임상 레이더 AI | ||
|---|---|---|
임상시험 NCT07405164은(는) 폰 히펠-린다우 병, 신세포 암종에 대해 모집중 상태입니다. 모든 세부 정보를 보려면 임상시험 레이더 카드 뷰와 AI 발견 도구를 확인하거나 여기에서 무엇이든 물어보세요. | ||
하나의 임상시험이 필터 기준과 일치합니다.
카드 뷰
검색으로 돌아가기
머크Extension Study for Participants in Studies That Include Belzutifan (MK-6482-043/LITESPARK-043) 3상 450
임상시험 세부 정보는 주로 영어로 제공됩니다. 하지만 임상 레이더 AI가 도와드릴 수 있습니다! '임상시험 설명'를 클릭하여 선택한 언어로 임상시험 정보를 확인하고, 이에 대해 AI와 논의해 보세요.
임상시험 NCT07405164은(는) 치료을(를) 알아보기 위한 연구입니다. 이 연구는 폰 히펠-린다우 병, 신세포 암종에 대해 진행되며, 3상 중재연구으로 현재 상태는 모집중입니다. 연구는 2026년 3월 23일에 시작되어 450명의 참여자를 모집하고 있습니다. 머크이(가) 진행하며, 2034년 1월 14일까지 완료될 예정입니다. ClinicalTrials.gov의 가장 최근 정보는 2026년 3월 31일에 갱신되었습니다.
간단한 개요
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 parent...
공식 제목
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)
질환명
폰 히펠-린다우 병신세포 암종기타 연구 식별자
- 6482-043
- U1111-1325-4582 (등록 식별자) (UTN)
- 2025-524160-38-00 (등록 식별자) (EU CT)
- MK-6482-043 (기타 식별자) (MSD)
NCT 번호
실제 연구 시작일
2026-03-23
최신 업데이트 게시
2026-03-31
예상 연구 완료일
2034-01-14
계획된 등록 인원
450
연구종류
중재연구
단계/상
3상
상태
모집중
주요 목적
치료
설계 할당
비랜덤화 배정
중재 모델
평행설계
맹검 (마스킹)
없음 (오픈 라벨)
시험군 / 개입
| 참가자 그룹/시험군 | 개입/치료 |
|---|---|
실험적Cohort 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 termin...더 보기 | Belzutifan Belzutifan is administered orally at 120 mg once daily (qd) OR 160 mg twice daily (bid) OR 160 mg three times daily (tid) OR 200 mg qd OR 240 mg qd until progressive disease (PD), unacceptable toxicity, withdrawal of consent, death, investigator decision, or study termination. |
실험적Cohort 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. | Belzutifan Belzutifan is administered orally at 120 mg once daily (qd) OR 160 mg twice daily (bid) OR 160 mg three times daily (tid) OR 200 mg qd OR 240 mg qd until progressive disease (PD), unacceptable toxicity, withdrawal of consent, death, investigator decision, or study termination. Palbociclib Palbociclib is administered orally at 75 mg qd OR 100 mg qd OR 125 mg qd for 21 consecutive days; 7 days off, until PD, unacceptable toxicity, withdrawal of consent, death, investigator decision, or study termination. Nivolumab Nivolumab is administered intravenously at 480 mg until PD, unacceptable toxicity, withdrawal of consent, death, investigator decision, or study termination. Lenvatinib Lenvatinib is administered orally at 20 mg qd until PD, unacceptable toxicity, withdrawal of consent, death, investigator decision, or study termination. Cabozantinib Cabozantinib is administered orally at 60 mg qd until PD, unacceptable toxicity, withdrawal of consent, death, investigator decision, or study termination. |
활성 대조군Cohort 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. | Lenvatinib Lenvatinib is administered orally at 20 mg qd until PD, unacceptable toxicity, withdrawal of consent, death, investigator decision, or study termination. Cabozantinib Cabozantinib is administered orally at 60 mg qd until PD, unacceptable toxicity, withdrawal of consent, death, investigator decision, or study termination. Everolimus Everolimus is administered orally at 10 mg qd until PD, unacceptable toxicity, withdrawal of consent, death, investigator decision, or study termination. |
주요결과변수
이차결과변수
| 결과변수 | 측정값 설명 | 시간 범위 |
|---|---|---|
Cohort A and Cohort B: Overall Survival (OS) | 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. | Up to approximately 7 years |
| 결과변수 | 측정값 설명 | 시간 범위 |
|---|---|---|
Number of Participants Who Experience One or More Adverse Events (AE) | An AE was defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it was considered related to the medical treatment or procedure, that occurred during the course of the study. | Up to approximately 2 years |
Number of Participants Who Discontinued Study Intervention Due to an AE | An AE was defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it was considered related to the medical treatment or procedure, that occurred during the course of the study. | Up to approximately 2 years |
참여 도우미
적격성 기준
연령대
성인, 노인
최소 연령
18 Years
참여 가능한 성별
전체
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.
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.
머크연구 대표 연락처
연락처: Toll Free Number, 1-888-577-8839, [email protected]
4 3개국에 임상시험 장소
Seoul
Samsung Medical Center ( Site 2902), Gangnam, Seoul, 06351, South Korea
Study Coordinator, 연락처, +82-2-3410-1767
모집중
Severance Hospital, Yonsei University Health System ( Site 2901), Seodaemun-gu, Seoul, 03722, South Korea
Study Coordinator, 연락처, +82-2-2228-8138
모집중
Texas
START San Antonio ( Site 0104), San Antonio, Texas, 78229, United States
Study Coordinator, 연락처, 210-593-5265
모집중
Taipei Veterans General Hospital ( Site 2800), Taipei, 11217, Taiwan
Study Coordinator, 연락처, +886228712121x86341
모집중