JOURNAL ONKOLOGIE – STUDIE
A Study of INCMGA00012 in Metastatic Merkel Cell Carcinoma (POD1UM-201)
Rekrutierend
NCT-Nummer:
NCT03599713
Studienbeginn:
Februar 2019
Letztes Update:
04.11.2020
Wirkstoff:
Retifanlimab
Indikation (Clinical Trials):
Carcinoma, Carcinoma, Merkel Cell
Geschlecht:
Alle
Altersgruppe:
Erwachsene (18+)
Phase:
Phase 2
Sponsor:
Incyte Corporation
Collaborator:
-
Studienleiter
Study Director
Incyte Corporation
Kontakt
Kontakt:
Phone: 1.855.463.3463
E-Mail: medinfo@incyte.com» Kontaktdaten anzeigen
Kontakt:
Phone: +800 00027423
E-Mail: globalmedinfo@incyte.com» Kontaktdaten anzeigen
Studienlocations (3 von 65)
Charite Universitaetsmedizin Berlin - Campus Charite Mitte
10117 Berlin
(Berlin)
GermanyRekrutierend» Google-MapsElbe Klinikum Buxtehude
21614 Buxtehude
(Niedersachsen)
GermanyRekrutierend» Google-MapsLungenkrebszentrum Helios Klinikum Erfurt
Nordhäuser Straße 74
99089 Erfurt
(Thüringen)
DeutschlandNoch nicht rekrutierend» Google-Maps
10117 Berlin
(Berlin)
GermanyRekrutierend» Google-MapsElbe Klinikum Buxtehude
21614 Buxtehude
(Niedersachsen)
GermanyRekrutierend» Google-MapsLungenkrebszentrum Helios Klinikum Erfurt
Nordhäuser Straße 74
99089 Erfurt
(Thüringen)
DeutschlandNoch nicht rekrutierend» Google-Maps
Universitatsklinikum Essen
45122 Essen
(Nordrhein-Westfalen)
GermanyRekrutierend» Google-MapsUniversitatsklinikum Schleswig-Holstein
24105 Kiel
(Schleswig-Holstein)
GermanyRekrutierend» Google-MapsUniversitatsklinikum Giessen Und Marburg Gmbh, Klinik Für Innere Medizin
35043 Marburg
(Hessen)
GermanyNoch nicht rekrutierend» Google-MapsUniversity Hospital Regensburg
93053 Regensburg
(Bayern)
GermanyNoch nicht rekrutierend» Google-MapsUniversitaetsklinikum in Tubingen
72076 Tubingen
(Baden-Württemberg)
GermanyRekrutierend» Google-MapsStanford Cancer Institute
94304 Palo Alto
United StatesRekrutierend» Google-MapsUniversity of California San Francisco Comprehensive Cancer Center
94143 San Francisco
United StatesRekrutierend» Google-MapsUniversity of Colorado Cancer Center
80045 Aurora
United StatesRekrutierend» Google-MapsGeorgetown University Hospital
20007 Washington
United StatesRekrutierend» Google-MapsRush University
60612 Chicago
United StatesRekrutierend» Google-MapsNorton Cancer Institute
40241 Louisville
United StatesRekrutierend» Google-MapsMayo Clinic Rochester
55905 Rochester
United StatesRekrutierend» Google-MapsJohn Theurer Cancer Center, Hackensack University Medical Center
07601 Hackensack
United StatesRekrutierend» Google-MapsRutgers Cancer Institute of Nj
08901 New Brunswick
United StatesAbgeschlossen» Google-MapsRoswell Park Cancer Institute
14263 Buffalo
United StatesRekrutierend» Google-MapsUniversity of Rochester Medical Center
14642 Rochester
United StatesRekrutierend» Google-MapsThe Christ Hospital
45219 Cincinnati
United StatesAbgeschlossen» Google-MapsUpmc Cancercenter
15232 Pittsburgh
United StatesRekrutierend» Google-MapsInova Fairfax Hospital
22031 Fairfax
United StatesRekrutierend» Google-MapsUniversity of Washington - Seattle Cancer Care Alliance
98109 Seattle
United StatesRekrutierend» Google-MapsWest Virginia University Hospitals Inc
26506 Morgantown
United StatesRekrutierend» Google-MapsSt Vincent'S Hospital Sydney
02010 Darlinghurst
AustraliaAbgeschlossen» Google-MapsCross Cancer Institute
T6G 1Z2 Edmonton
CanadaRekrutierend» Google-MapsTom Baker Cancer Centre
T2N 4N2 Calgary Ab
CanadaRekrutierend» Google-MapsLondon Health Sciences Centre Lhsc - South Street Hospital
N6A 4G5 London
CanadaRekrutierend» Google-MapsSir Mortimer B. Davis Jewish General Hospital Segal Cancer Ctr
H3T1E2 Montreal
CanadaRekrutierend» Google-MapsMcGill University Health Centre/Glen Site/Cedars Cancer Centre
