6 results
Objectives:Primary Objective: to investigate the anti-tumor efficacy of domatinostat in combination with avelumab in advanced unresectable/metastatic MCC patients progressing on anti-PD-(L)1 antibody monotherapy.Secondary Objectives: to investigate…
The purpose of the study is to assess the efficacy and safety in adolescents of AFQ056 in treating behavioral symptoms characteristic of patients with FXS. Data from this study will be used to support the registration of AFQ056 in this population…
PrimaryTo evaluate the long-term safety and tolerability of AFQ056 in adolescent patients with FXS as assessed by:* Incidence and severity of adverse events and serious adverse events* Changes in vital signs, laboratory assessments, and ECGs*…
Primary objectives: - To assess safety and feasibility of neoadjuvant nivolumab +/- domatinostat +/- ipilimumab- To identify pathologic response rates of nivolumab +/- domatinostat +/- ipilimumabSecondary objectives: - To describe all grade…
Primary Objective: to evaluate clinical efficacy of domatinostat in combination with avelumab in treatment-naïve metastatic or distally recurrent MCC patients as determined by the Objective Response Rate (ORR) according to Response Evaluation…
Primary objectives: 1. To compare the efficacy of vamorolone administered orally at daily doses of 6.0 mg/kg over a 24-week treatment period vs. placebo in ambulant boys ages 4 to <7 years with DMD; and2. To evaluate the safety and…