7 results
In this study, we explore the correlation between baseline intratumoral CD8+ cell density and objective response rate (ORR) as well as other biomarker parameters in subjects with unresected stage IIIB to IVM1c melanoma treated with talimogene…
Primary Objectives:To evaluate the efficacy of talimogene laherparepvec with pembrolizumab versus placebo with pembrolizumab, as assessed by progression free survival (PFS) (response evaluation by blinded independent central review using modified…
Primary objectiveTo determine the efficacy of chronic treatment with arimoclomol 1200 mg/day (400 mg TID) compared to placebo over 76 weeks in subjects with ALS as assessed with Combined Assessment of Function and Survival (CAFS).Secondary…
Primary Objectives:* To evaluate the effects of therapeutic and supratherapeutic plasma levels of arimoclomol on the heart rate-corrected QT interval (QTc).Secondary Objectives:* To evaluate the effect of arimoclomol on other ECG parameters: heart…
Primary objective:To evaluate the efficacy of talimogene laherparepvec in combination with pembrolizumab as assessed by objective response rate (ORR) in subjects with unresectable/metastatic stage IIIB-IVM1d melanoma who have progressed on prior…
Primary objective:To assess the long-term safety of arimoclomol treatment of ALS.Secondary objective:To evaluate the long-term efficacy of arimoclomol treatment of ALS.Exploratory objectives:Health-related quality of life* To evaluate the effect of…
To compare the effectiveness of weekly subcutaneously administered MTX for maintaining relapse-free sustained steroid/EN-free 1-year remission compared with:- daily oral AZA/6MP in low risk paediatric CD- subcutaneously administered adalimumab in…