155 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.
The primary objective is to characterize the change in the Pharmacodynamic (PD) biomarker, fecal calprotectin, during treatment with anrukinzumab.The secondary objectives include:* Characterization of the PK profile and total IL-13 of three multiple…
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…
We here propose a pilot immuno-PET study in active relapsing MS patients to investigate safety and sensitivity of 89Zr-rituximab in detecting CD20 positive (active) MS lesions and to assess inter-patient variability in 89Zr-rituximab biodistribition…
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:1) To compare OS in subjects with squamous cell carcinoma of the Esophagus.2) To compare OS in subjects with PD-L1 Combined Positive Score (CPS)*10%3) To compare OS in all subjectsSecondary:1) To evaluate the progression free survival (PFS)…
To evaluate the safety and tolerability of 4 different doses of GLPG2222 administered orally and q.d. for 29 days in adult subjects with CF whoare homozygous for the F508del CFTR mutation.Secondary objectives:To assess changes in biomarkers of CFTR…
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 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 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…
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…
Primary Objectives(1) To evaluate the overall survival (OS) of subjects with metastatic or locally advanced/unresectable urothelial cancer that has recurred or progressed following platinum-based chemotherapy (recurrent/progressive metastatic…
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…
The primary objective is to evaluate the peri-operative hemostatic efficacy of BAX 855 in male PTPs aged 18 - 75 years with severe hemophilia A (FVIII <1%) undergoing major or minor, elective or minor emergency surgical, dental or other…
ObjectivesPrimary objective1. To assess the efficacy of selumetinib in combination with dacarbazine compared with placebo in combination with dacarbazine in terms of Progression Free Survival (PFS) assessed by blinded independent central review (…
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…
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…
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…