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Human Epilepsy Project 3

Idiopathic Generalized Epilepsy

By carrying a careful, large-scale and ambitious prospective study of a cohort of participants with generalized epilepsy, the study team hopes to clarify the likelihood of response and remission in this type of epilepsy, and try to explore the underlying biological drivers of treatment response, including novel realms of exploration such as impact of the microbiome, and genetics. The identification of biomarkers that predict the likelihood of disease response would allow epilepsy patients to make more informed decisions about the factors affecting their quality of life, including plans for driving, relationships, pregnancy, schooling, work, and play. In addition to its impact on clinical care, the data and specimens collected in HEP3, including sequential electrophysiology, biochemical profiles and neuroimaging and banked DNA for future genomics studies, have the potential to provide new insights into the biological basis of IGE, thereby advancing the discovery of effective treatments and cures. By enrolling both newly diagnosed subjects (prognosis unknown) as well as subjects with established IGE who are already determined to be treatment resistant or treatment responsive, the study team can immediately test potential biomarkers in a confirmation cohort, which will accelerate identification of predictive biomarkers.

Начало: 09.03.2020 Край: 01.12.2025 Възраст: от 13 г.

Australia, United States NYU Langone Health NCT05374928

Активно (без набиране) Фаза 1/2

Safety and Efficacy of IMC-F106C as a Single Agent and in Combination With Checkpoint Inhibitors

Select Advanced Solid Tumors

Brenetafusp (IMC-F106C) is an immune-mobilizing monoclonal T cell receptor against cancer (ImmTAC ®) designed for the treatment of cancers positive for the tumor-associated antigen PRAME. This is a first-in-human trial designed to evaluate the safety and efficacy of brenetafusp in adult participants who have the appropriate HLA-A2 tissue marker and whose cancer is positive for PRAME.

Начало: 25.02.2020 Край: 01.12.2027 Възраст: от 18 г. Лечение

Australia, Belgium, Brazil +13 Immunocore Ltd NCT04262466

Активно (без набиране) Фаза 1/2

ENB003 Plus Pembrolizumab Phase 1b/2a in Solid Tumors

Cancer Melanoma Ovary Cancer Pancreatic Cancer +1

First-in Human study evaluating the safety, tolerability and efficacy of ENB003 in combination with Pembrolizumab in solid tumors. The study is separated into two parts. Part A is a 3+3 dose escalation to define the recommended RP2D; this part will include metastatic melanoma, platinum resistant ovarian cancer, and pancreatic cancer patients subjects, but other solid tumors will be allowed. Once the RP2D is selected, the study will be expanded into metastatic melanoma, platinum resistant ovarian cancer, and pancreatic cancer subjects. A small number of sarcoma subjects will be included, as exploratory.

Начало: 18.02.2020 Край: 31.03.2026 Възраст: 18–80 г. Лечение

Australia, United States ENB Therapeutics, Inc NCT04205227

Активно (без набиране) Фаза 3

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

Non-Small Cell Lung Cancer

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.

Начало: 17.02.2020 Край: 01.06.2030 Възраст: от 18 г. Лечение

Argentina, Australia, Belgium +23 Eli Lilly and Company NCT04194944

Активно (без набиране) Фаза 3

ZIP Study-OL Study of Safety, PK, Efficacy, PD, Immunogenicity of ATB200/AT2221 in Pediatrics Aged 0 to < 18 y.o. w/LOPD

Pompe Disease (Late-onset)

This is a Phase 3, open-label, multicenter study to evaluate the safety, PK, efficacy, PD, and immunogenicity of Cipaglucosidase Alfa/Miglustat treatment in enzyme replacement therapy (ERT)-experienced and ERT-naïve pediatric subjects with Pompe disease, aged 0 to \< 18 years

Начало: 13.02.2020 Край: 01.06.2026 Възраст: до 17 г. Лечение

Australia, Canada, Germany +3 Amicus Therapeutics NCT03911505

Активно (без набиране) Фаза 3

Clinical Trial of YH25448(Lazertinib) as the First-line Treatment in Patients With EGFR Mutation Positive Locally Advanced or Metastatic NSCLC (LASER301)

Non-Small Cell Lung Cancer

This Phase III study will be conducted to evaluate the efficacy and safety of YH25448 as first-line treatment in locally advanced or metastatic Non-small Cell Lung Cancer (NSCLC) patients with EGFR mutations

Начало: 13.02.2020 Край: 01.06.2026 Възраст: от 18 г. Лечение

Australia, Greece, Hungary +10 Yuhan Corporation NCT04248829

Активно (без набиране) Фаза 3

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)

Metastatic Hormone-Sensitive Prostate Cancer

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.

Начало: 12.02.2020 Край: 27.03.2026 Възраст: от 18 г. Лечение

Australia, Brazil, Canada +24 Merck Sharp & Dohme LLC NCT04191096

Активно (без набиране) Фаза 3

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

Medullary Thyroid Cancer

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.

