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NCT ID: NCT04047862 Active, not recruiting - Clinical trials for Locally Advanced and Metastatic Solid Tumors

Study of Ociperlimab (BGB-A1217) in Combination With Tislelizumab in Advanced Solid Tumors

Start date: August 26, 2019
Phase: Phase 1
Study type: Interventional

The primary objectives of this study are : to assess the safety and tolerability, to determine the maximum tolerated dose (MTD) or maximum administered dose (MAD) and to determine the recommended Phase 2 dose (RP2D) of BGB-A1217 (known as Ociperlimab) in combination with tislelizumab in participants with advanced solid tumors in phase 1. Primary objective of Phase 1b is to assess overall response rate (ORR) determined by Investigator per RECIST v1.1 for patients in each dose- expansion cohort

NCT ID: NCT04046224 Active, not recruiting - Fabry Disease Clinical Trials

Dose-Ranging Study of ST-920, an AAV2/6 Human Alpha Galactosidase A Gene Therapy in Subjects With Fabry Disease (STAAR)

Start date: July 23, 2019
Phase: Phase 1/Phase 2
Study type: Interventional

This is the first in human treatment with ST-920, a recombinant AAV2/6 vector encoding the cDNA for human a-Gal A. The purpose of this study is to evaluate the safety and tolerability of ascending doses of ST-920. ST-920 aims to provide stable, long-term production of α-Gal A at therapeutic levels in subjects with Fabry disease. The constant production of α-Gal A in humans should, importantly, enable reduction and potentially clearance of Fabry disease substrates Gb3 and lyso-Gb3. On Day 1, patients will be infused intravenously with a single dose of ST-920 and followed for a period of 52 weeks.

NCT ID: NCT04042025 Active, not recruiting - SMA Clinical Trials

Long-term Follow-up Study of Patients Receiving Onasemnogene Abeparvovec-xioi

Start date: February 10, 2020
Phase: Phase 3
Study type: Interventional

This is a long-term follow-up safety and efficacy study of participants in clinical trials for spinal muscular atrophy (SMA) who were treated with onasemnogene abeparvovec-xioi. Participants will roll over from their respective previous (parent) study into this long-term study for continuous monitoring of safety as well as monitoring of continued efficacy and durability of response to onasemnogene abeparvovec-xioi treatment.

NCT ID: NCT04041050 Active, not recruiting - Clinical trials for Myeloproliferative Neoplasm

A Study Evaluating Safety and Tolerability, and Pharmacokinetics of Navitoclax Monotherapy and in Combination With Ruxolitinib in Participants With Myeloproliferative Neoplasm

Start date: November 8, 2019
Phase: Phase 1
Study type: Interventional

There are 5 parts to this study for which the primary objectives are to evaluate safety, tolerability, and pharmacokinetics (PK) of navitoclax when administered alone (Part 1) or when administered in combination with ruxolitinib (Part 2). In Part 2, participants must have been receiving a stable dose of ruxolitinib therapy for at least 12 weeks prior to study enrollment. In Part 3, all eligible participants will receive navitoclax, with the primary objective being to evaluate potential navitoclax effect on QTc prolongation. In Part 4, effect of navitoclax is evaluated on the PK, safety, and tolerability of a single dose of celecoxib. In Part 5, all eligible participants will receive ruxolitinib twice daily and navitoclax once daily for drug-drug interaction (DDI) assessment, followed by continued administration of navitoclax in combination with ruxolitinib.

NCT ID: NCT04039607 Active, not recruiting - Clinical trials for Hepatocellular Carcinoma

A Study of Nivolumab in Combination With Ipilimumab in Participants With Advanced Hepatocellular Carcinoma

CheckMate 9DW
Start date: September 30, 2019
Phase: Phase 3
Study type: Interventional

The main purpose of this study is to compare the overall survival (OS) of nivolumab plus ipilimumab versus standard of care (SOC) (sorafenib or lenvatinib) in all randomized participants with advanced hepatocellular carcinoma (HCC) who have not received prior systemic therapy.

