Clinical Trail of Neoadjuvant of Tislelizumab Combined With Palbociclib in Patients With Platinum-refractory Bladder Urothelial Carcinoma

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

Trial Details

NCT ID
NCT06364956
Phase
PHASE1 / PHASE2
Sponsor
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Status
RECRUITING
Cancer Type
Urothelial Carcinoma Bladder Cancer
Interventions
  • Tislelizumab combined with two predefined dose groups of palbociclib
  • RP2D dose Of Tislelizumab combined with palbociclib was selected for phase II clinical trial.
Locations (sample)
  • Guangzhou, Guangdong, China|23.11667,113.25
  • Guangzhou, Guangdong, China|23.11667,113.25
  • Guangzhou, Guangdong, China|23.11667,113.25
  • Guangzhou, Guangdong, China|23.11667,113.25
  • Guangzhou, Guangdong, China|23.11667,113.25

Key Eligibility Criteria

  • Voluntarily participate in this study, able to provide written informed consent and can understand and agree to comply with the requirements of the…
  • Aged over 18 years on day of signing informed consent
  • Patients with urothelial bladder cancer, having residual lesions following TURBT surgery, staged cT2-T4aN0M0 as histologically confirmed and radiol…
  • Patients with mutations or copy number variation (CNV) alterations, such as CDKN2A, CDKN2B CNV deletion, indicating the activation of cell cycle-re…

For full eligibility, visit ClinicalTrials.gov.

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