UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000060476 |
|---|---|
| Receipt number | R000069060 |
| Scientific Title | A Multicenter Retrospective Study on the Efficacy and Safety of First-Line Treatments (Nivolumab plus Cabozantinib and Pembrolizumab plus Lenvatinib) for Advanced/Metastatic Renal Cell Carcinoma |
| Date of disclosure of the study information | 2026/01/27 |
| Last modified on | 2026/01/27 09:23:21 |
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Basic information
Public title
A Multicenter Retrospective Study on the Efficacy and Safety of First-Line Treatments (Nivolumab plus Cabozantinib and Pembrolizumab plus Lenvatinib) for Advanced/Metastatic Renal Cell Carcinoma
Acronym
FIRST-RCC
Scientific Title
A Multicenter Retrospective Study on the Efficacy and Safety of First-Line Treatments (Nivolumab plus Cabozantinib and Pembrolizumab plus Lenvatinib) for Advanced/Metastatic Renal Cell Carcinoma
Scientific Title:Acronym
FIRST-RCC
Region
| Japan |
Condition
Condition
Renal Cell Carcinoma
Classification by specialty
| Urology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To explore the efficacy and safety of nivolumab plus cabozantinib and pembrolizumab plus lenvatinib as optimal first-line treatments for patients with advanced or metastatic renal cell carcinoma.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
PFS(Progression-free Survival) in first-line treatment
Key secondary outcomes
Outcomes in the first-line setting
OS(Overall Survival), PFS-2(Progression-free Survival-2), ORR(Overall Response Rate), DOR(Duration of Overall Response), DCR(Disease Control Rate), TTF(Time to Treatment Failure), BOR(Best Overall Response), TTR(Time to Response), DOT(Duration of Therapy), TTNT(Time to Next Treatment), Reasons for treatment discontinuation, RDI(Relative Dose Intensity), Rate of dose modifications(reduction, interruption, discontinuation), Safety
Outcomes in second-line treatment and beyond
PFS by line of therapy, BOR by line of therapy, DOT by line of therapy, TTNT, Reasons for treatment discontinuation
Treatment sequence
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.Patients aged 18 years or older at the initiation of first-line treatment for advanced or metastatic renal cell carcinoma
2.Patients who have not refused to participate in the study following disclosure of study information via an opt-out method
3.Patients with histologically diagnosed renal cell carcinoma
4.Patients who initiated IO+TKI combination therapy (nivolumab plus cabozantinib or pembrolizumab plus lenvatinib) as first-line treatment for advanced or metastatic renal cell carcinoma between April 1, 2022, and September 30, 2023
Key exclusion criteria
1.Patients who had malignancies other than renal cell carcinoma within 2 years prior to the initiation of first-line treatment for advanced or metastatic renal cell carcinoma. However, patients with carcinoma in situ or intramucosal carcinoma that have been curatively treated by local resection or are considered curable are excluded from this restriction.
2.Patients with a history of treatment with immune checkpoint inhibitors prior to the first-line treatment for advanced or metastatic renal cell carcinoma.
3.Patients deemed inappropriate for the study by the principal investigator or investigator due to reasons such as insufficient medical records.
Target sample size
400
Research contact person
Name of lead principal investigator
| 1st name | Yasuhisa |
| Middle name | |
| Last name | Fujii |
Organization
Institute of Science Tokyo
Division name
Department of Urology
Zip code
113-8519
Address
Department of Urology
TEL
03-3813-6111
fujii.y.70fa@m.isct.ac.jp
Public contact
Name of contact person
| 1st name | Hajime |
| Middle name | |
| Last name | Tanaka |
Organization
Institute of Science Tokyo
Division name
Department of Urology
Zip code
113-8519
Address
1-5-45 Yushima, Bunkyo-ku, Tokyo, Japan
TEL
03-3813-6111
Homepage URL
hjtauro@tmd.ac.jp
Sponsor or person
Institute
Institute of Science Tokyo
Institute
Department
Personal name
Funding Source
Organization
Takeda Pharmaceutical Company Limited
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Maidashi
Address
3-1-1 Maidashi, Higashi-ku, Fukuoka, Fukuoka, Japan
Tel
092-643-7171
mail@crnfukuoka.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 01 | Month | 27 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2026 | Year | 01 | Month | 14 | Day |
Date of IRB
| 2026 | Year | 01 | Month | 23 | Day |
Anticipated trial start date
| 2026 | Year | 01 | Month | 27 | Day |
Last follow-up date
| 2026 | Year | 05 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Collection of medical information and patient characteristics for patients treated with nivolumab plus cabozantinib or pembrolizumab plus lenvatinib as first-line treatment
Management information
Registered date
| 2026 | Year | 01 | Month | 27 | Day |
Last modified on
| 2026 | Year | 01 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069060
