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NCT ID: NCT03992430 Active, not recruiting - Clinical trials for Muscular Dystrophy, Duchenne

A Study to Compare Safety and Efficacy of a High Dose of Eteplirsen in Participants With Duchenne Muscular Dystrophy (DMD) (MIS51ON)

Start date: July 13, 2020
Phase: Phase 3
Study type: Interventional

This study will be comprised of 2 parts: Part 1 (dose escalation) will be conducted to evaluate the safety and tolerability of 2 doses (100 milligrams/kilogram [mg/kg] and 200 mg/kg) of eteplirsen in approximately 10 participants with DMD; Part 2 (dose finding and dose comparison) will be conducted for the selection of a high dose (100 mg/kg versus 200 mg/kg) and its comparison with the 30 mg/kg dose of eteplirsen, in approximately 144 participants with genetically confirmed deletion mutations amenable to treatment by skipping exon 51.

NCT ID: NCT03989596 Active, not recruiting - Sarcoma Clinical Trials

Hypofractionated Radiotherapy With Hyperthermia in Unresectable or Marginally Resectable Soft Tissue Sarcomas

SINDIR
Start date: June 1, 2018
Phase: Phase 2
Study type: Interventional

After a screening, which consists of biopsy, physical examination, initial diffusion-weighted magnetic resonance imaging (DWI-MRI) or body computed tomography (CT) scan, blood tests and case analysis on Multidisciplinary Team (MDT) meeting, a patient will receive the hypofractionated radiotherapy 10x 3.25 Gy with regional hyperthermia (twice a week) within two weeks. The response analysis in CT or DWI-MRI and toxicity assessment will be performed after at least 6 weeks. At the second MDT meeting, a final decision about resectability of the tumor will be made. In case of resectability or consent for amputation, if required, a patient will be referred to surgery. In case of unresectability or amputation refusal, the patient will receive the second part of the treatment which consists of 4x 4 Gy with hyperthermia (twice a week).

NCT ID: NCT03989206 Active, not recruiting - Clinical trials for Moderate-to-Severe Atopic Dermatitis

Long-term Safety and Efficacy of Nemolizumab With Moderate-to-severe Atopic Dermatitis

Start date: December 30, 2019
Phase: Phase 3
Study type: Interventional

Long-Term Safety and Efficacy of Nemolizumab in Subjects with Moderate-to-Severe Atopic Dermatitis Description

NCT ID: NCT03982394 Active, not recruiting - Clinical trials for Chronic Plaque Psoriasis

Observational Study of Patients With Moderate to Severe Chronic Plaque Psoriasis

VALUE
Start date: July 1, 2019
Phase:
Study type: Observational

This study will assess the use of risankizumab in adult patients with moderate to severe chronic plaque psoriasis and compare risankizumab to other commonly used biologics.

NCT ID: NCT03981796 Active, not recruiting - Neoplasms Clinical Trials

A Study to Evaluate Dostarlimab Plus Carboplatin-paclitaxel Versus Placebo Plus Carboplatin-paclitaxel in Participants With Recurrent or Primary Advanced Endometrial Cancer

RUBY
Start date: July 18, 2019
Phase: Phase 3
Study type: Interventional

This is a 2 part study. Part 1 is to evaluate the efficacy and safety of dostarlimab plus carboplatin-paclitaxel followed by dostarlimab versus placebo plus carboplatin-paclitaxel followed by placebo; and Part 2 is to evaluate the efficacy and safety of dostarlimab plus carboplatin-paclitaxel followed by dostarlimab plus niraparib versus placebo plus carboplatin-paclitaxel followed by placebo in participants with recurrent or primary advanced (Stage III or IV) endometrial cancer.

NCT ID: NCT03978000 Active, not recruiting - Clinical trials for Necrotizing Enterocolitis

IBP-9414 for the Prevention of Necrotizing Enterocolitis - The Connection Study

Start date: July 4, 2019
Phase: Phase 3
Study type: Interventional

IBP-9414 will be evaluated in preterm infants with a birth weight of 500-1500g, compared to placebo with regards to efficacy and safety in the prevention of necrotizing enterocolitis.

NCT ID: NCT03976362 Active, not recruiting - Clinical trials for Carcinoma, Squamous Cell, Non-small-cell Lung

A Study of Pembrolizumab (MK-3475) With or Without Maintenance Olaparib in First-line Metastatic Squamous Non-small Cell Lung Cancer (NSCLC, MK-7339-008/KEYLYNK-008)

Start date: June 28, 2019
Phase: Phase 3
Study type: Interventional

The current study will compare pembrolizumab (MK-3475) plus maintenance olaparib, vs. pembrolizumab plus maintenance olaparib placebo for the treatment of squamous NSCLC. The study's 2 primary hypotheses are: 1. Pembrolizumab plus maintenance olaparib is superior to pembrolizumab plus maintenance olaparib placebo with respect to progression-free survival (PFS) per RECIST 1.1 by blinded independent clinical review (BICR). 2. Pembrolizumab plus maintenance olaparib is superior to pembrolizumab plus maintenance olaparib placebo with respect to overall survival (OS). As of Amendment 07, there will be no further analyses for OS and patient-reported outcome assessments.

NCT ID: NCT03976323 Active, not recruiting - Clinical trials for Carcinoma, Non-squamous Non-small-cell Lung

Study of Pembrolizumab With Maintenance Olaparib or Maintenance Pemetrexed in First-line (1L) Metastatic Non-squamous Non-Small-Cell Lung Cancer (NSCLC) (MK-7339-006, KEYLYNK-006)

Start date: June 28, 2019
Phase: Phase 3
Study type: Interventional

The current study will compare pembrolizumab (MK-3475) plus maintenance olaparib, vs pembrolizumab plus maintenance pemetrexed for the treatment of nonsquamous NSCLC. The study's 2 primary hypotheses are: 1. Pembrolizumab plus maintenance olaparib is superior to pembrolizumab plus maintenance pemetrexed with respect to progression-free survival (PFS) per Response Evaluation Criteria in Solid Tumors (RECIST 1.1) by blinded independent clinical review (BICR) and 2. Pembrolizumab plus maintenance olaparib is superior to pembrolizumab plus maintenance pemetrexed with respect to overall survival (OS).

NCT ID: NCT03970746 Active, not recruiting - Clinical trials for Non Small Cell Lung Cancer

Safety, Immunogenicity and Preliminary Clinical Activity Study of PDC*lung01 Cancer Vaccine in NSCLC

Start date: September 10, 2019
Phase: Phase 1/Phase 2
Study type: Interventional

PDC-LUNG-101 trial is an open-label, dose-escalation, phase I/II study to assess the safety, the tolerability, the immunogenicity and the preliminary clinical activity of the therapeutic cancer vaccine, PDC*lung01, associated or not with anti-PD-1 treatment in patients with non-small-cell lung cancer.

NCT ID: NCT03952559 Active, not recruiting - Atopic Dermatitis Clinical Trials

A Study of Baricitinib (LY3009104) in Children and Adolescents With Atopic Dermatitis

BREEZE-AD-PEDS
Start date: May 24, 2019
Phase: Phase 3
Study type: Interventional

The reason for this study is to see if the study drug called baricitinib works and is safe in children and teenage participants with atopic dermatitis.