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

Phase 2
Completed
Conditions
Squamous Cell Carcinoma of Anal Canal
Interventions
Registration Number
NCT03597295
Lead Sponsor
Incyte Corporation
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.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
94
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 โ‰ฅ 300/ฮผL, undetectable viral load, and receiving highly active antiretroviral therapy.
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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.
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Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
Retifanlimab 500 mgRetifanlimabRetifanlimab 500 milligrams (mg) intravenously every 4 weeks (Q4W).
Primary Outcome Measures
NameTimeMethod
Objective Response Rate (ORR)Cycle 1 Day 1, and every 4 weeks throughout the study, up to approximately 24 months

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.

Secondary Outcome Measures
NameTimeMethod
Progression-free Survival (PFS)up to 16.8 months

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.

Cmax of Retifanlimabpre-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

Cmax was defined as the maximum observed plasma concentration.

Disease Control Rate (DCR)Cycle 1 Day 1, and every 4 weeks throughout the study, up to approximately 24 months

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.

Tmax of Retifanlimabpre-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 was defined as the time to the maximum concentration.

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

AUC0-t of Retifanlimabpre-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 was defined as the area under the plasma concentration-time curve from time = 0 to the last measurable concentration at time = t.

Duration of Response (DOR)up to 18.2 months

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.

Overall Survivalup to 28.2 months

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.

Number of Participants With Treatment-emergent Adverse Events (TEAEs)up to 913 days

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.

Trial Locations

Locations (46)

Vejle Hospital

๐Ÿ‡ฉ๐Ÿ‡ฐ

Vejle, Denmark

Centre Hospitalier Universitaire de Besancon

๐Ÿ‡ซ๐Ÿ‡ท

Besancon, France

Maryland Oncology Hematology P.A.

๐Ÿ‡บ๐Ÿ‡ธ

Rockville, Maryland, United States

Renovatio Clinical

๐Ÿ‡บ๐Ÿ‡ธ

Spring, Texas, United States

Herlev Og Gentofte Hospital

๐Ÿ‡ฉ๐Ÿ‡ฐ

Herlev, Denmark

Icm Montpellier

๐Ÿ‡ซ๐Ÿ‡ท

Montpellier Cedex 5, France

Zna Middelheim

๐Ÿ‡ง๐Ÿ‡ช

Antwerp, Belgium

Hopital Erasme

๐Ÿ‡ง๐Ÿ‡ช

Brussels, Belgium

Chu de Rennes - Hรดpital Pontchaillou

๐Ÿ‡ซ๐Ÿ‡ท

Rennes Cedex 9, France

Aarhus Universitets Hospital

๐Ÿ‡ฉ๐Ÿ‡ฐ

Aarhus, Denmark

Azienda Ospedaliero Universitaria Ospedali Riuniti

๐Ÿ‡ฎ๐Ÿ‡น

Ancona, Italy

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

๐Ÿ‡ซ๐Ÿ‡ท

Saint Herblain Cedex, France

CHU Hopital De La Timone

๐Ÿ‡ซ๐Ÿ‡ท

Marseille, France

Chu Hopital de La Timone

๐Ÿ‡ซ๐Ÿ‡ท

Marseille Cedex 5, France

CHU Toulouse Hopital Rangueil

๐Ÿ‡ซ๐Ÿ‡ท

Toulouse, France

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

๐Ÿ‡ฎ๐Ÿ‡น

Catania, Italy

Clinica La Maddalena

๐Ÿ‡ฎ๐Ÿ‡น

Palermo, Italy

Ospedale Degli Infermi - Faenza

๐Ÿ‡ฎ๐Ÿ‡น

Faenza, Italy

St. James U Hospital

๐Ÿ‡ฌ๐Ÿ‡ง

Leeds, United Kingdom

St. James Univ Hospital

๐Ÿ‡ฌ๐Ÿ‡ง

Leeds, United Kingdom

The Christie NHS Foundation Trust

๐Ÿ‡ฌ๐Ÿ‡ง

Manchester, United Kingdom

University Medical Centre Hamburg-Eppendorf, Centre of Oncology

๐Ÿ‡ฉ๐Ÿ‡ช

Hamburg, Germany

Ridley-Tree Cancer Center

๐Ÿ‡บ๐Ÿ‡ธ

Santa Barbara, California, United States

Texas Oncology-Baylor Charles A. Sammons

๐Ÿ‡บ๐Ÿ‡ธ

Dallas, Texas, United States

UC Davis Comprehensive Cancer Center

๐Ÿ‡บ๐Ÿ‡ธ

Sacramento, California, United States

Hopital Universitaire Pitie-Salpetriere

๐Ÿ‡ซ๐Ÿ‡ท

Paris, France

Ospedale A. Perrino - Brindisi

๐Ÿ‡ฎ๐Ÿ‡น

Brindisi, Italy

Asklepios Klinik Altona

๐Ÿ‡ฉ๐Ÿ‡ช

Hamburg, Germany

Niguarda Cancer Center

๐Ÿ‡ฎ๐Ÿ‡น

Milano, Italy

Irccs Azienda Ospedaliera Universitaria San Martino

๐Ÿ‡ฎ๐Ÿ‡น

Genova, Italy

Aou Modena - Policlinico

๐Ÿ‡ฎ๐Ÿ‡น

Modena, Italy

Policlinico Universitario Agostino Gemelli Universita Cattolica Del Sacro Cuore

๐Ÿ‡ฎ๐Ÿ‡น

Rome, Italy

IRCCS Casa Sollievo Della Sofferenza

๐Ÿ‡ฎ๐Ÿ‡น

San Giovanni Rotondo, Italy

Oslo U

๐Ÿ‡ณ๐Ÿ‡ด

Oslo, Norway

Haukeland U Hospital Bergen

๐Ÿ‡ณ๐Ÿ‡ด

Bergen, Norway

Hospital General Universitari Vall D Hebron

๐Ÿ‡ช๐Ÿ‡ธ

Barcelona, Spain

Hospital Clinic I Provincial

๐Ÿ‡ช๐Ÿ‡ธ

Barcelona, Spain

Hospital Universitario 12 de Octubre

๐Ÿ‡ช๐Ÿ‡ธ

Madrid, Spain

Royal Sussex County Hospital

๐Ÿ‡ฌ๐Ÿ‡ง

Brighton, United Kingdom

Royal Marsden Hospital

๐Ÿ‡ฌ๐Ÿ‡ง

Sutton, United Kingdom

Castle Hill Hospital

๐Ÿ‡ฌ๐Ÿ‡ง

Cottingham, United Kingdom

The Royal Marsden Nhs Foundation Trust - Chelsea

๐Ÿ‡ฌ๐Ÿ‡ง

London, United Kingdom

Royal Cornwall Hospital, Sunrise Centre

๐Ÿ‡ฌ๐Ÿ‡ง

Truro, United Kingdom

City of Hope National Medical Center

๐Ÿ‡บ๐Ÿ‡ธ

Duarte, California, United States

Texas Oncology-McKinney

๐Ÿ‡บ๐Ÿ‡ธ

McKinney, Texas, United States

Royal Free London Nhs Foundation Trust

๐Ÿ‡ฌ๐Ÿ‡ง

London, United Kingdom

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