C4251008 - An Open-label Randomized Phase 3 Study of Tucatinib in Combination With Trastuzumab and mFOLFOX6 Versus mFOLFOX6 Given With or Without Either Cetuximab or Bevacizumab as First-line Treatment for Subjects With HER2+ Metastatic Colorectal Cancer (MOUNTAINEER-03)
Studio Clinico
Patologia: Tumori del colon retto
Osservazionale-Sperimentale: Sperimentale
Monocentrico-Multicentrico: Multicentrico
Randomizzato: Sì
Fase di studio: III
Richiesta mandatoria di tessuto: Sì
Linee di trattamento: Prima linea
Criteri di inclusione:
- Histologically and/or cytologically confirmed adenocarcinoma of the colon or rectum which is locally advanced unresectable or metastatic
- Able to provide the most recently available formalin-fixed paraffin-embedded (FFPE) tumor tissue blocks (or freshly sectioned slides) obtained prior to treatment initiation to a central laboratory
- If archival tissue is not available, a newly-obtained baseline biopsy of an accessible tumor lesion is required within 35 days prior to start of study treatment
- HER2+ disease as determined by a tissue based assay performed at a central laboratory.
- Participant has rat sarcoma viral oncogene homolog wild-type (RAS WT) disease as determined by local or central testing. For central RAS analysis, tissue sample must be analyzed within 1 year of biopsy date.
- Radiographically measurable disease per RECIST v1.1 with:
- At least one site of disease that is measurable and that has not been previously irradiated, or
- If the participant has had previous radiation to the target lesion(s), there must be evidence of progression since the radiation
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
- CNS Inclusion - based on contrast brain magnetic resonance imaging, participants may have any of the following:
- No evidence of brain metastases
- Previously treated brain metastases which are asymptomatic.
Criteri di esclusione:
- Prior systemic anticancer therapy for colorectal cancer (CRC) in the locally advanced unresectable or metastatic setting; note that participants may have received a maximum of 2 doses of mFOLFOX6 in the locally advanced/unresectable or metastatic setting prior to randomization.
- Note: May have received chemotherapy for CRC in the adjuvant setting if it was completed >6 months prior to enrollment
- Radiation therapy within 14 days prior to enrollment (or within 7 days in the setting of stereotactic radiosurgery)
- Previous treatment with anti-HER2 therapy
- Ongoing Grade 3 or higher neuropathy
- Active or untreated gastrointestinal (GI) perforation at the time of screening.
Numero di pazienti previsti:
48
Trattamento sperimentale:
Tucatinib + trastuzumab + mFOLFOX6
Trattamento di controllo:
Either (1) mFOLFOX6, (2) mFOLFOX6 and bevacizumab, or (3) mFOLFOX6 and cetuximab
Obiettivi primari dello studio:
Progression-free survival (PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) by Blinded Independent Central Review (BICR).
