A Study of Belzutifan (MK-6482) in Combination With Lenvatinib Versus Cabozantinib for Treatment of Renal Cell Carcinoma (MK-6482-011)
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT04586231 |
Recruitment Status :
Active, not recruiting
First Posted : October 14, 2020
Last Update Posted : May 17, 2024
|
Sponsor:
Merck Sharp & Dohme LLC
Collaborator:
Eisai Inc.
Information provided by (Responsible Party):
Merck Sharp & Dohme LLC
Tracking Information | |||||||
---|---|---|---|---|---|---|---|
First Submitted Date ICMJE | October 9, 2020 | ||||||
First Posted Date ICMJE | October 14, 2020 | ||||||
Last Update Posted Date | May 17, 2024 | ||||||
Actual Study Start Date ICMJE | February 25, 2021 | ||||||
Estimated Primary Completion Date | December 23, 2024 (Final data collection date for primary outcome measure) | ||||||
Current Primary Outcome Measures ICMJE |
|
||||||
Original Primary Outcome Measures ICMJE | Same as current | ||||||
Change History | |||||||
Current Secondary Outcome Measures ICMJE |
|
||||||
Original Secondary Outcome Measures ICMJE | Same as current | ||||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||
Descriptive Information | |||||||
Brief Title ICMJE | A Study of Belzutifan (MK-6482) in Combination With Lenvatinib Versus Cabozantinib for Treatment of Renal Cell Carcinoma (MK-6482-011) | ||||||
Official Title ICMJE | An Open-label, Randomized, Phase 3 Study of MK-6482 in Combination With Lenvatinib (MK-7902) vs Cabozantinib in Participants With Advanced Renal Cell Carcinoma Who Have Progressed After Prior Anti-PD-1/L1 Therapy | ||||||
Brief Summary | This study will compare the efficacy and safety of belzutifan + lenvatinib versus cabozantinib in participants with advanced renal cell carcinoma (RCC) with clear cell component after prior therapy. The primary hypothesis is that belzutifan + lenvatinib is superior to cabozantinib in terms of progression-free survival or overall survival. |
||||||
Detailed Description | Not Provided | ||||||
Study Type ICMJE | Interventional | ||||||
Study Phase ICMJE | Phase 3 | ||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment |
||||||
Condition ICMJE | Carcinoma, Renal Cell | ||||||
Intervention ICMJE |
|
||||||
Study Arms ICMJE |
|
||||||
Publications * | Not Provided | ||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||||
Recruitment Information | |||||||
Recruitment Status ICMJE | Active, not recruiting | ||||||
Estimated Enrollment ICMJE |
708 | ||||||
Original Estimated Enrollment ICMJE | Same as current | ||||||
Estimated Study Completion Date ICMJE | December 23, 2024 | ||||||
Estimated Primary Completion Date | December 23, 2024 (Final data collection date for primary outcome measure) | ||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
|
||||||
Sex/Gender ICMJE |
|
||||||
Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||||
Accepts Healthy Volunteers ICMJE | No | ||||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||
Listed Location Countries ICMJE | Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, Colombia, Czechia, Finland, France, Germany, Greece, Ireland, Italy, Japan, Korea, Republic of, Netherlands, Poland, Romania, Russian Federation, Spain, Switzerland, United Kingdom, United States | ||||||
Removed Location Countries | |||||||
Administrative Information | |||||||
NCT Number ICMJE | NCT04586231 | ||||||
Other Study ID Numbers ICMJE | 6482-011 MK-6482-011 ( Other Identifier: Merck ) jRCT2031210311 ( Other Identifier: jRCT(Japan Registry of Clinical Trials) ) 2024-510620-39 ( Registry Identifier: EU CT ) U1111-1302-2815 ( Other Identifier: UTN ) 2020-002075-35 ( EudraCT Number ) |
||||||
Has Data Monitoring Committee | Yes | ||||||
U.S. FDA-regulated Product |
|
||||||
IPD Sharing Statement ICMJE |
|
||||||
Current Responsible Party | Merck Sharp & Dohme LLC | ||||||
Original Responsible Party | Same as current | ||||||
Current Study Sponsor ICMJE | Merck Sharp & Dohme LLC | ||||||
Original Study Sponsor ICMJE | Same as current | ||||||
Collaborators ICMJE | Eisai Inc. | ||||||
Investigators ICMJE |
|
||||||
PRS Account | Merck Sharp & Dohme LLC | ||||||
Verification Date | May 2024 | ||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |