A Randomized, Open-label, Phase 3 Study of Rina-S +/- Bevacizumab Versus Investigator's Choice of Platinum-Based Chemotherapy +/- Bevacizumab as 2L Treatment in Participants With Recurrent Platinum-Sensitive Ovarian Cancer

未提供0 个研究点目标入组 688 人开始时间: 待定

适应症

试验速览

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•Participant must have histologically confirmed high-grade serous or endometrioid epithelial ovarian cancer (EOC), including primary peritoneal or fallopian tube cancer.
•Participant must have documented recurrence or progression after first-line (1L) platinum-based chemotherapy regimen (carboplatin + paclitaxel >= 4 cycles) with or without bevacizumab and have platinum-sensitive disease defined as radiographic progression at least 6 months (ie, >183 days) after their last dose administration of platinum-based therapy.
•Prior poly (ADP-ribose) polymerase inhibitor(s) (PARPi) maintenance therapy (alone or in combination with bevacizumab) is required for participants with breast cancer susceptibility gene (BRCA 1- and BRCA 2)-mutated (germline or somatic) or homologous recombination deficiency (HRD)-positive disease.
•Participants must have measurable disease per RECIST v1.1 by investigator at baseline.
•All participants must provide a tumor specimen.
•Participants must have Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 at baseline.
•Note: Other protocol-defined Inclusion criteria may apply.

•Participants with clear cell, mucinous, or sarcomatous histology, mixed tumors containing any of the above histologies, or low-grade/borderline ovarian tumors.
•Participant has received previous therapy with other anti-angiogenetic agents different from bevacizumab or biosimilar.
•Participant has received prior therapy with an antibody-drug conjugate (ADC) containing a topoisomerase-1 inhibitor.
•Participant has received prior therapy with an ADC targeting folate receptor alpha (FRalpha).
•Note: Other protocol-defined Exclusion criteria may apply.

发起方

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