Centri partecipanti
Nord Italia
Fondazione Poliambulanza Istituto Ospedaliero
Via Bissolati 57 - 25124 Brescia - BS
Riferimento: Prof. Alberto Zaniboni
Email: alberto.zaniboni@poliambulanza.it
IRCCS A.O.U. San Martino - IST
Largo Rosanna Benzi 10 - 16132 Genova - GE
Riferimento: Dr. Alessandro Pastorino
Email: alessandro.pastorino@hsanmartino.it
Grande Ospedale Metropolitano Niguarda
Piazza Ospedale Maggiore 3 - 20162 Milano - MI
Riferimento: Prof. Salvatore Siena
Email: oncologia@ospedaleniguarda.it
IRCCS Istituto Nazionale dei Tumori
Via Venezian 1 - 20133 Milano - MI
Riferimento: Dr. Filippo Pietrantonio
Email: filippo.pietrantonio@istitutotumori.mi.it
Istituto Europeo di Oncologia
Via Ripamonti 435 - 20141 Milano - MI
Riferimento: Dr.ssa Maria Giulia Zampino
Telefono: 0257489258
Istituto Oncologico Veneto IRCCS
Via Gattamelata 64 - 35128 Padova - PD
Riferimento: Dr.ssa Sara Lonardi
Email: sara.lonardi@iov.veneto.it
IRCCS Policlinico San Matteo
Viale Golgi 19 - 27100 Pavia - PV
Riferimento: Dr.ssa Anna Pagani
Email: a.pagani@smatteo.pv.it
AUSL/IRCCS di Reggio Emilia
Viale Risorgimento 80 - 42123 Reggio nell'Emilia - RE
Arcispedale Santa Maria Nuova
Riferimento: Dr. Carmine Pinto
Email: carmine.pinto@ausl.re.it
AO della Valtellina e Valchiavenna
Via Stelvio 25 - 23100 Sondrio - SO
ASST Valtellina e Alto Lario - PO Sondrio - Oncologia Medica
Email: info.oncologia.so@asst-val.it
A.O.U San Luigi Gonzaga
Regione Gonzole 10 - 10043 Orbassano - TO
NB: Arruolamento pazienti non ancora attivo
Riferimento: Prof.ssa Silvia Novello
Telefono: 0119026978
Email: silvia.novello@unito.it
AOUI Verona - Borgo Roma
Piazzale Ludovico Antonio Scuro 10 - 37134 Verona - VR
UOC Oncologia
Email: oncologia@aovr.veneto.it
Centro Italia
AOU Careggi
Largo Brambilla 3 - 50134 Firenze - FI
SOD Oncologia Medica e Clinica
Riferimento: Prof. Lorenzo Antonuzzo
Email: lorenzo.antonuzzo@unifi.it
AOU Pisana - Santa Chiara
Via Roma 67 - 56126 Pisa - PI
Riferimento: Prof.ssa Chiara Cremolini
Email: chiaracremolini@gmail.com
Fondazione Policlinico A. Gemelli
Largo Agostino Gemelli 8 - 00168 Roma - RM
UOC Oncologia Medica
Email: oncomedsperimentali@policlinicogemelli.it
Sud Italia e isole
A.O.S.G. Moscati
Contrada Amoretta - 83100 Avellino - AV
UOC Oncologia Medica
Riferimento: Dr. Giuseppe Santabarbara
Email: giuseppe.santabarbara@aornmoscati.it
AOU di Cagliari - Presidio Policlinico Monserrato
St.Statale 554, Km 4500 - 09100 Monserrato - CA
Riferimento: Prof. Mario Scartozzi
Email: sperimentazioniclinicheunica@gmail.com
Presidio Ospedaliero Garibaldi Nesima
Via Palermo 636 - 95122 Catania - CT
UOC Oncologia Medica
Riferimento: Dr. Roberto Bordonaro
Email: oncoct@hotmail.com
AOU Ospedali Riuniti di Foggia
Viale Luigi Pinto 1 - 71121 Foggia - FG
Struttura Semplice Dipartimentale di Oncologia Medica e Terapia Biomolecolare
Email: oncologiaterapbiomolecolare@ospedaliriunitifoggia.it
Ospedale 'Card. G. Panico'
Via San Pio X 4 - 73039 Tricase - LE
Riferimento: Dr. Emiliano Tamburini
Email: e.tamburini@piafondazionepanico.it
AOU degli studi della Campania Luigi Vanvitelli
Piazza Luigi Miraglia 2 - 80138 Napoli - NA
Riferimento: Dr.ssa Erika Martinelli
Email: erika.martinelli@unicampania.it
Informazioni Generali
Protocollo
Numero di iscrizione a registro: 2024-514180-25-00
Data di inserimento: 16.04.2025
Data di aggiornamento: 08.07.2025
Promotore
Seagen, a wholly owned subsidiary of Pfizer
Principal Investigator ITALIA
Riferimento: Dr. Info non applicabile
Telefono: 00000
Email: na@na.it
Localita: na