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NCT ID: NCT03816137 Active, not recruiting - HIV-1-infection Clinical Trials

Modelling the Interaction Between Rationally-designed Synthetic Model Viral Protein Immunogens

EAVI2020_01
Start date: March 19, 2019
Phase: Phase 1
Study type: Interventional

EVAI2020_01 is a single blinded two part experimental medicine study to determine the extent to which different prime-boost combinations of model immunogens based on HIV-1 envelope proteins (ConM and ConS), influence the breadth of viruses neutralised by induced antibodies and the associated diversity of B and T cell responses. Our research will investigate the effect of a second immunisation challenge with a combination of three model mosaic envelope proteins designed to increase the breadth of induced antibody neutralisation. The primary outcome will be measurement of specific viral neutralisation activity of serum antibodies. Exploratory outcomes will include characterisation of blood B and T cell responses to these model immunogens.

NCT ID: NCT03815942 Active, not recruiting - Clinical trials for Castration-resistant Prostate Cancer

VAccination in Early and ADvanced Prostate caNCEr

ADVANCE
Start date: December 10, 2018
Phase: Phase 1/Phase 2
Study type: Interventional

This is a clinical trial of a new treatment for prostate cancer that is a type of vaccine that could be a new way to treat cancer. A vaccine that could alert the immune system to the presence of cancer cells in the body may enable the immune system to target and kill those cells effectively. This vaccine is intended to work by making the immune system kill cells that have a special protein (called 5T4) that is present on the surface of cancer cells. The vaccine is made up of two recombinant viruses ("ChAdOx1"- chimpanzee adenovirus Ox1 and "MVA" - modified vaccinia Ankara) that have been designed to produce the 5T4 protein and have been modified so that they are weakened and cannot reproduce themselves within the body like normal viruses. Once injected into the body, these viruses make the 5T4 protein and help the body's immune system to learn to target this protein and destroy cancer cells. This vaccine will be used in combination with the immunotherapy drug called nivolumab which is an anti-PD-1 (Programmed Death protein-1) monoclonal antibody. This is a molecule that releases the brakes on the immune system and helps the immune system to kill cancer cells more efficiently. Nivolumab as a monotherapy was approved for treatment of several tumour types but not for the prostate cancer. This study will evaluate the safety and efficacy of ChAdOx1-MVA 5T4 vaccine in combination with nivolumab in low and intermediate risk prostate cancer patients who have elected to have their prostate removed and in patients with advanced metastatic prostate cancer.

NCT ID: NCT03815643 Active, not recruiting - Solid Tumors Clinical Trials

Avelumab Program Rollover Study

Start date: March 22, 2019
Phase: Phase 3
Study type: Interventional

The main purpose of this study is to monitor the safety and tolerability of avelumab in participants with solid tumors who continue treatment with avelumab under the same treatment regimen as in the parent avelumab study.

NCT ID: NCT03815058 Active, not recruiting - Advanced Melanoma Clinical Trials

A Study to Evaluate the Efficacy and Safety of Autogene Cevumeran (RO7198457) in Combination With Pembrolizumab Versus Pembrolizumab Alone in Participants With Previously Untreated Advanced Melanoma.

IMCODE001
Start date: January 8, 2019
Phase: Phase 2
Study type: Interventional

This study will evaluate the efficacy, safety, pharmacokinetics, and patient-reported outcomes (PROs) of autogene cevumeran (RO7198457) plus pembrolizumab compared with pembrolizumab alone in patients with previously untreated advanced melanoma.

NCT ID: NCT03814746 Active, not recruiting - Clinical trials for Sickle Cell Disease (SCD)

Study of Two Doses of Crizanlizumab Versus Placebo in Adolescent and Adult Sickle Cell Disease Patients

STAND
Start date: July 26, 2019
Phase: Phase 3
Study type: Interventional

The purpose of this study is to compare the efficacy and safety of 2 doses of crizanlizumab (5.0 mg/kg and 7.5 mg/kg) versus placebo in adolescent and adult sickle cell disease (SCD) patients with history of vaso-occlusive crisis (VOC) leading to healthcare visit.

NCT ID: NCT03811561 Active, not recruiting - Clinical trials for Diabetes Mellitus, Type 2

A Research Study to Look at How Semaglutide Compared to Placebo Affects Diabetic Eye Disease in People With Type 2 Diabetes

FOCUS
Start date: May 8, 2019
Phase: Phase 3
Study type: Interventional

This study will look at the long-term effects of semaglutide (active medicine) on diabetic eye disease when compared to placebo (dummy medicine). The study will be performed in people with type 2 diabetes. Participants will either get semaglutide or placebo in addition to their diabetes medicines - which treatment the participant gets is decided by chance. Participants will inject the study medicine using a pen-injector. The medicine must be injected in a skin fold in the stomach, thigh or upper arm once a week. The study will last for 5 years.

NCT ID: NCT03811535 Active, not recruiting - Clinical trials for Growth Hormone Deficiency in Children

A Research Study in Children With a Low Level of Hormone to Grow. Treatment is Somapacitan Once a Week Compared to Norditropin® Once a Day (REAL4)

REAL4
Start date: May 20, 2019
Phase: Phase 3
Study type: Interventional

The study compares 2 medicines for children who do not have enough hormone to grow: somapacitan given once a week (a new medicine) and Norditropin® given once a day (the medicine doctors can already prescribe). Researchers will test to see how well somapacitan works. The study will also test if somapacitan is safe. Participants will either get somapacitan or Norditropin® - which treatment participants get, is decided by chance. Both participants and the study doctor will know which treatment participants get. The study will last for 4 years. Participants will attend 19 clinic visits and have 1 phone call with the study doctor.

NCT ID: NCT03809377 Active, not recruiting - Cancer Clinical Trials

Transcriptional Responses as an Indicator of Individualised Responses to Radiation Effects (RTGene 2)

Start date: May 9, 2019
Phase:
Study type: Observational

Peripheral blood samples will be taken with informed consent from radiotherapy patients before and during treatment fractions for sarcoma, breast, lung, gut, genitourinary and head & neck tumours at The Royal Marsden. Candidate genes identified by PHE, Columbia and/or in the literature as being specific to radiation responses will be assessed, together with genes relevant to systemic inflammatory and immune responses, to identify transcriptional responses for a range of doses and exposures on an inter-individual basis. Data will be analysed using existing and new statistical tools focused on count data modelling. The intended outcome is identification of a radiation specific panel of genes to inform individual radiation responses and if the results are favourable, a large scale follow up to this project is expected.

NCT ID: NCT03808441 Active, not recruiting - Melanoma Clinical Trials

CAcTUS - Circulating Tumour DNA Guided Switch

CAcTUS
Start date: May 2, 2019
Phase: Phase 2
Study type: Interventional

The stay aims to determine whether switching from targeted therapy to immunotherapy based on a decrease in levels of circulating tumour DNA in the blood, will improve the outcome in melanoma patients.

NCT ID: NCT03808402 Active, not recruiting - Clinical trials for Bronchopulmonary Dysplasia

The Effect of Surfactant Dose on Outcomes in Preterm Infants With RDS

OPTI-SURF
Start date: October 26, 2018
Phase:
Study type: Observational

A prospective observational study using de-identified data from the Neonatal Network Research Database (NNRD) supplemented by additional information on dose, method of surfactant administration and dosing frequency to assess whether the dose and method of administration of surfactant given to preterm infants with respiratory distress syndrome (RDS) affects neonatal outcomes.