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A Phase 2, Multicenter, Open-label, Single-arm Trial to Evaluate the Correlation Between Objective Response Rate and Baseline Intratumoral CD8+ Cell Density in Subjects With Unresected Stage IIIB to IVM1c Melanoma Treated With Talimogene Laherparepvec

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…

TK008:Randomized phase III trial of haploidentical HCTwith or without an add back strategy of HSV-Tk donor lymphocytes in patients with high risk acute leukemia

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…

A phase I/II trial of a conditionally replication-competent adenovirus (delta-24-rgd) administered by convection enhanced delivery in patients with recurrent glioblastoma multiforme

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…

A Randomized, Double-blind, Phase 3 Efficacy Trial of PROSTVAC-V/F ± GM-CSF in Men With Asymptomatic or Minimally Symptomatic Metastatic, Castrate-Resistant Prostate Cancer

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…

A Phase 2b, Double-Blind, Placebo-Controlled, Multinational, Multicenter, Randomized Study Evaluating the Safety and Efficacy of Intracoronary Administration of MYDICAR® (AAV1/SERCA2a) in Subjects with Heart Failure

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…

A Phase 3 Clinical Trial to evaluate the safety and efficacy of treatment with 2 mg intralesional Allovectin-7® compared to Dacarbazine (DTIC) or Temozolomide (TMZ) in subjects with recurrent metastatic melanoma

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…

Phase I clinical trial to assess safety and immunogenicity of an MVA-based influenza H5 vaccine in healthy adults

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…

A Randomized, Placebo-Controlled, Phase 2 Study of HB-101, a Bivalent Cytomegalovirus (CMV) Vaccine, in CMV-Seronegative Recipient (R-) Patients Awaiting Kidney Transplantation from Living CMV-Seropositive Donors (D+)

To assess the safety and reactogenicity of HB-101.To assess the immunogenicity of HB-101.

Randomised, double-blind, placebo-controlled study to evaluate the safety, tolerability, immunogenicity and shedding of live-attenuated RSV vaccine in healthy adults

- 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…

Neo-adjuvant T-VEC + Nivolumab combination therapy for resectable early metastatic (stage IIIB/C/D-IV M1a) melanoma with injectable disease.

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…

Phase 3 study of ADXS11-001 administered following chemoradiation as adjuvant treatment for high risk locally advanced cervical cancer: AIM2CERV (Advaxis IMmunotherapy 2 prevent CERVical recurrence)

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…

SAKK 06/14. A phase I/II open label clinical trial assessing safety and efficacy of intravesical instillation of VPM1002BC in patients with recurrent non-muscle invasive bladder cancer after standard BCG therapy

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.

Safety and protective efficacy of genetically attenuated Pf*b9*slarp (PfSPZ-GA1) malaria parasites in healthy volunteers

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-…

Safety and protective efficacy of genetically modified Plasmodium berghei (Pb(PfCS@UIS4)) malaria parasites in healthy volunteers

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.…

A Phase 1b/3, Multicenter, Trial of Talimogene Laherparepvec in Combination With Pembrolizumab (MK-3475) for Treatment of Unresectable, Stage IIIB to IVM1c Melanoma (MASTERKEY-265)

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…

Safety and preliminary protective efficacy of genetically attenuated Pf*mei2 (GA2) malaria parasites in healthy Dutch volunteers

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…

A Phase 1/2 Open-Label, Multicenter, Dose Ranging and Confirmatory Study to Assess the Safety, Tolerability and Efficacy of PBKR03 Administered to Pediatric Subjects with Early Infantile Krabbe Disease (Globoid Cell Leukodystrophy) (GALax-C)

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…

A two-center, randomized, double-blind, placebo-controlled, phase Ib study to assess the safety, tolerability and immunogenicity of two ascending doses of the candidate vaccine MVA-MERS-S_DF-1 in healthy study subjects

• 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…

A Phase 2, Multicohort Open-Label Study of JNJ-68284528, a Chimeric Antigen Receptor T cell (CAR-T) Therapy Directed Against BCMA in Subjects with Multiple Myeloma

This study has been transitioned to CTIS with ID 2023-506587-13-00 check the CTIS register for the current data. The safety and efficacy of JNJ-68284528 in heavily pretreated patients with multiple myeloma is being evaluated in the Phase 1b/2 Study…

A Phase 1/2 Dose-Escalation and Dose-Expansion Study of the Safety and Efficacy of Anti-CD7 Allogeneic CAR-T cells (WU-CART-007) in Patients with Relapsed or Refractory T-cell Acute Lymphoblastic Leukemia (T-ALL)/Lymphoblastic Lymphoma (LBL)

Primary Objectives• To characterize the safety, tolerability, dose-limiting toxicities (DLT), and maximum tolerated dose (MTD) or maximum administered dose (MAD) (if no MTD is defined) and define the Recommended Phase 2 Dose (RP2D) of WU-CART-007 in…