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Randomized, open-label, multicenter phase III study of mirvetuximab soravtansine in combination with bevacizumab.

THE PRIMARY OBJECTIVE OF THIS STUDY IS TO COMPARE PROGRESSION-FREE SURVIVAL (PFS) AS ASSESSED BY THE INVESTIGATOR ACCORDING TO RESPONSE EVALUATION CRITERIA IN SOLID TUMORS VERSION 1.1 (RECIST V1.1), AFTER PLATINUM-BASED CHEMOTHERAPY PLUS BEVACIZUMAB (TRIPLE THERAPY), RANDOMIZED TO MAINTENANCE MIRVETUXIMAB SORAVTANSINE (MIRV) PLUS BEVACIZUMAB (GROUP 1) VERSUS BEVACIZUMAB ALONE (GROUP 2).

Cancer Center
Status
In recruitment
headquarters
Pamplona/Madrid

Technical Summary

  • RANDOMIZED, OPEN-LABEL, MULTICENTER PHASE III STUDY OF MIRVETUXIMAB SORAVTANSINE IN COMBINATION WITH BEVACIZUMAB VS. BEVACIZUMAB ALONE AS MAINTENANCE THERAPY FOR PATIENTS WITH RECURRENT, PLATINUM-SENSITIVE, HIGH FRA-EXPRESSING FALLOPIAN TUBE, PRIMARY PERITONEAL OR EPITHELIAL OVARIAN CANCER WHO HAVE NOT PROGRESSED AFTER SECOND-LINE PLATINUM PLUS BEVACIZUMAB (GLORIOSA) "IMMUNOTHERAPY" CHEMOTHERAPY.
  • Code EudraCT: 2022-501606-35-00
  • Protocol number: IMGN853-0421
  • Promoter: Immunogen
  • Molecule/Drug: Mirvetuximab soravtansina (MIRV)

* The trials only admit a limited number of patients and are subject to inclusion and exclusion criteria. The specialist who assesses your case will inform you of the conditions required to participate in the clinical trial.

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