Advanced and/or metastatic bladder cancer, which is under control according to first-line chemotherapy. MedDRA version: 20.0 Level: PT Classification code 10005003 Term: Bladder cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Product Code: S-588410
Pharmaceutical Form: Emulsion for injection
Current Sponsor code: S-588410
Other descriptive name: S-588410
Conce
Sponsors
Shionogi & Co., Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: ? Patients with advanced and/or metastatic bladder cancer (including urothelial cancer of renal pelvis, ureters, and urethra) who have 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 firstline platinum-containing systemic chemotherapy.Common Terminology Criteria for Adverse Events [CTCAE] version 4.03.) ? Patients who are male or female aged =20 years at the time of informed consent. ? Patients with the ECOG PS 0 or 1 at enrollment. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 42 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 42
Exclusion criteria
Exclusion criteria: ? Patients who have progressive disease (PD) on RECIST version 1.1 at the end of at least 4 cycles of first-line platinum-containing chemotherapy. ? Patients who are judged to have clinically progressive symptoms at the end of at least 4 cycles of first-line platinum-containing chemotherapy by the investigator or subinvestigator. ? Patients with a history of malignant cancer (except for carcinoma in situ or intra-mucosal cancer that resolved with endoscopic therapy) within 5 years before enrollment. ? Patients who received any prior therapies for target disease within 3 weeks before the first administration of S-588410. ? Patients who are expected to require any of the following therapies between enrollment and completion or discontinuation of the study treatment. – Anti-malignant tumor drug – Systemic corticosteroid (except for corticosteroid defined as the equivalent of prednisone = 10 mg/day orally) – Systemic immunosuppressant drug – Immunotherapy – Radiotherapy (except for restricted radiotherapy for pain relief of bone metastasis) for the target disease – Surgical therapy for the target disease – Hyperthermia for the target disease – Herbal medicine with anti-tumor or immunosuppressant effect – Other investigational new products ? Patients who have severe (CTCAE version 4.03 grade 3 or higher) concurrent hepatic impairment, renal impairment, heart disease, hematological disease, respiratory disease, or metabolic disease, with the exception of any symptoms and/or signs associated with target disease. ? Patients who have the following laboratory data with grade 3 or higher according to CTCAE version 4.03 criteria within 28 days before enrollment. – White blood cell count 100 000/mm3 – Platelet count 5.0 × the upper limit of normal (ULN) – Total bilirubin >3.0 × ULN – Serum creatinine >3.0 × ULN ? Patients who have known human immunodeficiency virus infection. ? Patients with uncontrolled systemic or active infection. ? Patients who had any diseases with the risk of sudden death within 12 months before enrollment. [Examples] – Myocardial infarction – Unstable angina – Coronary or peripheral artery bypass graft surgery – Thrombotic or embolic events such as pulmonary embolism, deep vein thrombosis, or transient ischemic attack ? Patients who have known brain metastases. ? Patients with a history or evidence of autoimmune diseases and/or immunodeficiency disorders. ? Patients with a history of severe (CTCAE version 4.03 grade 3 or higher) allergic reaction to a drug, vaccination, or biological preparation. ? Female patients who are lactating or pregnant. Female patients who are of childbearing potential, not included in any of the following, are positive for the pregnancy test at enrollment. – Postmenopausal woman (at least 2 years since their last regular menstrual pe
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the specific cytotoxic T lymphocyte (CTL) response in human leukocyte antigen (HLA)-A*24:02 positive patients receiving S-588410 for 12 weeks.; Secondary Objective: ? To evaluate the specific CTL induction over time in HLA-A*24:02-positive patients receiving S-588410 for 1 year. ? To estimate antitumor effect in HLA-A*24:02-positive patients receiving S-588410. ? To estimate progression-free survival (PFS) in HLA-A*24:02-positive patients receiving S-588410. ? To estimate overall survival (OS) in HLA-A*24:02-positive patients receiving S-588410. ? To evaluate the safety and tolerability in patients receiving S-588410. ? To assess the general health status in terms of European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 and Euro-QOL 5 dimension 5 level version (EQ-5D-5L) questionnaires in HLA-A*24:02-positive patients receiving S- 588410. ? To collect data of tumor evaluation, PFS, OS, and EORTC QLQ-C30 and EQ-5D-5L questionnaires in HLA-A*24:02-negative patients. ;Primary end point(s): [S-588410 Group]: CTL induction rate within 12 weeks after initial dose, defined as the proportion of patients who show CTL induction to at least any one of the 5 antigens.;Timepoint(s) of evaluation of this end point: 12 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): [S-588410 Group]: ? CTL induction rate within 1 year after initial dose, defined as the proportion of patients who show CTL induction to at least any one of the 5 antigens. [S-588410 Group and Observation Group]: ? Response rate (RR), defined as the proportion of patients who are assessed as CR or PR by using RECIST version 1.1 and immune-related response criteria (irRC), respectively. ? Disease control rate (DCR), defined as the proportion of patients who are assessed as CR, PR, or SD by using RECIST version 1.1 and irRC, respectively. ? Any response rate in image analysis such as tumor cavitation, defined as the proportion of patients who show any tumor change in image analysis (eg, tumor cavitation). ? PFS, defined as the time interval from the date of enrollment to the date of progression (progressive disease based on RECIST version 1.1, clinically progressive symptoms, or withdrawal due to aggravation of the target disease) or death due to any cause, whichever occurs first. ? OS, defined as the time interval from the date of enrollment to the date of death due to any cause. ? Change in QOL, defined as change from baseline in the global health status, the function scales, and the symptom scales on the EORTC QLQ C30 questionnaire, and the index value and the EQ visual analog scale (VAS) on the EQ-5D questionnaire, respectively. Baseline is defined as the value obtained at Visit 1 (pre-dose). ;Timepoint(s) of evaluation of this end point: 108 weeks | — |
Countries
Bulgaria, Japan, United Kingdom
Contacts
Public ContactCorporate Communications Department
Shionogi & Co., Ltd
Outcome results
None listed