Spots Global Cancer Trial Database for Axitinib Intensification Plus Nivolumab or Nivolumab Alone After Nivolumab Plus Ipilimumab in mRCC Patients
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Trial Identification
Brief Title: Axitinib Intensification Plus Nivolumab or Nivolumab Alone After Nivolumab Plus Ipilimumab in mRCC Patients
Official Title: Phase II Study of Axitinib Intensification Plus Nivolumab Compared to Nivolumab Alone After Induction With Nivolumab Plus Ipilimumab in mRCC Patients Without Previous Complete Response (AxIn Study).
Study ID: NCT05817903
Conditions
Study Description
Brief Summary: This phase II open label trial randomized patients who completed the induction with nivolumab plus ipilimumab without complete response or progressive disease will be randomized 1:1 to receive axitinib in addition to nivolumab (Arm A) or continue with nivolumab alone (Arm B).Treatment will be continued until progression of disease, unacceptable toxicity, patient's refusal, or physician decision whichever occurred first.
Detailed Description: The present study aims to demonstrate if the addition of axitinib to nivolumab maintenance after nivolumab plus ipilimumab induction can improve the rate of response considering that the incidence of partial response was 32% and 51% in Checkmate214 and Keynote426 trials respectively. This study requires 106 patients to show an improvement from 30% to 50% of the incidence of partial responses with a power of 80%, and alpha-error 0.10 (one-side p). Assuming a drop out of 10%, the final estimated number to enroll should be 118 (59 in arm A and 59 in arm B).
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
ASST degli Spedali Civili di Brescia, Brescia, , Italy
Istituto di Candiolo - Fondazione del Piemonte per l'Oncologia - IRCCS, Candiolo, , Italy
Azienda Ospedaliera per l'emergenza Cannizzaro, Catania, , Italy
ASST di Cremona, Cremona, , Italy
Azienda Ospedaliero Universitaria Careggi, Firenze, , Italy
Ospedale Policlinico San Martino, Genova, , Italy
Fondazione IRCCS - Istituto Nazionale dei Tumori, Milano, , Italy
Istituto Europeo di Oncologia - IEO, Milano, , Italy
A.O.U. Policlinico di Modena, Modena, , Italy
Policlinico Duilio Casula - Azienda Ospedaliero-Universitaria di Cagliari, Monserrato, , Italy
Azienda Ospedaliero-Universitaria Maggiore della Carità, Novara, , Italy
Istituto Oncologico Veneto, Padova, , Italy
Casa Di Cura La Maddalena S.P.A., Palermo, , Italy
Azienda Ospedaliera Universitaria di Parma, Parma, , Italy
Azienda Ospedalieo-Universitaria Pisana, Pisa, , Italy
San Carlo - Azienda Ospedaliera Regionale, Potenza, , Italy
Presidio Ospedaliero S. Maria Delle Grazie, Pozzuoli, , Italy
IRCCS - AUSL di Reggio Emilia, Reggio Emilia, , Italy
Azienda Ospedaliera San Camillo Forlanini, Romano Di Lombardia, , Italy
Fondazione Policlinico Universitario A. Gemelli IRCCS, Roma, , Italy
IRCCS - Istituto Clinico Humanitas, Rozzano, , Italy
Azienda Ospedaliera Universitaria Integrata Verona - Borgo Roma, Verona, , Italy
Ospedale di Belcolle, Viterbo, , Italy
Contact Details
Name: Roberto Iacovelli
Affiliation: Fondazione Policlinico "A. Gemelli", Università Cattolica Sacro Cuore
Role: PRINCIPAL_INVESTIGATOR
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