UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050778 |
|---|---|
| Receipt number | R000057199 |
| Scientific Title | JAPANESE PROSPECTIVE REAL WORLD REGISTRY OF CABOZANTINIB PLUS NIVOLUMABIN PATIENTS WITH PREVIOUSLY UNTREATED ADVANCED OR METASTATIC RENAL CELL CARCINOMA |
| Date of disclosure of the study information | 2023/04/06 |
| Last modified on | 2024/06/17 11:03:04 |
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Basic information
Public title
JAPANESE PROSPECTIVE REAL WORLD REGISTRY OF CABOZANTINIB PLUS NIVOLUMABIN PATIENTS WITH PREVIOUSLY UNTREATED ADVANCED OR METASTATIC RENAL CELL CARCINOMA
Acronym
JACUMET study
Scientific Title
JAPANESE PROSPECTIVE REAL WORLD REGISTRY OF CABOZANTINIB PLUS NIVOLUMABIN PATIENTS WITH PREVIOUSLY UNTREATED ADVANCED OR METASTATIC RENAL CELL CARCINOMA
Scientific Title:Acronym
JACUMET study
Region
| Japan |
Condition
Condition
advanced or metastatic renal cell carcinoma
Classification by specialty
| Urology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To assess the effectiveness and safety of Cabozantinib plus Nivolumab as treatment of patients with advanced or metastatic renal cell carcinoma in the Japanese real-world settings.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
ORR by cohort
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1)Patients with histologically confirmed ccRCC(Cohort A) or nccRCC(Cohort B). Includes patients with sarcomatoid features in both cohorts
2)Advanced (not amenable to curative surgery) or metastatic RCC
3)Plan to receive cabozantinib + nivolumab combination therapy
4) No prior systemic therapy for RCC
5) Karnofsky Performance Status (KPS) grade >= 70%
6) Measurable disease as per RECIST v1.1 per investigator.
7)Signed Written Informed Consent
Key exclusion criteria
1)Synchronous or metachronous (within 3 years) malignancies.
2)Surgery prior to initiation of cabozantinib + nivolumab combination therapy with incomplete wound healing or continued postoperative complications
3) Radiotherapy within 14 days before starting cabozantinib + nivolumab combination therapy. Must be fully recovered from radiotherapy
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Hirotsugu |
| Middle name | |
| Last name | Uemura |
Organization
Kindai University School of Medicine
Division name
Urology
Zip code
589-8511
Address
377-2, Ohno-higashi, Osakasayama City, Osaka
TEL
072-366-0221
huemura@med.kindai.ac.jp
Public contact
Name of contact person
| 1st name | Kazunori |
| Middle name | |
| Last name | Fujita |
Organization
Kindai University School of Medicine
Division name
Urology
Zip code
589-8511
Address
377-2,Ohno-higashi,Osakasayama City, Osaka
TEL
072-366-0221
Homepage URL
kfujita@med.kindai.ac.jp
Sponsor or person
Institute
Kindai University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Takeda Pharmaceutical Company Limited
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee, Faculty of Medicine, Kinki University
Address
377-2,Ohno-higashi,Osakasayama City, Osaka
Tel
072-366-0221
zizen@med.kindai.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
| 2023 | Year | 04 | Month | 06 | 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
213
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
No longer recruiting
Date of protocol fixation
| 2022 | Year | 11 | Month | 08 | Day |
Date of IRB
| 2023 | Year | 03 | Month | 22 | Day |
Anticipated trial start date
| 2023 | Year | 04 | Month | 30 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 28 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
･Data on the safety and efficacy of cabozantinib plus nivolumab for Cohort A (ccRCC patients) and Cohort B (nccRCC patients) were collected.
･Primary endpoint:ORR by Cohort
Management information
Registered date
| 2023 | Year | 04 | Month | 06 | Day |
Last modified on
| 2024 | Year | 06 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057199
