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Набира участници Фаза 2

A Study to Give Treatment Inside the Eye to Treat Retinoblastoma

Bilateral Retinoblastoma Childhood Intraocular Retinoblastoma Group D Retinoblastoma Stage I Retinoblastoma +1

This phase II trial tests the safety and side effects of adding melphalan (by injecting it into the eye) to standard chemotherapy in early treatment of patients with retinoblastoma (RB). RB is a type of cancer that forms in the tissues of the retina (the light-sensitive layers of nerve tissue at the back of the eye). It may be hereditary or nonhereditary (sporadic). RB is considered harder to treat (higher risk) when there are vitreous seeds present. Vitreous seeds are RB tumors in the jelly-like fluid of the eye (called the vitreous humor). The term, risk, refers to the chance of the cancer not responding to treatment or coming back after treatment. Melphalan is in a class of medications called alkylating agents. It may kill cancer cells by damaging their deoxyribonucleic acid (DNA) and stopping them from dividing. Other chemotherapy drugs given during this trial include carboplatin, vincristine, and etoposide. Carboplatin is in a class of medications known as platinum-containing compounds. It works in a way similar to the anticancer drug cisplatin, but may be better tolerated than cisplatin. Carboplatin works by killing, stopping or slowing the growth of cancer cells. Vincristine is in a class of medications called vinca alkaloids. It works by stopping cancer cells from growing and dividing and may kill them. Etoposide is in a class of medications known as podophyllotoxin derivatives. It blocks a certain enzyme needed for cell division and DNA repair and may kill cancer cells. Adding melphalan to standard chemotherapy early in treatment may improve the ability to treat vitreous seeds and may be better than standard chemotherapy alone in treating retinoblastoma.

Начало: 04.11.2022 Край: 31.03.2028 Възраст: до 18 г. Лечение

Australia, Canada, United States Children's Oncology Group NCT05504291

Набира участници

Evaluation of Fractional Ablative Laser Treatment for Skin Conditions

Skin Laxity

Evaluate the safety and efficacy of the fractional ablative laser for treatment of skin laxity and tightening

Начало: 01.11.2022 Край: 30.12.2027 Възраст: 18–85 г.

United States Sciton NCT05750901

Набира участници Фаза 1/2

Seviteronel in Combination With Chemotherapy in Androgen-receptor Positive Metastatic Triple-negative Breast Cancer

Triple Negative Breast Cancer

To facilitate the clinical testing of seviteronel and dexamethasone (SEVI-D) in combination with docetaxel in androgen receptor (AR) positive triple-negative breast cancer.

Начало: 01.11.2022 Край: 01.12.2027 Възраст: от 18 г. Лечение

Australia St Vincent's Hospital, Sydney NCT04947189

Набира участници Фаза 2

Pembrolizumab and Brentuximab Vedotin vs GDP and Stem Cell Transplant for Relapsed/Refractory Hodgkin Lymphoma

Hodgkin Lymphoma

This study is being done to determine if two new drugs can shrink or eliminate classical Hodgkins lymphoma.

Начало: 01.11.2022 Край: 31.12.2026 Възраст: от 18 г. Лечение

Australia, Canada Canadian Cancer Trials Group NCT05180097

Набира участници Фаза 1/2

Phase I/II Study of CAR.70- Engineered IL15-transduced Cord Blood-derived NK Cells in Conjunction With Lymphodepleting Chemotherapy for the Management of Relapse/Refractory Hematological Malignances

B-Cell Lymphoma Myelodysplastic Syndromes (MDS) Acute Myeloid Leukemia (AML) Multiple Myeloma +6

The goal of this clinical research study is to learn about the safety of giving immune cells called natural killer (NK) cells with chemotherapy to patients with leukemia, lymphoma, or multiple myeloma. Immune system cells (such as NK cells) are made by the body to attack foreign or cancerous cells. Researchers think that NK cells you receive from a donor may react against cancer cells in your body, which may help to control the disease.