H4A 3J1 Montreal
CanadaRekrutierend» Google-MapsNemocnice Na Bulovce
Czech Republic
CzechiaRekrutierend» Google-MapsFakultni Nemocnice Olomouc
775 20 Olomouc
CzechiaRekrutierend» Google-MapsThomayerova Nemocnice
140 59 Praha 4-krc
CzechiaRekrutierend» Google-MapsProf Mudr Petr Arenberger Drsc Mba
110 00 Praha
CzechiaRekrutierend» Google-MapsHopital Ambroise Pare
92100 Boulogne-billancourt
FranceRekrutierend» Google-MapsChu Hopital de La Timone
13385 Marseille Cedex 5
FranceRekrutierend» Google-MapsCentre Hospitalier Universitaire de Nantes (Chu de Nantes) - Hotel-Dieu
44093 Nantes Cedex
FranceRekrutierend» Google-MapsChu de Nice - Hopital L'Archet 1
06202 Nice Cedex 3
FranceRekrutierend» Google-MapsHopital Saint-Louis
75 010 Paris
FranceRekrutierend» Google-MapsHopital Charles Nicolle Chu Rouen - Hopital de Bois-Guillaume
76031 Rouen
FranceRekrutierend» Google-MapsInstitute Gustave Roussy (Igr)
94805 Villejuif Cedex
FranceRekrutierend» Google-MapsNational Institute of Oncology
01122 Budapest
HungaryRekrutierend» Google-MapsDebreceni Egyetem Klinikai Kozpon Belgyogy Klinika
04032 Debrecen
HungaryNoch nicht rekrutierend» Google-MapsSzte Borgyogyszati Es Allergologiai Klinika
06720 Szeged
HungaryNoch nicht rekrutierend» Google-MapsIstituto Tumori Giovanni Paolo Ii Irccs Ospedale Oncologico Bari
70124 Bari
ItalyRekrutierend» Google-MapsFondazione Del Piemonte Per L'Oncologia Ircc Candiolo
10060 Candiolo
ItalyRekrutierend» Google-MapsIrccs Azienda Ospedaliera Universitaria San Martino
16132 Liguria
ItalyRekrutierend» Google-MapsFondazione Irccs Istituto Nazionale Dei Tumori
20133 Milano
ItalyRekrutierend» Google-MapsIeo Istituto Europeo Di Oncologia Irccs
20141 Milano
ItalyRekrutierend» Google-MapsA.O.U. Di Modena - Policlinico
41124 Modena
ItalyRekrutierend» Google-MapsIstituto Nazionale Tumori Fondazione Irccs G. Pascale
80131 Naples
ItalyRekrutierend» Google-MapsIov - Istituto Oncologico Veneto Irccs
35128 Padova
ItalyRekrutierend» Google-MapsOncologia ? Idi Irccs Istituto Dermopatico Dell'Immacolata
00167 Rome
ItalyRekrutierend» Google-MapsAzienda Ospedaliera Universitaria Senese Policlinico Santa Maria Alle Scotte
53100 Siena
ItalyRekrutierend» Google-MapsCentrum Onkologii-Instytut Im. Marii Sklodowskiej-Curie
02-781 Warszawa
PolandRekrutierend» Google-MapsHospital General Universitari Vall D Hebron
08035 Barcelona
SpainRekrutierend» Google-MapsHospital Clinic I Provincial
08036 Barcelona
SpainRekrutierend» Google-MapsHospital General Universitario Gregorio Maranon
28007 Madrid
SpainRekrutierend» Google-MapsCentre Hospitalier Universitaire Vaudois (Chuv)
01011 Lausanne
SwitzerlandRekrutierend» Google-MapsZurich University Hospital
08091 Zuerich
SwitzerlandRekrutierend» Google-MapsCastle Hill Hospital
HU16 5JQ Cottingham
United KingdomRekrutierend» Google-MapsRoyal Free London Nhs Foundation Trust
NW3 2QG London
United KingdomRekrutierend» Google-MapsThe Royal Marsden Nhs Foundation Trust
SW3 6JJ London
United KingdomRekrutierend» Google-MapsThe Royal Marsden Nhs Foundation Trust - Sutton
SM2 5PT Sutton
United KingdomRekrutierend» Google-MapsRoyal Cornwall Hospital, Sunrise Centre
TR1 3LJ Truro
United KingdomRekrutierend» Google-Maps
Alle anzeigen 45122 Essen
(Nordrhein-Westfalen)
GermanyRekrutierend» Google-MapsUniversitatsklinikum Schleswig-Holstein
24105 Kiel
(Schleswig-Holstein)
GermanyRekrutierend» Google-MapsUniversitatsklinikum Giessen Und Marburg Gmbh, Klinik Für Innere Medizin
35043 Marburg
(Hessen)
GermanyNoch nicht rekrutierend» Google-MapsUniversity Hospital Regensburg
93053 Regensburg
(Bayern)
GermanyNoch nicht rekrutierend» Google-MapsUniversitaetsklinikum in Tubingen
