Clinical trial NCT04568304: A Study Evaluating Toripalimab Injection Combined With Standard Chemotherapy as a First-line Treatment for Locally Advanced or Metastatic Urothelial Carcinoma
Official title: A Phase III, Randomized, Double-blind, Placebo-controlled, Multi-center Clinical Study to Evaluate the Efficacy and Safety of Toripalimab Injection (JS001) in Combination With Standard Chemotherapy Versus Placebo in Combination With Standard Chemotherapy as the 1st-line Therapy for Treatment-naive Subjects With PD-L1-positive Locally Advanced or Metastatic Urothelial Carcinoma
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE3
Conditions: Locally Advanced or Metastatic Urothelial Carcinoma
Lead sponsor: Shanghai Junshi Bioscience Co., Ltd.
Sponsor class: OTHER
First posted: 2020-09-29
Enrollment: 364
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Investigator-assessed progression-free survival (INV-PFS) as per RECIST 1.1 criteria
timeFrame: Approximately 3 years
Secondary outcomes:
measure: IRC-PFS
timeFrame: Approximately 3 years
measure: INV-ORR, IRC-ORR
timeFrame: Approximately 3 years
measure: INV-DCR, IRC-DCR
timeFrame: Approximately 3 years
measure: INV-DoR, IRC- DoR
timeFrame: Approximately 3 years
measure: OS
timeFrame: Approximately 5 years
measure: OS rate at 1 year
timeFrame: Approximately 3 years
measure: OS rate at 2 years
timeFrame: Approximately 4 years
measure: INV-PFS rate and IRC-PFS rate at 6 months
timeFrame: Approximately 2.5 years
measure: INV-PFS rate and IRC-PFS rate at 1 year
timeFrame: Approximately 3 years
measure: Incidence of AEs/SAEs
timeFrame: Approximately 4 years
Other outcomes:
measure: Investigator-assessed PFS
timeFrame: Approximately 4 years
measure: Investigator-assessed ORR
timeFrame: Approximately 4 years
measure: Investigator-assessed DCR
timeFrame: Approximately 4 years
measure: Investigator-assessed DoR
timeFrame: Approximately 4 years
Locations:
city: Beijing
country: China
facility: Peking University Cancer Hospital
city: Beijing
country: China
facility: Peking University First Hospital
city: Shanghai
country: China
facility: Renji Hospital Affiliated to Shanghai Jiaotong University School of Medicine
Study officials:
References: