Phase Ib/II Trail of Neoadjuvant of Tislelizumab Combined With Palbociclib in Patients With Platinum-refractory Bladder Urothelial Carcinoma - Trial NCT06364956
Access comprehensive clinical trial information for NCT06364956 through Pure Global AI's free database. This Phase 1/2 trial is sponsored by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University and is currently Recruiting. The study focuses on Bladder Cancer. Target enrollment is 36 participants.
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Study Focus
Tislelizumab combined with two predefined dose groups of palbociclib
Interventional
drug
Sponsor & Location
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Timeline & Enrollment
Phase 1/2
May 01, 2024
Jun 01, 2026
Primary Outcome
Phase I: the safety dose of the combination of Tislelizumab and palbociclib,Phase II: Pathological complete response rate(pCR)
Summary
In order to explore the safety and antitumor efficacy of different doses of CDK4/6 inhibitor
 Palbociclib in combination with the Tislelizumab in platinum-refractory cT2-4aN0M0 bladder
 urothelial carcinoma, a phase Ib/II study was conducted.
 
 This study will adopt a 3+3 design and include two predefined dose groups of palbociclib:
 100mg QD, 125mg QD. Initially, Tislelizumab, 200 mg administered by intravenous infusion on
 Day 1 of each 21-day will be administered in combination. The trial will use the first cycle
 (28 days) as the observation period for tolerability, observing and evaluating the occurrence
 of DLTs after medication and determining the maximum tolerated dose/maximum administered dose
 (MTD/MAD) and recommended phase 2 dose (RP2D) of the combination therapy (30 patients) .
 
 This study provide further evidence for improving the efficacy of neoadjuvant treatment
 forplatinum-refractory cT2-4aN0M0 bladder urothelial carcinoma and to offer new options for
 precision treatment of bladder cancer.
ICD-10 Classifications
Data Source
ClinicalTrials.gov
NCT06364956
Non-Device Trial