Clinical trial NCT03597295: A Study of INCMGA00012 in Squamous Carcinoma of the Anal Canal Following Platinum-Based Chemotherapy (POD1UM-202)
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Squamous Cell Carcinoma of Anal Canal
Keywords: Squamous carcinoma of the anal canal
anti-PD-1 antibody
IgG4 monoclonal antibody
INCMGA00012
Lead sponsor: Incyte Corporation
Sponsor class: INDUSTRY
First posted: 2018-07-24
Enrollment: 94
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Objective Response Rate (ORR)
timeFrame: Cycle 1 Day 1, and every 4 weeks throughout the study, up to approximately 24 months
Secondary outcomes:
measure: Duration of Response (DOR)
timeFrame: up to 18.2 months
measure: Disease Control Rate (DCR)
timeFrame: Cycle 1 Day 1, and every 4 weeks throughout the study, up to approximately 24 months
measure: Progression-free Survival (PFS)
timeFrame: up to 16.8 months
measure: Overall Survival
timeFrame: up to 28.2 months
measure: Number of Participants With Treatment-emergent Adverse Events (TEAEs)
timeFrame: up to 913 days
measure: Cmax of Retifanlimab
timeFrame: 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
measure: Tmax of Retifanlimab
timeFrame: 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
measure: Cmin of Retifanlimab
timeFrame: 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
measure: AUC0-t of Retifanlimab
timeFrame: 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
Other outcomes:
Locations:
city: Duarte
country: United States
facility: City of Hope National Medical Center
state: California
city: Sacramento
country: United States
facility: UC Davis Comprehensive Cancer Center
state: California
city: Santa Barbara
country: United States
facility: Ridley-Tree Cancer Center
state: California
city: Rockville
country: United States
facility: Maryland Oncology Hematology P.A.
state: Maryland
city: Dallas
country: United States
facility: Texas Oncology-Baylor Charles A. Sammons
state: Texas
city: McKinney
country: United States
facility: Texas Oncology-McKinney
state: Texas
city: Spring
country: United States
facility: Renovatio Clinical
state: Texas
city: Antwerp
country: Belgium
facility: Zna Middelheim
city: Brussels
country: Belgium
facility: Hopital Erasme
city: Aarhus
country: Denmark
facility: Aarhus Universitets Hospital
city: Herlev
country: Denmark
facility: Herlev Og Gentofte Hospital
city: Vejle
country: Denmark
facility: Vejle Hospital
city: Besancon
country: France
facility: Centre Hospitalier Universitaire de Besancon
city: Marseille Cedex 5
country: France
facility: Chu Hopital de La Timone
city: Marseille
country: France
facility: CHU Hopital De La Timone
city: Montpellier Cedex 5
country: France
facility: Icm Montpellier
city: Paris
country: France
facility: Hopital Universitaire Pitie-Salpetriere
city: Rennes Cedex 9
country: France
facility: Chu de Rennes - Hôpital Pontchaillou
city: Saint Herblain Cedex
country: France
facility: Centre de Lutte Contre Le Cancer - Institut de Cancerologie de L'Ouest - Rene Gauducheau
city: Toulouse
country: France
facility: CHU Toulouse Hopital Rangueil
city: Hamburg
country: Germany
facility: University Medical Centre Hamburg-Eppendorf, Centre of Oncology
city: Hamburg
country: Germany
facility: Asklepios Klinik Altona
city: Ancona
country: Italy
facility: Azienda Ospedaliero Universitaria Ospedali Riuniti
city: Brindisi
country: Italy
facility: Ospedale A. Perrino - Brindisi
city: Catania
country: Italy
facility: A.O.U. Policlinico V. Emanuele G. Rodolico
city: Faenza
country: Italy
facility: Ospedale Degli Infermi - Faenza
city: Genova
country: Italy
facility: Irccs Azienda Ospedaliera Universitaria San Martino
city: Milano
country: Italy
facility: Niguarda Cancer Center
city: Modena
country: Italy
facility: Aou Modena - Policlinico
city: Palermo
country: Italy
facility: Clinica La Maddalena
city: Rome
country: Italy
facility: Policlinico Universitario Agostino Gemelli Universita Cattolica Del Sacro Cuore
city: San Giovanni Rotondo
country: Italy
facility: IRCCS Casa Sollievo Della Sofferenza
city: Bergen
country: Norway
facility: Haukeland U Hospital Bergen
city: Oslo
country: Norway
facility: Oslo U
city: Barcelona
country: Spain
facility: Hospital General Universitari Vall D Hebron
city: Barcelona
country: Spain
facility: Hospital Clinic I Provincial
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre
city: Brighton
country: United Kingdom
facility: Royal Sussex County Hospital
city: Chelsea
country: United Kingdom
facility: Royal Marsden Hospital
city: Cottingham
country: United Kingdom
facility: Castle Hill Hospital
city: Leeds
country: United Kingdom
facility: St. James U Hospital
city: Leeds
country: United Kingdom
facility: St. James Univ Hospital
city: London
country: United Kingdom
facility: Royal Free London Nhs Foundation Trust
city: London
country: United Kingdom
facility: The Royal Marsden Nhs Foundation Trust - Chelsea
city: Manchester
country: United Kingdom
facility: The Christie NHS Foundation Trust
city: Sutton
country: United Kingdom
facility: Royal Marsden Hospital
city: Truro
country: United Kingdom
facility: Royal Cornwall Hospital, Sunrise Centre
Study officials:
affiliation: Incyte Corporation
name: Incyte Medical Monitor
role: STUDY_DIRECTOR
References:
citation: 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.