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NCT ID: NCT04222972 Active, not recruiting - Neoplasms Clinical Trials

A Study of Pralsetinib Versus Standard of Care for First-Line Treatment of Advanced Non-Small Cell Lung Cancer (NSCLC)

AcceleRET-Lung
Start date: July 24, 2020
Phase: Phase 3
Study type: Interventional

This is an international, randomized, open-label, Phase 3 study designed to evaluate whether the potent and selective RET inhibitor, pralsetinib, improves outcomes when compared to a platinum chemotherapy-based regimen chosen by the Investigator from a list of standard of care treatments, as measured primarily by progression free survival (PFS), for participants with RET fusion-positive metastatic NSCLC who have not previously received systemic anticancer therapy for metastatic disease.

NCT ID: NCT04211337 Active, not recruiting - Clinical trials for Medullary Thyroid Cancer

A Study of Selpercatinib (LY3527723) in Participants With RET-Mutant Medullary Thyroid Cancer

LIBRETTO-531
Start date: February 11, 2020
Phase: Phase 3
Study type: Interventional

The reason for this study is to see if the study drug selpercatinib is safe and more effective compared to a standard treatment in participants with rearranged during transfection (RET)-mutant medullary thyroid cancer (MTC) that cannot be removed by surgery or has spread to other parts of the body. Participants who are assigned to the standard treatment and discontinue due to progressive disease have the option to potentially crossover to selpercatinib.

NCT ID: NCT04209855 Active, not recruiting - Clinical trials for Fallopian Tube Cancer

A Study of Mirvetuximab Soravtansine vs. Investigator's Choice of Chemotherapy in Platinum-Resistant, Advanced High-Grade Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancers With High Folate Receptor-Alpha Expression

MIRASOL
Start date: December 31, 2019
Phase: Phase 3
Study type: Interventional

This Phase 3 study is designed to compare the efficacy and safety of mirvetuximab soravtansine vs. investigator's choice chemotherapy in patients with platinum-resistant high-grade epithelial ovarian cancer, primary peritoneal, or fallopian tube cancer, whose tumors express a high-level of FRα. Patients will be, in the opinion of the Investigator, appropriate for single-agent therapy for their next line of therapy. Folate receptor alpha (FRα) positivity will be defined by the Ventana FOLR1 (FOLR1-2.1) CDx assay.

NCT ID: NCT04204616 Active, not recruiting - Prurigo Nodularis Clinical Trials

A Long-term Study of Nemolizumab (CD14152) in Participants With Prurigo Nodularis (PN)

Start date: January 11, 2021
Phase: Phase 3
Study type: Interventional

The primary purpose of this study is to assess the long-term safety of nemolizumab (CD14152) in participants with prurigo nodularis (PN).

NCT ID: NCT04203693 Active, not recruiting - Plaque Psoriasis Clinical Trials

Observational Study of Tildrakizumab in Patients With Moderate to Severe Plaque Psoriasis in Routine Clinical Practice

SAIL
Start date: October 30, 2019
Phase:
Study type: Observational

The observational, non-interventional study will assess the efficacy, safety, prescription and utilization patterns of Tildrakizumab in participants with moderate to severe plaque psoriasis in routine clinical practice.

NCT ID: NCT04194944 Active, not recruiting - Clinical trials for Non-Small Cell Lung Cancer

A Study of Selpercatinib (LY3527723) in Participants With Advanced or Metastatic RET Fusion-Positive Non-Small Cell Lung Cancer

LIBRETTO-431
Start date: February 17, 2020
Phase: Phase 3
Study type: Interventional

The reason for this study is to see if the study drug selpercatinib compared to a standard treatment is effective and safe in participants with rearranged during transfection (RET) fusion-positive non-squamous non-small cell lung cancer (NSCLC) that has spread to other parts of the body. Participants who are assigned to the standard treatment and discontinue due to progressive disease have the option to potentially crossover to selpercatinib.

