Advanced Renal Pelvis Cancer with PD-L1-Positive Tumour When Platinum-Based Chemotherapy Is Not an Option
This protocol addresses upper urinary tract urothelial carcinoma (UTUC) at the advanced or metastatic stage in a defined patient population: those with PD-L1-positive tumours who are not eligible for enfortumab vedotin plus pembrolizumab combination therapy and who also cannot receive platinum-based combination chemotherapy.
Clinical Scenario
This protocol applies to patients who meet all of the following criteria:
- Upper urinary tract urothelial carcinoma, advanced or metastatic disease
- Ineligible for enfortumab vedotin plus pembrolizumab combination
- Ineligible for platinum-based combination chemotherapy due to at least one of: glomerular filtration rate less than 30 ml/min, ECOG performance status greater than 2, or grade greater than 2 comorbidities
- PD-L1-positive tumour
Treatment Approach
For PD-L1-positive patients in this setting who cannot receive platinum-based combination chemotherapy, monotherapy is the recommended approach. The complete protocol — including which agents are indicated, the eligibility criteria for each, and clinical management considerations — is available in the full regimen.
References
DOI: 10.1016/j.eururo.2025.02.023
- Offer pembrolizumab or atezolizumab to patients with PD-L1-positive tumours.
- Pembrolizumab or atezolizumab are alternative choices for patients who are PD-L1-positive and not eligible or fit for PBC.
- In a single-arm phase 2 trial involving 370 cisplatin-ineligible patients with UC, pembrolizumab monotherapy was associated with an objective response rate of 26% in the cohort of 69 patients with metastatic UTUC.
- In a single-arm phase 2 trial involving 119 cisplatin-ineligible patients with UC, atezolizumab monotherapy was associated with an objective response rate of 39% in the cohort of 33 patients (28%) with metastatic UTUC.