157 results
CAEB071A2206 will assess safety, efficacy and target trough levels for optimal dosing of AEB071 combined with Certican in a CNI-free regimen in de novo renal transplant recipients. This study will combine the investigational drug AEB071 with an…
To assess whether a combination of ciprofloxacin and adalimumab is more effective than adalimumab alone.
To compare the long term efficacy of pasireotide LAR vs. octreotide LAR at month 6 in controlling diarrhea and/or flushing in patients with metastatic carcinoid tumors whose disease-related symptoms are inadequately controlled by the maximum…
The Primary Objectives for the study are:* Demonstrate the non-inferiority (NI) of lefamulin versus comparator with respect to the Early Clinical Response (96 ± 24 hours after the first dose of study drug) in the Intent to Treat (ITT) Analysis Set (…
Study Objectives:Primary Objective* To determine the safety profile of long-term MLN0002 treatmentResource Utilization and Patient-Reported Outcome Objectives* To determine the effect of long-term MLN0002 treatment on time to major inflammatory…
The primary objectives of this study are to:* Determine the safety, tolerability, maximum tolerated dose (MTD), and recommended Phase 2 dose (RP2D) of oral BAY 1217389 given in combination with intravenous (IV) paclitaxel using an intermittent…
To assess out to one-year the clinical status of patients who completed the double-blind part B of the 6-month study period in the Opsona phase II protocol (OPN305-102) by recording the following:• Incidence of biopsy-proven allograft rejection or…
To assess safety and tolerability of the combination of SBRT and combined CTLA-4/PD-L1 inhibition. In addition immune modulatory effect of the combination of an ablative dose of radiotherapy to the primary tumor and response to durvalumab/…
The primary efficacy objective for this study is to evaluate the efficacy of MPDL3280Ain patients with PD-L1*positive locally advanced or metastatic NSCLC, as measuredby investigator-assessed ORR according to modified RECIST.SECONDARY OBJECTIVESThe…
For the primary and secondary efficacy objectives, analyses will be performed in patients in different patient subpopulations according to programmed death*ligand 1 (PD-L1) expression in tumor tissue as evaluated by immunohistochemistry (IHC). The…
Primary objective:To compare the Progression Free Survival (PFS) per RECIST 1.1 as assessed by blinded independent central radiologists* review in subjects with PD-L1 strong, 1L metastatic NSCLC treated with MK-3475 compared to standard of care (SOC…
To assess the efficacy of MEDI4736 + tremelimumab combination therapy compared to SoC in terms of PFS and OS in patients with PD-L1- positieve (equal or greater than 25%) NSCLC.To assess the efficacy of MEDI4736 therapy compared to SoC in terms of…
The primary objective of this study is to assess whether the efficacy of ocrelizumab given as two dose regimens of 600 mg (given as 300 mg infusions on days 1 and 15 and 600 mg infusion in the following cycles) or 400 mg (given as 200 mg infusions…
The primary objective of the Phase I portion of the study is the following:* To estimate the maximum tolerated dosing schedule for venetoclax given in combination with R-CHOP or G-CHOP to patients with B-cell NHL, either previously untreated or…
Study Purpose* To continue the evaluation of the safety and efficacy of prophylaxis with BAX 855 for the prevention and treatment of bleeding episodes in PTPs (children and adults from 0 to 75 years of age) with severe hemophilia A.Primary…
To assess and compare efficacy (complete response [CR] rate and overall survival [OS]) between SGI-110 and TC in adults with previously untreated AML who are not considered candidates for intensive remission induction chemotherapy.
To evaluate the safety and efficacy of PRX-102 compared to agalsidase beta in Fabry disease patients with impaired renal function.
To evaluate the safety and efficacy of abicipar (2 mg), compared to 0.5 mg ranibizumab in treatment-naïve patients with neovascular AMD.
Primary Objective: To assess the efficacy of AMG 714 in treating RCD-II in adult patients Secondary Objective: To assess the safety and tolerability of AMG 714 when administered to adult patients with RCD-IIExploratory Objective: To assess the…
Primary: To demonstrate the superiority of the insulin glargine/lixisenatide fixed ratio combination to insulinglargine in HbA1c change from baseline to week 30.Secondary: To compare the overall efficacy and safety of insulin glargine/lixisenatide…