Начало: 11.02.2020 Край: 01.11.2027 Възраст: от 12 г. Лечение

Australia, Belgium, Brazil +17 Loxo Oncology, Inc. NCT04211337

Активно (без набиране) Фаза 3

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

Spinal Muscular Atrophy Type I Spinal Muscular Atrophy Type II Spinal Muscular Atrophy Type III SMA

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.

Начало: 10.02.2020 Край: 31.12.2035 Лечение

Australia, Belgium, Canada +6 Novartis Gene Therapies NCT04042025

Активно (без набиране) Фаза 3

SAR408701 Versus Docetaxel in Previously Treated, Carcinoembryonic Antigen-related Cell Adhesion Molecule 5 (CEACAM5) Positive Metastatic Non-squamous Non-small-cell Lung Cancer Patients

Non-small Cell Lung Cancer Metastatic

Primary Objectives: * Study was designed with multiple primary endpoints analyzed on randomized participants at the time of the cut-off date for each given analysis (progression free survival \[PFS\] and overall survival \[OS\]) * Study success was defined either on PFS or OS * The primary objective was to determine whether tusamitamab ravtansine improves the progression free survival (PFS) when compared to docetaxel in participants with metastatic non-squamous non-small-cell lung cancer (NSCLC) expressing CEACAM5 greater than or equal to 2+ in intensity in at least 50% of the tumor cell population and previously treated with standard-of-care platinum-based chemotherapy and an immune checkpoint inhibitor (ICI) * The primary objective was to determine whether tusamitamab ravtansine improves the overall survival (OS) when compared with docetaxel in participants with metastatic non-squamous NSCLC expressing CEACAM5 greater than or equal to 2+ in intensity in at least 50% of the tumor cell population and previously treated with standard-of-care platinum-based chemotherapy and an immune checkpoint inhibitor. Secondary Objectives: * Compared the objective response rate (ORR) of tusamitamab ravtansine with docetaxel * Compared the health-related quality of life (HRQOL) of tusamitamab ravtansine with docetaxel * Evaluated the safety of tusamitamab ravtansine compared to docetaxel * Assessed the duration of response (DOR) of tusamitamab ravtansine as compared with docetaxel

Начало: 06.02.2020 Край: 31.03.2026 Възраст: от 18 г. Лечение

Argentina, Australia, Belgium +22 Sanofi NCT04154956

Активно (без набиране) Фаза 2/3

A Study Evaluating the Efficacy and Safety of Inavolisib + Palbociclib + Fulvestrant vs Placebo + Palbociclib + Fulvestrant in Participants With PIK3CA-Mutant, Hormone Receptor-Positive, HER2-Negative, Locally Advanced or Metastatic Breast Cancer

Breast Cancer

This study will evaluate the efficacy, safety, and pharmacokinetics of inavolisib in combination with palbociclib and fulvestrant compared with placebo plus palbociclib and fulvestrant in participants with PIK3CA-mutant, hormone receptor (HR)-positive, HER2-negative locally advanced or metastatic breast cancer whose disease progressed during treatment or within 12 months of completing adjuvant endocrine therapy and who have not received prior systemic therapy for metastatic disease.

Начало: 29.01.2020 Край: 15.11.2027 Възраст: от 18 г. Лечение

Argentina, Australia, Belgium +23 Hoffmann-La Roche NCT04191499

Активно (без набиране) Фаза 2

SBRT With Combination Ipilimumab/Nivolumab for Metastatic Kidney Cancer

Metastatic Renal Cell Carcinoma

This trial will evaluate the addition of cytoreductive stereotactic body radiation therapy (SBRT) to standard of care combination ipilimumab and nivolumab (I/N) versus I/N alone for the treatment of metastatic kidney cancer.

Начало: 29.01.2020 Край: 30.04.2026 Лечение

Australia, Canada Ontario Clinical Oncology Group (OCOG) NCT04090710

Активно (без набиране) Фаза 1/2

CAMPFIRE: A Study of Ramucirumab (LY3009806) in Children and Young Adults With Desmoplastic Small Round Cell Tumor

Desmoplastic Small Round Cell Tumor

This study is being conducted to test the safety and efficacy of ramucirumab in combination with other chemotherapy in the treatment of relapsed, recurrent, or refractory desmoplastic small round cell tumor (DSRCT) in children and young adults. This trial is part of the CAMPFIRE master protocol (NCT05999994) which is a platform to accelerate the development of new treatments for pediatric and young adult participants with cancer. Your participation in this trial could last 12 months or longer, depending on how you and your tumor respond.

