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NCT07284849

Un estudio para evaluar la eficacia y la seguridad de la quimioterapia estándar y el bevacizumab, con o sin INCA33890, en el tratamiento de primera línea del cáncer colorrectal metastásico con estabilidad de microsatélites.

Reclutando Fase 3

Descripción

El objetivo de este estudio es evaluar la eficacia y la seguridad de la quimioterapia estándar y el bevacizumab, con o sin INCA33890, en el tratamiento de primera línea del cáncer colorrectal metastásico con estabilidad microsatelital.

Evidencia de la diana molecular en cáncer colorrectal (BRAF)

Fármaco / régimen ORR SLP (m) Fase / n Evidencia Fuente
Anti-EGFR/BRAF with or without anti-MEK or anti-PI3K este fármaco — — Retrospective / n=4633 1 PMID 41355781
FOLFIRI-cetuximab then mFOLFOX6-bevacizumab este fármaco 82.4% — Phase 3 / n=131 1 PMID 41980919
Standard care (chemotherapy ± bevacizumab) este fármaco — 7.1 Phase 3 1 PMID 40444708 · 2026
OPTIMOX-bevacizumab then FOLFIRI-bevacizumab then EGFR monoclonal antibody +/- irinotecan este fármaco 65.4% — Phase 3 / n=132 1 PMID 41980919
Standard care (chemotherapy with or without bevacizumab) este fármaco — 7.1 Phase 3 1 PMID 40444708
FOLFOXIRI + Bevacizumab este fármaco 56% 7.5 Phase 3 / n=28 2A PMID 33539752 · 2019

Criterios de Elegibilidad

Criterios de inclusión:

  • Adenocarcinoma colorrectal en estadio IV que no sea susceptible de resección curativa.
  • No haber recibido tratamiento sistémico previo para enfermedad irresecable o metastásica. Los participantes que hayan recibido terapia adyuvante o neoadyuvante podrán participar si no ha habido recurrencia en los 12 meses posteriores al final del tratamiento.
  • Enfermedad medible según RECIST v1.1.
  • ECOG de 0 o 1.
  • Función orgánica adecuada determinada por los resultados de laboratorio.

Criterios de exclusión:

  • MSI-H/dMMR según los datos históricos del historial médico.
  • Mutación BRAF V600E según los datos históricos del historial médico.
  • Metástasis del SNC no tratadas y/o en progresión.
  • Antecedentes de otra neoplasia maligna en los últimos 2 años.
  • Tratamiento con un inhibidor anti-PD-(L)1 u otro inhibidor del punto de control inmunitario para cualquier indicación en los últimos 3 años.
  • Enfermedad autoinmune activa que haya requerido tratamiento sistémico en los últimos 2 años.
  • Afección médica concurrente y/o no controlada significativa.
  • Antecedentes de trasplante de órganos, incluido el trasplante de células madre alogénicas.

Se aplican otros criterios de inclusión/exclusión definidos en el protocolo.