Начало: 01.11.2022 Край: 31.08.2026 Възраст: 12–80 г.

United States M.D. Anderson Cancer Center NCT05092451

Набира участници

A Study to Learn About How 20-Valent Pneumococcal Conjugate Vaccine Works in a Real-world Setting

Pneumonia

The purpose of this study is to learn about how well the 20-valent pneumococcal conjugate vaccine (20vPnC) works against radiologically-confirmed community-acquired pneumonia (RAD+CAP) due to the 7 new serotypes (types of a bacteria called Streptococcus pneumoniae that cause pneumonia) included in 20vPnC vaccine. This study is seeking participants who: * are male or female ≥65 years of age. * are hospitalized with physician suspicion of community acquired pneumonia (CAP). * have pneumonia confirmed with imaging like a chest x-ray Participants will be asked to provide demographic and medical history information, and to provide a urine sample that will be used to test for pneumonia caused by specific strains of a bacteria called Streptococcus pneumoniae. We will compare the proportion of participants who have pneumonia caused by specific strains of the bacteria Streptococcus pneumoniae and were previously vaccinated with 20vPnC with the proportion of participants who have pneumonia caused by something other than vaccine type Streptococcus pneumoniae and have been vaccinated with 20vPnC. Participants will actively take part in the study for about 1-2 days. Information on participant's illness and hospitalization details will be collected through day 30 of their hospitalization through medical chart review.

Начало: 27.10.2022 Край: 04.06.2027 Възраст: от 65 г.

Israel, Spain, United States Pfizer NCT05452941

Набира участници

An Observational Study to Assess the Effectiveness and Safety of a Cemiplimab in Adult Patients With Advanced Non-Small Cell Lung Cancer (NSCLC) in Routine Clinical Practice Settings in Europe

Non-small Cell Lung Cancer

This study is focused on patients with non-small cell lung cancer (NSCLC) and have been prescribed a cemiplimab (Libtayo®) based treatment regimen under standard care. The goal of this study is to learn more about the use, benefits, and safety of cemiplimab based treatment regimens in participants with NSCLC.

Начало: 26.10.2022 Край: 30.10.2028 Възраст: от 18 г.

Austria, France, Germany +2 Regeneron Pharmaceuticals NCT05363319

Набира участници Фаза 1

A Study Evaluating the Safety, Pharmacokinetics, and Efficacy of Mosunetuzumab or Glofitamab in Combination With CC-220 and/or CC-99282 in Participants With B-Cell Non-Hodgkin Lymphoma

Non-Hodgkin Lymphoma

This study will evaluate the safety, efficacy, and pharmacokinetics of mosunetuzumab or glofitamab in combination with CELMoDs (CC-220 and/or CC-99282) in participants with B-cell NHL.

Начало: 26.10.2022 Край: 15.09.2029 Възраст: от 18 г.

Israel, Italy, Spain +2 Hoffmann-La Roche NCT05169515

Набира участници

Magnesium and Cognition After Stroke

Stroke Cognition Magnesium Neurologic Disorder

Cognitive impairments such as memory impairments, word-finding difficulties, compromised orientation and perception are often observed in stroke patients. Low serum-mg-concentrations are associated with cognitive impairments in ischemic stroke patients one month after stroke onset. It is not clear, if cognitive impairments after stroke is caused by the mg-deficiency or by the stroke itself. Until now, no studies investigating the relationship between mg-concentration, stroke severity and cognition during treatment course are available. Thus, this study aimed to investigate the relationship between mg-concentration and cognition of stroke patients.

Начало: 26.10.2022 Край: 30.09.2027 Възраст: от 18 г.

