A Study Evaluating Toripalimab Injection Combined With Standard Chemotherapy as a First-line Treatment for Locally Advanced or Metastatic Urothelial Carcinoma

NCT ID: NCT04568304

Last Updated: 2020-09-29

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 364 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-11-30
• Study Completion Date: 2025-11-30

Brief Summary

The study is being conducted to evaluate the efficacy and safety of Toripalimab Injection in combination with chemotherapy compared to placebo in combination with chemotherapy in subjects with PD-L1-positive unresectable locally advanced or metastatic urothelial carcinoma who have received no previous systemic therapy.

Conditions

Locally Advanced or Metastatic Urothelial Carcinoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Toripalimab Injection + chemotherapy group

Group Type: EXPERIMENTAL

Toripalimab Injection

Intervention Type: BIOLOGICAL

Toripalimab Injection 240 mg iv infusion on Day 1 of each 3-week cycle. The cumulative duration of Toripalimab Injection is up to 2 years.

Gemcitabine Hydrochloride for Injection

Intervention Type: DRUG

Gemcitabine 1000mg/㎡ iv infusion, on Day 1 and Day 8 of each cycle, each treatment cycle is 3 weeks.

The chemotherapy regimen will be administered for 6 cycles.

Cisplatin for Injection / Carboplatin Injection

Intervention Type: DRUG

Cisplatin 70mg/㎡ iv infusion, on Day 1 or Day 2 of each cycle, each treatment cycle is 3 weeks.

Carboplatin AUC 4.5 iv infusion, on Day 1 or Day 2 of each cycle, each treatment cycle is 3 weeks.

The chemotherapy regimen will be administered for 6 cycles.

Placebo + chemotherapy group

Group Type: PLACEBO_COMPARATOR

Gemcitabine Hydrochloride for Injection

Intervention Type: DRUG

Gemcitabine 1000mg/㎡ iv infusion, on Day 1 and Day 8 of each cycle, each treatment cycle is 3 weeks.

The chemotherapy regimen will be administered for 6 cycles.

Cisplatin for Injection / Carboplatin Injection

Intervention Type: DRUG

Cisplatin 70mg/㎡ iv infusion, on Day 1 or Day 2 of each cycle, each treatment cycle is 3 weeks.

Carboplatin AUC 4.5 iv infusion, on Day 1 or Day 2 of each cycle, each treatment cycle is 3 weeks.

The chemotherapy regimen will be administered for 6 cycles.

Placebo

Intervention Type: DRUG

Placebo iv infusion on Day 1 of each 3-week cycle. The cumulative duration of placebo is up to 2 years.

Interventions

Toripalimab Injection

Toripalimab Injection 240 mg iv infusion on Day 1 of each 3-week cycle. The cumulative duration of Toripalimab Injection is up to 2 years.

Intervention Type: BIOLOGICAL

Gemcitabine Hydrochloride for Injection

Gemcitabine 1000mg/㎡ iv infusion, on Day 1 and Day 8 of each cycle, each treatment cycle is 3 weeks.

The chemotherapy regimen will be administered for 6 cycles.

Intervention Type: DRUG

Cisplatin for Injection / Carboplatin Injection

Cisplatin 70mg/㎡ iv infusion, on Day 1 or Day 2 of each cycle, each treatment cycle is 3 weeks.

Carboplatin AUC 4.5 iv infusion, on Day 1 or Day 2 of each cycle, each treatment cycle is 3 weeks.

The chemotherapy regimen will be administered for 6 cycles.

Intervention Type: DRUG

Placebo

Placebo iv infusion on Day 1 of each 3-week cycle. The cumulative duration of placebo is up to 2 years.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Have full knowledge on this study and are willing to sign informed consent form (ICF);

2. Age 18-75 years at time of signing ICF, male or female;

3. The investigator judged that the subject is eligible for platinum-based chemotherapy;

4. Presence of histopathologically confirmed unresectable locally advanced (T4, any N; or any T, N2-3) or metastatic urothelial carcinoma;

5. No prior systemic anti-tumor therapy;

6. Subjects who are able to provide tumor tissue slides (≥ 5 slides) for PD-L1 test and the corresponding pathology report and whose PD-L1 test must be positive before randomization;

7. With at least one measurable lesion as per RECIST 1.1 criteria;

8. ECOG performance status score of 0-1;

9. Adequate function of vital organs.

Exclusion Criteria

1. Have received anti-tumor treatments, including chemotherapy, radiotherapy or investigational product within 28 days before randomization;

2. Have received traditional Chinese medicines with anti-tumor activity or immunomodulators (eg. Interferon and Interleukin) within 14 days before randomization;

3. Previous use of anti-PD-1/PD-L1 agent or a drug acting on another co-inhibitory T cell receptor;

4. Subjects who are currently participating in or have participated in a study with investigational product within 4 weeks before administration;

5. Having received systemic corticosteroid therapy (dose equivalent to prednisone > 10 mg/day) within 14 days before randomization;

6. Subjects with active central nervous system (CNS) metastasis;

7. Grade 2 or higher peripheral neuropathy or hearing loss.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai Junshi Bioscience Co., Ltd.

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Peking University Cancer Hospital

Beijing, , China

Peking University First Hospital

Beijing, , China

Renji Hospital Affiliated to Shanghai Jiaotong University School of Medicine

Shanghai, , China

Countries

China

Central Contacts

Jun Guo, Prof

Role: CONTACT

guoj307@126.com

86-010-88196348

Facility Contacts

Jun Guo, Prof

Role: primary

Zhisong He, Prof

Role: primary

Yiran Huang, Prof

Role: primary

Other Identifiers

JS001-038-III-UBC

Identifier Type: -

Identifier Source: org_study_id