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Squamous Cell Carcinoma of Anal CanalPhase 2NCT03597295

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

A Phase 2 study testing Retifanlimab in people with Squamous Cell Carcinoma of Anal Canal, run by Incyte Corporation at 46 sites in 9 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Squamous Cell Carcinoma of Anal Canal
What is being tested?
Retifanlimab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
94 participants
Where
46 sitesin 9 countries
Study dates
8 Oct 2018to 10 Nov 2021
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

46 sites in 9 countries.

46 sites in 9 countries

Italy10 sites

  • Azienda Ospedaliero Universitaria Ospedali Riuniti

    Ancona, 60126

  • Ospedale A. Perrino - Brindisi

    Brindisi, 72100

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

    Catania, 95123

  • Ospedale Degli Infermi - Faenza

    Faenza, 48018

  • Irccs Azienda Ospedaliera Universitaria San Martino

    Genova, 16132

  • Niguarda Cancer Center

    Milan, 20162

  • Aou Modena - Policlinico

    Modena, 41124

  • Clinica La Maddalena

    Palermo, 90146

  • Policlinico Universitario Agostino Gemelli Universita Cattolica Del Sacro Cuore

    Rome, 00168

  • IRCCS Casa Sollievo Della Sofferenza

    San Giovanni Rotondo, 71013

Other trials in Italy

United Kingdom10 sites

  • Royal Sussex County Hospital

    Brighton, BN2 5BE

  • Royal Marsden Hospital

    Chelsea, SW3 6JJ

  • Castle Hill Hospital

    Cottingham, HU16 5JQ

  • St. James U Hospital

    Leeds, L59 7TF

  • St. James Univ Hospital

    Leeds, L59 7TF

  • Royal Free London Nhs Foundation Trust

    London, NW3 2QG

  • The Royal Marsden Nhs Foundation Trust - Chelsea

    London, SW3 6JI

  • The Christie NHS Foundation Trust

    Manchester, M20 4BV

  • Royal Marsden Hospital

    Sutton, SM2 5PT

  • Royal Cornwall Hospital, Sunrise Centre

    Truro, TR1 3LQ

Other trials in United Kingdom

United States7 sites

  • Texas Oncology-Baylor Charles A. Sammons

    Dallas, Texas, 75246

  • City of Hope National Medical Center

    Duarte, California, 91010

  • Texas Oncology-McKinney

    McKinney, Texas, 75071

  • Maryland Oncology Hematology P.A.

    Rockville, Maryland, 20850

  • UC Davis Comprehensive Cancer Center

    Sacramento, California, 95817

  • Ridley-Tree Cancer Center

    Santa Barbara, California, 95817

  • Renovatio Clinical

    Spring, Texas, 77380

Other trials in United States

France7 sites

  • Centre Hospitalier Universitaire de Besancon

    Besançon, 2500

  • CHU Hopital De La Timone

    Marseille, 13385

  • Icm Montpellier

    Montpellier, 34298

  • Hopital Universitaire Pitie-Salpetriere

    Paris, 75013

  • Chu de Rennes - Hôpital Pontchaillou

    Rennes, 35033

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

    Saint-Herblain, 44805

  • CHU Toulouse Hopital Rangueil

    Toulouse, 31059

Other trials in France

Denmark3 sites

  • Aarhus Universitets Hospital

    Aarhus, 8000

  • Herlev Og Gentofte Hospital

    Herlev, 2730

  • Vejle Hospital

    Vejle, 7100

Other trials in Denmark

Spain3 sites

  • Hospital General Universitari Vall D Hebron

    Barcelona, 08035

  • Hospital Clinic I Provincial

    Barcelona, 08036

  • Hospital Universitario 12 de Octubre

    Madrid, 28041

Other trials in Spain

Belgium2 sites

  • Zna Middelheim

    Antwerp, 2020

  • Hopital Erasme

    Brussels, 1070

Other trials in Belgium

Germany2 sites

  • University Medical Centre Hamburg-Eppendorf, Centre of Oncology

    Hamburg, 20246

  • Asklepios Klinik Altona

    Hamburg, 22763

Other trials in Germany

Norway2 sites

  • Haukeland U Hospital Bergen

    Bergen, 5021

  • Oslo U

    Oslo, 0450

Other trials in Norway

About this study

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)

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.

Being tested
Retifanlimab
Keywords
Squamous carcinoma of the anal canal, anti-PD-1 antibody, IgG4 monoclonal antibody, INCMGA00012

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RetifanlimabDrug

    Also called MGA012, INCMGA00012

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

Study groups in NCT03597295
Study groupRoleWhat they receive
Retifanlimab 500 mgExperimentalRetifanlimab 500 milligrams (mg) intravenously every 4 weeks (Q4W).
Receives: Drug: Retifanlimab

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

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

Secondary outcomes (9)

  1. 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.

    Measured: up to 18.2 months

  2. 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.

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

  3. 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.

    Measured: up to 16.8 months

  4. 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.

    Measured: up to 28.2 months

  5. 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.

    Measured: up to 913 days

  6. Cmax of Retifanlimab

    Cmax was defined as the maximum observed plasma concentration.

    Measured: 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

  7. Tmax of Retifanlimab

    tmax was defined as the time to the maximum concentration.

    Measured: 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

  8. Cmin of Retifanlimab

    Cmin was defined as the minimum observed plasma concentration over the dose interval.

    Measured: 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

  9. 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.

    Measured: 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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Jul 2018
  2. Study start8 Oct 2018
  3. Primary completion8 Jun 2020
  4. Study completion10 Nov 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
94 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03597295
Sponsor's protocol ID
INCMGA 0012-202
Other IDs
2018-002070-51, 2018
Status last verified
Aug 2025
First submitted
16 Jul 2018
Last updated
21 Aug 2025
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

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.

    PubMed 35816951

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Retifanlimab in people with Squamous Cell Carcinoma of Anal Canal, run by Incyte Corporation at 46 sites in 9 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 46 sites in Italy, United Kingdom, United States, France, Denmark and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 23 Aug 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective Response Rate (ORR) (time frame: Cycle 1 Day 1, and every 4 weeks throughout the study, up to approximately 24 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03597295, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2025.

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