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JOURNAL ONKOLOGIE – STUDIE
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A Study of Encorafenib Plus Cetuximab Taken Together With Pembrolizumab Compared to Pembrolizumab Alone in People With Previously Untreated Metastatic Colorectal Cancer

Rekrutierend

NCT-Nummer:
NCT05217446

Studienbeginn:
Juli 2022

Letztes Update:
21.03.2024

Wirkstoff:
Encorafenib, Cetuximab, Pembrolizumab

Indikation (Clinical Trials):
Colorectal Neoplasms

Geschlecht:
Alle

Altersgruppe:
Alle

Phase:
Phase 2

Sponsor:
Pfizer

Collaborator:
Merck Sharp & Dohme LLC, Merck KGaA, Darmstadt, Germany, Eli Lilly and Company,

Studienleiter

Pfizer CT.gov Call Center
Study Director
Pfizer

Kontakt

Pfizer CT.gov Call Center
Kontakt:
Phone: 1-800-718-1021
E-Mail: ClinicalTrials.gov_Inquiries@pfizer.com» Kontaktdaten anzeigen

Studienlocations
(3 von 102)

Muenchen Klinik Neuperlach, Klinik fuer Haematologie und Onkologie
81737 Muenchen
(Bayern)
GermanyRekrutierend» Google-Maps
Institut für Klinisch Onkologische Forschung
60488 Frankfurt
(Hessen)
GermanyRekrutierend» Google-Maps
Brustzentrum Klinikum Oldenburg
Rahel-Straus-Straße 10
26133 Oldenburg
DeutschlandRekrutierend» Google-Maps
Studiengesellschaft BSF Unternehmergesellschaft
06108 Halle (Saale)
(Sachsen-Anhalt)
GermanyRekrutierend» Google-Maps
Gynäkologisches Tumorzentrum am Universitätsklinikum Leipzig
4103 Leipzig
DeutschlandRekrutierend» Google-Maps
Onkologische Schwerpunktpraxis Kurfuerstendamm
10707 Berlin
(Berlin)
GermanyRekrutierend» Google-Maps
Studiengesellschaft BSF UG
06108 Halle /Saale
(Sachsen-Anhalt)
GermanyRekrutierend» Google-Maps
Facharztzentrum Eppendorf
20249 Hamburg
(Hamburg)
GermanyRekrutierend» Google-Maps
Mayo Clinic Building - Phoenix
85054 Phoenix
United StatesRekrutierend» Google-Maps
Keck Hospital of USC
90033 Los Angeles
United StatesRekrutierend» Google-Maps
Keck School of Medicine of USC
90033 Los Angeles
United StatesRekrutierend» Google-Maps
LAC USC Medical Center
90033 Los Angeles
United StatesRekrutierend» Google-Maps
USC Norris Comprehensive Cancer Center
90033 Los Angeles
United StatesRekrutierend» Google-Maps
USC/Norris Comprehensive Cancer Center / Investigational Drug Services
90033 Los Angeles
United StatesRekrutierend» Google-Maps
USC/Norris Comprehensive Cancer Center
90033 Los Angeles
United StatesRekrutierend» Google-Maps
Keck Hospital of USC Pasadena
91105 Pasadena
United StatesRekrutierend» Google-Maps
Mount Sinai Cancer Center
33140 Miami Beach
United StatesRekrutierend» Google-Maps
University of Miami Hospital and Clinics, Sylvester Cancer Center
33136 Miami
United StatesRekrutierend» Google-Maps
University of Miami Hospital and Clinics, Sylvester Cancer Center
33324 Plantation
United StatesRekrutierend» Google-Maps
Mayo Clinic Cancer Center Outpatient Pharmacy
55905 Rochester
United StatesRekrutierend» Google-Maps
Columbia University Medical Center
10032 New York
United StatesRekrutierend» Google-Maps
The West Clinic, PLLC dba West Cancer Center
38138 Germantown
United StatesRekrutierend» Google-Maps
MD Anderson Cancer Center
77030 Houston
United StatesRekrutierend» Google-Maps
GenesisCare North Shore
2065 St Leonards
AustraliaRekrutierend» Google-Maps
Gallipoli Medical Research Foundation
4120 Brisbane
AustraliaRekrutierend» Google-Maps
Greenslopes Private Hospital
4120 Greenslopes
AustraliaRekrutierend» Google-Maps
Peter MacCallum Cancer Centre
3000 Melbourne
AustraliaRekrutierend» Google-Maps
Cliniques universitaires Saint-Luc
1200 Brussels
BelgiumRekrutierend» Google-Maps
William Osler Health System
L6R 3J7 Brampton
CanadaRekrutierend» Google-Maps
The Ottawa Hospital - General Campus
K1H 8L6 Ottawa
CanadaRekrutierend» Google-Maps
Sunnybrook Health Sciences - Odette Cancer Centre
M4N 3M5 Toronto
CanadaRekrutierend» Google-Maps
CIUSSS de l'Est-de-l'Île-de-Montréal
h1t2m4 Montreal
CanadaRekrutierend» Google-Maps
Fakultni nemocnice Hradec Kralove
500 05 Hradec Kralove
CzechiaRekrutierend» Google-Maps
Fakultni Thomayerova nemocnice
14059 Prague
CzechiaRekrutierend» Google-Maps
