Study of Tislelizumab in Combination With Chemotherapy Compared to Chemotherapy Alone for Participants With Urothelial Carcinoma

Phase 3Active Not RecruitingNCT03967977

BeiGene420 enrolled

Overview

This is a multicenter, randomized, double-blind, placebo-controlled, Phase 3 study designed to compare the efficacy and safety of tislelizumab + either cisplatin or carboplatin + gemcitabine versus placebo+ either cisplatin or carboplatin + gemcitabine in approximately 420 participants with locally advanced or metastatic urothelial carcinoma who have not received prior systemic therapy.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

420

Conditions

Urothelial Carcinoma

Interventions

TislelizumabDRUG

200 mg administered Intravenously (IV) as specified in the treatment arm

PlaceboDRUG

Tislelizumab placebo to match

CisplatinDRUG

70 mg/m2 administered IV as specified in the treatment arm

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

Key Inclusion Criteria: 1. Male or female aged 18 to 75 years on the day of signing the Informed Consent Form (ICF) 2. Histologically confirmed, inoperable, locally advanced, or metastatic urothelial cancer (UC) 3. Must be eligible to receive cisplatin or carboplatin in the investigator's judgment 4. Have had no prior systemic chemotherapy for locally advanced or metastatic UC 5. Must be able to provide fresh or archival tumor tissues with an associated pathological report. 6. Must have evaluable disease (either measurable or non-measurable) as defined per RECIST v1.1. 7. Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1. 8. Adequate organ function before randomization: Key Exclusion Criteria: 1. Received prior therapies targeting PD-1, PD-L1, PD-L2, CTLA4, or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways. 2. Any approved anticancer therapy within 28 days before randomization. 3. Active leptomeningeal disease or uncontrolled, untreated brain metastasis 4. Participants with uncontrolled hypercalcemia 5. Participants with active autoimmune diseases or history of autoimmune diseases that may relapse 6. History of interstitial lung disease, noninfectious pneumonitis, or uncontrolled diseases 7. A known history of HIV infection. 8. Prior allogeneic stem cell transplantation or organ transplantation. 9. History of severe hypersensitivity reactions to other monoclonal antibodies. 10．History of allergic reactions to cisplatin, carboplatin, or other platinum-containing compounds. NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Locations (46)

Outcomes

Primary Outcomes

Overall survival (OS) in the Intent to Treat (ITT) set

Time frame: From first randomization up to 3.5 years, approximately

Secondary Outcomes

Overall response rate (ORR) per RECIST v1.1 in ITT

the proportion of participants who had Complete Response (CR) or Partial Response (PR) as assessed by the investigator per RECIST v1.1 in the ITT Analysis Set

Time frame: From first randomization up to 3.5 years, approximately

Duration of response (DOR)

the time from the first occurrence of a documented objective response to documented Progressive Disease (PD), or death from any cause, whichever occurs first, as determined by the investigator per RECIST v1.1 in the ITT Analysis Set

Time frame: From first randomization up to 3.5 years, approximately

Progression-free survival (PFS)

the time from randomization to the first objectively documented PD, or death from any cause, whichever occurs first, as determined by the investigator per RECIST v1.1 in the ITT Analysis Set

Time frame: From first randomization up to 3.5 years, approximately

Overall survival rate at 1 and 2 years for each treatment arm

the proportion of OS participants at 1 year and 2 years from randomization in the ITT Analysis Set

Time frame: From first randomization up to 3.5 years, approximately

Change from baseline in European Organization for Research and Treatment of Cancer Quality of Life-Core 30(EORTC QLQC30)

1\) to assess overall health status/Quality of Life with 2 questions which are with range from minimum score 1 as worse outcome and maximum score 7 as higher values represent a better 2) to assess quality of life with 28 questions about Physical functioning, emotional functioning, social functioning etc. which are with range from minimum scores 1 representing as better to maximum scores 4 as worse outcome.

Data from ClinicalTrials.gov

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Anhui Provincial Hospital

Hefei, Anhui, China

Peking University Third Hospital