A Study of INCMGA00012 in Squamous Carcinoma of the Anal Canal Following Platinum-Based Chemotherapy (POD1UM-202)
- 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
- 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.
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Retifanlimab 500 mg Retifanlimab Retifanlimab 500 milligrams (mg) intravenously every 4 weeks (Q4W).
- Primary Outcome Measures
Name Time Method 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
Name Time Method 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 Retifanlimab 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 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 Retifanlimab 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 was defined as the time to the maximum concentration.
Cmin of Retifanlimab 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 was defined as the minimum observed plasma concentration over the dose interval.
AUC0-t of Retifanlimab 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 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 Survival up 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
🇩🇰Vejle, Denmark
Centre Hospitalier Universitaire de Besancon
🇫🇷Besancon, France
Maryland Oncology Hematology P.A.
🇺🇸Rockville, Maryland, United States
Renovatio Clinical
🇺🇸Spring, Texas, United States
Herlev Og Gentofte Hospital
🇩🇰Herlev, Denmark
Icm Montpellier
🇫🇷Montpellier Cedex 5, France
Zna Middelheim
🇧🇪Antwerp, Belgium
Hopital Erasme
🇧🇪Brussels, Belgium
Chu de Rennes - Hôpital Pontchaillou
🇫🇷Rennes Cedex 9, France
Aarhus Universitets Hospital
🇩🇰Aarhus, Denmark
Azienda Ospedaliero Universitaria Ospedali Riuniti
🇮🇹Ancona, Italy
Centre de Lutte Contre Le Cancer - Institut de Cancerologie de L'Ouest - Rene Gauducheau
🇫🇷Saint Herblain Cedex, France
CHU Hopital De La Timone
🇫🇷Marseille, France
Chu Hopital de La Timone
🇫🇷Marseille Cedex 5, France
CHU Toulouse Hopital Rangueil
🇫🇷Toulouse, France
A.O.U. Policlinico V. Emanuele G. Rodolico
🇮🇹Catania, Italy
Clinica La Maddalena
🇮🇹Palermo, Italy
Ospedale Degli Infermi - Faenza
🇮🇹Faenza, Italy
St. James U Hospital
🇬🇧Leeds, United Kingdom
St. James Univ Hospital
🇬🇧Leeds, United Kingdom
The Christie NHS Foundation Trust
🇬🇧Manchester, United Kingdom
University Medical Centre Hamburg-Eppendorf, Centre of Oncology
🇩🇪Hamburg, Germany
Ridley-Tree Cancer Center
🇺🇸Santa Barbara, California, United States
Texas Oncology-Baylor Charles A. Sammons
🇺🇸Dallas, Texas, United States
UC Davis Comprehensive Cancer Center
🇺🇸Sacramento, California, United States
Hopital Universitaire Pitie-Salpetriere
🇫🇷Paris, France
Ospedale A. Perrino - Brindisi
🇮🇹Brindisi, Italy
Asklepios Klinik Altona
🇩🇪Hamburg, Germany
Niguarda Cancer Center
🇮🇹Milano, Italy
Irccs Azienda Ospedaliera Universitaria San Martino
🇮🇹Genova, Italy
Aou Modena - Policlinico
🇮🇹Modena, Italy
Policlinico Universitario Agostino Gemelli Universita Cattolica Del Sacro Cuore
🇮🇹Rome, Italy
IRCCS Casa Sollievo Della Sofferenza
🇮🇹San Giovanni Rotondo, Italy
Oslo U
🇳🇴Oslo, Norway
Haukeland U Hospital Bergen
🇳🇴Bergen, Norway
Hospital General Universitari Vall D Hebron
🇪🇸Barcelona, Spain
Hospital Clinic I Provincial
🇪🇸Barcelona, Spain
Hospital Universitario 12 de Octubre
🇪🇸Madrid, Spain
Royal Sussex County Hospital
🇬🇧Brighton, United Kingdom
Royal Marsden Hospital
🇬🇧Sutton, United Kingdom
Castle Hill Hospital
🇬🇧Cottingham, United Kingdom
The Royal Marsden Nhs Foundation Trust - Chelsea
🇬🇧London, United Kingdom
Royal Cornwall Hospital, Sunrise Centre
🇬🇧Truro, United Kingdom
City of Hope National Medical Center
🇺🇸Duarte, California, United States
Texas Oncology-McKinney
🇺🇸McKinney, Texas, United States
Royal Free London Nhs Foundation Trust
🇬🇧London, United Kingdom