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 (POD1UM-202)
  • Official Title: A Phase 2 Study of INCMGA00012 in Participants With Squamous Carcinoma of the Anal Canal Who Have Progressed Following Platinum-Based Chemotherapy (POD1UM-202)

Clinical Trial IDs

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

Conditions

  • Squamous Cell Carcinoma of Anal Canal

Interventions

DrugSynonymsArms
RetifanlimabMGA012, INCMGA00012INCMGA00012

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
  • Retifanlimab

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:Cycle 1 day 1, and every 4 weeks throughout the study, up to approximately 24 months.
Safety Issue:
Description:Defined as Complete Response (CR),- Disappearance of all target lesions; Partial Response (PR)->=30% decrease in the sum of the longest diameter (LD) of target lesions from baseline; Overall Response (OR) = CR + PR, as per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions as assessed by independent central radiographic review (ICR)

Secondary Outcome Measures

Measure:Duration of Response
Time Frame:Up to approximately 3 years
Safety Issue:
Description:The time measurement from initial objective response Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions), as per RECIST v1.0, until the first date that disease progression is determined by ICR or death.
Measure:Disease Control Rate
Time Frame:Up to approximately 3 years
Safety Issue:
Description:The number of participants with a confirmed overall response of CR, PR, or SD, as per RECIST 1.1, at any postbaseline visit until the first PD or start of new anticancer therapy.
Measure:Progression-free Survival
Time Frame:Up to approximately 3 years
Safety Issue:
Description:According to RECIST 1.1, PFS is defined as the length of time from initial infusion of study drug until the earliest date of disease progression, determined by ICR, or death due to any cause, if occurring sooner than progression.
Measure:Overall Survival
Time Frame:Up to approximately 3 years
Safety Issue:
Description:Overall survival is defined as the time in months between the first dose date (Day 1) and the date of death due to any cause.
Measure:Number of Treatment-emergent Adverse Events
Time Frame:Up to approximately 3 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:Preinfusion on Day 1 of Cycles 1, 2, 4, 6, and 7 and 10 minutes and 4 hrs post-infusion on D1C1 and D1C6
Safety Issue:
Description:Maximum observed plasma concentration
Measure:Tmax of INCMGA00012
Time Frame:Preinfusion, 10 minutes post-infusion D1C6
Safety Issue:
Description:Time to maximum concentration.
Measure:Cmin of INCMGA00012
Time Frame:Preinfusion on Day 1 of Cycles 1, 2, 4, 6, and 7 and 10 minutes and 4 hrs post-infusion on D1C1 and D1C6
Safety Issue:
Description:Minimum observed plasma concentration over the dose interval.
Measure:AUC0-t of INCMGA00012
Time Frame:Preinfusion on Day 1 of Cycles 1, 2, 4, 6, and 7 and 10 minutes post-infusion and 4 hrs post-infusion on D1C1 and D1C6
Safety Issue:
Description:Area under the plasma concentration-time curve from time = 0 to the last measurable concentration at time = t. Cycle 1 and Cycle 6: Day 1 predose and 10 min and 4 h after infusion Cycles 2, 4, and 7: Day 1 predose

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Active, not recruiting
Lead Sponsor:Incyte Corporation

Trial Keywords

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

Last Updated

August 23, 2021