Anal Cancer

carboplatin-paclitaxel with retifanlimab or placebo in participants with locally advanced or metastatic Squamous Cell Anal Carcinoma (POD1UM-303/InterAACT 2).

Incyte Study ID:
INCMGA 0012-303
CT.gov ID:
NCT04472429
Eudra ID:
N/A
Sponsor:
Incyte Corporation
Collaborator:
N/A
Study Contact Information:
1.855.463.3463 or [email protected]
Recruitment Complete
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Results Available

Protocol
Available Languages: English
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Statistical Analysis Plan (SAP)
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Clinical Study Purpose

This study is a Phase 3 global, multicenter, placebo-controlled double-blind randomized study that will enroll participants with inoperable locally recurrent or metastatic SCAC not previously treated with systemic chemotherapy.

Clinical Study Summary

MEDICAL CONDITION(S)
  • Anal Cancer
    • PRODUCT
  • Drug: carboplatin
  • Drug: paclitaxel
  • Drug: retifanlimab
    • COLLABORATORS
    N/A
    DATE
    Jan 2021 - Apr 2024
    TYPE
    Interventional
    PHASE
    Phase 3
    SEX
    Female & Male
    AGE
    18+ years
    ACCEPTS HEALTHY VOLUNTEERS
    No

    Clinical Study Locations

    Name
    Contact Us
    Name
    RENOVATIO CLINICAL CONSULTANTS LLC
    THE WOODLANDS, TX, US, 77380
    Name
    CITY OF HOPE NATIONAL MEDICAL CENTER
    DUARTE, CA, US, 91010
    Name
    BAYLOR SCOTT AND WHITE RESEARCH INSTITUTE
    DALLAS, TX, US, 75246
    Name
    ROCKY MOUNTAIN CANCER CENTER
    DENVER, CO, US, 80218
    Name
    TEXAS ONCOLOGY-WICHITA FALLS TEXOMA CANCER CENTER
    WICHITA FALLS, TX, US, 76310
    Name
    VIRGINIA CANCER SPECIALISTS, PC
    ARLINGTON, VA, US, 22205

    Key Inclusion and Exclusion Criteria

    Inclusion Criteria

    • -Able to comprehend and willing to sign a written ICF for the study.
    • Are 18 years of age or older (or as applicable per local country requirements).

    Exclusion Criteria

    • Has received prior PD-(L)1 directed therapy
    • Has received prior radiotherapy with or without radiosensitizing chemotherapy within 28 days of Cycle 1 Day 1 except for palliative radiation (30 Gy or less) which is restricted for 14 days of Cycle 1 Day 1 (note: all toxicities associated should have resolved to Grade ≤ 1).

    Protocol Summary

    Incyte Study ID:
    INCMGA 0012-303
    Primary Purpose:
    Treatment
    Allocation:
    Randomized
    Study Design:
    Parallel Assignment
    Masking:
    Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
    Interventions:
    Drug
    Enrollment:
    308
    Primary Outcome
    Open

    Progression Free Survival (PFS)

    Timeframe: up to 4.5 years

    Secondary Outcome
    Open

    Overall Survival (OS)

    Timeframe: Up to 4.5 years

    Overall Response Rate (ORR)

    Timeframe: Up to 4.5 years

    Duration of Response (DOR)

    Timeframe: Up to 4.5 years

    Disease Control Rate(DCR)

    Timeframe: Up to 4.5 years

    Number of treatment-emergent adverse events

    Timeframe: Up to 4.5 years

    Cmax of retifanlimab when administered with chemotherapy

    Timeframe: Up to 4.5 years

    tmax of retifanlimab when administered with chemotherapy

    Timeframe: Up to 4.5 years

    Cmin of retifanlimab when administered with chemotherapy

    Timeframe: Up to 4.5 years

    AUC0-t of retifanlimab when administered with chemotherapy

    Timeframe: Up to 4.5 years