72076 Tubingen
(Baden-Württemberg)
GermanyRekrutierend» Google-MapsStanford Cancer Institute
94304 Palo Alto
United StatesRekrutierend» Google-MapsUniversity of California San Francisco Comprehensive Cancer Center
94143 San Francisco
United StatesRekrutierend» Google-MapsUniversity of Colorado Cancer Center
80045 Aurora
United StatesRekrutierend» Google-MapsGeorgetown University Hospital
20007 Washington
United StatesRekrutierend» Google-MapsRush University
60612 Chicago
United StatesRekrutierend» Google-MapsNorton Cancer Institute
40241 Louisville
United StatesRekrutierend» Google-MapsMayo Clinic Rochester
55905 Rochester
United StatesRekrutierend» Google-MapsJohn Theurer Cancer Center, Hackensack University Medical Center
07601 Hackensack
United StatesRekrutierend» Google-MapsRutgers Cancer Institute of Nj
08901 New Brunswick
United StatesAbgeschlossen» Google-MapsRoswell Park Cancer Institute
14263 Buffalo
United StatesRekrutierend» Google-MapsUniversity of Rochester Medical Center
14642 Rochester
United StatesRekrutierend» Google-MapsThe Christ Hospital
45219 Cincinnati
United StatesAbgeschlossen» Google-MapsUpmc Cancercenter
15232 Pittsburgh
United StatesRekrutierend» Google-MapsInova Fairfax Hospital
22031 Fairfax
United StatesRekrutierend» Google-MapsUniversity of Washington - Seattle Cancer Care Alliance
98109 Seattle
United StatesRekrutierend» Google-MapsWest Virginia University Hospitals Inc
26506 Morgantown
United StatesRekrutierend» Google-MapsSt Vincent'S Hospital Sydney
02010 Darlinghurst
AustraliaAbgeschlossen» Google-MapsCross Cancer Institute
T6G 1Z2 Edmonton
CanadaRekrutierend» Google-MapsTom Baker Cancer Centre
T2N 4N2 Calgary Ab
CanadaRekrutierend» Google-MapsLondon Health Sciences Centre Lhsc - South Street Hospital
N6A 4G5 London
CanadaRekrutierend» Google-MapsSir Mortimer B. Davis Jewish General Hospital Segal Cancer Ctr
H3T1E2 Montreal
CanadaRekrutierend» Google-MapsMcGill University Health Centre/Glen Site/Cedars Cancer Centre
H4A 3J1 Montreal
CanadaRekrutierend» Google-MapsNemocnice Na Bulovce
Czech Republic
CzechiaRekrutierend» Google-MapsFakultni Nemocnice Olomouc
775 20 Olomouc
CzechiaRekrutierend» Google-MapsThomayerova Nemocnice
140 59 Praha 4-krc
CzechiaRekrutierend» Google-MapsProf Mudr Petr Arenberger Drsc Mba
110 00 Praha
CzechiaRekrutierend» Google-MapsHopital Ambroise Pare
92100 Boulogne-billancourt
FranceRekrutierend» Google-MapsChu Hopital de La Timone
13385 Marseille Cedex 5
FranceRekrutierend» Google-MapsCentre Hospitalier Universitaire de Nantes (Chu de Nantes) - Hotel-Dieu
44093 Nantes Cedex
FranceRekrutierend» Google-MapsChu de Nice - Hopital L'Archet 1
06202 Nice Cedex 3
FranceRekrutierend» Google-MapsHopital Saint-Louis
75 010 Paris
FranceRekrutierend» Google-MapsHopital Charles Nicolle Chu Rouen - Hopital de Bois-Guillaume
76031 Rouen
FranceRekrutierend» Google-MapsInstitute Gustave Roussy (Igr)
94805 Villejuif Cedex
FranceRekrutierend» Google-MapsNational Institute of Oncology
01122 Budapest
HungaryRekrutierend» Google-MapsDebreceni Egyetem Klinikai Kozpon Belgyogy Klinika
04032 Debrecen
HungaryNoch nicht rekrutierend» Google-MapsSzte Borgyogyszati Es Allergologiai Klinika
06720 Szeged
HungaryNoch nicht rekrutierend» Google-MapsIstituto Tumori Giovanni Paolo Ii Irccs Ospedale Oncologico Bari
70124 Bari
ItalyRekrutierend» Google-MapsFondazione Del Piemonte Per L'Oncologia Ircc Candiolo
10060 Candiolo
ItalyRekrutierend» Google-MapsIrccs Azienda Ospedaliera Universitaria San Martino
16132 Liguria
ItalyRekrutierend» Google-MapsFondazione Irccs Istituto Nazionale Dei Tumori
20133 Milano
ItalyRekrutierend» Google-MapsIeo Istituto Europeo Di Oncologia Irccs
