OncoMatch/Clinical Trials/NCT06364956
Clinical Trail of Neoadjuvant of Tislelizumab Combined With Palbociclib in Patients With Platinum-refractory Bladder Urothelial Carcinoma
Is NCT06364956 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies multiple treatments including Tislelizumab combined with two predefined dose groups of palbociclib and RP2D dose Of Tislelizumab combined with palbociclib was selected for phase II clinical trial. for bladder cancer.
Treatment: Tislelizumab combined with two predefined dose groups of palbociclib · RP2D dose Of Tislelizumab combined with palbociclib was selected for phase II clinical trial. — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Urothelial Carcinoma
Biomarker criteria
Required: CDKN2A mutation or copy number variation (CNV) alteration
Patients with mutations or copy number variation (CNV) alterations, such as CDKN2A, CDKN2B CNV deletion, indicating the activation of cell cycle-related pathways.
Required: CDKN2B CNV deletion
Patients with mutations or copy number variation (CNV) alterations, such as CDKN2A, CDKN2B CNV deletion, indicating the activation of cell cycle-related pathways.
Disease stage
Required: Stage CT4AN0M0 (TNM Staging System for Bladder Cancer of American Joint Committee on Cancers (AJCC))
staged cT2-T4aN0M0 as histologically confirmed and radiologically assessed based on the TNM Staging System for Bladder Cancer of American Joint Committee on Cancers (AJCC)
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: PD-1/PD-L1/PD-L2/CTLA4 inhibitor or other T-cell checkpoint/costimulation agent
Received prior therapies targeting PD-1, PD-L1, PD-L2, CTLA4, or other antibodies or drugs specifically targeting T-cell costimulation or checkpoint pathways.
Cannot have received: systemic anticancer therapy or systemic immunomodulator (interferon, interleukin 2, tumor necrosis factor)
Exception: within 28 days prior to enrollment
Received other approved systemic anticancer therapies or systemic immunomodulators (including but not limited to interferon, interleukin 2, and tumor necrosis factor) within 28 days prior to enrollment.
Cannot have received: radiation therapy
Exception: for bladder cancer
Received prior radiotherapy for bladder cancer.
Cannot have received: systemic chemotherapy
Exception: treatment-free interval of at least 12 months from the last dose of chemotherapy until the start of neoadjuvant therapy is required
For patients who have received prior systemic chemotherapy, a treatment-free interval of at least 12 months from the last dose of chemotherapy until the start of neoadjuvant therapy is required
Cannot have received: local intravesical chemotherapy or immunotherapy
Exception: must be discontinued at least 1 week before start of the investigational neoadjuvant medication treatment
Local intravesical chemotherapy or immunotherapy must be discontinued at least 1 week before start of the investigational neoadjuvant medication treatment
Lab requirements
Blood counts
Absolute neutrophil count ≥ 1.5 x 10^9/L; Platelets ≥ 90 x 10^9/L; Hemoglobin ≥ 90 g/L; INR or aPTT ≤ 1.5 x ULN
Kidney function
creatinine clearance less than 60 mL/min (for cisplatin ineligibility); other renal function not specified
Liver function
Serum total bilirubin ≤ 1.5 x ULN (≤ 3 x ULN, if Gilbert's syndrome or if indirect bilirubin concentrations were suggestive of extrahepatic source of the elevation); AST, ALT, and alkaline phosphatase ≤ 2.5 x ULN
Cardiac function
≥ Grade 3 cardiac failure according to New York Heart Association Cardiac Function Classification (for cisplatin ineligibility)
Have adequate organ function as indicated by the following screening laboratory values (obtained ≤ 14 days prior to enrollment): ... Serum total bilirubin ≤ 1.5 x ULN (≤ 3 x ULN, if Gilbert's syndrome or if indirect bilirubin concentrations were suggestive of extrahepatic source of the elevation). AST, ALT, and alkaline phosphatase ≤ 2.5 x ULN ... Absolute neutrophil count ≥ 1.5 x 10^9/L; Platelets ≥ 90 x 10^9/L; Hemoglobin ≥ 90 g/L; INR or aPTT ≤ 1.5 x ULN
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