32 results
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…
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…
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…
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…
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…
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…
The safety and efficacy of JNJ-68284528 in heavily pretreated patients with multiple myeloma is being evaluated in the Phase 1b/2 Study 68284528MMY2001. As the degree of benefit of the CAR-T therapy is dependent on a patient*s immune response, JNJ-…
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…
- 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:- 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 reactogenicity of HB-101.To assess the immunogenicity of HB-101.
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…
• 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…
Phase 1 • Primary objective: to determine the safety and tolerability, including the attenuation phenotype of a novel late-arresting GAP, named GA2 parasite, administered by sequentially increasing numbers of mosquito bites.• Secondary objective: to…
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…
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…
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-…
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 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.
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…