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

NCT03597295 | Completed Phase 2 Results DMC FDA Drug

• 2 other identifiers: INCMGA 0012-2022018-002070-51
• Study Type: interventional
• Target: 94
• Locations: 9 countries
• Sites: 46

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.

Conditions

Squamous Cell Carcinoma of Anal Canal

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• Duration of Response (DOR)

  up to 18.2 months

• Disease Control Rate (DCR)

  Cycle 1 Day 1, and every 4 weeks throughout the study, up to approximately 24 months

• Progression-free Survival (PFS)

  up to 16.8 months

• Overall Survival

  up to 28.2 months

• Number of Participants With Treatment-emergent Adverse Events (TEAEs)

  up to 913 days

Study Arms (1)

Retifanlimab 500 mg

EXPERIMENTAL

Retifanlimab 500 milligrams (mg) intravenously every 4 weeks (Q4W).

Drug: Retifanlimab

Interventions

Retifanlimab DRUG

Retifanlimab 500 milligrams (mg) intravenously every 4 weeks (Q4W).

Also known as: MGA012, INCMGA00012

Retifanlimab 500 mg

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Incyte Corporation: lead

Study Sites (46)

City of Hope National Medical Center

Duarte, California, 91010, United States

Location

UC Davis Comprehensive Cancer Center

Sacramento, California, 95817, United States

Location

Ridley-Tree Cancer Center

Santa Barbara, California, 95817, United States

Location

Maryland Oncology Hematology P.A.

Rockville, Maryland, 20850, United States

Location

Texas Oncology-Baylor Charles A. Sammons

Dallas, Texas, 75246, United States

Location

Texas Oncology-McKinney

McKinney, Texas, 75071, United States

Location

Renovatio Clinical

Spring, Texas, 77380, United States

Location

Zna Middelheim

Antwerp, 2020, Belgium

Location

Hopital Erasme

Brussels, 1070, Belgium

Location

Aarhus Universitets Hospital

Aarhus, 8000, Denmark

Location

Herlev Og Gentofte Hospital

Herlev, 2730, Denmark

Location

Vejle Hospital

Vejle, 7100, Denmark

Location

Centre Hospitalier Universitaire de Besancon

Besançon, 2500, France

Location

CHU Hopital De La Timone

Marseille, 13385, France

Location

Icm Montpellier

Montpellier, 34298, France

Location

Hopital Universitaire Pitie-Salpetriere

Paris, 75013, France

Location

Chu de Rennes - Hôpital Pontchaillou

Rennes, 35033, France

Location

Centre de Lutte Contre Le Cancer - Institut de Cancerologie de L'Ouest - Rene Gauducheau

Saint-Herblain, 44805, France

Location

CHU Toulouse Hopital Rangueil

Toulouse, 31059, France

Location

University Medical Centre Hamburg-Eppendorf, Centre of Oncology

Hamburg, 20246, Germany

Location

Asklepios Klinik Altona

Hamburg, 22763, Germany

Location

Azienda Ospedaliero Universitaria Ospedali Riuniti

Ancona, 60126, Italy

Location

Ospedale A. Perrino - Brindisi

Brindisi, 72100, Italy

Location

A.O.U. Policlinico V. Emanuele G. Rodolico

Catania, 95123, Italy

Location

Ospedale Degli Infermi - Faenza

Faenza, 48018, Italy

Location

Irccs Azienda Ospedaliera Universitaria San Martino

Genova, 16132, Italy

Location

Niguarda Cancer Center

Milan, 20162, Italy

Location

Aou Modena - Policlinico

Modena, 41124, Italy

Location

Clinica La Maddalena

Palermo, 90146, Italy

Location

Policlinico Universitario Agostino Gemelli Universita Cattolica Del Sacro Cuore

Rome, 00168, Italy

Location

IRCCS Casa Sollievo Della Sofferenza

San Giovanni Rotondo, 71013, Italy

Location

Haukeland U Hospital Bergen

Bergen, 5021, Norway

Location

Oslo U

Oslo, 0450, Norway

Location

Hospital General Universitari Vall D Hebron

Barcelona, 08035, Spain

Location

Hospital Clinic I Provincial

Barcelona, 08036, Spain

Location

Hospital Universitario 12 de Octubre

Madrid, 28041, Spain

Location

Royal Sussex County Hospital

Brighton, BN2 5BE, United Kingdom

Location

Royal Marsden Hospital

Chelsea, SW3 6JJ, United Kingdom

Location

Castle Hill Hospital

Cottingham, HU16 5JQ, United Kingdom

Location

St. James U Hospital

Leeds, L59 7TF, United Kingdom

Location

St. James Univ Hospital

Leeds, L59 7TF, United Kingdom

Location

Royal Free London Nhs Foundation Trust

London, NW3 2QG, United Kingdom

Location

The Royal Marsden Nhs Foundation Trust - Chelsea

London, SW3 6JI, United Kingdom

Location

The Christie NHS Foundation Trust

Manchester, M20 4BV, United Kingdom

Location

Royal Marsden Hospital

Sutton, SM2 5PT, United Kingdom

Location

Royal Cornwall Hospital, Sunrise Centre

Truro, TR1 3LQ, United Kingdom

Location

Related Publications (1)

• 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: 35816951 RESULT

Results Point of Contact

• Title: Incyte Corporation Call Center (US)
• Organization: Incyte

medinfo@incyte.com

1.855.463.3463

Study Officials

• Incyte Medical Monitor

  Incyte Corporation

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 16, 2018
• First Posted: July 24, 2018
• Study Start: October 8, 2018
• Primary Completion: June 8, 2020
• Study Completion: November 10, 2021
• Last Updated: August 21, 2025
• Results First Posted: August 23, 2021

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

GB (10); FR (7); IT (10); NO (2); ES (3); DK (3); DE (2); US (7); BE (2)