A Multicenter, Open-label, Phase 3 Extension Study to Evaluate the Long-term Efficacy and Safety in Participants Who Are Currently on Treatment in a Belzutifan Study (LITESPARK-043)
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 450
- 试验地点
- 58
- 主要终点
- Cohort A and Cohort B: Overall Survival (OS)
研究概览
简要总结
Researchers are looking for new ways to treat advanced solid tumors and von Hippel-Lindau (VHL)-related tumors:
- Advanced means the cancer has spread to other parts of the body (metastatic) or cannot be removed with surgery
- Solid tumors are cancers mostly in body organs and tissues, not in the blood or other body liquids
- VHL-related tumors are tumors caused by VHL disease. VHL disease is passed down from parents to children and people with VHL disease have a higher chance of getting certain types of cancer
Researchers want to learn about the long-term effects of a trial medicine called belzutifan. Belzutifan, also called MK-6482, is designed to block a protein that helps tumors grow and survive. This is an extension trial, which means only people who were in certain other belzutifan trials (called parent trials) may be able to join. The goal of this trial is to learn how long people live after they start taking belzutifan.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The main inclusion criteria include but are not limited to the following:
- •Participants with advanced solid tumors or von Hippel-Lindau-related neoplasms who are participating in belzutifan-containing studies and on active treatment in a belzutifan parent study.
排除标准
- •The main exclusion criteria include but are not limited to the following:
- •Has an on-going serious adverse event in the parent study, unless no longer hospitalized and considered clinically stable.
- •Is currently on a dose interruption due to an Adverse Event (AE) in the parent study; once treatment has been resumed in the parent study, the participant is eligible to enroll.
研究组 & 干预措施
Cohort B: Belzutifan Combination Therapy
Participants on active treatment assigned to a belzutifan combination therapy in a parent study are transitioned to this extension study. Participants will continue the same dose and frequency of intervention as they were receiving in the parent study at the time of the transition. Treatment will continue until PD, unacceptable toxicity, withdrawal of consent, death, investigator decision, or study termination.
干预措施: Cabozantinib (Drug)
Cohort B: Belzutifan Combination Therapy
Participants on active treatment assigned to a belzutifan combination therapy in a parent study are transitioned to this extension study. Participants will continue the same dose and frequency of intervention as they were receiving in the parent study at the time of the transition. Treatment will continue until PD, unacceptable toxicity, withdrawal of consent, death, investigator decision, or study termination.
干预措施: Lenvatinib (Drug)
Cohort C: Non-Belzutifan Therapy
Participants on active treatment assigned to a non-belzutifan therapy in a parent study are transitioned to this extension study. Participants will continue the same dose and frequency of intervention as they were receiving in the parent study at the time of the transition. Treatment will continue until PD, unacceptable toxicity, withdrawal of consent, death, investigator decision, or study termination.
干预措施: Cabozantinib (Drug)
Cohort B: Belzutifan Combination Therapy
Participants on active treatment assigned to a belzutifan combination therapy in a parent study are transitioned to this extension study. Participants will continue the same dose and frequency of intervention as they were receiving in the parent study at the time of the transition. Treatment will continue until PD, unacceptable toxicity, withdrawal of consent, death, investigator decision, or study termination.
干预措施: Belzutifan (Drug)
Cohort A: Belzutifan Monotherapy
Participants on active treatment assigned to belzutifan monotherapy in a parent study are transitioned to this extension study. Participants will continue the same dose and frequency of intervention as they were receiving in the parent study at the time of the transition. Treatment will continue until progressive disease (PD), unacceptable toxicity, withdrawal of consent, death, investigator decision, or study termination.
干预措施: Belzutifan (Drug)
Cohort C: Non-Belzutifan Therapy
Participants on active treatment assigned to a non-belzutifan therapy in a parent study are transitioned to this extension study. Participants will continue the same dose and frequency of intervention as they were receiving in the parent study at the time of the transition. Treatment will continue until PD, unacceptable toxicity, withdrawal of consent, death, investigator decision, or study termination.
干预措施: Lenvatinib (Drug)
Cohort B: Belzutifan Combination Therapy
Participants on active treatment assigned to a belzutifan combination therapy in a parent study are transitioned to this extension study. Participants will continue the same dose and frequency of intervention as they were receiving in the parent study at the time of the transition. Treatment will continue until PD, unacceptable toxicity, withdrawal of consent, death, investigator decision, or study termination.
干预措施: Nivolumab (Drug)
结局指标
主要结局
Cohort A and Cohort B: Overall Survival (OS)
时间窗: Up to approximately 7 years
Overall survival is defined as the time from randomization or the first dose of any study intervention in the parent study to death due to any cause.
次要结局
- Number of Participants Who Experience One or More Adverse Events (AE)(Up to approximately 2 years)
- Number of Participants Who Discontinued Study Intervention Due to an AE(Up to approximately 2 years)