UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062879 |
|---|---|
| Receipt number | R000071992 |
| Scientific Title | Translational Research of the FIRST-RCC Study: A Multicenter Retrospective Study on the Efficacy and Safety of First-Line Treatment with Nivolumab plus Cabozantinib or Pembrolizumab plus Lenvatinib for Advanced or Metastatic Renal Cell Carcinoma |
| Date of disclosure of the study information | 2026/09/10 |
| Last modified on | 2026/09/10 22:31:22 |
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Basic information
Public title
Translational Research of the FIRST-RCC Study: A Multicenter Retrospective Study on the Efficacy and Safety of First-Line Treatment with Nivolumab plus Cabozantinib or Pembrolizumab plus Lenvatinib for Advanced or Metastatic Renal Cell Carcinoma
Acronym
FIRST-RCC TR Study
Scientific Title
Translational Research of the FIRST-RCC Study: A Multicenter Retrospective Study on the Efficacy and Safety of First-Line Treatment with Nivolumab plus Cabozantinib or Pembrolizumab plus Lenvatinib for Advanced or Metastatic Renal Cell Carcinoma
Scientific Title:Acronym
FIRST-RCC TR Study
Region
| Japan |
Condition
Condition
Kidney cancer
Classification by specialty
| Hematology and clinical oncology | Urology |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
The FIRST-RCC study is a multicenter retrospective observational study evaluating the efficacy and safety of first-line treatment with nivolumab plus cabozantinib or pembrolizumab plus lenvatinib in patients with advanced or metastatic renal cell carcinoma. This translational research study aims to perform comprehensive gene expression profiling of renal cell carcinoma tissues from patients eligible for the FIRST-RCC study and to investigate the associations between gene expression-based molecular subtypes and clinical outcomes of each first-line treatment, as well as other clinical characteristics.
Basic objectives2
Bio-availability
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Association between molecular subtypes based on whole-gene expression profiles of renal cell carcinoma and clinical outcomes of first-line treatment, including objective response rate (ORR) and progression-free survival (PFS).
Key secondary outcomes
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients eligible for the FIRST-RCC study with available pathological specimens of renal cell carcinoma for this translational research study.
Key exclusion criteria
Patients eligible for the FIRST-RCC study who decline participation in this translational research study through the informed consent or opt-out process.
Target sample size
400
Research contact person
Name of lead principal investigator
| 1st name | Hisashi |
| Middle name | |
| Last name | Hasumi |
Organization
Yokohama City University
Division name
Department of Urology
Zip code
2360004
Address
3-9 Fukuura, Kanazawa-ku, Yokohama, Kanagawa, Japan
TEL
0457872679
hisahasu@gmail.com
Public contact
Name of contact person
| 1st name | HISASHI |
| Middle name | |
| Last name | HASUMI |
Organization
Yokohama City University
Division name
Department of Urology
Zip code
2360004
Address
3-9 Fukuura, Kanazawa-ku, Yokohama, Kanagawa, Japan
TEL
08022124210
Homepage URL
hisahasu@gmail.com
Sponsor or person
Institute
Yokohama City University
Institute
Department
Personal name
Funding Source
Organization
Yokohama City University
Organization
Division
Category of Funding Organization
Local Government
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Yokohama City University Hospital
Address
Open Innovation Laboratory, 1F, 3-9 Fukuura, Kanazawa-ku, Yokohama, Kanagawa 236-0004, Japan
Tel
045-370-7627
rinri@yokohama-cu.ac.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 | 09 | Month | 10 | 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 | 08 | Month | 21 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 08 | Month | 21 | Day |
Last follow-up date
| 2031 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
n/a
Management information
Registered date
| 2026 | Year | 09 | Month | 10 | Day |
Last modified on
| 2026 | Year | 09 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071992
