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Imfinzi NSCLC
Imfinzi NSCLC

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

Incyte Medical Monitor
Study Director
Incyte Corporation

Kontakt

Incyte Corporation Call Center (ex-US)
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-Maps
Elbe Klinikum Buxtehude
21614 Buxtehude
(Niedersachsen)
GermanyRekrutierend» Google-Maps
Lungenkrebszentrum Helios Klinikum Erfurt
Nordhäuser Straße 74
99089 Erfurt
(Thüringen)
DeutschlandNoch nicht rekrutierend» Google-Maps
Universitatsklinikum Essen
45122 Essen
(Nordrhein-Westfalen)
GermanyRekrutierend» Google-Maps
Universitatsklinikum Schleswig-Holstein
24105 Kiel
(Schleswig-Holstein)
GermanyRekrutierend» Google-Maps
Universitatsklinikum Giessen Und Marburg Gmbh, Klinik Für Innere Medizin
35043 Marburg
(Hessen)
GermanyNoch nicht rekrutierend» Google-Maps
University Hospital Regensburg
93053 Regensburg
(Bayern)
GermanyNoch nicht rekrutierend» Google-Maps
Universitaetsklinikum in Tubingen
72076 Tubingen
(Baden-Württemberg)
GermanyRekrutierend» Google-Maps
Stanford Cancer Institute
94304 Palo Alto
United StatesRekrutierend» Google-Maps
University of California San Francisco Comprehensive Cancer Center
94143 San Francisco
United StatesRekrutierend» Google-Maps
University of Colorado Cancer Center
80045 Aurora
United StatesRekrutierend» Google-Maps
Georgetown University Hospital
20007 Washington
United StatesRekrutierend» Google-Maps
Norton Cancer Institute
40241 Louisville
United StatesRekrutierend» Google-Maps
Mayo Clinic Rochester
55905 Rochester
United StatesRekrutierend» Google-Maps
John Theurer Cancer Center, Hackensack University Medical Center
07601 Hackensack
United StatesRekrutierend» Google-Maps
Rutgers Cancer Institute of Nj
08901 New Brunswick
United StatesAbgeschlossen» Google-Maps
Roswell Park Cancer Institute
14263 Buffalo
United StatesRekrutierend» Google-Maps
University of Rochester Medical Center
14642 Rochester
United StatesRekrutierend» Google-Maps
The Christ Hospital
45219 Cincinnati
United StatesAbgeschlossen» Google-Maps
Inova Fairfax Hospital
22031 Fairfax
United StatesRekrutierend» Google-Maps
University of Washington - Seattle Cancer Care Alliance
98109 Seattle
United StatesRekrutierend» Google-Maps
West Virginia University Hospitals Inc
26506 Morgantown
United StatesRekrutierend» Google-Maps
St Vincent'S Hospital Sydney
02010 Darlinghurst
AustraliaAbgeschlossen» Google-Maps
London Health Sciences Centre Lhsc - South Street Hospital
N6A 4G5 London
CanadaRekrutierend» Google-Maps
Sir Mortimer B. Davis Jewish General Hospital Segal Cancer Ctr
H3T1E2 Montreal
CanadaRekrutierend» Google-Maps
McGill University Health Centre/Glen Site/Cedars Cancer Centre
H4A 3J1 Montreal
CanadaRekrutierend» Google-Maps
Prof Mudr Petr Arenberger Drsc Mba
110 00 Praha
CzechiaRekrutierend» Google-Maps
Hopital Ambroise Pare
92100 Boulogne-billancourt
FranceRekrutierend» Google-Maps
Chu Hopital de La Timone
13385 Marseille Cedex 5
FranceRekrutierend» Google-Maps
Centre Hospitalier Universitaire de Nantes (Chu de Nantes) - Hotel-Dieu
44093 Nantes Cedex
FranceRekrutierend» Google-Maps
Chu de Nice - Hopital L'Archet 1
06202 Nice Cedex 3
FranceRekrutierend» Google-Maps
Hopital Charles Nicolle Chu Rouen - Hopital de Bois-Guillaume
76031 Rouen
FranceRekrutierend» Google-Maps
Institute Gustave Roussy (Igr)
94805 Villejuif Cedex
FranceRekrutierend» Google-Maps
National Institute of Oncology
01122 Budapest
HungaryRekrutierend» Google-Maps
Debreceni Egyetem Klinikai Kozpon Belgyogy Klinika
04032 Debrecen
HungaryNoch nicht rekrutierend» Google-Maps
Szte Borgyogyszati Es Allergologiai Klinika
06720 Szeged
HungaryNoch nicht rekrutierend» Google-Maps
Istituto Tumori Giovanni Paolo Ii Irccs Ospedale Oncologico Bari
70124 Bari
ItalyRekrutierend» Google-Maps
Fondazione Del Piemonte Per L'Oncologia Ircc Candiolo
10060 Candiolo
ItalyRekrutierend» Google-Maps
Irccs Azienda Ospedaliera Universitaria San Martino
16132 Liguria
ItalyRekrutierend» Google-Maps
Fondazione Irccs Istituto Nazionale Dei Tumori
20133 Milano
ItalyRekrutierend» Google-Maps
Ieo Istituto Europeo Di Oncologia Irccs
20141 Milano
ItalyRekrutierend» Google-Maps
Istituto Nazionale Tumori Fondazione Irccs G. Pascale
80131 Naples
ItalyRekrutierend» Google-Maps
Iov - Istituto Oncologico Veneto Irccs
35128 Padova
ItalyRekrutierend» Google-Maps
Oncologia ? Idi Irccs Istituto Dermopatico Dell'Immacolata
00167 Rome
ItalyRekrutierend» Google-Maps
Azienda Ospedaliera Universitaria Senese Policlinico Santa Maria Alle Scotte
53100 Siena
ItalyRekrutierend» Google-Maps
Centrum Onkologii-Instytut Im. Marii Sklodowskiej-Curie
02-781 Warszawa
PolandRekrutierend» Google-Maps
Hospital General Universitari Vall D Hebron
08035 Barcelona
SpainRekrutierend» Google-Maps
Hospital Clinic I Provincial
08036 Barcelona
SpainRekrutierend» Google-Maps
Hospital General Universitario Gregorio Maranon
28007 Madrid
SpainRekrutierend» Google-Maps
Centre Hospitalier Universitaire Vaudois (Chuv)
01011 Lausanne
SwitzerlandRekrutierend» Google-Maps
Zurich University Hospital
08091 Zuerich
SwitzerlandRekrutierend» Google-Maps
Castle Hill Hospital
HU16 5JQ Cottingham
United KingdomRekrutierend» Google-Maps
Royal Free London Nhs Foundation Trust
NW3 2QG London
United KingdomRekrutierend» Google-Maps
The Royal Marsden Nhs Foundation Trust
SW3 6JJ London
United KingdomRekrutierend» Google-Maps
The Royal Marsden Nhs Foundation Trust - Sutton
SM2 5PT Sutton
United KingdomRekrutierend» Google-Maps
Royal Cornwall Hospital, Sunrise Centre
TR1 3LJ Truro
United KingdomRekrutierend» Google-Maps
Alle anzeigen

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


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