A Phase 3 Open-Label, Randomized Controlled Trial of T-bren (BL‑M07D1) vs. Platinum-based Chemotherapy in Patients with HER2‑expressing metastatic urothelial cancer with disease progression on or after anti-PD-(L)1-based therapy

Condition studied

Urothelial carcinoma metastatic

Investigational medicinal product(s)

Every trial of Gemcitabine and Cisplatin across our registers →

Eligibility

Primary endpoint

PFS by BICR according to RECIST v1.1 in the primary population

Endpoint detail

Key: OS in the primary population, Key: PFS in the ITT population, Key: OS in the ITT population, Other: PFS by investigator in the primary population and the ITT population, Other: ORR, defined as the proportion of participants achieving best overall response (BOR) of confirmed complete response (CR) or partial response (PR) using RECIST v1.1 per BICR and investigator in the primary population and the ITT population, Other: DCR, defined as the proportion of participants achieving a BOR of confirmed CR or PR or stable disease (SD) using RECIST v1.1 per BICR and investigator in the primary population and the ITT population, Other: DOR, defined as the time from the first objective response (CR or PR that is subsequently confirmed) to the first documented PD using RECIST v1.1 per BICR and investigator or death from any cause, whichever occur first, in the primary population and the ITT population, Other: TTR (time to response), defined as the time from randomization to the date of first documented response (CR or PR) that is subsequently confirmed, using RECIST v1.1 per BICR and investigator in the primary population and the ITT population, Other: • AE, SAE • TEAE leading to discontinuation • Death • Laboratory abnormalities, Other: • PRO using 2 EORTC QLQ − EORTC QLQ-C30 − Functional Assessment of Chronic Illness Therapy (FACIT) Item GP5 − EuroQol Group’s 5-level EQ-5D version (EQ-5D-5L)