Spots Global Cancer Trial Database for CAVE-2 GOIM Study: a Clinical Study of the Combination of Avelumab Plus Cetuximab as Rechallenge Strategy
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Trial Identification
Brief Title: CAVE-2 GOIM Study: a Clinical Study of the Combination of Avelumab Plus Cetuximab as Rechallenge Strategy
Official Title: CAVE-2 (Cetuximab-AVElumab) mCRC: A Phase II Randomized Clinical Study of the Combination of Avelumab Plus Cetuximab as Rechallenge Strategy in Pre-treated RAS/BRAF Wild Type Metastatic Colorectal Cancer Patients.
Study ID: NCT05291156
Conditions
Study Description
Brief Summary: This is a non-profit phase II, randomized clinical study of the combination of avelumab plus cetuximab as rechallenge strategy, compared to cetuximab alone, in pre-treated RAS/BRAF wild type metastatic colorectal cancer patients (according to liquid biopsy at baseline). Patients have been treated in first line with chemotherapy in combination with cetuximab and have had a clinical benefit (complete or partial response) from treatment.
Detailed Description: This is a non-profit phase II, open-label, randomized clinical study of the combination of avelumab plus cetuximab as rechallenge strategy in pre-treated RAS, BRAF wild type metastatic colorectal cancer patients treated in first line with chemotherapy in combination with cetuximab and have had a clinical benefit (complete or partial response) from treatment. 173 patients will be randomized (2:1) as follows: cetuximab + avelumab (115 patients) or cetuximab only (58 patients). For each patient, before treatment, a blood sample will be obtained and analyzed for circulating free tumorDNA, to identify RAS/BRAF wild type patient to be enrolled. The same procedure will be performed at progression of the disease. Treatment will continue until: * disease progression. * significant clinical deterioration * any criterion for withdrawal from the trial or trial drug is fulfilled * treatment may continue past the initial determination of disease progression according to RECIST 1.1. if the subject's performance status has remained stable, and if in the opinion of the Investigator, the subject will benefit from continued treatment and if other criteria are fulfilled as outlined in the protocol, that is, no new symptoms or worsening of existing symptoms and no decrease in performance score.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
A.O.U. Ospedali Riuniti, Ancona, , Italy
A.O. San Giuseppe Moscati, Avellino, , Italy
Centro di Riferimento Oncologico (C.R.O.), Aviano, , Italy
Fondazione Poliambulanza Istituto Ospedaliero, Brescia, , Italy
P.O. Antonio Perrino, Brindisi, , Italy
Ospedale IRCCS 'Saverio de Bellis', Castellana Grotte, , Italy
A.R.N.A.S. Garibaldi - P.O. GaribaldiNesima, Catania, , Italy
A.O.U. Careggi, Firenze, , Italy
Ospedale Policlinico San Martino IRCCS per l'Oncologia, Genova, , Italy
P.O. 'Vito Fazzi', Lecce, , Italy
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano, , Italy
Istituto Europeo di Oncologia, Milano, , Italy
A.O.U dell'Università degli Studi della Campania "Luigi Vanvitelli", Napoli, , Italy
IRCCS Istituto Nazionale Tumori "Fondazione G. Pascale", Napoli, , Italy
A.O.U. Policlinico 'P. Giaccone', Palermo, , Italy
ARNAS Civico - Di Cristina-Benfratelli - P. O. 'Civico e Benfratelli', Palermo, , Italy
A.S.P. Ragusa - Ospedale Maria Paternò Arezzo, Ragusa, , Italy
Azienda USL IRCCS di Reggio Emilia, Reggio Emilia, , Italy
Fondazione Policlinico Universitario 'Agostino Gemelli' IRCCS, Roma, , Italy
Fondazione IRCCS Ospedale Casa Sollievo della Sofferenza, San Giovanni Rotondo, , Italy
Ospedale San Giuseppe Moscati, Taranto, , Italy
A.O. Ordine Mauriziano, Torino, , Italy
A.O. 'Pia Fondazione Cardinale G.Panico', Tricase, , Italy
A.O.U. Integrata di Verona - Policlinico 'Giambattista Rossi', Verona, , Italy
Contact Details
Name: Fortunato Ciardiello
Affiliation: A.O.U. dell'Università degli studi della Campania "Luigi Vanvitelli"
Role: PRINCIPAL_INVESTIGATOR
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