Información del Ensayo

NCT07284849
Reclutando
Fase 3
700 participantes
Mar 2026
Dic 2028

Ubicaciones275

Argentina (11)
Hospital Britanico de Buenos Aires
Buenos Aires
Instituto Medico Especializado Alexander Fleming
Buenos Aires
Investigaciones Clinicas Moleculares Icm
Buenos Aires
Centro Medico Austral
Ciudad Autonoma Buenos Aires
Hospital Italiano de Buenos Aires
Ciudad Autonoma Buenos Aires
Hospital Privado Centro Medico de Cordoba S.A
Córdoba
Instituto de Investigaciones Clinicas Cordoba S.A.
Córdoba
Centro Oncologico Riojano Integral (Cori)
La Rioja
Investigaciones Oncologicas C Colon
Mar del Plata
Instituto de Oncologia de Rosario
Rosario
Exelsus Srl
San Miguel de Tucumán
Australia (18)
Border Cancer Hospital Dispensary - Albury Wodonga Regional Cancer Centre
Albury
Flinders Medical Centre
Bedford Park
Box Hill Hospital
Box Hill
The Canberra Hospital
Canberra
Kinghorn Cancer Centre
Darlinghurst
Austin Hospital
Heidelberg
Icon Cancer Centre Kurralta Park
Kurralta Park
Peter Maccallum Cancer Centre
Melbourne
The Alfred Hospital
Melbourne
Fiona Stanley Hospital
Murdoch
Port Macquarie Base Hospital
Port Macquarie
Prince of Wales Hospital Au
Randwick
Gold Coast University Hospital
Southport
Townsville Cancer Centre
Townsville
Calvary Mater Newcastle
Waratah
Westmead Hospital
Westmead
Wollongong Hospital
Wollongong
Princess Alexandra Hospital Australia
Woolloongabba
Austria (4)
Lkh - Universitaetsklinikum Graz
Graz
Ordensklinikum Krankenhaus Der Barmherzigen Schwestern Linz
Linz
Lkh - Universitatsklinikum Der Pmu Salzburg
Salzburg
Akh - Medizinische Universität Wien
Vienna
Belgium (7)
C.H.U. Brugmann - Site Victor Horta
Brussels
Cliniques Universitaires Ucl Saint-Luc
Brussels
Universitair Ziekenhuis Brussel
Brussels
Universitair Ziekenhuis Antwerpen (Uza)
Edegem
Universitair Ziekenhuis Gent (Uz Gent)
Ghent
Universitaire Ziekenhuis Leuven - Gasthuisberg
Leuven
Chu Ucl Namur University Hospital Mont-Godinne
Yvoir
Brazil (16)
Fundacao Pio Xii Hospital de Cancer de Barretos
Barretos
Centro de Pesquisas Clinica Reichow
Blumenau
Hospital Erasto Gaertner - Liga Paranaense de Combate Ao Cancer
Curitiba
Oncosite - Centro de Pesquisa Clinica E Oncologia
Ijuí
Clinica de Neoplasias Litoral Ltda
Itajaí
Hospital Bruno Born
Lajeado
Liga Norte-Rio-Grandense Contra O Câncer
Natal
Hgb - Hospital Giovanni Battista - Mae de Deus Center
Porto Alegre
Hospital de Clinicas de Porto Alegre
Porto Alegre
Hospital Moinhos de Vento
Porto Alegre
Irmandade Da Santa Casa de Misericordia de Porto Alegre
Porto Alegre
Hospital Das Clínicas Fmrp-Usp
Ribeirão Preto
Nob - Nucleo de Oncologia Da Bahia
Salvador
Ceon Pesquisas
São Caetano do Sul
Fundacao Faculdade Regional de Medicina de Sao Jose Do Rio Preto
SAO JOSE RIO Preto
Icavc - Instituto Do Câncer Arnaldo Vieira de Carvalho
São Paulo
Canada (5)
Cross Cancer Institute
Edmonton
Juravinski Cancer Clinic
Hamilton
Hotel-Dieu de Levis
Lévis
Saskatoon Cancer Centre
Saskatoon
Princess Margaret Cancer Center
Toronto
Denmark (5)
Aalborg Universitetshospital
Aalborg
Rigshospitalet
Copenhagen
OUH
Odense C
Sjaellands Universitetshospital
Roskilde
Sygehus Lillebælt - Vejle
Vejle
France (11)
Institut de Cancerologie de L'Ouest
Angers
Chu Bordeaux-Hopital Pellegrin
Bordeaux
Hôpital de La Timone
