Multicenter, prospective study using the novel predictive factor of the anti PD-1 antibody for urological cancers (renal cell carcinoma, urothelial cancer)

Multicenter, prospective study using the novel predictive factor of the anti PD-1 antibody for urological cancers (renal cell carcinoma, urothelial cancer) - Prospective study using the novel predictive factor of the anti PD-1 antibody for urological cancers

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000033039

Enrollment

Registered

2018-07-01

Start date

2018-08-01

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

renal cell carcinoma urothelial cancer

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: renal cell carcinoma 1) Impossible of resection or metastatic clear cell RCC 2) The patient that the treatment with VEGFR tyrosine kinase repressor is enforced as previous treatment more than 1 course 3) Patient older than age at agreement acquisition 20 years old 4) The case that they receive enough explanation about this study contents, and a written agreement of person or alternate is provided Urothelial cancer 1) Urinary cancer which is impossible of resection after the chemotherapy 2) The patient that treatment with platinum combination chemotherapy is enforced as previous treatment more than 1 course 3) Patient older than age at agreement acquisition 20 years old 4) The case that they receive enough explanation about this study contents, and a written agreement of person or alternate is provided

Exclusion criteria

Exclusion criteria: 1)A synchronism overlap cancer or the patient whom a disease-free period has heterochrony overlap cancer within five years *But I do not do Carcinoma in situ (cancer in the epithelium) and the intramucosal carcinoma judged that I was cured by local treatment with the exclusion. 2) The patient whom I am complicated with mental disease or a mind symptom, and it is judged to have difficulty in participation in study 3) The patient who gives it from head to foot of steroids more than four weeks *But I permit it to the steroid within 10 mg/day by prednisolone conversion. 4) in addition, the patient that a study responsibility doctor or an allotment doctor judged the participation in this study to be inappropriate

Design outcomes

Primary

Measure	Time frame
Association between disease control rate and PBMC biomarker	—

Secondary

Measure	Time frame
ORR Objective Response Rate TTF Time to Treatment Failure PFS Progression Free Survival OS Overall Survival safety and tolerability Comparison of the DCR, ORR PFS OS with non effective patient	—

Countries

Japan

Contacts

Public ContactKen Toyoda

Clinical Research Support Center Kyusyu Data center

uro1801@cres-kyushu.or.jp092-631-2920

Outcome results