Skin Cancer

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

Incyte Study ID:
INCMGA 0012-201
CT.gov ID:
NCT03599713
View Results Summary
Eudra ID:
N/A
Sponsor:
Incyte Corporation
Collaborator:
N/A
Study Contact Information:
1.855.463.3463 or [email protected]
Study Complete
Subscribe to UpdatesContact Us

Results Available

Protocol
Available Languages: English
Download document(s)
Statistical Analysis Plan (SAP)
Available Languages: English
Download document(s)

Clinical Study 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).

Clinical Study Summary

MEDICAL CONDITION(S)
  • Skin Cancer
    • PRODUCT
  • Drug: Retifanlimab
    • COLLABORATORS
    N/A
    DATE
    Feb 2019 - Jan 2022
    TYPE
    Interventional
    PHASE
    Phase 2
    SEX
    Female & Male
    AGE
    18+ years
    ACCEPTS HEALTHY VOLUNTEERS
    No

    Clinical Study Locations

    Name
    Contact Us
    Name
    STANFORD CANCER INSTITUTE
    PALO ALTO, CA, US, 94304
    Name
    UNIVERSITY OF CALIFORNIA SAN FRANCISCO COMPREHENSIVE CANCER CENTER
    SAN FRANCISCO, CA, US, 94143
    Name
    GEORGETOWN UNIVERSITY HOSPITAL
    WASHINGTON, DC, US, 20007
    Name
    RUSH UNIVERSITY
    CHICAGO, IL, US, 60612
    Name
    MAYO CLINIC ROCHESTER
    ROCHESTER, MN, US, 55905
    Name
    RUTGERS CANCER INSTITUTE OF NJ
    NEW BRUNSWICK, NJ, US, 08901

    Key Inclusion and Exclusion Criteria

    Inclusion Criteria

    • Signed informed consent.
    • Diagnosis of MCC with distant metastatic disease or recurrent, advanced locoregional disease not amenable to surgery or radiation

    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.

    Protocol Summary

    Incyte Study ID:
    INCMGA 0012-201
    Primary Purpose:
    Treatment
    Allocation:
    Non-randomized
    Study Design:
    Parallel Assignment
    Masking:
    None (Open Label)
    Interventions:
    Drug
    Enrollment:
    107
    Primary Outcome
    Open

    Objective Response Rate (ORR) in chemotherapy-naive participants with advanced/metastatic MCC, according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, as Determined by independent Central Radiographic Review (ICR)

    Timeframe: up to approximately 8 months

    Secondary Outcome
    Open

    Duration of Response (DOR) in chemotherapy-naive participants with advanced/metastatic MCC, according to RECIST v1.1, as Determined by ICR

    Timeframe: up to approximately 2 years

    Disease Control Rate (DCR) in chemotherapy-naive participants with advanced/metastatic MCC

    Timeframe: up to approximately 2 years

    Progression-free Survival (PFS) in chemotherapy-naive participants with advanced/metastatic MCC

    Timeframe: up to approximately 2 years

    Overall Survival in chemotherapy-naive participants with advanced/metastatic MCC

    Timeframe: up to approximately 2 years

    Number of participants with any treatment-emergent adverse event (TEAE)

    Timeframe: up to approximately 2 years

    Cmax of retifanlimab

    Timeframe: pre-infusion on Day 1 of Cycles 1, 2, 4, 6, and 7; 10 minutes post-infusion and 4 hours post-infusion on Day 1 of Cycles 1 and 6 (each Cycle is 28 days).

    tmax of retifanlimab

    Timeframe: pre-infusion on Day 1 of Cycles 1, 2, 4, 6, and 7; 10 minutes post-infusion and 4 hours post-infusion on Day 1 of Cycles 1 and 6 (each Cycle is 28 days).

    Cmin of retifanlimab

    Timeframe: pre-infusion on Day 1 of Cycles 1, 2, 4, 6, and 7; 10 minutes post-infusion and 4 hours post-infusion on Day 1 of Cycles 1 and 6 (each Cycle is 28 days).

    AUCt of retifanlimab

    Timeframe: pre-infusion on Day 1 of Cycles 1, 2, 4, 6, and 7; 10 minutes post-infusion and 4 hours post-infusion on Day 1 of Cycles 1 and 6 (each Cycle is 28 days).