Improve Checkpoint-blockade Response in Advanced Urothelial Cancer
Status:
Recruiting
Trial end date:
2023-02-01
Target enrollment:
Participant gender:
Summary
This trial will include metastatic urothelial carcinoma patients who progressed during or
after treatment with anti-PD(L)1 therapy and have been treated by a platinum-containing
regimen, or are cisplatin-ineligible. Patients will receive either paclitaxel in combination
with durvalumab (anti-PDL-1) and a single dose (300 mg) of tremelimumab (anti-CTLA4), or
paclitaxel with only a high dose of tremelimumab (750 mg). Tremelimumab (750 mg), without
paclitaxel will be used as a comparison arm.
A run-in safety phase will be followed by a non-comparative 3-arm randomized study with a
Simon's 2-stage optimal design.