NCT ID: NCT04036435 Active, not recruiting - Psoriasis Clinical Trials

Long-Term Study That Measures the Safety and Efficacy of Deucravacitinib (BMS-986165) in Participants With Psoriasis

POETYK PSO-LTE
Start date: August 12, 2019
Phase: Phase 3
Study type: Interventional

The main purpose of this study is to characterize the long-term safety and efficacy of the drug Deucravacitinib (BMS-986165) in patients who have been previously enrolled in an applicable Phase 3 psoriasis study.

NCT ID: NCT04035486 Active, not recruiting - Clinical trials for Non-Small Cell Lung Cancer

A Study of Osimertinib With or Without Chemotherapy as 1st Line Treatment in Patients With Mutated Epidermal Growth Factor Receptor Non-Small Cell Lung Cancer (FLAURA2)

FLAURA2
Start date: July 2, 2019
Phase: Phase 3
Study type: Interventional

The reason for the study is to find out if an experimental combination of an oral medication called osimertinib (TAGRISSO®) when used in combination with chemotherapy is more effective than giving osimertinib alone for the treatment of locally advanced or metastatic non-small cell lung cancer. Some lung cancers are due to mutations in the Deoxyribonucleic acid (DNA) which, if known, can help physicians decide the best treatment for their patients. One type of mutation can occur in the gene that produces a protein on the surface of cells called the Epidermal Growth Factor Receptor (EGFR). Osimertinib is an Epidermal Growth Factor Receptor (EGFR) tyrosine kinase inhibitor (TKI) that targets Epidermal Growth Factor Receptor (EGFR) mutations. Unfortunately, despite the benefit observed for patients treated with osimertinib, the vast majority of cancers are expected to develop resistance to the drug over time. The exact reasons why resistance develops are not fully understood but based upon clinical research it is hoped that combining osimertinib with another type of anti-cancer therapy known as chemotherapy will delay the onset of resistance and the worsening of a patient's cancer. In total the study aims to enroll approximately 586 patients, consisting of approximately 30 patients who will participate in a safety run-in component of the trial, and approximately 556 who will receive osimertinib alone or osimertinib in combination with chemotherapy in the main trial. In the main part of the trial there is a one in two chance of receiving osimertinib alone, and the treatment is decided at random by a computer. The study involves a Screening Period, Treatment Period, and Follow up Period. Whilst receiving study medication, it is expected patients will attend, on average, approximately 15 visits over the first 12 months and then approximately 4 visits per year afterwards. Each visit will last about 2 to 6 hours depending on the arrangement of medical assessments by the study centre.

NCT ID: NCT04033952 Active, not recruiting - Stroke Clinical Trials

Strategy Training on Improving Executive Functions in Persons Following Acquired Brain Injury

Start date: May 29, 2018
Phase: N/A
Study type: Interventional

About two-third individuals with acquired brain injury (ABI) experience cognitive impairments. Deficits in executive functions is one of the most prevalent cognitive impairments following ABI which result in decline of recovery and independence. Lack of intervention shows evidence of immediate and long-term effect on executive function which is critical after returning to the community. The overall aim of this study is to examine the efficacy of strategy training intervention on executive functions and participation on community-dwelling people with ABI. Findings of the study will provide unequivocal evidence on the duration of effectiveness of strategy training and support the development and application of the program in rehabilitation practice.

NCT ID: NCT04033445 Active, not recruiting - Ulcerative Colitis Clinical Trials

A Study of Guselkumab in Participants With Moderately to Severely Active Ulcerative Colitis

QUASAR
Start date: September 26, 2019
Phase: Phase 2/Phase 3
Study type: Interventional

The purpose of this study is to evaluate the efficacy and safety of guselkumab in participants with moderately to severely active ulcerative colitis (UC).

NCT ID: NCT04026412 Active, not recruiting - Clinical trials for Non-Small Cell Lung Cancer (NSCLC)

A Study of Nivolumab and Ipilimumab in Untreated Participants With Stage 3 Non-small Cell Lung Cancer (NSCLC) That is Unable or Not Planned to be Removed by Surgery

CheckMate73L
Start date: October 8, 2019
Phase: Phase 3
Study type: Interventional

The primary purpose of the study is to compare the effectiveness of nivolumab plus concurrent chemoradiotherapy (CCRT) followed by nivolumab plus ipilimumab vs CCRT followed by durvalumab in participants with untreated Locally Advanced Non-small Cell Lung Cancer (LA NSCLC).