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

NCT04568304 | Withdrawn Phase 3

• 1 other identifier: JS001-038-III-UBC
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 3

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

Outcome Measures

Primary Outcomes (1)

• Investigator-assessed progression-free survival (INV-PFS) as per RECIST 1.1 criteria

  To evaluate the investigator-assessed progression-free survival following 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

  Approximately 3 years

Secondary Outcomes (10)

• IRC-PFS

  Approximately 3 years

• INV-ORR, IRC-ORR

  Approximately 3 years

• INV-DCR, IRC-DCR

  Approximately 3 years

• INV-DoR, IRC- DoR

  Approximately 3 years

• OS

  Approximately 5 years

Other Outcomes (4)

• Investigator-assessed PFS

  Approximately 4 years

• Investigator-assessed ORR

  Approximately 4 years

• Investigator-assessed DCR

  Approximately 4 years

Study Arms (2)

Toripalimab Injection + chemotherapy group

EXPERIMENTAL

Biological: Toripalimab Injection; Drug: Gemcitabine Hydrochloride for Injection; Drug: Cisplatin for Injection / Carboplatin Injection

Placebo + chemotherapy group

PLACEBO COMPARATOR

Drug: Gemcitabine Hydrochloride for Injection; Drug: Cisplatin for Injection / Carboplatin Injection; Drug: Placebo

Interventions

Toripalimab Injection 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.

Toripalimab Injection + chemotherapy group

Gemcitabine Hydrochloride for Injection 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.

Placebo + chemotherapy group; Toripalimab Injection + chemotherapy group

Cisplatin for Injection / Carboplatin Injection 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; Toripalimab Injection + chemotherapy group

Placebo DRUG

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

Placebo + chemotherapy group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Have full knowledge on this study and are willing to sign informed consent form (ICF);
• Age 18-75 years at time of signing ICF, male or female;
• The investigator judged that the subject is eligible for platinum-based chemotherapy;
• Presence of histopathologically confirmed unresectable locally advanced (T4, any N; or any T, N2-3) or metastatic urothelial carcinoma;
• No prior systemic anti-tumor therapy;
• 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;
• With at least one measurable lesion as per RECIST 1.1 criteria;
• ECOG performance status score of 0-1;
• Adequate function of vital organs.

You may not qualify if:

• Have received anti-tumor treatments, including chemotherapy, radiotherapy or investigational product within 28 days before randomization;
• Have received traditional Chinese medicines with anti-tumor activity or immunomodulators (eg. Interferon and Interleukin) within 14 days before randomization;
• Previous use of anti-PD-1/PD-L1 agent or a drug acting on another co-inhibitory T cell receptor;
• Subjects who are currently participating in or have participated in a study with investigational product within 4 weeks before administration;
• Having received systemic corticosteroid therapy (dose equivalent to prednisone \> 10 mg/day) within 14 days before randomization;
• Subjects with active central nervous system (CNS) metastasis;
• Grade 2 or higher peripheral neuropathy or hearing loss.

Sponsors & Collaborators

• Shanghai Junshi Bioscience Co., Ltd.: lead

Study Sites (3)

Peking University Cancer Hospital

Beijing, China

Location

Peking University First Hospital

Beijing, China

Location

Renji Hospital Affiliated to Shanghai Jiaotong University School of Medicine

Shanghai, China

Location

MeSH Terms

Conditions

Carcinoma, Transitional Cell

Interventions

toripalimab; Gemcitabine; Injections; Cisplatin; Carboplatin

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Drug Administration Routes; Drug Therapy; Therapeutics; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Coordination Complexes; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 17, 2020
• First Posted: September 29, 2020
• Study Start: September 6, 2022
• Primary Completion: September 6, 2022
• Study Completion: September 6, 2022
• Last Updated: July 9, 2026

Record last verified: 2026-07

Locations

CN (3)