7 results
Primary: Assess the effect of i.v. infusions of BYM338 on muscle volume of the thigh (assessed by MRI) at 4, 8, 16 and 24 weeks, compared to placebo, in COPD patients with pulmonary cachexia.Secondary: Effect on 6-minute walk test, safety and…
Primary: to demonstrate that at least one dose regimen of BYM338 in sporadic inclusion body myositis patients will increase the distance traveled as measured by change from baseline at Week 52 of the 6 minute walking distance test relative to…
The primary objective will be to assess the safety and tolerability of this combination and to determine whether the MTD ofEMD 521873 is reached up to a dose of 0.45 mg/kg. Secondary objectives will be the evaluation of the PK, immunogenicity,…
Main Objective:To evaluate the long-term safety and tolerability of BYM338 in the treatment of sIBM and to further evaluate the effect of three BYM338dose regimens against placebo in increasing the distance traveled as measured by the 6 Minute…
Primary Part 1:-To evaluate ORR in participants treated with MK-4280A plus EV (Arm A), MK-7684A plus EV (Arm B), and pembrolizumab plus EV(Arm C) per RECIST 1.1 by BICR.- To evaluate the safety and tolerability in participants treated with MK-4280A…
Study Objective(s):Primary-To compare the overall survival (OS) of subjects with locally advanced or metastatic urothelialcancer treated with enfortumab vedotin (EV) to the OS of subjects treated with chemotherapySecondary-To compare progression-…
Primary:* * To determine the antitumor activity of single-agent enfortumab vedotin as measured by confirmed objective response rate (ORR) in patients with locally advanced or metastatic urothelial cancer who have previously received systemic therapy…