Marseille
Institut Paoli Calmettes
Marseille
Hôpital Européen Georges Pompidou
Paris
Hospital Universitaire Pitie-Salpetriere
Paris
Hospital de La Miletrie
Poitiers
Chu de Reims
Reims
University Hospital of Saint Etienne
Saint-Etienne
Chu Toulouse Hopital Rangueil
Toulouse
Institut Gustave Roussy
Villejuif
Georgia (10)
High Technology Hospital Medcenter
Batumi
Jsc Evex Hospitals
Kutaisi
Aversi Clinic Ltd
Marneuli
Caucasus Medical Centre Llc
Tbilisi
Institute of Clinical Oncology Ltd
Tbilisi
Israel-Georgian Medical Research Clinic Helsicore
Tbilisi
K. Eristavi National Center of Experimental and Clinical Surgery
Tbilisi
Medulla Chemotherapy and Immunotherapy Clinic
Tbilisi
Tbilisi State Medical University and Ingorokva High Medical Technology University Clinic, Llc
Tbilisi
Todua Clinic, Llc
Tbilisi
Germany (16)
Charite - Campus Virchow-Klinikum
Berlin
University Hospital Carl Gustav Carus
Dresden
Universitaetsklinikum Essen
Essen
Krankenhaus Nordwest Gmbh
Frankfurt am Main
University Medical Center Freiburg
Freiburg im Breisgau
Asklepios Klinik Altona
Hamburg
Haematologisch-Onkologischen Praxis Eppendorf (Hope)
Hamburg
University Medical Centre Hamburg-Eppendorf Centre of Oncology
Hamburg
Hannover Medical School
Hanover
Universitaetsklinikum Leipzig Aoer
Leipzig
Uksh Campus Lubeck
Lübeck
Klinikum Der University Munchen - Campus Grosshadern
München
Klinikum Neuperlach
München
Roche Diagnostics Gmbh
Penzberg
Universitaetsklinikum Regensburg
Regensburg
Universitatkinikums Ulm
Ulm
Italy (18)
Azienda Ospedaliero Universitaria Delle Marche
Ancona
Irccs Centro Di Riferimento Oncologico
Aviano
Istituto Tumori Giovanni Paolo Ii Irccs Ospedale Oncologico Bari
Bari
Fondazione Poliambulanza Istituto Ospedaliero
Brescia
Istituto Di Candiolo Fondazione Del Piemonte Per L'Oncologia - Irccs
Candiolo
Azienda Ospedaliera Di Rilievo Nazionale E Di Alta Specializzazione Garibaldi
Catania
Asst Grande Ospedale Metropolitano Niguarda
Milan
Comitato Etico Fondazione Irccs Istituto Nazionale Dei Tumori Milano
Milan
Azienda Ospedaliera Universitaria- Università Degli Studi Della Campania "Luigi Vanvitelli"
Naples
Iov - Istituto Oncologico Veneto Irccs
Padova
Azienda Ospedaliero Universitaria Pisana
Pisa
Ospedale Santa Maria Delle Croci
Ravenna
Arcispedale S. Maria Nuova Azienda Ospedaliera Di Reggio Emilia
Reggio Emilia
Azienda Ospedaliera San Camillo Forlanini
Roma
Agostino Gemelli Policlinico Universitario
Rome
Irccs Istituto Clinico Humanitas
Rozzano
I.R.C.C.S. Casa Sollievo Della Sofferenza
San Giovanni Rotondo
Centro Ricerche Cliniche Di Verona
Verona
Japan (16)
Hyogo Cancer Center
Akashi-shi
Chiba Cancer Center
Chiba
National Cancer Center Hospital
Chūōku
Nho Kyushu Cancer Center
Fukuoka
Saitama Medical University International Medical Center
Hidaka-shi
National Cancer Center Hospital East
Kashiwa-shi
St. Marianna University Hospital
Kawasaki-shi
Kagawa University Hospital
Kita-gun
Kobe City Hospital Organization Kobe City Medical Center General Hospital
Kobe
Cancer Institute Hospital of Jfcr
Kōtoku
Nho Shikoku Cancer Center
Matsuyama
Kochi Medical School Hospital
Nankoku-shi
Osaka International Cancer Institute
Osaka
The University of Osaka Hospital
Suita-shi
Shizuoka Cancer Center
Sunto-gun
Kanagawa Cancer Center
