma

Interventions

DrugSynonymsArms
RetifanlimabMGA012, INCMGA00012INCMGA00012

Purpose

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

Trial Arms

NameTypeDescriptionInterventions
INCMGA00012Experimental
  • Retifanlimab

Eligibility Criteria

        Inclusion Criteria:

          -  Signed informed consent.

          -  Diagnosis of MCC with distant metastatic disease or recurrent, advanced locoregional
             disease not amenable to surgery or radiation

          -  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 systemic therapy for MCC, including chemotherapy and prior PD-1 or
             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 to 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 28 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 (ORR)
Time Frame:Baseline up to approximately 8 months
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:Duration of Response (DOR)
Time Frame:Up to approximately 2 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 (DCR)
Time Frame:Up to approximately 2 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 (PFS)
Time Frame:Up to approximately 2 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 (OS)
Time Frame:Up to approximately 2 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 (TEAE)
Time Frame:Up to approximately 2 years
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

Last Updated

November 4, 2020