5 results
ObjectivesPrimary Efficacy Objective• To assess the sustained clinical effect of BM32 during 2 consecutive treatment years compared to placebo. The clinical effect of BM32 is evaluated by a combined Symptom-Medication-Score (SMS) which is recorded…
The main objectives for this study are: - To assess the safety and tolerability of the combination of pembrolizumab and lenvatinib and belzutifan.- To evaluate the confirmed objective response rate (ORR) per RECIST 1.1 as assessed by blinded…
Primary objectives:# Safety Lead-in Phase: To assess the safety and tolerability, and to establish an RP2D if applicable, of treatment combinations that have not been evaluated in a separate study.# Efficacy Phase: To assess the safety and…
To evaluate the ORR of belzutifan per RECIST 1.1 by blinded independent central review (BICR).
Primary objectives:# Safety Lead-in Phase: To assess the safety and tolerability, and to establish an RP2D if applicable, of treatment combinations that have not been evaluated in a separate study.# Efficacy Phase: To assess the safety and…