UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000060270 |
|---|---|
| Receipt number | R000068941 |
| Scientific Title | An Open-Label, Single-Arm Phase II Study of Enfortumab Vedotin Plus Pembrolizumab in Patients with Unresectable Urothelial Carcinoma |
| Date of disclosure of the study information | 2026/01/06 |
| Last modified on | 2026/01/06 15:00:17 |
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Basic information
Public title
An Open-Label, Single-Arm Phase II Study of Enfortumab Vedotin Plus Pembrolizumab in Patients with Unresectable Urothelial Carcinoma
Acronym
BiCURE trial
Scientific Title
An Open-Label, Single-Arm Phase II Study of Enfortumab Vedotin Plus Pembrolizumab in Patients with Unresectable Urothelial Carcinoma
Scientific Title:Acronym
BiCURE trial
Region
| Japan |
Condition
Condition
Urothelial Carcinoma
Classification by specialty
| Urology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy of enfortumab vedotin in combination with pembrolizumab in patients with unresectable urothelial carcinoma, with the objective response rate (ORR) as the primary efficacy endpoint.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
ORR
Key secondary outcomes
Overall survival
Progression-free survival
Time to performance status progression
Disease control rate
Safety
Incidence of adverse events
Duration of enfortumab vedotin treatment
Duration of pembrolizumab treatment
Discontinuation rate due to adverse events
Relative dose intensity
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
One treatment cycle consists of 42 days. Enfortumab vedotin is administered at a dose of 1.25 mg/kg on Days 1, 15, and 29, and pembrolizumab is administered at a fixed dose of 200 mg per body on Days 1 and 22.
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
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Histologically confirmed locally advanced or metastatic urothelial carcinoma that is unresectable.
Eastern Cooperative Oncology Group performance status of 0 to 2.
Written informed consent to participate in this clinical study obtained voluntarily from the patient after sufficient explanation.
Patients who agree to use adequate contraception: male patients from the initiation of study treatment until 1 month after the last dose, and female patients of childbearing potential from the initiation of study treatment until 4 months after the last dose.
Key exclusion criteria
Patients who have received any prior systemic therapy for unresectable locally advanced or metastatic urothelial carcinoma.
Patients with a history of hypersensitivity to enfortumab vedotin or to anti PD1 or anti PDL1 antibodies.
Patients who have participated in another clinical study or clinical trial within 3 months prior to the initiation of study treatment.
Patients with severe bone marrow suppression.
Patients with active infection or suspected infection.
Patients with severe hepatic impairment classified as Child Pugh class C.
Patients with diabetes mellitus with poor glycemic control within 3 months prior to enrollment.
Patients with end-stage renal disease receiving dialysis, or with an estimated glomerular filtration rate under 15 mL min
Pregnant or breastfeeding women.
Patients deemed inappropriate for participation in the study by the principal investigator or sub-investigators.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Ryunosuke |
| Middle name | |
| Last name | Nakagawa |
Organization
Kanazawa University
Division name
Urology
Zip code
920-8641
Address
Takaramachi 13-1, Kanazawa, Ishikawa
TEL
0762652393
r_a_rhero0226southern@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Ryunosuke |
| Middle name | |
| Last name | Nakagawa |
Organization
Kanazawa University
Division name
Urology
Zip code
920-8641
Address
Takaramachi 13-1, Kanazawa, Ishikawa
TEL
0762652393
Homepage URL
https://kanazawa-univ-urology.jp
r_a_rhero0226southern@yahoo.co.jp
Sponsor or person
Institute
Kanazawa University
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Research and Development for the Advancement of Clinical Medicine
Address
Takaramachi 13-1, Kanazawa, Ishikawa
Tel
076-265-2049
r_a_rhero0226southern@yahoo.co.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 | 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
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
| 2025 | Year | 10 | Month | 07 | Day |
Date of IRB
| 2025 | Year | 10 | Month | 07 | Day |
Anticipated trial start date
| 2025 | Year | 10 | Month | 07 | Day |
Last follow-up date
| 2033 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 01 | Month | 06 | Day |
Last modified on
| 2026 | Year | 01 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068941
