34 results
Primary Efficacy Objectives:To ascertain whether the overall survival of subjects randomized to Arm V+G (PROSTVAC-V/F plus GM-CSF) or to Arm V (PROSTVAC-V/F) is superior to that from subjects randomized to Arm P (placebo control).Secondary Efficacy…
Primary objectiveSafety assessment of the MVA-H5-sfMR vaccine in humans. Study subjects will undergo physical examinations performed before and on fixed time points during the study. Clinical chemistry is performed on the blood samples that are…
Primary objective:-To compare disease-free survival (DFS) in high risk leukemia patients who underwent haploidentical HCT followed by an add back strategy of HSV-Tk donor lymphocytes or standard haploidentical HCTSecondary objectives:- To compare…
GBM is difficult to treat, due to the fact that tumor cells can move until several centimeters in the brain around the visible tumor location. these infiltrated cellscan not be removed by surgery and are resistant to chemotherapy and radiation. This…
The primary objective of this study is to evaluate effectiveness of the Philips Sonalleve MR-HIFU device for the palliation of pain in patients with bone metastases.
The study primary goal is to determine the effectiveness of a single infusion of 1 x 10E13 DRP MYDICAR® in the coronary arteries in addition to an optimal HF regimen in patients with ischemic or non-ischemic cardiomyopathy and moderate to advanced…
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 objective- To evaluate the uptake of 68Ga-PSMA in locally advanced, recurrent and metastatic ACC or SDC by performing 68Ga-PSMA-PET/CT scans.Secondary objectives- To calculate the SUV tumor-to-background ratio and tumor-to-*healthy salivary…
The objective of the trial is to compare the efficacy and safety of treatment with Allovectin 7® versus treatment with DTIC or TMZ in subjects with recurrent metastatic melanoma. The results of the trial will be used to support registration of…
To assess the safety and reactogenicity of HB-101.To assess the immunogenicity of HB-101.
Primary objective:- To investigate if neo-adjuvant combination of talimogene laherparepvec and nivolumab will achieve a pathologic response rate of 45% complete responses (either *pathological complete response (pCR)* or *pathological near complete…
- To assess the safety and tolerability of live-attenuated RSV vaccine in healthy adults.- To assess the immunogenicity of the live-attenuated RSV vaccine (systemic and mucosal immunity) - To assess the viral load/shedding of the live-attenuated RSV…
Primary objective:- Disease free survival (DFS)Secondary objective:- Safety & tolerability- Overall survival (OS)Exploratory objective:- Association between HPV subtypes and efficacy- Patient reported outcomes (PRO)Please refer to section 1…
The objective of the trial is to determine safety, tolerability and efficacy of VPM1002BC, in order to establish this medication as a therapy for non-muscle invasive bladder cancer in the future.
Phase 1Primary objective:To determine the safety and tolerability of administration of Pb(PfCS@UIS4) to healthy volunteers delivered by infectious mosquito bites.Secondary objective:Immunogenicity of Pb(PfCS@UIS4) as assessed by ELISA and IFA.…
The study is divided in Stage A and BGA1 stage A1. To determine the safety and tolerability of direct venous inoculation of PfSPZ-GA1 in healthy volunteers.GA1 stage B Primary objective:1. To determine the safety, and tolerability of PfSPZ-…
The primary objective of the study is to evaluate the feasibility, safety, and efficacy of point-of-care manufactured 19CP02 in subjects with relapsed/refractory B-cell non-Hodgkin lymphoma.In the phase I part of the study the main objective is to…
This first-in-human study is planned to include both a dose ranging phase and a confirmatory phase, with the intention that all data collected throughout the study may support registration. The dose ranging phase will be conducted in cohorts of 3-4…
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…
• To investigate the safety and tolerability of two ascending dose levels and two different dosing intervals of the candidate vaccine MVA-MERS-S_DF-1 in healthy study subjects.• To investigate safety and tolerability of three intramuscular dose…