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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: NCT03800134 Active, not recruiting - Clinical trials for Non-Small Cell Lung Cancer

A Study of Neoadjuvant/Adjuvant Durvalumab for the Treatment of Patients With Resectable Non-small Cell Lung Cancer

AEGEAN
Start date: December 6, 2018
Phase: Phase 3
Study type: Interventional

This is a Phase III, randomized, double-blind, placebo-controlled, multi-center international study assessing the activity of durvalumab and chemotherapy administered prior to surgery compared with placebo and chemotherapy administered prior to surgery in terms of pathological complete response.

NCT ID: NCT03797326 Active, not recruiting - Colorectal Cancer Clinical Trials

Efficacy and Safety of Pembrolizumab (MK-3475) Plus Lenvatinib (E7080/MK-7902) in Previously Treated Participants With Select Solid Tumors (MK-7902-005/E7080-G000-224/LEAP-005)

Start date: February 12, 2019
Phase: Phase 2
Study type: Interventional

The purpose of this study is to determine the safety and efficacy of combination therapy with pembrolizumab (MK-3475) and lenvatinib (E7080/MK-7902) in participants with triple negative breast cancer (TNBC), ovarian cancer, gastric cancer, colorectal cancer (CRC), glioblastoma (GBM), biliary tract cancers (BTC), or pancreatic cancer.

NCT ID: NCT03782207 Active, not recruiting - Clinical trials for Non-Small Cell Lung Cancer

A Study Investigating the Outcomes and Safety of Atezolizumab Under Real-World Conditions in Patients Treated in Routine Clinical Practice

IMreal
Start date: February 7, 2019
Phase:
Study type: Observational

This is a non-interventional, multi-country, multi-centre, multiple cohort prospective study, with retrospective collection of prior medical/treatment history data from medical records, designed to assess the real-world outcomes and safety of atezolizumab for indications in the existing label in the real world setting of routine clinical practice.

NCT ID: NCT03778931 Active, not recruiting - Breast Cancer Clinical Trials

Phase 3 Trial of Elacestrant vs. Standard of Care for the Treatment of Patients With ER+/HER2- Advanced Breast Cancer

EMERALD
Start date: May 10, 2019
Phase: Phase 3
Study type: Interventional

This Phase 3 clinical study compares the efficacy and safety of elacestrant to the standard of care (SoC) options of fulvestrant or an aromatase inhibitor (AI) in women and men with breast cancer whose disease has advanced on at least one endocrine therapy including a CDK4/6 inhibitor in combination with fulvestrant or an aromatase inhibitor (AI) .

NCT ID: NCT03771898 Active, not recruiting - Clinical trials for Metachromatic Leukodystrophy (MLD)

A Study of Intrathecal SHP611 in Children With Metachromatic Leukodystrophy

EMBOLDEN
Start date: May 13, 2019
Phase: Phase 2
Study type: Interventional

The main aim of the study is to determine if SHP611 given by injection into the spinal fluid that surrounds the brain and spinal cord (intrathecal; IT) prolongs the time for children with Metachromatic Leukodystrophy (MLD) to retain the ability to move from place to place. Other aims of the study are to determine the effects of intrathecal administration of SHP611 on movement and speech functions and to learn how well SHP611 injected in the spinal fluid that surrounds the brain and spinal cord is tolerated. Study participants will receive SHP611 for about 2 years with the possibility of an extended treatment period.

NCT ID: NCT03767244 Active, not recruiting - Prostatic Neoplasms Clinical Trials

A Study of Apalutamide in Participants With High-Risk, Localized or Locally Advanced Prostate Cancer Who Are Candidates for Radical Prostatectomy

PROTEUS
Start date: June 11, 2019
Phase: Phase 3
Study type: Interventional

The purpose of this study is to determine if treatment with apalutamide plus androgen deprivation therapy (ADT) before and after radical prostatectomy (RP) with pelvic lymph node dissection (pLND) in participants with high-risk localized or locally advanced prostate cancer results in an improvement in pathological complete response (pCR) rate and metastasis-free survival (MFS) as compared to placebo plus ADT.

NCT ID: NCT03766789 Active, not recruiting - Clinical trials for Adherence, Medication

Use of a Smartphone Application to Increase Adherence to Medical Treatment in Patients With an Acute Coronary Syndrome.

ADHERENCE
Start date: June 12, 2018
Phase: N/A
Study type: Interventional

ADHERENCE is a randomized unicentric study that will be carried out from a monovalent center of cardiology of the Autonomous City of Buenos Aires. Patients will be randomized hospitalization for acute coronary syndromes (ACS) with and without ST segment elevation at the time of hospital discharge to receive access to a digital application for smartphones or receive written instructions regarding the taking of medication as prescribed by doctors . They will have a total follow-up period of 90 days, in which the adherence to medical treatment will be evaluated through a questionnaire validated for that purpose. The objective of the study is to demonstrate that the use of a digital platform for smartphones increases the adherence to medical treatment by 30% in relation to the group without intervention

NCT ID: NCT03765918 Active, not recruiting - Clinical trials for Head and Neck Neoplasms

Study of Pembrolizumab Given Prior to Surgery and in Combination With Radiotherapy Given Post-surgery for Advanced Head and Neck Squamous Cell Carcinoma (MK-3475-689)

Start date: December 17, 2018
Phase: Phase 3
Study type: Interventional

This is a randomized, active-controlled, open-label study of pembrolizumab (Pembro) given prior to surgery and pembrolizumab in combination with standard of care radiotherapy (with or without cisplatin), as post-surgical therapy in treatment naïve participants with newly diagnosed Stage III/IVA, resectable, locoregionally advanced, head and neck squamous cell carcinoma (LA-HNSCC). Efficacy outcomes will be stratified by programmed cell death ligand 1 (PD-L1) combined positive score (CPS) status. The primary hypothesis is that pembrolizumab given before surgery and after surgery in combination with radiotherapy (with or without cisplatin) improves event-free survival compared to radiotherapy (with or without cisplatin) given after surgery alone.

NCT ID: NCT03759379 Active, not recruiting - Clinical trials for Transthyretin Amyloidosis

HELIOS-A: A Study of Vutrisiran (ALN-TTRSC02) in Patients With Hereditary Transthyretin Amyloidosis (hATTR Amyloidosis)

Start date: February 14, 2019
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the efficacy and safety of vutrisiran (ALN-TTRSC02) in participants with hereditary transthyretin amyloidosis (hATTR amyloidosis). Participants will receive vutrisiran subcutaneous (SC) injection once every 3 months (q3M) or the reference comparator patisiran intravenous (IV) injection once every 3 weeks (q3w) during the 18 month Treatment Period. This study will use the placebo arm of the APOLLO study (NCT01960348) as an external comparator for the primary and most other efficacy endpoints during the 18 Month Treatment Period. Following the 18 Month Treatment Period, all participants will be randomized to receive vutrisiran SC injection once every 6 months (q6M) or q3M in the Randomized Treatment Extension (RTE) Period.