33 results
Phase I Dose Escalation1.To determine the RP2D in terms of safety and tolerability for:•IV admin of HB-201 in patients with HPV 16+ confirmed HNSCC•IT admin of HB-201 in patients with HPV 16+ confirmed cancers•IV admin of HB-202 in patients with HPV…
Primary objective: To compare the efficacy of JNJ-68284528 with standard therapy, either pomalidomide, bortezomib and dexamethasone (PVd) or daratumumab, pomalidomide and dexamethasone (DPd).
Primary objective:To evaluate the efficacy of talimogene laherparepvec in combination with pembrolizumab as assessed by objective response rate (ORR) in subjects with unresectable/metastatic stage IIIB-IVM1d melanoma who have progressed on prior…
Primary objectives for the dose-escalation part of the study: • To assess the safety and tolerability of HA-1H TCR transduced T cells (MDG1021) in patients with relapsed or persistent hematologic malignancies after allo-HSCT with or without…
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…
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 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 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…
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 investigate the long-term safety, tolerability and acceptability of Nasalfent in the treatment BTCP
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-…
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…
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 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…