Yokohama
Netherlands (7)
Meander Medisch Centrum
Amersfoort
Amsterdam Umc
Amsterdam
Netherlands Cancer Institute Antoni Van Leeuwenhoek Ziekenhuis
Amsterdam
Martini Ziekenhuis
Groningen
Maastricht Umc+
Maastricht
Erasmus Medical Center
Rotterdam
University Medical Center Utrecht
Utrecht
Norway (4)
Haukeland Universitetssjukehus
Bergen
Akershus Universitetssykehus Hf
Lørenskog
Utprovingsenheten, Oslo University Hospital Radiumhospitalet
Oslo
Universitetssykehuset I Trondheim - St. Olavs Hospital
Trondheim
Poland (5)
Wojewodzkie Centrum Szpitalne Kotliny Jeleniogorskiej
Jelenia Góra
Uniwersytecki Szpital Kliniczny Im. Fryderyka Chopina W Rzeszowie
Rzeszów
Mazowiecki Szpital Wojewodzki Im. SW. Jana Pawla Ii W Siedlcach Sp Z O O
Siedlce
Luxmed Onkologia Sp. Z O.O.
Warsaw
Narodowy Instytut Onkologii Im. Marii Skłodowskiej-Curie - Państwowy Instytut Badawczy
Warsaw
Puerto Rico (1)
Pan American Center For Oncology Trials Llc Dorado Office
Dorado
South Korea (13)
Samsung Changwon Hospital
Changwon-si
National Cancer Center
Goyang-si
Seoul National University Bundang Hospital
Seongnam
Cha Bundang Medical Center
Seongnam-si
Asan Medical Center
Seoul
Hanyang University Seoul Hospital
Seoul
Kangbuk Samsung Hospital
Seoul
Korea University Anam Hospital
Seoul
Seoul National University Hospital
Seoul
Severance Hospital Yonsei University Health System
Seoul
The Catholic University of Korea Seoul St. Mary'S Hospital
Seoul
The Catholic University of Korea, Eunpyeong St. Mary'S Hospital
Seoul
Ajou University Hospital
Suwon
Spain (17)
Hospital Universitari Germans Trias I Pujol
Badalona
Hospital Clinic Barcelona Main
Barcelona
Hospital de La Santa Creu I Sant Pau
Barcelona
Hospital General Universitario Vall D Hebron
Barcelona
Complejo Hospitalario Universitario Insular-Materno Infantil
Las Palmas de Gran Canaria
Hospital General Universitario Gregorio Maranon
Madrid
Hospital Universitario 12 de Octubre
Madrid
Hospital Universitario Fundacion Jimenez Diaz
Madrid
Hospital Universitario Puerta de Hierro de Majadahonda
Majadahonda
Son Espases University Hospital
Palma de Mallorca
Hospital Universitario de Navarra
Pamplona
Hospital Universitario Marques de Valdecilla
Santander
Hospital Universitari Mutua de Terrassa
Terrassa
Hospital Clinico Universitario de Valencia
Valencia
Hospital General Universitario de Valencia
Valencia
Instituto Valenciano de Oncologia
Valencia
Hospital Universitario Miguel Servet
Zaragoza
Switzerland (3)
Inselspital - Universitaetsspital Bern
Bern
Chuv, Lausanne University Hospital
Lausanne
Hoch Health Ostschweiz
Sankt Gallen
United Kingdom (8)
Bristol Haematology and Oncology Centre
Bristol
Velindre Cancer Centre
Cardiff
St James University Hospital
Leeds
Barts Hospital
London
Guys Hospital
London
Kent Oncology Centre - Maidstone Hospital
Maidstone
The Christie Nhs Foundation Trust Uk
Manchester
The Royal Marsden Nhs Foundation Trust - Sutton
Sutton
United States (80)
Los Angeles Cancer Network
Anaheim
St. Joseph Mercy Hospital
Ann Arbor
University of Michigan
Ann Arbor
Messino Cancer Center
Asheville
Sarah Cannon Research Institute Scri Oncology Partners
Aurora
Ascension Seton Spclty Care Ctr
Austin
Texas Oncology
Austin
Saint Agnes Hospital
Baltimore
