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

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

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.

Study Overview

• Status: Completed
• Conditions: Squamous Cell Carcinoma of Anal Canal
• Intervention / Treatment: Drug: Retifanlimab

• Study Type: Interventional
• Enrollment (Actual): 94
• Phase: Phase 2

Contacts and Locations

Study Locations

• Belgium
  • Antwerp, Belgium, 2020
    • ZNA Middelheim
  • Brussels, Belgium, 1070
    • Hopital Erasme
• Denmark
  • Aarhus, Denmark, 8000
    • Aarhus Universitets Hospital
  • Herlev, Denmark, 2730
    • Herlev og Gentofte Hospital
  • Vejle, Denmark, 7100
    • Vejle Hospital
• France
  • Besancon, France, 2500
    • CENTRE HOSPITALIER UNIVERSITAIRE de BESANCON
  • Marseille, France, 13385
    • CHU Hôpital de la Timone
  • Marseille Cedex 5, France, 13385
    • CHU Hôpital de la Timone
  • Montpellier Cedex 5, France, 34298
    • ICM Montpellier
  • Paris, France, 75013
    • Hôpital Universitaire Pitié-Salpêtrière
  • Rennes Cedex 9, France, 35033
    • CHU de Rennes - Hopital Pontchaillou
  • Saint Herblain Cedex, France, 44805
    • Centre de Lutte Contre Le Cancer - Institut de Cancerologie de L'Ouest - Rene Gauducheau
  • Toulouse, France, 31059
    • Chu Toulouse Hopital Rangueil
• Germany
  • Hamburg, Germany, 22763
    • Asklepios Klinik Altona
  • Hamburg, Germany, 20246
    • University Medical Centre Hamburg-Eppendorf, Centre of Oncology
• Italy
  • Ancona, Italy, 60126
    • Azienda Ospedaliero Universitaria Ospedali Riuniti
  • Brindisi, Italy, 72100
    • Ospedale A. Perrino - Brindisi
  • Catania, Italy, 95123
    • A.O.U. Policlinico V. Emanuele G. Rodolico
  • Faenza, Italy, 48018
    • Ospedale Degli Infermi - Faenza
  • Genova, Italy, 16132
    • Irccs Azienda Ospedaliera Universitaria San Martino
  • Milano, Italy, 20162
    • Niguarda Cancer Center
  • Modena, Italy, 41124
    • Aou Modena - Policlinico
  • Palermo, Italy, 90146
    • Clinica La Maddalena
  • Rome, Italy, 00168
    • Policlinico Universitario Agostino Gemelli Universita Cattolica Del Sacro Cuore
  • San Giovanni Rotondo, Italy, 71013
    • IRCCS Casa Sollievo della Sofferenza
• Norway
  • Bergen, Norway, 5021
    • Haukeland U Hospital Bergen
  • Oslo, Norway, 0450
    • Oslo U
• Spain
  • Barcelona, Spain, 08036
    • Hospital Clínic i Provincial
  • Barcelona, Spain, 08035
    • Hospital General Universitari Vall d Hebron
  • Madrid, Spain, 28041
    • Hospital Universitario 12 de Octubre
• United Kingdom
  • Brighton, United Kingdom, BN2 5BE
    • Royal Sussex County Hospital
  • Chelsea, United Kingdom, SW3 6JJ
    • Royal Marsden Hospital
  • Cottingham, United Kingdom, HU16 5JQ
    • Castle Hill Hospital
  • Leeds, United Kingdom, L59 7TF
    • St. James U Hospital
  • Leeds, United Kingdom, L59 7TF
    • St. James Univ Hospital
  • London, United Kingdom, NW3 2QG
    • Royal Free London NHS Foundation Trust
  • London, United Kingdom, SW3 6JI
    • The Royal Marsden Nhs Foundation Trust - Chelsea
  • Manchester, United Kingdom, M20 4BV
    • The Christie NHS Foundation Trust
  • Sutton, United Kingdom, SM2 5PT
    • Royal Marsden Hospital
  • Truro, United Kingdom, TR1 3LQ
    • Royal Cornwall Hospital, Sunrise Centre
• United States
  • California
    • Duarte, California, United States, 91010
      • City Of Hope National Medical Center
    • Sacramento, California, United States, 95817
      • UC Davis Comprehensive Cancer Center
    • Santa Barbara, California, United States, 95817
      • Ridley-Tree Cancer Center
  • Maryland
    • Rockville, Maryland, United States, 20850
      • Maryland Oncology Hematology P.A.
  • Texas
    • Dallas, Texas, United States, 75246
      • Texas Oncology-Baylor Charles A. Sammons
    • McKinney, Texas, United States, 75071
      • Texas Oncology-McKinney
    • Spring, Texas, United States, 77380
      • Renovatio Clinical

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Retifanlimab 500 mg; Retifanlimab 500 milligrams (mg) intravenously every 4 weeks (Q4W).	Drug: Retifanlimab; Retifanlimab 500 milligrams (mg) intravenously every 4 weeks (Q4W).; Other Names: INCMGA00012; MGA012

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Objective Response Rate (ORR)	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.	Cycle 1 Day 1, and every 4 weeks throughout the study, up to approximately 24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Duration of Response (DOR)	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.	up to 18.2 months
Disease Control Rate (DCR)	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.	Cycle 1 Day 1, and every 4 weeks throughout the study, up to approximately 24 months
Progression-free Survival (PFS)	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.	up to 16.8 months
Overall Survival	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.	up to 28.2 months
Number of Participants With Treatment-emergent Adverse Events (TEAEs)	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.	up to 913 days
Cmax of Retifanlimab	Cmax was defined as the maximum observed plasma concentration.	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
Tmax of Retifanlimab	tmax was defined as the time to the maximum concentration.	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
Cmin of Retifanlimab	Cmin was defined as the minimum observed plasma concentration over the dose interval.	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
AUC0-t of Retifanlimab	AUC0-t was defined as the area under the plasma concentration-time curve from time = 0 to the last measurable concentration at time = t.	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

Collaborators and Investigators

• Sponsor: Incyte Corporation
• Investigators: Study Director: Incyte Medical Monitor, Incyte Corporation

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 8, 2018
• Primary Completion (Actual): June 8, 2020
• Study Completion (Actual): November 10, 2021

Study Registration Dates

• First Submitted: July 16, 2018
• First Submitted That Met QC Criteria: July 16, 2018
• First Posted (Actual): July 24, 2018

Study Record Updates

• Last Update Posted (Actual): August 21, 2025
• Last Update Submitted That Met QC Criteria: August 19, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: INCMGA00012; anti-PD-1 antibody; Squamous carcinoma of the anal canal; IgG4 monoclonal antibody
• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Neoplasms, Squamous Cell; Carcinoma; Carcinoma, Squamous Cell
• Other Study ID Numbers: INCMGA 0012-202; 2018-002070-51 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No