Начало: 22.01.2020 Край: 01.10.2026 Възраст: 12–29 г. Лечение

Australia, Germany, Italy +4 Eli Lilly and Company NCT04145349

Активно (без набиране) Фаза 3

A Study of Selexipag as Add-On Treatment to Standard of Care in Children With Pulmonary Arterial Hypertension

Hypertension, Pulmonary

The purpose of this study is to evaluate whether the addition of selexipag to standard of care treatment delays disease progression in children with Pulmonary Arterial Hypertension (PAH) in comparison to placebo.

Начало: 16.01.2020 Край: 01.10.2027 Възраст: 2–17 г. Лечение

Australia, Belarus, Brazil +26 Actelion NCT04175600

Активно (без набиране) Фаза 3

Long-term Extension Study of Zanubrutinib (BGB-3111) Regimens in Participants With B-cell Malignancies

B-cell Malignancies

The purpose of this study is to evaluate the long-term safety of zanubrutinib regimens in participants with B-cell malignancies who participated in a BeiGene parent study for zanubrutinib.

Начало: 16.01.2020 Край: 01.12.2028 Възраст: от 18 г. Лечение

Australia, China, Czechia +14 BeiGene NCT04170283

Активно (без набиране)

Liver Ablative Radiotherapy Utilising Kilovoltage Intrafraction Monitoring (KIM)

Liver Cancer

Primary and secondary liver cancer patients will receive liver SABR with or without KIM intervention.

Начало: 14.01.2020 Край: 01.01.2026 Възраст: 18–85 г. Лечение

Australia University of Sydney NCT02984566

Активно (без набиране) Фаза 3

TAK-788 as First-Line Treatment Versus Platinum-Based Chemotherapy for Non-Small Cell Lung Cancer (NSCLC) With EGFR Exon 20 Insertion Mutations

Advanced/Metastatic Non-Small Cell Lung Cancer (NSCLC)

The purpose of this study is to compare effectiveness of TAK-788 as first-line treatment with that of platinum-based chemotherapy in participants with locally advanced or metastatic non-small cell lung cancer (NSCLC) whose tumors has epidermal growth factor receptor (EGFR) exon 20 insertion mutations. Participants will be randomly assigned to one of the two treatment groups- TAK-788 group or Platinum-based chemotherapy group. Participants will receive TAK-788 orally and pemetrexed/cisplatin or pemetrexed/carboplatin via vein until the participants experience worsening disease (PD) as assessed by blinded independent review committee (IRC), intolerable harmful effects or another discontinuation criteria.

Начало: 10.01.2020 Край: 31.10.2026 Възраст: от 18 г. Лечение

Australia, Belgium, Canada +20 Takeda NCT04129502

Активно (без набиране) Фаза 3

A Study of Atezolizumab Plus Bevacizumab Versus Active Surveillance as Adjuvant Therapy in Patients With Hepatocellular Carcinoma at High Risk of Recurrence After Surgical Resection or Ablation

Carcinoma, Hepatocellular

This study will evaluate the efficacy and safety of adjuvant therapy with atezolizumab plus bevacizumab compared with active surveillance in participants with completely resected or ablated hepatocellular carcinoma (HCC) who are at high risk for disease recurrence.

Начало: 31.12.2019 Край: 15.05.2026 Възраст: от 18 г. Лечение

Australia, Belgium, Brazil +22 Hoffmann-La Roche NCT04102098

Активно (без набиране) Фаза 3

A Study of Sasanlimab in People With Non-muscle Invasive Bladder Cancer

Non-muscle Invasive Bladder Cancer

The purpose of this study is to learn about the safety and effects of the study medicine (sasanlimab) in people with non-muscle invasive bladder cancer. This study is seeking participants whose bladder cancer is still in early stages, has not spread outside of the bladder, has been removed with surgery, and is high risk (Part A) or was previously treated with BCG (Bacillus Calmette Guerin), a standard treatment for bladder cancer (Part B). In Part A (enrollment closed), each participant was assigned to one of three study treatment groups. * One group is given sasanlimab and BCG at the study clinic. * The second group is given sasanlimab and BCG at the study clinic. This group will receive BCG for the first six weeks only. * The third group is given BCG only and will not receive sasanlimab. In Part B of the study, each new participant will be assigned to a study treatment group based on the type of their bladder tumor. \- Both groups will be given sasanlimab at the study clinic. On August 31, 2022, the Sponsor announced the discontinuation of enrollment to Part B. The decision to discontinue enrollment to Part B was not made for safety reasons.

Начало: 30.12.2019 Край: 02.12.2026 Възраст: от 18 г. Лечение

Australia, Belgium, Canada +11 Pfizer NCT04165317

Активно (без набиране) Фаза 3

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

Moderate-to-Severe Atopic Dermatitis

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

Начало: 30.12.2019 Край: 31.08.2026 Възраст: от 12 г. Лечение

Australia, Belgium, Bulgaria +18 Galderma R&D NCT03989206

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