Clinical Trials /

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

NCT03597295

Description:

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.

Related Conditions:
  • Anal Canal Squamous Cell Carcinoma
Recruiting Status:

Active, not recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: A Study of INCMGA00012 in Squamous Carcinoma of the Anal Canal Following Platinum-Based Chemotherapy
  • Official Title: A Phase 2 Study of INCMGA00012 in Participants With Squamous Carcinoma of the Anal Canal Who Have Progressed Following Platinum-Based Chemotherapy

Clinical Trial IDs

  • ORG STUDY ID: INCMGA 0012-202
  • NCT ID: NCT03597295

Conditions

  • Squamous Cell Carcinoma of Anal Canal

Interventions

DrugSynonymsArms
INCMGA00012MGA012INCMGA00012

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.

Trial Arms

NameTypeDescriptionInterventions
INCMGA00012Experimental
  • INCMGA00012

Eligibility Criteria

        Inclusion Criteria:

          -  Ability to comprehend and willingness to sign a written informed consent form.

          -  Confirmed diagnosis of locally advanced or metastatic SCAC.

          -  Must have received (or been intolerant to or ineligible for) at least 1 prior line of
             platinum-based chemotherapy and received no more than 2 prior systemic treatments.

          -  Must have measurable disease by RECIST v1.1.

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

          -  If HIV-positive, then all of the following criteria must also be met: CD4+ count ≥
             300/μL, undetectable viral load, and receiving highly active antiretroviral therapy.

        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.

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

          -  Active autoimmune disease requiring systemic immunosuppression.

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

          -  Known active hepatitis infection.

          -  Active infections requiring systemic therapy.

          -  Is pregnant or breastfeeding or is expecting to conceive or father children within the
             projected duration of the study, from screening through 6 months after the last dose
             of study drug.
      
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:Up to approximately 3 years
Safety Issue:
Description:Defined as the percentage of participants having a 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
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
Time Frame:Up to approximately 3 years
Safety Issue:
Description:Defined as the number of participants maintaining either an ORR or stable disease.
Measure:Progression-free survival
Time Frame:Up to approximately 3 years
Safety Issue:
Description:Defined as the time from the first dose of study treatment until disease progression by ICR or death due to any cause.
Measure:Overall survival
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 plasma 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 plasma concentration over the dose interval.
Measure:AUC0-t of INCMGA00012
Time Frame:Up to approximately 6 months
Safety Issue:
Description:Area under the plasma concentration-time curve from time = 0 to the last measurable concentration at time = t.

Details

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

Trial Keywords

  • Squamous carcinoma of the anal canal
  • anti-PD-1 antibody
  • IgG4 monoclonal antibody
  • INCMGA00012

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