2025-524202-15-00招募中3 期
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
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- Genmab A/S
- 入组人数
- 83
- 试验地点
- 23
- 主要终点
- 1. Progression-free Survival (PFS) per RECIST v1.1, as Determined by Blinded Independent Central Review (BICR)
研究概览
简要总结
To evaluate PFS of Rina-S ± bevacizumab as compared to IC of platinum-based chemotherapy ± bevacizumab as 2L treatment in participants with recurrent PSOC
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Participant must have histologically confirmed high-grade serous or endometrioid 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 Response Evaluation Criteria in Solid Tumours (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.
排除标准
- •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 (FRα).
研究组 & 干预措施
Caelyx pegylated liposomal 2 mg/ml concentrate for solution for infusion
Comparator
干预措施: Caelyx pegylated liposomal 2 mg/ml concentrate for solution for infusion (Drug)
Vegzelma 25 mg/mL concentrate for solution for infusion
Comparator
干预措施: Vegzelma 25 mg/mL concentrate for solution for infusion (Drug)
Ziextenzo 6 mg solution for injection in pre-filled syringe
Auxiliary
干预措施: Ziextenzo 6 mg solution for injection in pre-filled syringe (Drug)
Paclitaxel 6 mg/ml Concentrate for Solution for Infusion
Comparator
干预措施: Paclitaxel 6 mg/ml Concentrate for Solution for Infusion (Drug)
Gemcitabin Hikma 38 mg/ml Konzentrat zur Herstellung einer Infusionslösung
Comparator
干预措施: Gemcitabin Hikma 38 mg/ml Konzentrat zur Herstellung einer Infusionslösung (Drug)
Carboplatin 10 mg/ml concentrate for solution for infusion
Comparator
干预措施: Carboplatin 10 mg/ml concentrate for solution for infusion (Drug)
Rinatabart Sesutecan
Test
干预措施: Rinatabart Sesutecan (Drug)
结局指标
主要结局
1. Progression-free Survival (PFS) per RECIST v1.1, as Determined by Blinded Independent Central Review (BICR)
1. Progression-free Survival (PFS) per RECIST v1.1, as Determined by Blinded Independent Central Review (BICR)
次要结局
- 1. Overall Survival (OS)
- 2. PFS per RECIST v1.1, as Determined by Investigator
- 3. Objective Response Rate (ORR) per RECIST v1.1
- 4. Duration of Response (DOR) per RECIST v1.1
- 5. Progression-free Survival on the Next Line of Therapy After the First Progression (PFS2)
- 6. Time to First Subsequent Therapy (TFST)
- 7. Cancer Antigen 125 (CA-125) Response per Gynecologic Cancer Intergroup (GCIG) Criteria
- 8. Number of Participants with Treatment-emergent Adverse Events (TEAEs)
- 9. Overall Change from Baseline in Global Health Status (GHS)/Quality of Life (QoL) Score Using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ C30)
- 10. Time to Deterioration (TTD) in the GHS/QoL Score Using the EORTC QLQ C30 Questionnaire
研究者
Genmab Trial Information
Scientific
Genmab A/S
研究点 (23)
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