Anal Cancer

A Study of INCMGA00012 in Squamous Carcinoma of the Anal Canal Following Platinum-Based Chemotherapy (POD1UM-202)

Incyte Study ID:
INCMGA 0012-202
CT.gov ID:
NCT03597295
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 efficacy of INCMGA00012 in participants with locally advanced or metastatic squamous carcinoma of the anal canal (SCAC) who have progressed after platinum-based chemotherapy.

Clinical Study Summary

MEDICAL CONDITION(S)
  • Anal Cancer
    • PRODUCT
  • Drug: Retifanlimab
    • COLLABORATORS
    N/A
    DATE
    Oct 2018 - Jun 2020
    TYPE
    Interventional
    PHASE
    Phase 2
    SEX
    Female & Male
    AGE
    18+ years
    ACCEPTS HEALTHY VOLUNTEERS
    No

    Clinical Study Locations

    Name
    Contact Us
    Name
    City of Hope National Medical Center
    Duarte, California, US, 91010
    Name
    UC Davis Comprehensive Cancer Center
    Sacramento, California, US, 95817
    Name
    Maryland Oncology Hematology P.A.
    Rockville, Maryland, US, 20850
    Name
    Texas Oncology-Baylor Charles A. Sammons
    Dallas, Texas, US, 75246
    Name
    Renovatio Clinical
    Spring, Texas, US, 77380
    Name
    Zna Middelheim
    Antwerp, Belgium, 2020

    Key Inclusion and Exclusion Criteria

    Inclusion Criteria

    • Ability to comprehend and willingness to sign a written informed consent form.
    • Confirmed diagnosis of locally advanced or metastatic SCAC.

    Exclusion Criteria

    • Receipt of anticancer therapy or participation in another interventional clinical study within 21 days before the first administration of study drug; 6 weeks for mitomycin C.
    • 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.

    Protocol Summary

    Incyte Study ID:
    INCMGA 0012-202
    Primary Purpose:
    Treatment
    Allocation:
    N/A
    Study Design:
    Single Group Assignment
    Masking:
    None (Open Label)
    Interventions:
    Drug
    Enrollment:
    94
    Primary Outcome
    Open

    Overall response rate (ORR)

    Timeframe: Up to approximately 6 months

    Secondary Outcome
    Open

    Duration of response

    Timeframe: Up to approximately 3 years

    Disease control rate

    Timeframe: Up to approximately 3 years

    Progression-free survival

    Timeframe: Up to approximately 3 years

    Overall survival

    Timeframe: Up to approximately 3 years

    Number of treatment-emergent adverse events

    Timeframe: Up to approximately 3 years

    Cmax of INCMGA00012

    Timeframe: Up to approximately 6 months

    tmax of INCMGA00012

    Timeframe: Up to approximately 6 months

    Cmin of INCMGA00012

    Timeframe: Up to approximately 6 months

    AUC0-t of INCMGA00012

    Timeframe: Up to approximately 6 months