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

Shanghai Junshi Biosciences

Status and phase: Not yet enrolling; Phase 3

Conditions: Locally Advanced or Metastatic Urothelial Carcinoma

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

Study type: Interventional

Funder types: Other

Identifiers

NCT04568304

JS001-038-III-UBC

Details and patient eligibility

About

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.

Enrollment: 364 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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364 participants in 2 patient groups, including a placebo group

Toripalimab Injection + chemotherapy group

Experimental group

Treatment:

Drug: Gemcitabine Hydrochloride for Injection

Drug: Cisplatin for Injection / Carboplatin Injection

Biological: Toripalimab Injection

Placebo + chemotherapy group

Placebo Comparator group

Treatment:

Drug: Placebo

Drug: Gemcitabine Hydrochloride for Injection

Drug: Cisplatin for Injection / Carboplatin Injection