NCT04568304

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
364

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Nov 2020

Longer than P75 for phase_3

Geographic Reach
1 country

3 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 17, 2020

Completed
12 days until next milestone

First Posted

Study publicly available on registry

September 29, 2020

Completed
2 months until next milestone

Study Start

First participant enrolled

November 30, 2020

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2023

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2025

Completed
Last Updated

September 29, 2020

Status Verified

September 1, 2020

Enrollment Period

3 years

First QC Date

September 17, 2020

Last Update Submit

September 23, 2020

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

  • +5 more secondary outcomes

Other Outcomes (4)

  • Investigator-assessed PFS

    Approximately 4 years

  • Investigator-assessed ORR

    Approximately 4 years

  • Investigator-assessed DCR

    Approximately 4 years

  • +1 more other outcomes

Study Arms (2)

Toripalimab Injection + chemotherapy group

EXPERIMENTAL
Biological: Toripalimab InjectionDrug: Gemcitabine Hydrochloride for InjectionDrug: Cisplatin for Injection / Carboplatin Injection

Placebo + chemotherapy group

PLACEBO COMPARATOR
Drug: Gemcitabine Hydrochloride for InjectionDrug: Cisplatin for Injection / Carboplatin InjectionDrug: Placebo

Interventions

Toripalimab InjectionBIOLOGICAL

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 InjectionDRUG

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 groupToripalimab Injection + chemotherapy group
Cisplatin for Injection / Carboplatin InjectionDRUG

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 groupToripalimab Injection + chemotherapy group
PlaceboDRUG

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

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

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

toripalimabGemcitabineInjectionsCisplatinCarboplatin

Condition Hierarchy (Ancestors)

CarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasms

Intervention Hierarchy (Ancestors)

Heterocyclic CompoundsDeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingDrug Administration RoutesDrug TherapyTherapeuticsChlorine CompoundsInorganic ChemicalsNitrogen CompoundsPlatinum CompoundsCoordination ComplexesOrganic Chemicals

Central Study Contacts

Jun Guo, Prof

CONTACT

86-010-88196348guoj307@126.com

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

November 30, 2020

Primary Completion

November 30, 2023

Study Completion

November 30, 2025

Last Updated

September 29, 2020

Record last verified: 2020-09

Locations

CN(3)