9 results
Primary objective:The objective is to evaluate if the LCPT dose can be reduced in comparison with tacrolimus-ER and still achieve similar tacrolimus levels in the therapeutic range in patients who are tacrolimus who need a relatively high dose of…
Main objective:English To determine the antitumor activity of SAR444245 in combination with other anticancer therapiesSecondary objectives: English - To assess the safety of SAR444245 when combined with other anticancer therapies- To assess other…
We aim to establish proof-of-concept for use of pembrolizumab as novel neo-adjuvant therapy in dMMR and POLE-EDM UC. When ICB proves to be feasible as defined in the primary endpoint (see 2.1), we will follow-up with larger studies to determine…
Based on the success of the pilot feasibility study, we propose a follow-up efficacy study to explore neo-adjuvant ICB therapy as potential alternative for SoC adjuvant radio(chemo)therapy in MMRd UC.
Primary:To determine the safety and tolerability and to establish a preliminary recommended Phase 2 dose (RP2D) of MK-5890 when used as monotherapy and in combination with pembrolizumab in the dose escalation and confirmation phase and the dose…
Primary Objective:* To assess the effect of BGF MDI relative to GFF MDI and BFF MDI on the rate of moderate or severe chronic obstructive pulmonary disease (COPD) exacerbationsSecondary Objectives:* To assess the effect of BGF MDI relative to GFF…
The primary efficacy objective of this trial is to evaluate the anti-tumor activity of pembrolizumab in subjects with any of a *basket* of rare malignancies (biomarker unselected and biomarker selected). ORR will be used as the primary endpoint per…
The primary objective of the study is to demonstrate that lenvatinib in combination with everolimus (Arm A) or pembrolizumab (Arm B) is superior compared to sunitinib alone (Arm C) in improving progressionfree survival (PFS) (by independent imaging…
To prospectively assess whether post-operative adjuvant therapy with pembrolizumab improves recurrence-free survival (RFS) as compared to placebo in high-risk patients with complete resection of Stage IIIA (> 1 mm metastasis), IIIB and IIIC…