Germany BDH-Klinik Hessisch Oldendorf NCT05132517

Набира участници Фаза 1

A Phase 1 Study of AB521 Monotherapy and Combination Therapies in Renal Cell Carcinoma and Other Solid Tumors

Clear Cell Renal Cell Carcinoma Solid Tumors

The purpose of this study is to evaluate the safety and tolerability of: * casdatifan when taken alone in participants with advanced solid tumor malignancies and clear cell renal cell carcinoma (ccRCC) during the dose escalation stage; and * casdatifan monotherapy and casdatifan in combination with cabozantinib or zimberelimab or zimberelimab and ipilimumab in participants with ccRCC in the dose expansion stage.

Начало: 26.10.2022 Край: 01.03.2029 Възраст: от 18 г. Лечение

Australia, South Korea, Spain +1 Arcus Biosciences, Inc. NCT05536141

Набира участници Фаза 1

A First-in-human Study of IBI343 in Subjects With Locally Advanced Unresectable or Metastatic Solid Tumors

Locally Advanced Unresectable or Metastatic Solid Tumors

This is a Phase Ia/Ib, multicenter, open-label, first-in-human study to evaluate the safety, tolerability, PK, and efficacy of IBI343 in participants with locally advanced unresectable or metastatic solid tumors. It is planned to be carried out in different countries or regions such as China, Australia and US. There are three parts in phase Ia. Part 1 includes dose escalation and expansion phase and part 2 is designed for dose optimization for IBI343 monotherapy. Part 3 1L G/GEJ AC and 1L PDAC cohorts will include an initial safety lead-in stage to confirm the tolerability of IBI343 in combination with chemotherapy in 1L PDAC and G/GEJ AC, followed by a randomized dose-optimization stage designed to further characterize safety, pharmacokinetics, and preliminary efficacy to inform selection of the recommended Phase 3 dose. Part 3 metabolite profiling cohort is designed to explore the payload metabolites in an advanced PDAC population.

Начало: 26.10.2022 Край: 31.12.2027 Възраст: от 18 г. Лечение

Australia, China, United States Innovent Biologics (Suzhou) Co. Ltd. NCT05458219

Набира участници Фаза 1

A Study of PF-08046054/SGN-PDL1V in Advanced Solid Tumors

Carcinoma, Non-Small-Cell Lung Squamous Cell Carcinoma of the Head and Neck Esophageal Squamous Cell Carcinoma Triple Negative Breast Neoplasms +4

This study will test the safety of a drug called PF-08046054/SGN-PDL1V alone and with pembrolizumab in participants with solid tumors. It will also study the side effects of this drug. A side effect is anything a drug does to your body besides treating your disease. Participants will have solid tumor cancer that has spread through the body (metastatic) or cannot be removed with surgery (unresectable). This study will have five parts. Parts A and B of the study will find out how much PF-08046054/SGN- PDL1V should be given to participants. Part C will use the dose found in Parts A and B to find out how safe PF-08046054/SGN-PDL1V is and if it works to treat solid tumor cancers. In Part D and E, participants will be given PF-08046054/SGN-PDL1V with pembrolizumab to find out how safe this combination is and if it works to treat solid tumor cancers.

Начало: 25.10.2022 Край: 04.01.2029 Възраст: от 18 г.

Belgium, Canada, China +8 Seagen, a wholly owned subsidiary of Pfizer NCT05208762

Набира участници Фаза 3

A Study of Teclistamab in Combination With Daratumumab and Lenalidomide (Tec-DR) and Talquetamab in Combination With Daratumumab and Lenalidomide (Tal-DR) in Participants With Newly Diagnosed Multiple Myeloma

Multiple Myeloma

The purpose of this study is to compare the efficacy of teclistamab in combination with daratumumab and lenalidomide (Tec-DR) and talquetamab in combination with daratumumab and lenalidomide (Tal-DR) versus daratumumab, lenalidomide, dexamethasone (DRd).