Herlev and Gentofte Hospital
2730 Copenhagen
DenmarkRekrutierend» Google-Maps
Aalborg Universitetshospital, Syd
9000 Aalborg
DenmarkRekrutierend» Google-Maps
Hôpital Européen Georges Pompidou
75015 Paris Cedex 15
FranceRekrutierend» Google-Maps
Centre Hospitalier Universitaire Estaing
63100 Clermont-Ferrand
FranceRekrutierend» Google-Maps
Institut Regional du Cancer de Montpellier - ICM Val d'Aurelle
34298 Montpellier Cedex 5
FranceRekrutierend» Google-Maps
Institut Régional du Cancer Montpellier
34298 Montpellier
FranceRekrutierend» Google-Maps
Policlinico Universitario Monserrato
09042 Monserrato
ItalyRekrutierend» Google-Maps
Azienda Ospedaliera Universitaria dell'Università "Luigi Vanvitelli" Piazza Luigi Miraglia, 2 Napoli
80131 Napoli
ItalyRekrutierend» Google-Maps
IRCCS Casa Sollievo della Sofferenza
71013 San Giovanni Rotondo
ItalyRekrutierend» Google-Maps
ASST Grande Ospedale Metropolitano Niguarda
20162 Milan
ItalyRekrutierend» Google-Maps
Istituto di Candiolo IRCCS - Fondazione del Piemonte per l'Oncologia
10060 Candiolo
ItalyRekrutierend» Google-Maps
Azienda USL Toscana Nord Ovest_Ospedale Civile di Livorno
57124 Livorno
ItalyRekrutierend» Google-Maps
Azienda Ospedaliero Universitaria Pisana
56126 Pisa
ItalyRekrutierend» Google-Maps
Istituto Oncologico Veneto IRCCS
35128 Padova
ItalyRekrutierend» Google-Maps
Fondazione Poliambulanza Istituto Ospedaliero
25124 Brescia
ItalyRekrutierend» Google-Maps
Istituto Europeo di Oncologia IRCCS
20141 Milano
ItalyRekrutierend» Google-Maps
Arcispedale Santa Maria Nuova
42123 Reggio Emilia
ItalyRekrutierend» Google-Maps
Haaglanden MC - locatie Antoniushove
2262 BA Leidschendam
NetherlandsRekrutierend» Google-Maps
Oslo Universitetssykehus Ullevål
0450 Oslo
NorwayRekrutierend» Google-Maps
Szpital Specjalistyczny w Brzozowie Podkarpacki Osrodek Onkologiczny im. Ks. B. Markiewicza
36-200 Brzozow
PolandRekrutierend» Google-Maps
SPZOZ Wojewodzki Szpital Specjalistyczny nr 4 w Bytomiu
41-902 Bytom
PolandRekrutierend» Google-Maps
Copernicus Podmiot Leczniczy Sp. z o.o. Wojewodzkie Centrum Onkologii
80-219 Gdansk
PolandRekrutierend» Google-Maps
Radomskie Centrum Onkologii im. Bohaterow Radomskiego Czerwca 76
26-600 Radom
PolandRekrutierend» Google-Maps
Fakultna nemocnica s poliklinikou F. D. Roosevelta Banska Bystrica
975 17 Banska Bystrica
SlovakiaRekrutierend» Google-Maps
Onkologicky ustav sv. Alzbety, s.r.o.
812 50 Bratislava
SlovakiaRekrutierend» Google-Maps
Narodny onkologicky ustav
833 10 Bratislava
SlovakiaRekrutierend» Google-Maps
Vychodoslovensky onkologicky ustav, a.s.
04191 Kosice
SlovakiaRekrutierend» Google-Maps
CHUS - Hospital Clinico Universitario
15706 Santiago de Compostela
SpainRekrutierend» Google-Maps
Hospital General Universitario de Elche
03202 Elche
SpainRekrutierend» Google-Maps
Hospital Universitari Vall d'Hebron
08035 Barcelona
SpainRekrutierend» Google-Maps
Hospital Clínic de Barcelona
08036 Barcelona
SpainRekrutierend» Google-Maps
Institut Català d'Oncologia - L'Hospitalet
08908 L'Hospitalet de Llobregat
SpainRekrutierend» Google-Maps
Hospital Universitario Ramón y Cajal
28034 Madrid
SpainRekrutierend» Google-Maps
Hospital Universitario 12 de Octubre
28041 Madrid
SpainRekrutierend» Google-Maps
Hospital General Universitario Gregorio Marañon
28007 Madrid
SpainRekrutierend» Google-Maps
Hospital Universitario 12 de Octubre
28041 Madrid
SpainRekrutierend» Google-Maps
Hospital Universitario Virgen Del Rocio
41013 Sevilla
SpainRekrutierend» Google-Maps
Hospital General Universitario de Valencia
46014 Valencia
SpainRekrutierend» Google-Maps
Hospital Universitario Miguel Servet
50009 Zaragoza
SpainRekrutierend» Google-Maps
Karolinska Universitetssjukhuset Solna
171 64 Solna
SwedenRekrutierend» Google-Maps
Aberdeen Royal Infirmary
AB25 2ZN Aberdeen
United KingdomRekrutierend» Google-Maps
Guy's & St Thomas's NHS Foundation Trust
SE1 9RT London
United KingdomRekrutierend» Google-Maps
Guy's & St Thomas' NHS Foundation Trust
SE1 9RT London
United KingdomRekrutierend» Google-Maps
Heartlands Hospital
B9 5SS Birmingham
United KingdomRekrutierend» Google-Maps
Alle anzeigen

