Clinical trial NCT03599713: A Study of INCMGA00012 in Metastatic Merkel Cell Carcinoma (POD1UM-201)
Official title: A Phase 2 Study of INCMGA00012 in Participants With Metastatic Merkel Cell Carcinoma (POD1UM-201)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Metastatic Merkel Cell Carcinoma
Keywords: Metastatic merkel cell carcinoma
anti-PD-1 antibody
immunoglobulin G4 (IgG4) monoclonal antibody
INCMGA00012
Lead sponsor: Incyte Corporation
Sponsor class: INDUSTRY
First posted: 2018-07-26
Enrollment: 107
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess the clinical activity and safety of INCMGA00012 in participants with advanced/metastatic Merkel cell carcinoma (MCC).


Eligibility criteria: Inclusion Criteria:

* Signed informed consent.
* Diagnosis of MCC with distant metastatic disease or recurrent, advanced locoregional disease not amenable to surgery or radiation
* Eastern Cooperative Oncology Group performance status of 0 to 1.
* Measurable disease according to RECIST v1.1.
* Availability of tumor tissue (fresh or archival) for central pathology review.
* Willingness to avoid pregnancy or fathering children based on protocol-defined criteria.

Exclusion Criteria:

* Prior systemic therapy for MCC, including chemotherapy and prior PD-1 or PD-L1-directed therapy.
* Treatment with anticancer drugs or participation in another interventional clinical study within 21 days before the first administration of study drug.
* Has not recovered to ≤ Grade 1 or baseline from toxic effects of prior therapy (with the exceptions for anemia not requiring transfusion support and any grade of alopecia) and/or complications from prior surgical intervention within 7 days before starting study treatment.
* Radiation therapy administered within 2 weeks of first dose of study treatment or radiation therapy to the thoracic region that is \> 30 Gy within 6 months of the first dose of study treatment.
* Known central nervous system (CNS) metastases and/or carcinomatous meningitis.
* History of second malignancy within 3 years (with exceptions).
* Laboratory values outside the protocol-defined range at screening.
* Clinically significant pulmonary, cardiac, gastrointestinal or autoimmune disorders.
* Active bacterial, fungal, or viral infections, including hepatitis A, B, and C.
* Receipt of a live vaccine within 28 days of planned start of study therapy.
* Current use of protocol-defined prohibited medication.
* Known hypersensitivity to another monoclonal antibody that cannot be controlled with standard measures (eg, antihistamines and corticosteroids).
* Inability or unlikely, in the opinion of the investigator, to comply with the Protocol requirements.
* Participant who is pregnant or breastfeeding.

