2025-522167-15-00招募中3 期
A Randomized, Open-Label, Phase 3 Study of Rinatabart Sesutecan (Rina-S) Plus Standard of Care Versus Standard of Care as Maintenance Treatment After 2L PlatinumBased Doublet Chemotherapy in Participants With Recurrent Platinum-Sensitive Ovarian Cancer (PSOC)
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
- 257
- 试验地点
- 103
- 主要终点
- 1. PFS per Response Evaluation Criteria in Solid Tumours (RECIST) 1.1, as determined by blinded independent central review (BICR)
研究概览
简要总结
To compare progression-free survival (PFS) of RinaS+standard of care (SOC) vs SOC as maintenance treatment after 2L platinum-based doublet chemotherapy in participants with recurrent platinum-sensitive ovarian cancer
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
- •Must have histologically or cytologically confirmed high-grade serous or endometrioid epithelial ovarian cancer (EOC), primary peritoneal cancer, or fallopian tube cancer.
- •Must have PSOC defined as progressive disease > 6 months (ie, >183 days) from the last dose of primary (1L) platinum therapy.
- •Participants with known breast cancer (BRCA)-mutated (somatic or germline) or homologous recombination deficiency (HRD)-positive ovarian cancer who achieved complete response (CR)/no clinical evidence of disease (NED) or partial response (PR) following 1L platinum-based chemotherapy regimen must have previously received PARPi maintenance therapy as part of their 1L treatment.
- •Must have completed platinum-based chemotherapy in the 2L treatment for recurrent PSOC.
- •Must be randomized no later than 8 weeks from the last dose of the 2L platinum-based therapy.
- •Participants must have achieved a CR/NED, PR, or SD permitted only if bevacizumab was given in 2L in combination with platinum-based chemotherapy, as assessed by the investigator, following completion of 2L platinum-based chemotherapy.
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
- •More than 2 prior lines of systemic therapy.
- •Progression while on or following 2L platinum-based regimen prior to randomization.
- •Participants who receive an intervening systemic anticancer treatment (excluding bevacizumab) after the last dose of 2L platinum-based chemotherapy and prior to randomization.
研究组 & 干预措施
Rinatabart Sesutecan
Test
干预措施: Rinatabart Sesutecan (Drug)
BEVACIZUMAB
Comparator
干预措施: BEVACIZUMAB (Drug)
结局指标
主要结局
1. PFS per Response Evaluation Criteria in Solid Tumours (RECIST) 1.1, as determined by blinded independent central review (BICR)
1. PFS per Response Evaluation Criteria in Solid Tumours (RECIST) 1.1, as determined by blinded independent central review (BICR)
次要结局
- 2. Overall change from baseline in Global Health Status/Quality of Life (GHS/Qol) Score using the EORTC QLQ-C30 questionnaire Time to deterioration (TTD) in the GHS/Qol Scousing the EORTC QLQ-C30 questionnaire
- 1. Overall survival (OS) PFS, per RECIST 1.1, as determined by investigator assessment; Second determination of PFS (PFS2) Treatment-emergent adverse events
研究者
Genmab Trial Information
Scientific
Genmab A/S
研究点 (103)
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