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Primary Radiotherapy Versus Primary Surgery for HPV-Associated Oropharyngeal Cancer

Oropharyngeal Cancer

The goal of this randomized treatment de-escalation study is to formally compare outcomes in HPV related oropharyngeal cancer tumors treated with a primary radiotherapy versus a primary surgical approach, to provide a high level of evidence to guide the selection of treatment options for a subsequent phase III trial

Начало: 26.01.2018 Край: 15.08.2028 Възраст: от 18 г. Лечение

Australia, Canada London Health Sciences Centre Research Institute OR Law NCT03210103

Активно (без набиране)

Cardiac Resynchronization Therapy in Previously Untreatable and High Risk Upgrade Patients

Heart Failure

This study is a prospective, multi-center, pivotal trial to study the safety and efficacy of the WiSE-CRT System for Cardiac Re-synchronization Therapy.

Начало: 17.01.2018 Край: 01.06.2026 Възраст: от 18 г. Лечение

Australia, France, Germany +4 EBR Systems, Inc. NCT02922036

Активно (без набиране) Фаза 1

Study Evaluating Safety, Tolerability and Pharmacokinetics (PK) of Tarlatamab in Adults With Small Cell Lung Cancer (SCLC)

Small Cell Lung Carcinoma

A study to assess the safety, tolerability, and PK of tarlatamab in participants with SCLC

Начало: 26.12.2017 Край: 31.12.2027 Възраст: от 18 г. Лечение

Australia, France, Germany +9 Amgen NCT03319940

Активно (без набиране) Фаза 3

Study of Seladelpar in Participants With Primary Biliary Cholangitis (PBC)

Primary Biliary Cirrhosis

An Open Label Long-Term Study to Evaluate the Safety and Tolerability of Seladelpar in Subjects with Primary Biliary Cholangitis (PBC)

Начало: 12.12.2017 Край: 01.11.2028 Възраст: 18–75 г. Лечение

Argentina, Australia, Belgium +20 Gilead Sciences NCT03301506

Активно (без набиране) Фаза 3

An Extension Study to Evaluate the Efficacy and Safety of BMN 111 in Children With Achondroplasia

Achondroplasia

The intent and design of this Phase 3 study is to assess BMN 111 as a therapeutic option for the treatment of children with Achondroplasia

Начало: 12.12.2017 Край: 01.06.2031 Възраст: от 6 г. Лечение

Australia, Germany, Japan +4 BioMarin Pharmaceutical NCT03424018

Активно (без набиране) Фаза 3

A Study to Investigate the Clinical Benefit of Isatuximab in Combination With Bortezomib, Lenalidomide and Dexamethasone in Adults With Newly Diagnosed Multiple Myeloma Not Eligible for Transplant

Plasma Cell Myeloma

Primary Objective: -To demonstrate the benefit of isatuximab in combination with bortezomib, lenalidomide, and dexamethasone in the prolongation of progression free survival (PFS) as compared to bortezomib, lenalidomide, and dexamethasone, in participants with newly diagnosed multiple myeloma (NDMM) not eligible for transplant. Secondary Objectives: * To evaluate in both randomized (isatuximab, bortezomib, lenalidomide and dexamethasone combination (IVRd) and bortezomib, lenalidomide and dexamethasone combination (VRd)) arms: * Complete response (CR) rate, as defined by the International Myeloma Working Group (IMWG) criteria. * Minimal residual disease (MRD) negativity rate in participants with CR. * Very good partial response or better rate, as defined by the IMWG criteria. * Overall survival (OS). * To evaluate the overall response rate (ORR) as per IMWG criteria. * To evaluate the time to progression (TTP) overall and by MRD status. * To evaluate PFS by MRD status. * To evaluate the duration of response (DOR) overall and by MRD status. * To evaluate time to first response (TT1R). * To evaluate time to best response (TTBR). * To evaluate progression-free survival on next line of therapy (PFS2). * To evaluate the sustained MRD negativity \>12 months rate. * To evaluate safety. * To determine the pharmacokinetic (PK) profile of isatuximab in combination with bortezomib, lenalidomide, and dexamethasone (IVRd arm only). * To evaluate the immunogenicity of isatuximab in participants receiving isatuximab (IVRd and crossover arms). * To assess disease-specific and generic health-related quality of life (HRQL), disease and treatment-related symptoms, health state utility, and health status.

