背景:耐铂,复发性卵巢癌预后不佳,治疗选择有限.聚(ADP-核糖)聚合酶(PARP),血管生成,免疫检查点抑制剂可能会改善铂耐药的结果,复发性卵巢癌,但准确的患者选择这些疗法仍然是一个重大的临床挑战。
目的:评估生物标志物驱动的帕米帕里布联合治疗的疗效和安全性,tislelizumab,贝伐单抗,和耐铂的nab-紫杉醇,复发性卵巢癌。
目的:PARP抑制剂的精准药物组合,抗血管生成治疗,免疫疗法,化疗将改善铂耐药的疾病结果,考虑基因组和免疫学特征的复发性卵巢癌。
方法:BRIGHT试验是一个前瞻性的,开放标签,多中心,第二阶段,伞式研究计划招募160名浆液患者,子宫内膜样,或透明细胞抗铂,来自中国11个临床中心的复发性卵巢癌。基于生物标志物将患者分配到三个实验组之一。BRCA1/2突变的患者将接受帕米帕利布加贝伐单抗(第1组,n=40),无论CD8+肿瘤浸润淋巴细胞计数。野生型BRCA1/2(BRCAwt)和≥3CD8+肿瘤浸润淋巴细胞计数的患者将接受tislelizumab的组合,贝伐单抗,和nab-紫杉醇(第2组,n=50),而CD8+肿瘤浸润淋巴细胞计数<3的BRCAwt患者将接受贝伐单抗加剂量密集的nab-紫杉醇(第3组,n=50)。在完成第2组的患者登记后,将包括另外20名CD8+肿瘤浸润淋巴细胞计数≥3的BRCAwt患者作为第2组扩增。治疗将持续到疾病进展或无法耐受的毒性,并记录所有不良事件。
■符合条件的患者包括年龄≥18岁的患者,子宫内膜样,或者透明细胞卵巢癌,铂耐药复发,东部肿瘤协作组(ECOG)的表现状态为0或1。
方法:研究者根据RECIST1.1标准评估客观反应率(ORR)。
方法:160例患者。
■招聘预计将于2024年完成,结果可能于2027年公布。
背景:ClinicalTrials.gov:NCT05044871。
BACKGROUND: Platinum-resistant, recurrent ovarian cancer has an abysmal prognosis with limited treatment options. Poly-(ADP-ribose)-polymerase (PARP), angiogenesis, and immune checkpoint inhibitors might improve the outcomes of platinum-resistant, recurrent ovarian cancer, but accurate patient selections for those therapies remain a significant clinical challenge.
OBJECTIVE: To evaluate the efficacy and safety of biomarker-driven combinatorial therapies of pamiparib, tislelizumab, bevacizumab, and nab-paclitaxel in platinum-resistant, recurrent ovarian cancer.
OBJECTIVE: A precision medicine combination of PARP inhibitors, anti-angiogenic therapy, immunotherapy, and chemotherapy will improve disease outcomes of platinum-resistant, recurrent ovarian cancer by accounting for genomic and immunologic features.
METHODS: The BRIGHT
Trial is a prospective, open-label, multicenter, phase II, umbrella
study planning to enroll 160 patients with serous, endometrioid, or clear cell platinum-resistant, recurrent ovarian cancer from 11 clinical centers in China. Patients are assigned to one of three experimental arms based on biomarkers. Patients with BRCA1/2 mutations will receive pamiparib plus bevacizumab (arm 1, n=40) regardless of CD8+ tumor-infiltrating lymphocytes count. Patients with wild-type BRCA1/2 (BRCAwt) and ≥3 CD8+ tumor-infiltrating lymphocytes count will receive the combination of tislelizumab, bevacizumab, and nab-paclitaxel (arm 2, n=50), while BRCAwt patients with <3 CD8+ tumor-infiltrating lymphocytes count will receive bevacizumab plus dose-dense nab-paclitaxel (arm 3, n=50). After completing patient enrollment in arm 2, another 20 BRCAwt patients with ≥3 CD8+ tumor-infiltrating lymphocytes count will be included as an arm 2 expansion. Treatment will continue until disease progression or intolerable toxicity, and all adverse events will be recorded.
UNASSIGNED: Eligible patients include those aged ≥18 with serous, endometrioid, or clear cell ovarian cancer, platinum-resistant recurrence, and Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
METHODS: Objective response rate (ORR) assessed by the investigators by the RECIST 1.1 criteria.
METHODS: 160 patients.
UNASSIGNED: Recruitment is estimated to be completed by 2024 and results may be published by 2027.
BACKGROUND: ClinicalTrials.gov: NCT05044871.