20141 Milano
ItalyRekrutierend» Google-MapsA.O.U. Di Modena - Policlinico
41124 Modena
ItalyRekrutierend» Google-MapsIstituto Nazionale Tumori Fondazione Irccs G. Pascale
80131 Naples
ItalyRekrutierend» Google-MapsIov - Istituto Oncologico Veneto Irccs
35128 Padova
ItalyRekrutierend» Google-MapsOncologia ? Idi Irccs Istituto Dermopatico Dell'Immacolata
00167 Rome
ItalyRekrutierend» Google-MapsAzienda Ospedaliera Universitaria Senese Policlinico Santa Maria Alle Scotte
53100 Siena
ItalyRekrutierend» Google-MapsCentrum Onkologii-Instytut Im. Marii Sklodowskiej-Curie
02-781 Warszawa
PolandRekrutierend» Google-MapsHospital General Universitari Vall D Hebron
08035 Barcelona
SpainRekrutierend» Google-MapsHospital Clinic I Provincial
08036 Barcelona
SpainRekrutierend» Google-MapsHospital General Universitario Gregorio Maranon
28007 Madrid
SpainRekrutierend» Google-MapsCentre Hospitalier Universitaire Vaudois (Chuv)
01011 Lausanne
SwitzerlandRekrutierend» Google-MapsZurich University Hospital
08091 Zuerich
SwitzerlandRekrutierend» Google-MapsCastle Hill Hospital
HU16 5JQ Cottingham
United KingdomRekrutierend» Google-MapsRoyal Free London Nhs Foundation Trust
NW3 2QG London
United KingdomRekrutierend» Google-MapsThe Royal Marsden Nhs Foundation Trust
SW3 6JJ London
United KingdomRekrutierend» Google-MapsThe Royal Marsden Nhs Foundation Trust - Sutton
SM2 5PT Sutton
United KingdomRekrutierend» Google-MapsRoyal Cornwall Hospital, Sunrise Centre
TR1 3LJ Truro
United KingdomRekrutierend» Google-Maps
Studien-Informationen
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).
Ein-/Ausschlusskriterien
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.
Studien-Rationale
Primary outcome:1. Overall Response Rate (ORR) (Time Frame - Baseline up to approximately 8 months):
Defined as the percentage of participants with an objective response (complete response [CR] or partial response [PR]) according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) as determined by independent central radiographic review (ICR).
Secondary outcome:
1. Duration of Response (DOR) (Time Frame - Up to approximately 2 years):
Defined as the time from an initial objective response (CR or PR) according to RECIST v1.1 until disease progression as determined by ICR or death due to any cause.
2. Disease Control Rate (DCR) (Time Frame - Up to approximately 2 years):
Defined as the proportion of participants with either an objective response or stable disease lasting at least 6 months.
3. Progression Free Survival (PFS) (Time Frame - Up to approximately 2 years):
Defined as the time from the start of therapy until disease progression as determined by the ICR or death due to any cause.
4. Overall survival (OS) (Time Frame - Up to approximately 2 years):
Defined as the time from the start of therapy until death due to any cause.
5. Number of Treatment-Emergent Adverse Events (TEAE) (Time Frame - Up to approximately 2 years):
Adverse events reported for the first time or worsening of a pre-existing event after first dose of study treatment.
6. Cmax of INCMGA00012 (Time Frame - Up to approximately 6 months):
Maximum observed serum concentration.
7. tmax of INCMGA00012 (Time Frame - Up to approximately 6 months):
Time to maximum concentration.
8. Cmin of INCMGA00012 (Time Frame - Up to approximately 6 months):
Minimum observed serum concentration over the dose interval.
9. AUCt of INCMGA00012 (Time Frame - Up to approximately 6 months):
Area under the serum concentration-time curve.
Geprüfte Regime
- Retifanlimab (MGA012 / INCMGA00012 / ):
INCMGA00012 administered at the recommended Phase 2 dose by IV infusion once every 28 days.
Quelle: ClinicalTrials.gov