A multicenter, open-label, phase 2 study of S-588410 after first-line chemotherapy in patients with advanced and/or metastatic bladder cancer

A multicenter, open-label, phase 2 study of S-588410 after first-line chemotherapy in patients with advanced and/or metastatic bladder cancer - A multicenter, open-label, phase 2 study of S-588410 after first-line chemotherapy in patients with advanced and/or metastatic bladder cancer

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000013656

Enrollment

Registered

2014-04-07

Start date

2014-03-31

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

bladder cancer

Interventions

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. Patients in the untreated control group will not receive

Eligibility

Sex/Gender

All

Inclusion criteria

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.

Exclusion criteria

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.

Design outcomes

Primary

Measure	Time frame
Safety: Assessment of AEs (CTCAE) Efficacy: Specific CTL measurement	—

Secondary

Measure	Time frame
Tumor evaluation, overall survival, progression free survival, quality of life	—

Countries

Japan,Europe

Contacts

Public ContactKyokawa Yoshimasa

Shionogi & Co., Ltd. Corporate Communications Department

shionogiclintrials-admin@shionogi.co.jp06-6209-7885

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026