Étude GLORIOSA - Cancer Ovaire

Fiche descriptive de l'étude

Étude ovaire

GLORIOSA

Titre de l'étude

GLORIOSA  : Randomized, multicenter, open-label, phase 3 study of mirvetuximab soravtansine in combination with bevacizumab versus bevacizumab alone as maintenance therapy for patients with FRα-positive recurrent platinum-sensitive epithelial ovarian, fallopian tube, or primary peritoneal cancers who have not progressed after second-line platinum-based chemotherapy plus bevacizumab  

Statut

En cours de lancement

Plan de traitement de l'étude

Promoteur

ImmunoGen, Inc.

But

OBJECTIF PRINCIPAL :

To compare progression-free survival (PFS), as assessed by the investigator per the Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) criteria, after platinum-based chemotherapy (doublet) plus bevacizumab and randomized to maintenance mirvetuximab soravtansine (MIRV) plus bevacizumab (Arm 1) versus bevacizumab alone (Arm 2)   

OBJECTIFS SECONDAIRES :

Key Secondary Objective:  To compare overall survival (OS) between patients randomized to maintenance MIRV plus bevacizumab (Arm 1) versus bevacizumab alone (Arm 2)

Additional Secondary Objectives: To assess the following parameters in patients without progressive disease (PD) after platinumbased chemotherapy plus bevacizumab and randomized between maintenance MIRV plus bevacizumab versus bevacizumab alone:

• Safety and tolerability of MIRV in combination with bevacizumab

• Time to second disease progression (PFS2)

• Objective response rate (ORR) as assessed by the investigator and by BICR in patients who have measurable disease per RECIST v1.1 at randomization

• Duration of response (DOR) as assessed by the investigator and by BICR in patients who achieved a best overall response of complete response (CR) or partial response (PR) upon completion of triplet therapy

• Disease-free survival (DFS) as assessed by the investigator and by BICR in patients who have no measurable disease per RECIST v1.1 at randomization

• CA-125 response rate per Gynecologic Cancer Intergroup (GCIG) criteria

• Patient-reported outcome (PRO)/quality of life (QoL) using the NCCN-FACT Ovarian Symptom Index (NFOSI-18) and Euroqol Group EQ-5D-5L questionnaires

Phase

Phase III 

Critères principaux d'évaluation 

PFS, as assessed by the investigator per RECIST v1.1, defined as the time from date of randomization until investigator-assessed PD or death, whichever occurs first  PFS as assessed by a BICR, as a sensitivity analysis, in the same patient population

Type de patiente

Patients without PD after platinum-based chemotherapy doublet plus bevacizumab (hereafter referred to as triplet therapy) for platinum-sensitive, high-grade serous epithelial ovarian, primary peritoneal, or fallopian tube cancer (PSOC) in first recurrence and with high folate receptor-alpha (FR) expression

Nombre de patientes prévues : 

418 patientes dans environ 250 centres

50 patientes en France dans environ 7 centres