Начало: 25.10.2022 Край: 28.10.2033 Възраст: от 18 г. Лечение

Australia, Belgium, Brazil +18 Janssen Research & Development, LLC NCT05552222

Набира участници

A Natural History Study of Metabolic Sizing in Health and Disease

Metabolic Disorders Cancer Chronic Kidney Disease Diabetes +1

Background: Scientists have long used simple measures (such as height and weight) to estimate how much a person s body uses food (calories) as energy, as commonly called the metabolic rate. But metabolism varies among people with similar body sizes. Scientists now believe the old formulas for estimating metabolic rates may not work well for all people. Researchers want to find more accurate ways to measure a person s metabolism. Objective: This natural history study will examine the relationships between metabolism, body composition, and body surface area in a wide range of people. Eligibility: Healthy children and adults aged 2 years or older. Also, people aged 2 years or older with conditions that may alter metabolism. These may include diabetes, obesity, renal disease, or cancer. Design: Participants will spend 2 days and 1 night in the hospital. They will provide a medical history and answer questions about their activity levels, the foods they eat, and their lifestyle. They will also eat a special diet. Participants will undergo many tests: They will lie in a bed with a clear hood covering their head for 30 to 45 minutes to measure the gases in their breath. They will lie on a padded table for about 15 minutes while their body is scanned. They will stand on a platform while a 3D scanner measures their body. They will have a test to measure how fast an electric signal moves through their body. They will grip an instrument to measure the strength of their hands. They will drink salty water and provide blood and urine samples. Participants may be invited to return for these 2-day visits up to 8 times per year. Return visits must be at least 2 weeks apart.

Начало: 25.10.2022 Край: 01.07.2031 Възраст: 2–99 г.

United States National Institute of Diabetes and Digestive and Kidney NCT05398783

Набира участници Фаза 3

A Study of Tucatinib With Trastuzumab and mFOLFOX6 Versus Standard of Care Treatment in First-line HER2+ Metastatic Colorectal Cancer

Colorectal Neoplasms

This study is being done to find out if tucatinib with other cancer drugs works better than standard of care to treat participants with HER2 positive colorectal cancer. This study will also determine what side effects happen when participants take this combination of drugs. A side effect is anything a drug does to the body besides treating your disease. Participants in this study have colorectal cancer that has spread through the body (metastatic) and/or cannot be removed with surgery (unresectable). Participants will be assigned randomly to the tucatinib group or standard of care group. The tucatinib group will get tucatinib, trastuzumab, and mFOLFOX6. The standard of care group will get either: * mFOLFOX6 alone, * mFOLFOX6 with bevacizumab, or * mFOLFOX6 with cetuximab mFOLFOX6 is a combination of multiple drugs. All of the drugs given in this study are used to treat this type of cancer.

Начало: 24.10.2022 Край: 27.07.2029 Възраст: от 18 г. Лечение

Argentina, Australia, Belgium +20 Seagen, a wholly owned subsidiary of Pfizer NCT05253651

Набира участници Фаза 2/3

Combined Dose-Finding and CV Outcomes Study With CSL300 (Clazakizumab) in Adult Subjects With ESKD Undergoing Dialysis

Atherosclerotic Cardiovascular Disease End Stage Kidney Disease Atherosclerotic Cardiovascular Disease in Patients With ESKD

This is a 2-part (phase 2b/3) prospective, interventional, multicenter, randomized, double-blind, placebo-controlled study. Part 1 (phase 2b) is a dose-finding study for CSL300 vs placebo. Part 2 (phase 3) aims to assess the efficacy of CSL300 on cardiovascular (CV) outcomes and safety in subjects with systemic inflammation and either atherosclerotic cardiovascular disease (ASCVD) or diabetes with end stage kidney disease (ESKD) undergoing maintenance dialysis.