NCT ID: NCT04193410 Active, not recruiting - Clinical trials for Health and Wellbeing of Primary School-aged Children

Healthy Childcare Centre of the Future

HCCF
Start date: June 15, 2020
Phase:
Study type: Observational

Rationale: In 2015-2020, the Dutch 'Healthy Primary School of the Future' intervention took place. Two schools became 'Healthy Primary Schools of the Future'; providing a healthy lunch and structured physical activity (PA) sessions. Two other 'Physical Activity Schools' only implemented the PA sessions. The intervention showed promising effects on children's BMI z-score and dietary and PA behaviours. Following these promising results, childcare centres of educational board Prisma have expressed their interest in implementing changes fitting the 'Healthy Primary School of the Future'. However, this is more complex than it seems to be, as budget to implement changes is lower and all childcare centres have a unique context. Therefore, there is a need to investigate how 'Healthy Primary School of the Future' can successfully be implemented in various, real-life school-settings. It is hypothesised that to maximise implementation and sustainability, each childcare centre will need to put together a set of changes and interventions which fit the context and needs of all stakeholders involved. No intervention is allocated in this study other than activities planned by childcare centres in accordance with wishes and needs of stakeholders. Objective: To study the implementation of 'Healthy Childcare Centre of the Future' in different school-contexts and develop guidelines that can be used to facilitate widespread dissemination of the initiative. Secondary objectives include evaluating the initiative's effects on children's BMI z-score, general health, dietary and PA behaviours and school well-being. To reach these objectives, a process evaluation, effect evaluation and cost-effectiveness evaluation will be executed. Data will be collected using questionnaires (parents, children, teachers, directors), anthropometric measures (children), interviews (teachers, directors), observations and analyses of minutes of meetings.

NCT ID: NCT04191096 Active, not recruiting - Clinical trials for Metastatic Hormone-Sensitive Prostate Cancer

Efficacy and Safety of Pembrolizumab (MK-3475) Plus Enzalutamide Plus Androgen Deprivation Therapy (ADT) Versus Placebo Plus Enzalutamide Plus ADT in Participants With Metastatic Hormone-Sensitive Prostate Cancer (mHSPC) (MK-3475-991/KEYNOTE-991)

Start date: February 12, 2020
Phase: Phase 3
Study type: Interventional

This study will assess the efficacy and safety of pembrolizumab plus enzalutamide plus Androgen Deprivation Therapy (ADT) versus placebo plus enzalutamide plus ADT in participants with mHSPC. The primary hypothesis is that in participants with mHSPC, the combination of pembrolizumab plus enzalutamide plus ADT is superior to placebo plus enzalutamide plus ADT with respect to 1) radiographic progression-free survival (rPFS) per Prostate Cancer Working Group (PCWG)-modified Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 as assessed by blinded independent central review (BICR) and 2) overall survival (OS). As of 19-JAN-2023, the study was unblinded and all study participants stopped ongoing treatment with pembrolizumab/placebo and will continue to receive Standard of Care treatment until meeting protocol-specified discontinuation criteria if deriving clinical benefit. Safety analysis will be performed at the end of the study; there will be no further analyses for efficacy and electronic patient-reported outcome (ePRO) endpoints collected from participants beyond the IA1 cutoff date. All study participants will stop ongoing treatment with pembrolizumab/placebo. Exceptions may be requested for study participants who, in the assessment of their study physician, are benefitting from the combination of enzalutamide and pembrolizumab, after consulting with the Sponsor. All other study participants should be discontinued from study and be offered standard of care (SOC) treatment as deemed necessary by the Investigator. If enzalutamide as SOC is not accessible off study to the participant, central sourcing may continue. As of Amendment 04, disease progression will no longer be centrally verified, participants will only be assessed locally. As of Amendment 4, Second Course treatment is not an option for participants. There are currently no participants in the Second Course Phase.

NCT ID: NCT04189445 Active, not recruiting - Clinical trials for Advanced or Metastatic Solid Tumor

Futibatinib in Patients With Specific FGFR Aberrations

Start date: August 24, 2020
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the efficacy and safety of futibatinib in patients with FGFR aberrations in 3 distinct cohorts. Patients will be enrolled into one of 3 cohorts: patients with advanced, metastatic or locally-advanced solid tumors harboring FGFR1-4 rearrangements (excluding primary brain tumors and intrahepatic cholangiocarcinoma [iCCA]); patients with gastric or gastro-esophageal junction (GEJ) cancer harboring FGFR2 amplification; and patients with myeloid or lymphoid neoplasms with FGFR1 rearrangements.

NCT ID: NCT04187404 Active, not recruiting - Pheochromocytoma Clinical Trials

A Novel Therapeutic Vaccine (EO2401) in Metastatic Adrenocortical Carcinoma, or Malignant Pheochromocytoma/Paraganglioma

Spencer
Start date: July 23, 2020
Phase: Phase 1/Phase 2
Study type: Interventional

This is a multicenter, Phase 1/2, First-In-Human study to assess the safety, tolerability, immunogenicity, and preliminary efficacy of EO2401 in Metastatic Adrenocortical Carcinoma, or Malignant Pheochromocytoma/Paraganglioma.