Начало: 07.12.2017 Край: 30.06.2027 Възраст: 18–80 г. Лечение

Australia, Belgium, China +16 Sanofi NCT03319667

Активно (без набиране)

Age-related Clonal Haematopoiesis in an HIV Evaluation Cohort (ARCHIVE)

HIV Infections Aging

The ARCHIVE study is an observational longitudinal cohort study of people with and without HIV who are over the age of 55. The duration of the study is planned for 10 years, with study visits every 1-2 years. The objectives of the study are to evaluate genomic and other factors associated with aging, stratified by HIV status.

Начало: 05.12.2017 Край: 04.12.2027

Australia Kirby Institute NCT04641013

Активно (без набиране) Фаза 1

A Study of GDC-9545 Alone or in Combination With Palbociclib and/or Luteinizing Hormone-Releasing Hormone (LHRH) Agonist in Locally Advanced or Metastatic Estrogen Receptor-Positive Breast Cancer

Breast Cancer

This study will evaluate the safety, pharmacokinetic (PK), pharmacodynamic (PD) activity, and preliminary anti-tumor activity of GDC-9545 as a single agent and in combination with palbociclib and/or luteinizing hormone-releasing hormone (LHRH) agonist in participants with advanced or metastatic estrogen receptor (ER)-positive (human epidermal growth factor receptor 2 \[HER2\]-negative) breast cancer.

Начало: 24.11.2017 Край: 31.07.2026 Възраст: от 18 г. Лечение

Australia, South Korea, Spain +2 Genentech, Inc. NCT03332797

Активно (без набиране) Фаза 2

Reduced Craniospinal Radiation Therapy and Chemotherapy in Treating Younger Patients With Newly Diagnosed WNT-Driven Medulloblastoma

Medulloblastoma

This phase II trial studies how well reduced doses of radiation therapy to the brain and spine (craniospinal) and chemotherapy work in treating patients with newly diagnosed type of brain tumor called WNT)/Wingless (WNT)-driven medulloblastoma. Recent studies using chemotherapy and radiation therapy have been shown to be effective in treating patients with WNT-driven medulloblastoma. However, there is a concern about the late side effects of treatment, such as learning difficulties, lower amounts of hormones, or other problems in performing daily activities. Radiotherapy uses high-energy radiation from x-rays to kill cancer cells and shrink tumors. Drugs used in chemotherapy, such as cisplatin, vincristine sulfate, cyclophosphamide and lomustine, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving reduced craniospinal radiation therapy and chemotherapy may kill tumor cells and may also reduce the late side effects of treatment.

Начало: 17.11.2017 Край: 31.03.2028 Възраст: 3–21 г. Лечение

Australia, Canada, Puerto Rico +2 Children's Oncology Group NCT02724579

Активно (без набиране) Фаза 3

A Study Comparing the Efficacy and Safety of Polatuzumab Vedotin With Rituximab-Cyclophosphamide, Doxorubicin, and Prednisone (R-CHP) Versus Rituximab-Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (R-CHOP) in Participants With Diffuse Large B-Cell Lymphoma

Diffuse Large B-Cell Lymphoma

This Phase III, randomized, double-blind, placebo-controlled study will compare the efficacy, safety, and pharmacokinetics of polatuzumab vedotin plus R-CHP versus R-CHOP in participants with previously untreated diffuse large B-cell lymphoma (DLBCL).

Начало: 16.11.2017 Край: 30.04.2026 Възраст: 18–80 г. Лечение

Australia, Belgium, Brazil +18 Hoffmann-La Roche NCT03274492

Активно (без набиране)

Metastatic Tumor Research and Outcomes Network

Metastatic Spine Tumor

The registry aims to collect patient information such as patient demographics, co-morbidities, clinical, diagnostic, and therapeutic data, as well as information on adverse events and HRQOL outcomes specific for patients with metastatic spine tumor(s).

Начало: 15.11.2017 Край: 15.08.2026 Възраст: от 18 г.

