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.
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
Drug | Synonyms | Arms |
---|
Retifanlimab | MGA012, INCMGA00012 | INCMGA00012 |
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
Name | Type | Description | Interventions |
---|
INCMGA00012 | Experimental | | |
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