Studien-Informationen

Brief Summary:

The purpose of this study is to learn about the effects of three study medicines

(encorafenib, cetuximab, and pembrolizumab) given together for the treatment of colorectal

cancer that:

- is metastatic (spread to other parts of the body);

- has the condition of genetic hypermutability (tendency to mutation) or impaired DNA

mismatch repair (MMR)

- has a certain type of abnormal gene called "BRAF" and;

- has not received prior treatment.

All participants in this study will receive pembrolizumab at the study clinic as an

intravenous (IV) infusion (given directly into a vein) at the study clinic.

In addition, half of the participants will take encorafenib by mouth at home every day and

cetuximab by IV infusion at the study clinic.

The study team will monitor how each participant is doing with the study treatment during

regular visits at the study clinic.

Ein-/Ausschlusskriterien

Inclusion Criteria:

- Locally confirmed microsatellite instability-high/ deficient mismatch repair

(MSI-H/dMMR) stage IV colorectal carcinoma

- Locally confirmed BRAF V600E mutation in tumor tissue or blood

- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

- Have not received prior systemic regimens for metastatic disease.

- Measurable disease per RECIST 1.1

- Adequate organ function

Exclusion Criteria:

- Colorectal adenocarcinoma that is RAS mutant or for which RAS mutation status is

unknown

- Known active central nervous system metastases and/or carcinomatous meningitis;

leptomeningeal disease

- Immunodeficiency or active autoimmune disease requiring systemic treatment in the past

2 years

- Presence of acute or chronic pancreatitis

- Clinically significant cardiovascular diseases (eg, thromboembolic or cerebrovascular

accident events ≤ 12 wks prior)

- Received a live or live-attenuated vaccine within 30 days of planned start of study

medication

- Previous treatment with any selective BRAF inhibitor (eg, encorafenib, dabrafenib,

vemurafenib, XL281/BMS-908662) or any epidermal growth factor receptor (EGFR)

inhibitor (eg, cetuximab, panitumumab).

- Previous treatment with an immune checkpoint inhibitor (eg, anti-programmed cell death

[PD-1], anti-PD-L1 or anti-PD-L2 agent); or with an agent directed to another

stimulatory or co-inhibitory T-cell receptor (eg, CTLA-4, OX 40, CD137).

Studien-Rationale

Primary outcome:

1. Progression-free Survival (PFS) (Time Frame - Duration of study, approximately 45 months):
PFS per investigator, defined as the time from randomization until PD based on investigator assessment per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 or death due to any cause, whichever occurs first:



Secondary outcome:

1. Incidence of adverse events (Time Frame - Duration of study, approximately 45 months):
Incidence and severity of AEs graded according to the NCI CTCAE v4.03: encorafenib and cetuximab + pembrolizumab (Arm A) vs pembrolizumab (Arm B)

2. Overall Survival (OS) (Time Frame - Duration of study, approximately 45 months):
OS is defined as the time from the date of randomization to the date of death due to any cause: encorafenib and cetuximab + pembrolizumab (Arm A) vs pembrolizumab (Arm B)

3. Objective Response (OR) (Time Frame - Duration of study, approximately 45 months):
OR is defined as a CR or PR per RECIST version 1.1 recorded from the date of randomization until date of first documentation of PD, death, or start of new anti-cancer therapy: encorafenib and cetuximab + pembrolizumab (Arm A) vs pembrolizumab (Arm B)

Studien-Arme

  • Experimental: Arm A: encorafenib, cetuximab and pembrolizumab
    Participants receive encorafenib orally + cetuximab IV + pembrolizumab IV.
  • Active Comparator: Arm B: pembrolizumab
    Participants receive pembrolizumab IV.

Geprüfte Regime

  • Encorafenib (PF-07263896 LGX818 ONO-7702 W0090):
    capsule
  • Cetuximab (Erbitux):
    IV
  • Pembrolizumab (Keytruda®, MK-3475):
    IV

Quelle: ClinicalTrials.gov


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"A Study of Encorafenib Plus Cetuximab Taken Together With Pembrolizumab Compared to Pembrolizumab Alone in People With Previously Untreated Metastatic Colorectal Cancer"

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