Australia, Canada, Germany +7 AO Innovation Translation Center NCT02830451

Активно (без набиране) Фаза 3

A Study of Subcutaneous Daratumumab Versus Active Monitoring in Participants With High-Risk Smoldering Multiple Myeloma

Smoldering Multiple Myeloma

The primary objective of this study is to determine whether treatment with daratumumab administered subcutaneously (SC) prolongs progression-free survival (PFS) compared with active monitoring in participants with high-risk smoldering multiple myeloma (SMM).

Начало: 07.11.2017 Край: 30.06.2026 Възраст: от 18 г. Лечение

Argentina, Australia, Belgium +20 Janssen Research & Development, LLC NCT03301220

Активно (без набиране) Фаза 3

A Study Comparing Zanubrutinib With Bendamustine Plus Rituximab in Participants With Previously Untreated CLL or SLL

Chronic Lymphocytic Leukemia Small Lymphocytic Lymphoma

To compare efficacy between zanubrutinib versus bendamustine and rituximab in patients with previously untreated CLL/SLL, as measured by progression free survival assess by Independent Central Review.

Начало: 31.10.2017 Край: 31.10.2027 Възраст: от 18 г. Лечение

Australia, Belgium, China +11 BeiGene NCT03336333

Активно (без набиране) Фаза 3

Efficacy, Safety and Tolerability Study of Long-acting Cabotegravir Plus Long-acting Rilpivirine (CAB LA + RPV LA) in Human-immunodeficiency Virus-1 (HIV-1) Infected Adults

HIV Infections

This Antiretroviral Therapy as Long Acting Suppression every 2 Months (ATLAS-2M) study is designed to demonstrate the non-inferior antiviral activity and safety of CAB LA + RPV LA administered every 8 weeks (Q8W) compared to CAB LA + RPV LA administered every 4 weeks (Q4W) over a 48-week treatment period in approximately 1020 adult HIV-1 infected subjects. Subjects will be divided in 2 groups; Group 1 will include subjects receiving current anti-retroviral (ART) standard of care (SOC) therapy whereas group 2 will include subjects currently receiving CAB LA + RPV LA Q4W in ATLAS study. Subjects in both groups will be randomized to receive CAB LA + RPV LA Q4W or Q8W. The study will be carried out in 3 phases including screening phase, maintenance phase and extension phase. Subjects choosing not to enter the Extension phase can complete their study participation at the Week 100 visit and enter into the 52-week Long-Term Follow-Up (LTFU) Phase as required. A sub-study in the ATLAS-2M study will evaluate the pharmacokinetics, tolerability and efficacy of CAB and RPV long acting injections following intramuscular administration in the Vastus Lateralis Muscle (thigh) in HIV-infected Adult Participants who have received at least three years of Gluteal Injections in this ATLAS-2M Study.

Начало: 27.10.2017 Край: 31.12.2029 Възраст: от 18 г. Лечение

Argentina, Australia, Canada +10 ViiV Healthcare NCT03299049

Активно (без набиране) Фаза 1/2

Astra Zeneca (Immuno Stereotactic Ablative Body Radiotherapy) ISABR Study: Randomized Phase I/II Study of Stereotactic Body Radiotherapy

Carcinoma, Non-Small-Cell Lung

This study uses durvalumab (MEDI 4736), an experimental type of drug made by Astra Zeneca Pharmaceuticals, (limited partnership) LP, which in early studies has shown to possibly reduce the growth of certain types of lung cancer. The Investigators will enroll up to 105 subjects into the study. After an initial safety sample of 15 individuals receiving durvalumab (MEDI 4736) and Stereotactic Ablative Body Radiotherapy (SABR), if it is shown to be safe to administer this combination of therapies, the next enrolled subjects will be randomized in a 1:1 fashion (each subject with a "50-50 chance" like the flip of a coin) to receive either SABR and durvalumab (MEDI 4736), or SABR alone. Once treatment is completed, all subjects will return to the University of California at Los Angeles (UCLA) for regular follow-up visits to check on their health and outcomes. At visits both prior to and after treatment special blood samples will be drawn to be studied by UCLA scientists to look into the basic science aspects of how durvalumab (MEDI 4736) and radiation work in the body. It is hoped that we will learn more about the basic safety and science of durvalumab (MEDI 4736) combined with Stereotactic Ablative Body Radiotherapy (SABR) vs. SABR alone, while extending the life and quality of life of these subjects.

