UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056632 |
|---|---|
| Receipt number | R000064724 |
| Scientific Title | A multicenter prospective observational study of a sequential regimen of immune-checkpoint inhibitors and BRAF/MEK inhibitors for advanced BRAF V600-mutant melanoma (B-CHECK-SW study) |
| Date of disclosure of the study information | 2025/01/05 |
| Last modified on | 2025/07/13 18:44:11 |
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Basic information
Public title
A multicenter prospective observational study of a sequential regimen of immune-checkpoint inhibitors and BRAF/MEK inhibitors for advanced BRAF V600-mutant melanoma (B-CHECK-SW study)
Acronym
B-CHECK-SW
Scientific Title
A multicenter prospective observational study of a sequential regimen of immune-checkpoint inhibitors and BRAF/MEK inhibitors for advanced BRAF V600-mutant melanoma (B-CHECK-SW study)
Scientific Title:Acronym
B-CHECK-SW
Region
| Japan |
Condition
Condition
malignant melanoma
Classification by specialty
| Dermatology |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
This multicenter prospective observational study aims to collect real-world data on the treatment sequencing patterns in daily practice in Japan and to evaluate clinical outcomes in East Asian patients with advanced BRAF V600-mutant melanoma receiving immune-checkpoint inhibitor-upfront versus BRAF/MEK inhibitor-upfront sequential therapies.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
2-year overall survival
Key secondary outcomes
Treatment sequencing patterns in daily practice
Progression-free survival (PFS)
Objective response rate (ORR)
Treatment-related adverse events (TRAEs)
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) Histopathologically confirmed melanoma.
2) BRAF V600 mutation confirmed by in vitro diagnostic test approved in Japan.
3) Presence of distant metastases or surgically unresectable disease.
4) For cutaneous primary melanoma, diagnosed as stage III or IV according to AJCC 8th edition.
5) Measurable lesions on whole-body CT scan at baseline.
6) Aged 18 years or older at enrollment.
7) ECOG Performance Status of 0-2.
8) Able to swallow oral medications and the absence of clinically significant gastrointestinal disorders that may affect drug absorption.
9) Adequate bone marrow and organ function.
10) Written informed consent.
Key exclusion criteria
1) Prior history of systemic therapy with BRAF/MEK inhibitors or immune-checkpoint inhibitors (excluding adjuvant/neoadjuvant therapy).
2) History of Grade 3 or higher adverse events induced by adjuvant/neoadjuvant therapy with BRAF/MEK inhibitors or immune checkpoint inhibitors (excluding patients who could continue treatment with hormone replacement therapy).
3) Presence of other active malignancy.
4) Presence of active autoimmune disease.
5) Receiving systemic corticosteroids exceeding 10 mg/day prednisolone equivalent or immunosuppressive medications.
6) History or presence of uncontrolled or severe cardiac disease.
7) History of interstitial lung disease.
8) Pregnant or lactating women.
9) Any other condition deemed unsuitable for enrollment by the treating physician.
Target sample size
140
Research contact person
Name of lead principal investigator
| 1st name | Kenjiro |
| Middle name | |
| Last name | Namikawa |
Organization
National Cancer Center Hospital
Division name
Department of Dermatologic Oncology
Zip code
104-0045
Address
5-1-1 Tsukiji, Chuo-Ku, Tokyo, Japan
TEL
03-3542-2511
knamikaw@ncc.go.jp
Public contact
Name of contact person
| 1st name | Kenjiro |
| Middle name | |
| Last name | Namikawa |
Organization
National Cancer Center Hospital
Division name
Department of Dermatologic Oncology
Zip code
104-0045
Address
5-1-1 Tsukiji, Chuo-Ku, Tokyo, Japan
TEL
03-3542-2511
Homepage URL
knamikaw@ncc.go.jp
Sponsor or person
Institute
National Cancer Center Hospital
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development (AMED)
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
National Cancer Center Research and Development Fund
IRB Contact (For public release)
Organization
National Cancer Center Institutional Review Board
Address
5-1-1 Tsukiji, Chuo-Ku, Tokyo, Japan
Tel
03-3542-2511
NCC_IRBoffice@ml.res.ncc.go.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
| 2025 | Year | 01 | Month | 05 | 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
Open public recruiting
Date of protocol fixation
| 2024 | Year | 11 | Month | 08 | Day |
Date of IRB
| 2024 | Year | 12 | Month | 04 | Day |
Anticipated trial start date
| 2025 | Year | 01 | Month | 06 | Day |
Last follow-up date
| 2028 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2029 | Year | 12 | Month | 31 | Day |
Other
Other related information
None
Management information
Registered date
| 2025 | Year | 01 | Month | 05 | Day |
Last modified on
| 2025 | Year | 07 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064724