Cancer Center For Blood Disorders A Division of American Oncology Partners P.A
Bethesda
St. Luke'S Health Network
Bethlehem
St Lukes Mountain States Tumor Institute Msti Boise
Boise
Massachusetts General Hospital
Boston
Sarah Cannon Research Institute Scri Oncology Partners
Brandywine
Ironwood Cancer & Research Centers
Chandler
The University of North Carolina At Chapel Hill
Chapel Hill
Vandalia Health Charleston Area Medical Center
Charleston
Oncology Specialists of Charlotte
Charlotte
University of Virginia Medical Center
Charlottesville
University of Illinois Cancer Center
Chicago
University of Cincinnati Cancer Institute
Cincinnati
Missouri Cancer Associates
Columbia
Ohio Health
Columbus
Ohio State University-Arthur G James Comprehensive Cancer Center
Columbus
University of Texas Southwestern Medical Center
Dallas
Henry Ford Hospital
Detroit
Alliance Cancer Specialists
Doylestown
Endeavor Health
Evanston
Inova Schar Cancer Institute
Fairfax
Florida Oncology & Hematology
Fort Myers
Memorial Care Orange Coast Medical Center
Fountain Valley
Providence Medical Foundation
Fullerton
University of Florida Health
Gainesville
Hartford Hospital
Hartford
Penn State Milton S. Hershey Medical Center
Hershey
University of Hawaii Cancer Center
Honolulu
Md Anderson Cancer Center
Houston
Community Health Network, Inc.
Indianapolis
Hematology Oncology of Indiana
Indianapolis
Iu Simon Cancer Center
Indianapolis
University of Iowa Hospital and Clinics
Iowa City
Midamerica Cancer Care
Kansas City
Saint Luke'S Hospital of Kansas City
Kansas City
Provision Center For Biomedical Research
Knoxville
Piedmont Cancer Institute
Locust Grove
Cancer & Blood Research Center
Los Alamitos
University of California Los Angeles Health
Los Angeles
Sylvester Comprehensive Cancer Center
Miami
Hillman Cancer Center
Monroeville
West Virginia University Cancer Institute
Morgantown
Morristown Medical Center
Morristown
Sarah Cannon Research Institute Scri Oncology Partners
Nashville
Tennessee Oncology, Pllc
Nashville
Monter Cancer Center
New Hyde Park
Ochsner Clinic Foundation Ocf Ochsner Cancer Institute Oci
New Orleans
Icahn School of Medicine At Mount Sinai
New York
Memorial Sloan Kettering Cancer Center
New York
Advent Health
Orlando
Orlando Health Cancer Institute Downtown Orlando
Orlando
Ascension Sacred Heart Pensacola
Pensacola
Sidney Kimmel Comprehensive Cancer Center
Philadelphia
University of Pennsylvania
Philadelphia
Allegheny General Hospital Cancer Institute
Pittsburgh
Presbyterian Rust Medical Center
Rio Rancho
University of Rochester
Rochester
Fred Hutchinson Cancer Center
Seattle
Ny Cancer and Blood Specialists
Shirley
Avera Cancer Institute
Sioux Falls
Cancer Care Northwest
Spokane
Oncology Hematology Associates
Springfield
Springfield Clinic
Springfield
Washington University School of Medicine
St Louis
H. Lee Moffitt Cancer Center and Research Institute Hospital
Tampa
Tampa General Hospital-Cancer Institute
Tampa
Baylor Scott & White Health
Temple
Montefiore Einstein For Cancer Care
The Bronx
Roche Tissue Diagnostics, Companion Diagnostics
Tucson
The University of Arizona Cancer Center
Tucson
George Washington University
Washington D.C.
Shenandoah Oncology
Winchester
Cancer Care Associates of York
York

Fuente Oficial

Ver en ClinicalTrials.gov