Начало: 21.10.2022 Край: 27.09.2029 Възраст: от 18 г. Поддържаща грижа

Argentina, Australia, Belgium +27 CSL Behring NCT05485961

Набира участници Фаза 1

A Study to Evaluate the Safety, Pharmacokinetics, and Activity of Enzelkitug as a Single Agent and in Combination With Checkpoint Inhibitor in Participants With Locally Advanced or Metastatic Solid Tumors

Locally Advanced or Metastatic Solid Tumors NSCLC HNSCC Melanoma +8

This is a first-in-human study to evaluate the safety, tolerability, pharmacokinetics (PK), and anti-tumor activity of enzelkitug when administered as a single agent and in combination with atezolizumab or pembrolizumab in adult participants with locally advanced or metastatic solid tumors, including non small cell lung cancer (NSCLC), head and neck squamous cell carcinoma (HNSCC), melanoma, triple-negative breast cancer (TNBC), esophageal cancer, gastric cancer, cervical cancer, colorectal cancer (CRC), urothelial carcinoma (UC), clear cell renal cell carcinoma (RCC) and hepatocellular carcinoma (HCC). Participants will be enrolled in 2 stages: dose escalation and dose expansion.

Начало: 20.10.2022 Край: 31.07.2028 Възраст: от 18 г. Лечение

Australia, Belgium, Canada +7 Genentech, Inc. NCT05581004

Набира участници Фаза 2

A Study Comparing Rituximab/Bendamustin(RB) Alternating With Rituximab/Bendamustin/Cytarabin(RBAC) With RB Therapy in Elderly Patients With Mentle Cell Lymphoma

Mantle Cell Lymphoma

This is a phase 2, multicenter, open-label, active-controlled randomized trial to determine efficacy and safety of rituximab/bendamustine (RB) alternating with rituximab/bendamustine/cytarabine (RBAC) compared with standard RB alone in the first-line treatment of elderly patients with mantle cell lymphoma, who are not eligible for high-dose therapy followed by autologous stem cell transplantation.

Начало: 18.10.2022 Край: 31.12.2029 Възраст: от 60 г.

South Korea Kim, Seok Jin NCT05245656

Набира участници

Subthreshold Nanosecond Laser for Non-resolving Central Serous Chorioretinopathy

Central Serous Chorioretinopathy

This is a prospective, multicentre, sham-controlled, participant- and assessor-masked superiority trial with two parallel treatment arms which aims to investigate the safety and efficacy of subthreshold nanosecond laser (SNL) in a series of adults with sub-retinal fluid secondary to non-resolving central serous chorioretinopathy (CSCR) by visual and anatomical outcomes. The study population will be individuals with adults (aged 18-70 years inclusive) with non-resolving CSCR (defined as CSCR present for a duration of more than 3 months presenting with either focal or diffuse leakage) who meet all eligibility criteria. 60 subjects total will be enrolled into the study - 40 randomized to receive SNL treatment and 20 to receive sham treatment as per a 2:1 randomization schedule and stratified by type of CSCR (focal vs diffuse). The study has a 24-week study period with five scheduled visits: screening, randomisation (first treatment), 6-week follow up (with second treatment where eligible), 12-week follow-up , 18-week follow-up, and 24-week follow-up. The primary outcome is the proportion of laser-treated study eyes that show resolution of sub-retinal fluid (SRF) as observed on optical coherence tomography (OCT) compared to sham-treated study eyes at 24 weeks. The safety endpoint will be proportion of laser-treated eyes that lose ≥10 letters of of vision (measured on a standard vision chart) compared to sham-treated study eyes and fellow eyes over 24 weeks.

Начало: 18.10.2022 Край: 31.12.2024 Възраст: 18–70 г. Лечение

Australia Nova Eye Medical Pty Ltd. NCT05570591

Набира участници

Radio-opaque Contrast Agents for Liver Cancer Targeting With KIM During Radiation Therapy

Liver Neoplasm

This observational study will investigate the properties of image files standardly collected during radiation therapy treatment in a cross-section of liver cancer patients who received stereotactic ablative body radiation therapy (SABR) after trans-catheter arterial chemo emobilisation (TACE). Specifically, it will determine whether the radio-opaque contrast agents in the image files can be detected by tumour-tracking software (KIM).

Начало: 17.10.2022 Край: 31.10.2026 Възраст: от 18 г.

Australia University of Sydney NCT05169177

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