NCT05405192撤回2 期
Phase 2 Single Agent Dostarlimab in Chemoresistant Gestational Trophoblastic Neoplasia (GTN)
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Proportion of patients with successful normalization of beta hCG
研究概览
简要总结
The purpose of this study is to see if Dostarlimab is an effective treatment for Gestational Trophoblastic Neoplasia (GTN).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients with persistent unresectable Gestational Trophoblastic Neoplasia (GTN) disease
- •Female patients >18 years old.
- •Pretreatment archival tissue (if available) must be submitted for correlative studies. If pre-treatment tissue is not available, this does not exclude the patient.
- •Patients must have recovered from the effects of recent surgery or radiotherapy (persistent toxicity, CTCAE grade ≤1 except for alopecia, sensory neuropathy, or fatigue).
排除标准
- •Prior therapy with anti-Programed Death (PD)1/Programed Death Ligand-1 (PD-L1) or anti-CTLA4 antibody
- •Participant must not be simultaneously enrolled in any interventional clinical trial.
- •Participant must not have had major surgery ≤3 weeks prior to initiating protocol therapy and participant must have recovered from any surgical effects.
- •Participant must not have received investigational therapy ≤ 4 weeks, or within a time interval less than at least 5 half-lives of the investigational agent, whichever is shorter, prior initiating protocol therapy.
研究组 & 干预措施
Dostarlimab Group
Experimental
Participants will receive a total of up to 20 cycles of Dostarlimab: 4 cycles of Dostarlimab at a dose of 500 mg on day 1 of each of the 21-day cycle and 16 cycles of Dostarlimab at a dose of 1000 mg on day 1 of each of the 42-day cycle.
干预措施: Dostarlimab (Drug)
结局指标
主要结局
Proportion of patients with successful normalization of beta hCG
时间窗: Up to 24 months
Proportion of patients with a successful normalized serum human chorionic gonadotropin (hCG) level (complete response) as measured by serum samples.
次要结局
- Proportion of patients with objective response rate (ORR)(Up to 25 months)
- Number of Participants with treatment related-adverse events(Up to 25 months)
- Progression-free survival (PFS)(Up to 48 months)
- Overall survival (OS)(Up to 48 months)
研究者
研究点 (1)
Loading locations...
相似试验
招募中
2 期
SATELLITE Study (feaSibility sAfeTy Efficacy dostarLimab earLy-stage defIcient endomeTrial cancEr)Endometrial Cancer Stage IMmr DeficiencyEndometrioid Endometrial AdenocarcinomaImmune-related Adverse EventNCT06278857Queensland Centre for Gynaecological Cancer10
进行中（未招募）
3 期
A Study of Belrestotug Plus Dostarlimab Compared With Placebo Plus Pembrolizumab in Previously Untreated Participants With Programmed Death Ligand 1 (PD-L1) High Non-small-cell Lung Cancer (NSCLC)Lung Cancer, Non-Small CellNCT06472076GlaxoSmithKline88
进行中（未招募）
2 期
Dostarlimab and Cobolimab in Advanced Cervical CancerAdvanced Cervical CarcinomaMetastatic Cervical CancerMetastatic Cervical CarcinomaRecurrent Cervical CarcinomaCervical CancerNCT06238635Meghan Shea66
招募中
2 期
Dostarlimab for Locally Advanced or Metastatic Cancer (Non-colorectal/Non-endometrial) With Tumor dMMR/MSIPancreatic AdenocarcinomaAmpulla of Vater CarcinomaNeuroendocrine CarcinomaSoft Tissue SarcomaSmall Bowel AdenocarcinomaDuodenum AdenocarcinomaGastric AdenocarcinomaAdrenocortical CarcinomaNCT06333314UNICANCER120
进行中（未招募）
2 期
A Study of Dostarlimab in Untreated dMMR/MSI-H Locally Advanced Rectal CancerNeoplasms, RectalNCT05723562GlaxoSmithKline154