NCT04211012

A Study on Toripalimab Plus Nab-Paclitaxel With or Without Cisplatin as First-line Treatment of Urothelial Carcinoma

A Phase II Study to Evaluate the Efficacy and Safety of Toripalimab Plus Nab-Paclitaxel With or Without Cisplatin as First-line Treatment of Unresectable Locally Advanced or Metastatic Urothelial Carcinoma

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Jun Guo · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a single-center, open-label，phase II study designed to evaluate the efficacy and safety of Toripalimab plus nab-paclitaxel with or without cisplatin as first-line treatment of unresectable locally advanced or metastatic urothelial carcinoma.Each enrolled Patient will receive Toripalimab plus nab-paclitaxel with or without cisplatin until progressive disease or intolerable toxicity occurs, then enter a survival follow-up period. Nab-paclitaxel with or without cisplatin will be administered for up to 6 cycles, and Toripalimab up to 2 years.

Detailed description

Unresectable locally advanced or metastatic urothelial carcinoma

Conditions

• Urothelial Carcinoma

Interventions

Type	Name	Description
DRUG	Toripalimab plus Nab-Paclitaxel +/- cisplatin	Toripalimab injection (JS001): 240mg, i.v.gtt, q3w; Nab-Paclitaxel: 260mg/m2, i.v.gtt, q3w Cisplatin: total dosage of 70 mg/m2 i.v.gtt, q3w，, complete all doses within the first 2 days of each cycle. Study treatment will be continued until disease progression or intolerable toxicity, or withdrawal at the discretion of the investigator or the subject, loss to follow-up, or initiation of other anti-cancer therapy, or death, whichever occurs first. Toripalimab will be administered no more than 2 years,and nab-paclitaxel with or without cisplatin will be administered up to 6 cycles.. If the subject is intolerable to cisplatin treatment according to the investigator's judgment, JS001 + Nab-Paclitaxel may be dosed. Dosing sequence: Toripalimab, Nab-Paclitaxel, cisplatin

Timeline

• Start date: 2020-11-30
• Primary completion: 2022-01-30
• Completion: 2023-01-30
• First posted: 2019-12-26
• Last updated: 2020-11-13

Locations

1 site across 1 country: China