Начало: 11.10.2017 Край: 01.06.2027 Възраст: от 18 г. Лечение

Australia, United States Jonsson Comprehensive Cancer Center NCT03148327

Активно (без набиране) Фаза 2/3

A Study to Evaluate the Efficacy and Safety of Multiple Targeted Therapies as Treatments for Participants With Non-Small Cell Lung Cancer (NSCLC)

Non-Small Cell Lung Cancer

This is a phase 2/3, global, multicenter, open-label, multi-cohort study designed to evaluate the safety and efficacy of targeted therapies or immunotherapy as single agents or in combination in participants with unresectable, advanced or metastatic NSCLC determined to harbor oncogenic somatic mutations or positive by tumor mutational burden (TMB) assay as identified by a blood-based next-generation sequencing (NGS) circulating tumor DNA (ctDNA) assay.

Начало: 22.09.2017 Край: 31.10.2026 Възраст: от 18 г. Лечение

Argentina, Australia, Belgium +24 Hoffmann-La Roche NCT03178552

Активно (без набиране) Фаза 1

Phase 1 Study of CK-301 (Cosibelimab) as a Single Agent in Subjects With Advanced Cancers

Lung Neoplasms Carcinoma, Non-Small-Cell Lung Carcinoma, Small Cell Malignant Mesothelioma, Advanced +9

CK-301 (cosibelimab) is a fully human monoclonal antibody of IgG1 subtype that directly binds to Programmed Death-Ligand 1 (PD-L1) and blocks its interactions with the Programmed Death-1 (PD-1) and B7.1 receptors. The primary objectives of this study are to assess the safety, tolerability and efficacy of CK-301 when administered intravenously as a single agent to subjects with selected recurrent or metastatic cancers.

Начало: 20.09.2017 Край: 01.12.2025 Възраст: от 18 г. Лечение

Australia, France, New Zealand +6 Checkpoint Therapeutics, Inc. NCT03212404

Активно (без набиране) Фаза 3

A Study in Participants Previously Enrolled in a Genentech- and/or F. Hoffmann-La Roche Ltd-Sponsored Atezolizumab Study (IMbrella A)

Cancer

This is an open-label, multicenter, non-randomized extension and long-term observational study. Participants receiving atezolizumab monotherapy or atezolizumab combined with other agent(s) or comparator agent(s) in a Genentech or Roche-sponsored study (the parent study) and who continue to receive study treatment at the time of the parent-study closure and do not have access to the study treatment locally are eligible for continued treatment in the extension study. Dosing regimen for a given participant and indication will be the same or equivalent to the respective parent study protocol. Study treatment in the extension study can continue until disease progression or beyond if the patient continues to derive clinical benefit as judged by the investigator and if allowed by the parent study or local prescribing information until death; withdrawal of study consent; unacceptable toxicity; pregnancy; patient non-compliance; or study termination by the Sponsor, whichever occurs first.

Начало: 20.09.2017 Край: 06.03.2030 Лечение

Argentina, Australia, Belgium +27 Hoffmann-La Roche NCT03148418

Активно (без набиране)

ATTUNE® Revision- Complex Primary in Total Knee Arthroplasty Population

Primary Knee Arthroplasty

Five-year, Prospective, multi-center, non-randomized, non-controlled study of the ATTUNE® Revision total knee prostheses, utilizing the fixed bearing (FB) and rotating platform (RP) tibial component with the posterior stabilizing (PS) femoral component in complex primary total knee arthroplasty.

Начало: 19.09.2017 Край: 30.06.2028 Възраст: 22–80 г. Лечение

Australia, Canada, France +6 DePuy Orthopaedics NCT03153449

Активно (без набиране)

Global Fenestrated Anaconda Clinical STudy

Abdominal Aortic Aneurysm

This study is a prospective non-interventional, multi-centre study of the Vascutek Fenestrated Anaconda™ system, and is essentially a post-market study. The Vascutek Fenestrated Anaconda™ system is a custom made device used for the treatment of Abdominal Aortic Aneurysm.

Начало: 11.09.2017 Край: 31.12.2030 Възраст: от 18 г.

Australia, Canada, Netherlands +1 Vascutek Ltd. NCT03180996

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