OncoMatch/Clinical Trials/NCT03967977

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

Is NCT03967977 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies multiple treatments including Tislelizumab and Cisplatin for urothelial carcinoma.

Phase 3RecruitingBeiGeneNCT03967977Data as of May 2026

Treatment: Tislelizumab · Cisplatin · Gemcitabine Hydrochloride · Carboplatin — 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.

Check if I qualify

Extracted eligibility criteria

Cancer type

Urothelial Carcinoma

Performance status

ECOG 0–1(Restricted strenuous activity)

Prior therapy

No prior treatment (treatment-naive required)

Max 0 prior lines

Cannot have received: anti-PD-1/PD-L1/PD-L2 or co-inhibitory T-cell receptor therapy

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

Cannot have received: any approved anticancer therapy

Exception: within 28 days before randomization

Any approved anticancer therapy within 28 days before randomization

Lab requirements

Blood counts

Adequate organ function before randomization

Kidney function

Adequate organ function before randomization

Liver function

Adequate organ function before randomization

Adequate organ function before randomization

Structured fields extracted by AI. May contain errors — verify against the official protocol.

Could you qualify for this trial?

Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.

Check if I qualify