Primary outcomes:
measure: Objective Response Rate (ORR)
timeFrame: up to 26.8 months
Secondary outcomes:
measure: Duration of Response (DOR)
timeFrame: up to 24.9 months
measure: Disease Control Rate (DCR)
timeFrame: up to 26.8 months
measure: Progression-free Survival (PFS)
timeFrame: up to 26.8 months
measure: Overall Survival
timeFrame: up to 33.9 months
measure: Number of Participants With Any Treatment-emergent Adverse Event (TEAE)
timeFrame: up to 823 days (up to approximately 2.3 years)
measure: First-dose Cmax of Retifanlimab
timeFrame: preinfusion, 10 minutes postinfusion (± 10 minutes), and 4 hours postinfusion (± 10 minutes) on Day 1 of Cycle 1
measure: First-dose Cmin of Retifanlimab
timeFrame: preinfusion, 10 minutes postinfusion (± 10 minutes), and 4 hours postinfusion (± 10 minutes) on Day 1 of Cycle 1
measure: First-dose AUC0-t of Retifanlimab
timeFrame: preinfusion, 10 minutes postinfusion (± 10 minutes), and 4 hours postinfusion (± 10 minutes) on Day 1 of Cycle 1
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Stanford Cancer Institute
state: California
city: San Francisco
country: United States
facility: University of California San Francisco Comprehensive Cancer Center
state: California
city: Aurora
country: United States
facility: University of Colorado Cancer Center
state: Colorado
city: Washington
country: United States
facility: Georgetown University Hospital
state: District of Columbia
city: Chicago
country: United States
facility: Rush University
state: Illinois
city: Louisville
country: United States
facility: Norton Cancer Institute
state: Kentucky
city: Rochester
country: United States
facility: Mayo Clinic Rochester
state: Minnesota
city: Hackensack
country: United States
facility: John Theurer Cancer Center, Hackensack University Medical Center
state: New Jersey
city: New Brunswick
country: United States
facility: Rutgers Cancer Institute of Nj
state: New Jersey
city: Buffalo
country: United States
facility: Roswell Park Cancer Institute
state: New York
city: Rochester
country: United States
facility: University of Rochester Medical Center
state: New York
city: Cincinnati
country: United States
facility: The Christ Hospital
state: Ohio
city: Pittsburgh
country: United States
facility: Upmc Cancercenter
state: Pennsylvania
city: Fairfax
country: United States
facility: Inova Fairfax Hospital
state: Virginia
city: Seattle
country: United States
facility: University of Washington - Seattle Cancer Care Alliance
state: Washington
city: Morgantown
country: United States
facility: West Virginia University Hospitals Inc
state: West Virginia
city: Darlinghurst
country: Australia
facility: St Vincent'S Hospital Sydney
state: New South Wales
city: Edmonton
country: Canada
facility: Cross Cancer Institute
state: Alberta
city: Calgary Ab
country: Canada
facility: Tom Baker Cancer Centre
state: CA
city: London
country: Canada
facility: London Health Sciences Centre Lhsc - South Street Hospital
state: Ontario
city: Montreal
country: Canada
facility: Sir Mortimer B. Davis Jewish General Hospital Segal Cancer Ctr
state: Quebec
city: Montreal
country: Canada
facility: McGill University Health Centre/Glen Site/Cedars Cancer Centre
state: Quebec
city: Olomouc
country: Czechia
facility: Fakultni Nemocnice Olomouc
city: Praha 4-krc
country: Czechia
facility: Thomayerova Nemocnice
city: Praha
country: Czechia
facility: Prof Mudr Petr Arenberger Drsc Mba
city: Praha
country: Czechia
facility: Nemocnice Na Bulovce
city: Boulogne-billancourt
country: France
facility: Hï¿½PITAL AMBROISE PAR
city: Marseille Cedex 5
country: France
facility: Chu Hopital de La Timone
city: Nantes Cedex
country: France
facility: Centre Hospitalier Universitaire de Nantes (Chu de Nantes) - Hotel-Dieu
city: Nice Cedex 3
country: France
facility: CHU DE NICE - Hï¿½PITAL L'ARCHET 1
city: Paris
country: France
facility: Hospital Saint Louis
city: Rouen
country: France
facility: HOPITAL CHARLES NICOLLE CHU ROUEN - Hï¿½PITAL DE BOIS-GUILLAUME
city: Villejuif Cedex
country: France
facility: Institut Gustave Roussy
city: Berlin
country: Germany
facility: Charite Universitaetsmedizin Berlin - Campus Charite Mitte
city: Buxtehude
country: Germany
facility: Elbe Klinikum Buxtehude
city: Erfurt
country: Germany
facility: Helios Klinikum Erfurt
city: Essen
country: Germany
facility: Universitatsklinikum Essen
city: Kiel
country: Germany
facility: Universitatsklinikum Schleswig-Holstein
city: Marburg
country: Germany
facility: Universitatsklinikum Giessen Und Marburg Gmbh, Klinik Für Innere Medizin
city: Regensburg
country: Germany
facility: University Hospital Regensburg
city: Tubingen
country: Germany
facility: Universitaetsklinikum in Tubingen
city: Budapest
country: Hungary
facility: National Institute of Oncology
city: Debrecen
country: Hungary
facility: Debreceni Egyetem Klinikai Kozpon Belgyogy Klinika
city: Szeged
country: Hungary
facility: Szte Borgyogyszati Es Allergologiai Klinika
city: Bari
country: Italy
facility: Istituto Tumori Giovanni Paolo Ii Irccs Ospedale Oncologico Bari
city: Candiolo
country: Italy
facility: Fondazione Del Piemonte Per L'Oncologia Ircc Candiolo
city: Genova
country: Italy
facility: Irccs Azienda Ospedaliera Universitaria San Martino
city: Milan
country: Italy
facility: Fondazione Irccs Istituto Nazionale Dei Tumori
city: Milan
country: Italy
facility: European Institute of Oncology
city: Modena
country: Italy
facility: A.O.U. Di Modena - Policlinico
city: Naples
country: Italy
facility: Istituto Nazionale Tumori Irccs Fondazione Pascale
city: Padova
country: Italy
facility: Iov - Istituto Oncologico Veneto Irccs
city: Rome
country: Italy
facility: ONCOLOGIA ï¿½ IDI IRCCS ISTITUTO DERMOPATICO DELL'IMMACOLATA
city: Siena
country: Italy
facility: Azienda Ospedaliera Universitaria Senese Policlinico Santa Maria Alle Scotte
city: Warsaw
country: Poland
facility: Centrum Onkologii - Instytut Im. Marii Sklodowskiej - Curie
city: Barcelona
country: Spain
facility: Hospital General Universitario Vall D Hebron
city: Barcelona
country: Spain
facility: Hospital Clinic I Provincial
city: Madrid
country: Spain
facility: Hospital General Universitario Gregorio Maranon
city: Lausanne
country: Switzerland
facility: Centre Hospitalier Universitaire Vaudois (Chuv)
city: Zuerich
country: Switzerland
facility: Universitatsspital Zurich
city: Cottingham
country: United Kingdom
facility: Castle Hill 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
city: Sutton
country: United Kingdom
facility: The Royal Marsden Nhs Foundation Trust - Sutton
city: Truro
country: United Kingdom
facility: Royal Cornwall Hospital Truro Sunrise Centre
Study officials:
affiliation: Incyte Corporation
name: Incyte Medical Monitor
role: STUDY_DIRECTOR
References: