OncoMatch/Clinical Trials/NCT05394337

Neoadjuvant PD-1 Plus TIGIT Blockade in Patients With Cisplatin-Ineligible Operable High-Risk Urothelial Carcinoma

Is NCT05394337 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies multiple treatments including Atezolizumab and Tiragolumab for metastatic malignancy.

Phase 1/2RecruitingM.D. Anderson Cancer CenterNCT05394337Data as of May 2026

Treatment: Atezolizumab · Tiragolumab — To learn if the combination of atezolizumab and tiragolumab can help to control bladder cancer when it is given before surgery to remove the bladder and tumor.

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Extracted eligibility criteria

Cancer type

Tumor Agnostic

Disease stage

Required: Stage CT2-4AN0M0

Grade: 3

muscle invasive disease (cT2-4aN0M0)...high grade (grade 3) tumors of the ureter, renal pelvis, or tumors in these areas with radiographic abnormality...direct invasion of the prostatic stroma or the vaginal wall (i.e. cT4a disease)

Performance status

ECOG 0–1(Restricted strenuous activity)

Prior therapy

No prior treatment (treatment-naive required)

Max 0 prior lines

Cannot have received: immunotherapy

Any prior therapy for urothelial cancer, including immunotherapy, chemotherapy, or radiotherapy

Cannot have received: chemotherapy

Any prior therapy for urothelial cancer, including immunotherapy, chemotherapy, or radiotherapy

Cannot have received: radiation therapy

Any prior therapy for urothelial cancer, including immunotherapy, chemotherapy, or radiotherapy

Lab requirements

Blood counts

ANC > 1.5 x 10^9/L (1500/µL) without G-CSF support; Lymphocyte count >0.5 x 10^9/L (500/µL); Platelet count >100 x10^9/L (100,000/µL) without transfusion; Hemoglobin >90 g/L (9 g/dL) (transfusion allowed); Serum albumin >25 g/L (2.5 g/dL)

Kidney function

Creatinine clearance >45 mL/min (Cockcroft-Gault formula)

Liver function

AST, ALT, and ALP <2.5 x upper limit of normal (ULN); Total bilirubin <1.5 xULN (Gilbert disease exception: <3.0 mg/dL)

Adequate hematologic and -end organ and marrow function, defined by the following laboratory test results, obtained within 14 days prior to initiation of study treatment: ANC > 1.5 x 10^9/L (1500/µL) without granulocyte colony-stimulating factor support; Lymphocyte count >0.5 x 10^9/L (500/µL); Platelet count >100 x10^9/L (100,000/µL) without transfusion; Hemoglobin >90 g/L (9 g/dL) (Patients may be transfused to meet this criterion). AST, ALT, and ALP <2.5 x upper limit of normal (ULN); Total bilirubin <1.5 xULN with the following exception: Patients with known Gilbert disease (>3 xULN): who must have a baseline total bilirubin <3.0 mg/dL; Creatinine clearance >45 mL/min (calculated using the Cockcroft-Gault formula); Serum albumin >25 g/L (2.5 g/dL)

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

US trial sites

M D Anderson Cancer Center · Houston, Texas

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