TriangleNCT03597295 · CITED IN SOURCE DOCUMENTS
A Study of INCMGA00012 in Squamous Carcinoma of the Anal Canal Following Platinum-Based Chemotherapy (POD1UM-202)
An NCI or FDA source cites this study. A citation does not establish that it applies to an individual diagnosis.
- Phase
- PHASE2
- Status at capture
- COMPLETED
- Registry last update
- 2025-08-21
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.
Open the original ClinicalTrials.gov record → · Download preserved record
What did the study report?
Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.
Participant flow
Baseline characteristics
Objective Response Rate (ORR)
Duration of Response (DOR)
Disease Control Rate (DCR)
Progression-free Survival (PFS)
Overall Survival
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Cmax of Retifanlimab
Tmax of Retifanlimab
Cmin of Retifanlimab
AUC0-t of Retifanlimab
Adverse events
Limitations, agreements, and source contact
Who could take part
- 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.
- healthy Volunteers
- false
- minimum Age
- 18 Years
- sex
- ALL
- std Ages
- ADULT
- OLDER_ADULT
Treatment arms and interventions
- arm Groups
- description
- Retifanlimab 500 milligrams (mg) intravenously every 4 weeks (Q4W).
- intervention Names
- Drug: Retifanlimab
- label
- Retifanlimab 500 mg
- type
- EXPERIMENTAL
- interventions
- arm Group Labels
- Retifanlimab 500 mg
- description
- Retifanlimab 500 milligrams (mg) intravenously every 4 weeks (Q4W).
- name
- Retifanlimab
- other Names
- MGA012
- INCMGA00012
- type
- DRUG
Study design
- allocation
- NA
- intervention Model
- SINGLE_GROUP
- masking Info
- masking
- NONE
- primary Purpose
- TREATMENT
Enrollment
- count
- 94
- type
- ACTUAL
Registered outcome plans (not posted results)
- primary Outcomes
- description
- ORR was defined as the percentage of participants with a best overall response of complete response (CR) or partial response (PR), per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 (v1.1), as assessed by independent central radiographic (ICR) review, at any post-Baseline visit until new anti-cancer therapy or first Progressive Disease. CR: disappearance of all target and non-target lesions and no appearance of any new lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to \<10 millimeters (mm). PR: complete disappearance or at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters, no new lesions, and no progression of non-target lesions.
- measure
- Objective Response Rate (ORR)
- time Frame
- Cycle 1 Day 1, and every 4 weeks throughout the study, up to approximately 24 months
- secondary Outcomes
- description
- DOR was defined as the time from an initial objective response (CR or PR) per RECIST v1.1 until the first observation of documented disease progression (PD), as determined by ICR, or death due to any cause. CR: disappearance of all target and non-target lesions and no appearance of any new lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to \<10 mm. PR: complete disappearance or at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters, no new lesions, and no progression of non-target lesions. PD: progression of a target or non-target lesion or presence of a new lesion.
- measure
- Duration of Response (DOR)
- time Frame
- up to 18.2 months
- description
- DCR was defined as the percentage of participants with a confirmed overall response of CR, PR, or stable disease (SD), per RECIST v1.1, at any post-baseline visit until the first progressive disease (PD) or new anti-cancer therapy. CR: disappearance of all target and non-target lesions and no appearance of any new lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to \<10 mm. PR: complete disappearance or at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters, no new lesions, and no progression of non-target lesions. PD: progression of a target or non-target lesion or presence of a new lesion. SD: no change in target lesions to qualify for CR, PR, or PD.
- measure
- Disease Control Rate (DCR)
- time Frame
- Cycle 1 Day 1, and every 4 weeks throughout the study, up to approximately 24 months
- description
- According to RECIST 1.1, PFS was defined as the length of time from the initial infusion of study drug until the earliest date of disease progression, as determined by ICR, or death due to any cause, if occurring sooner than progression.
- measure
- Progression-free Survival (PFS)
- time Frame
- up to 16.8 months
- description
- Overall survival was defined as the time in months between the first dose date (Day 1) and the date of death due to any cause.
- measure
- Overall Survival
- time Frame
- up to 28.2 months
- description
- An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. An AE could have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of the study drug. A TEAE was defined as any AE either reported for the first time or the worsening of a pre-existing event after the first dose of retifanlimab and within 90 days of the last administration of retifanlimab.
- measure
- Number of Participants With Treatment-emergent Adverse Events (TEAEs)
- time Frame
- up to 913 days
- description
- Cmax was defined as the maximum observed plasma concentration.
- measure
- Cmax of Retifanlimab
- time Frame
- pre-infusion on Day 1 of Cycles 1, 2, 4, 6, and 7; 10 minutes and 4 hours post-infusion on Day 1 of Cycles 1 and 6
- description
- tmax was defined as the time to the maximum concentration.
- measure
- Tmax of Retifanlimab
- time Frame
- pre-infusion on Day 1 of Cycles 1, 2, 4, 6, and 7; 10 minutes and 4 hours post-infusion on Day 1 of Cycles 1 and 6
- description
- Cmin was defined as the minimum observed plasma concentration over the dose interval.
- measure
- Cmin of Retifanlimab
- time Frame
- pre-infusion on Day 1 of Cycles 1, 2, 4, 6, and 7; 10 minutes and 4 hours post-infusion on Day 1 of Cycles 1 and 6
- description
- AUC0-t was defined as the area under the plasma concentration-time curve from time = 0 to the last measurable concentration at time = t.
- measure
- AUC0-t of Retifanlimab
- time Frame
- pre-infusion on Day 1 of Cycles 1, 2, 4, 6, and 7; 10 minutes and 4 hours post-infusion on Day 1 of Cycles 1 and 6
Full study description
- brief Summary
- 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.
Source references
- references
- citation
- Rao S, Anandappa G, Capdevila J, Dahan L, Evesque L, Kim S, Saunders MP, Gilbert DC, Jensen LH, Samalin E, Spindler KL, Tamberi S, Demols A, Guren MG, Arnold D, Fakih M, Kayyal T, Cornfeld M, Tian C, Catlett M, Smith M, Spano JP. A phase II study of retifanlimab (INCMGA00012) in patients with squamous carcinoma of the anal canal who have progressed following platinum-based chemotherapy (POD1UM-202). ESMO Open. 2022 Aug;7(4):100529. doi: 10.1016/j.esmoop.2022.100529. Epub 2022 Jul 8.
- pmid
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- type
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Source notices and limitations
Discovery and provenance
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Preserved source evidence · Not medical advice