臨床研究等提出・公開システム

Date of registration	Aug. 23, 2018
Last modified on	May. 29, 2026
Trial ID	jRCT2080224017

Scientific Title	A Phase 3, Randomized, Open-Label Study of Nivolumab Combined with Cabozantinib Versus Sunitinib in Participants with Previously Untreated, Advanced or Metastatic Renal Cell Carcinoma (ONO-4538-81/CA2099ER)
Public Title	A phase 3 study of nivolumab combined with Cabozantinib (ONO-4538-81/CA2099ER)

Contact for Scientific Queries	Name
	Contact Name for Scientific Queries	ONO PHARMACEUTICAL CO.,LTD.
	Address	3 -1 -1 Sakurai, Shimamoto-cho, Mishima-gun, Osaka
	Phone Number	+81-120-626-190
	E-mail Address	clinical_trial@ono-pharma.com

Contact for Public Queries	Name
	Contact Name for Public Queries	ONO PHARMACEUTICAL CO.,LTD.
	Address	3 -1 -1 Sakurai, Shimamoto-cho, Mishima-gun, Osaka
	Phone Number	+81-120-626-190
	E-mail Address	clinical_trial@ono-pharma.com

Recruitment Status	completed

Date of First Enrolment		Aug. 22, 2017
Target Sample Size		630
Study Type		Interventional
Study Design	Study Design	A randomized, Open-Label Study
Study Design	Objective	treatment purpose
Phase		3
Key inclusion & exclusion criteria	Inclusion Criteria	1. Histological confirmation of RCC with a clear-cell component, including participants who may also have sarcomatoid features 2. Advanced (not amenable to curative surgery or radiation therapy) or metastatic (AJCC Stage IV) RCC 3. No prior systemic therapy for RCC with the following exception : One prior adjuvant or neo adjuvant therapy for completley resectable RCC if such therapy did not include an agent that targets VEGF or VEGF receptors and if reccurence occurred at least 6 months after the last dose of adjuvant or neoadjuvant therapy
	Exclusion Criteria	1. Any active CNS metastases 2. Any active, known or suspected autoimmune disease 3. Any condition requiring systemic treatment with either corticosteroids (>10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of randomization
	Minimum Age	18age old over
	Maximum Age	No limit
	Gender	Both
Health Condition or Problem Studied		Previously Untreated, advanced or metastatic Renal Cell Carcinoma
Intervention(s)		investigational material(s) Generic name etc : Nivolumab (ONO-4538/BMS-936558) INN of investigational material : Nivolumab Therapeutic category code : 429 Other antitumor agents Dosage and Administration for Investigational material : Intravenous administration Generic name etc : Cabozantinib (XL-184) INN of investigational material : Cabozantinib Therapeutic category code : 429 Other antitumor agents Dosage and Administration for Investigational material : Oral administration control material(s) Generic name etc : Sunitinib INN of investigational material : Sunitinib Therapeutic category code : 429 Other antitumor agents Dosage and Administration for Investigational material : Oral administration
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome		efficacy Progression-free survival
Secondary Outcome		safety efficacy Overall survival, Objective response rate, Safety

Primary Sponsor	ONO PHARMACEUTICAL CO.,LTD.
Secondary Sponsor	TAKEDA Pharmaceutical CO.,LTD.
Secondary Sponsor	Bristol-Myers Squibb
Secondary Sponsor	Exelixis

Name of Funding Organization	-
Name of Research Funding	-

Name of IRB	keio university hospital IRB
Address of IRB	35 Shinanomachi, Shinjuku-ku, Tokyo
Phone Number of IRB
E-mail Address of IRB
Status of IRB Review	approved
Date of Approval by IRB	Oct. 04, 2018

Secondary ID No.	NCT03141177
Name of Other Registries	ClinicalTrials.gov

Secondary ID No.	JapicCTI-184076
Name of Other Registries

Countries / Regions of Recruitment	Japan/North America/South America/Europe/Oceania/Middle East

History of Changes

No	Publication date
13	May. 29, 2026	(this page)	Changes
12	July. 24, 2025	Detail	Changes
11	July. 24, 2025	Detail	Changes
10	June. 11, 2024	Detail	Changes
9	Oct. 15, 2021	Detail	Changes
8	Jan. 18, 2021	Detail	Changes
7	Dec. 29, 2020	Detail	Changes
6	Oct. 14, 2020	Detail	Changes
5	Jan. 10, 2020	Detail	Changes
4	Sept. 05, 2019	Detail	Changes
3	Dec. 17, 2018	Detail	Changes
2	Aug. 23, 2018	Detail	Changes
1	Aug. 23, 2018	Detail

List of change history