OncoMatch/Clinical Trials/NCT05600127
Chemotherapy and Sequential Immunotherapy for Locally Advanced Urothelial Cancer
Is NCT05600127 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Avelumab for urothelial carcinoma.
Treatment: Avelumab — Patients with locally advanced or clinically node positive urothelial carcinoma treated with chemotherapy, will receive 3 cycles of avelumab, followed by radical surgery.
Check if I qualifyExtracted eligibility criteria
Cancer type
Urothelial Carcinoma
Disease stage
Required: Stage CT4NXM0, CTXN1-N3M0
Excluded: Stage DISTANT METASTATIC DISEASE
clinical stage cT4NxM0 or cTxN1-N3M0 as assessed by bimanual examination under anaesthesia, CT scan, MRI scan or PET-CT scan
Performance status
WHO 0–2
Prior therapy
Must have received: platinum-based chemotherapy (cisplatin, carboplatin, gemcitabine) — induction
at least stable disease after a minimum of 3 or a maximum of 4 cycles of induction chemotherapy with cisplatin / carboplatin + gemcitabine according to RECIST v1.1
Cannot have received: immune-mediated therapy
Exception: Bacillus-Calmette Guérin intravesical instillations
Prior exposure to immune-mediated therapy with exclusion of Bacillus-Calmette Guérin intravesical instillations, including but not limited to other anti-CTLA-4, anti PD-1, anti PD-L1, or anti-PD-L2 antibodies
Cannot have received: pelvic radiation therapy
Previous pelvic radiation therapy
Lab requirements
Blood counts
ANC ≥1,500/mm3 or 1.5 x 10^9/L; Platelets ≥100 x 10^9/L; Hemoglobin ≥5.6 mmol/L (may have been transfused)
Kidney function
estimated creatinine clearance ≥30 mL/min as calculated by the CKD-EPI eGFR
Liver function
Total serum bilirubin <1.5 x ULN; AST and ALT <2.5 x ULN
Adequate bone marrow function... Adequate renal function... Adequate liver function...
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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