臨床研究等提出・公開システム

Date of registration	April. 15, 2026
Last modified on	April. 15, 2026
Trial ID	jRCT2061260008

Scientific Title	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)
Public Title	Extension Study for Participants in Studies That Include Belzutifan

Contact for Scientific Queries	Name	Fujita Tomoko
	Affiliation	MSD K.K.
	Address	KITANOMARU SQUARE,1-13-12,Kudan-kita,Chiyoda-ku,Tokyo 102-8667,Japan
	Telephone	+81-3-6272-1957
	E-mail	msdjrct@msd.com
Contact for Public Queries	Name	MSDJRCT inquiry mailbox
	Affiliation	MSD K.K.
	Address	KITANOMARU SQUARE,1-13-12,Kudan-kita,Chiyoda-ku,Tokyo 102-8667,Japan
	Telephone	+81-3-6272-1957
	E-mail	msdjrct@msd.com

Recruitment status	Pending

Anticipated date of first enrollment		June. 12, 2026
Target sample size		4
Study Type		Interventional
Study Design	allocation	non-randomized controlled trial
	masking	open(masking not used)
	control	active control
	assignment	parallel assignment
	purpose	treatment purpose
Key inclusion & exclusion criteria	Inclusion Criteria	- 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.
	Exclusion Criteria	- 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.
	Age Minimum	18age old over
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		advanced solid tumors or von Hippel-Lindau-related neoplasms
Intervention(s)		Belzutifan 120 mg, oral, once daily (QD) until progressive disease or discontinuation
Primary Outcome(s)		Overall Survival (OS) :The time from randomization or the first dose of any study intervention in the parent study to death due to any cause
Secondary Outcome(s)		- AEs - Discontinuation of study intervention due to AEs

Primary Sponsor	MSD K.K.

Secondary Sponsor

Secondary Sponsor

Name of Certified Review Board	Institutional Review Board of Tokushima University Hospital
Address	2-50-1, Kuramoto-cho, Tokushima-shi, Tokushima
Telephone	+81-88-633-9294
E-Mail	ctcdt@tokushima-u.ac.jp
Approval Status	Not approval

Plan to share IPD	Yes
Plan description	https://engagezone.msd.com/

Secondary ID(s)	NCT07405164
Issuing Authority	ClinicalTrials.gov

Countries of Recruitment（Except Japan）	USA/Canada/Brazil/Chile/Colombia/Belgium/Czech Republic/Denmark/Finland/France/Germany/Hungary/Israel/Netherlands/Poland/Russia/Spain/United Kingdom/Ukraine/Australia/New Zealand/South Korea/Taiwan