UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013656 |
|---|---|
| Receipt number | R000015815 |
| Scientific Title | A multicenter, open-label, phase 2 study of S-588410 after first-line chemotherapy in patients with advanced and/or metastatic bladder cancer |
| Date of disclosure of the study information | 2014/04/07 |
| Last modified on | 2023/11/08 15:08:36 |
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Basic information
Public title
A multicenter, open-label, phase 2 study of S-588410 after first-line chemotherapy in patients with advanced and/or metastatic bladder cancer
Acronym
A multicenter, open-label, phase 2 study of S-588410 after first-line chemotherapy in patients with advanced and/or metastatic bladder cancer
Scientific Title
A multicenter, open-label, phase 2 study of S-588410 after first-line chemotherapy in patients with advanced and/or metastatic bladder cancer
Scientific Title:Acronym
A multicenter, open-label, phase 2 study of S-588410 after first-line chemotherapy in patients with advanced and/or metastatic bladder cancer
Region
| Japan | Europe |
Condition
Condition
bladder cancer
Classification by specialty
| Urology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the specific cytotoxic T lymphocyte response patients receiving S-588410.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Phase II
Assessment
Primary outcomes
Safety: Assessment of AEs (CTCAE)
Efficacy: Specific CTL measurement
Key secondary outcomes
Tumor evaluation, overall survival, progression free survival, quality of life
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
S-588410 will be injected subcutaneously once weekly for 12 weeks and once every 2 weeks thereafter for up to 24 months in the S-588410 group.
Interventions/Control_2
Patients in the untreated control group will not receive the study drug.
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 advanced and/or metastatic bladder cancer who have received first-line chemotherapy.
2.Patients who are male or female aged >=20 years at the time of informed consent.
3.Patients with the ECOG PS 0 or 1 at enrollment.
4.Patients who provide a personally signed and dated informed consent document for participation in the study.
Key exclusion criteria
1.Patients who are expected to require anti-malignant tumor drug between enrollment and completion or discontinuation of the study treatment.
2.Patients with uncontrolled systemic or active infection.
Target sample size
84
Research contact person
Name of lead principal investigator
| 1st name | Iwasaki |
| Middle name | |
| Last name | Toshinobu |
Organization
Shionogi & Co., Ltd.
Division name
Global Development
Zip code
541-0045
Address
1-8, Doshomachi 3-chome, Chuo-ku, Osaka 541-0045, Japan
TEL
06-6209-7885
shionogiclintrials-admin@shionogi.co.jp
Public contact
Name of contact person
| 1st name | Kyokawa |
| Middle name | |
| Last name | Yoshimasa |
Organization
Shionogi & Co., Ltd.
Division name
Corporate Communications Department
Zip code
541-0045
Address
1-8, Doshomachi 3-chome, Chuo-ku, Osaka 541-0045, Japan
TEL
06-6209-7885
Homepage URL
shionogiclintrials-admin@shionogi.co.jp
Sponsor or person
Institute
Shionogi & Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kyoto University Hospital IRB
Address
54 Shogoinkawahara-cho, Sakyo-ku, Kyoto, Japan
Tel
075-751-4389
tiken@kuhp.kyoto-u.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
| 2014 | Year | 04 | Month | 07 | Day |
Related information
URL releasing protocol
https://content.iospress.com/articles/bladder-cancer/blc211592
Publication of results
Published
Result
URL related to results and publications
https://content.iospress.com/articles/bladder-cancer/blc211592
Number of participants that the trial has enrolled
81
Results
The proportion of patients who showed CTL induction to at least one of the antigens for the initial 12 weeks after initial dose in the S-588410 group (primary endpoint) was 93.3% and the null hypothesis that the CTL induction rate for 12 weeks would be 50% or less was rejected significantly (P < 0.0001, one-sided binomial test).
Results date posted
| 2023 | Year | 11 | Month | 08 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2022 | Year | 06 | Month | 03 | Day |
Baseline Characteristics
This study was conducted in patients with advanced and/or metastatic bladder cancer who had complete response (CR), partial response (PR), or stable disease (SD) based on the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 at the end of at least 4 cycles of first-line platinum-containing chemotherapy.
Participant flow
Forty-five participants with HLA-A*24:02 were enrolled to the S-588410 group and 36 participants without HLA-A*24:02 were enrolled to the observation group.
Adverse events
Treatment-emergent adverse events (TEAEs) were reported in 97.8% of the S-588410 group and 61.1% of the Observation group. Most TEAEs in the S-588410 group were grade 3 or less and all TEAEs in the Observation group were grade 3 or less. Frequent TEAEs were injection site reaction, pyrexia, and nasopharyngitis; the incidence of these TEAEs were higher in the S-588410 group than the Observation group.
Outcome measures
Tumor evaluation was performed by central review based on RECIST guideline version 1.1 and immune-related response criteria (irRC). The response rate (CR + PR) was 8.9% in the S-588410 group and 0% in the Observation group both in the RECIST and the irRC. The disease control rate (CR + PR + SD) was 24.4% in the S-588410 group and 13.9% in the Observation group based in the RECIST; and 22.2% in the S-588410 group and 13.9% in the Observation group in the irRC.
The median progression-free survival (range of event time) was 18.1 (2.1 to 141.7) weeks in the S-588410 group and 12.5 (3.4 to 176.1) weeks in the Observation group. The median overall survival (range of event time) was 71.0 (8.9 to 188.7) weeks in the S-588410 group and 99.0 (8.7 to 145.7) weeks in the Observation group.
Quality of life was assessed by EORTC QLQ-C30, EQ-5D-5L, and EQ VAS. Each QOL score was worse in the S-588410 group than in the Observation group at the last observation.
Plan to share IPD
Not determined
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2013 | Year | 12 | Month | 25 | Day |
Date of IRB
| 2014 | Year | 02 | Month | 17 | Day |
Anticipated trial start date
| 2014 | Year | 03 | Month | 31 | Day |
Last follow-up date
| 2017 | Year | 11 | Month | 21 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 04 | Month | 07 | Day |
Last modified on
| 2023 | Year | 11 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015815
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