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Набира участници Фаза 1/2

Adding IL-2 to Tebentafusp to Eradicate Cancer Progression

Uveal Melanoma Metastatic Uveal Melanoma Metastatic Uveal Melanoma in the Liver

A recent clinical trial found that after 36 months, patients taking tebentafusp had a median survival of 21.6 months, compared to 16.9 months for those in the control group. Since recruitment for tebentafusp in metastatic uveal melanoma (mUM) has ended, a new trial is starting to test whether adding IL-2 can help overcome resistance to tebentafusp and improve its effectiveness. This study aims to answer: 1. Can combining tebentafusp with IL-2 improve tumor response and overall survival? 2. What are the benefits and side effects of this combination therapy? All participants will receive both IL-2 and tebentafusp in a 28-day treatment cycle. The dosing schedule is as follows: Cycle1: Day1-3 IL-2 Day4 Tebentafusp Day 10 IL-2 Day 11 Tebentafusp Day 17 IL-2 Day 18 Tebentafusp Day 24 IL-2 Day 25 Tebentafusp Cycle 2 \& thereafter Day 1 IL-2 Day 2 Tebentafusp Day 8 IL-2 Day 9 Tebentafusp Day 15 IL-2 Day 16 Tebentafusp Day 22 IL-2 Day 23 Tebentafusp

Начало: 01.06.2025 Край: 01.09.2027 Възраст: от 18 г. Лечение

Australia St Vincent's Hospital, Sydney NCT07063875

Набира участници

Unravelling Energy Issues Underpinning Low Energy Availability in High Performance Athletes

Relative Energy Deficiency in Sport

The goal of this clinical trial is to understand how the body responds to short-term, severe low energy availability (LEA) in healthy, weight-bearing endurance athletes aged 18-45 years old. LEA describes a mismatch between an individual's dietary energy intake and the energy cost of their commitments for training and competition. The main questions this trial aims to answer are: 1. What effect does short-term, severe LEA have on sleeping metabolic rate? 2. What effect does short-term, severe LEA have on other body systems identified within the Relative Energy Deficiency in Sport (REDs) Health and Performance Conceptual models? Researchers will compare a control trial with both a LEA trial achieved through diet restriction and a LEA trial achieved through increased exercise to see if there are differences in the body's response. Participants will complete three 6-day trials, a minimum of 3-weeks apart, involving: * Prescribed diet (all food provided) * Prescribed running and/or cycling exercise * Two visits to ACU Fitzroy campus for blood tests and exercise testing * 50 hour stay (two nights and two days) in the ACU metabolic chamber

Начало: 01.06.2025 Край: 01.06.2027 Възраст: 18–45 г. Фундаментална наука

Australia Australian Catholic University NCT07026175

Набира участници Фаза 1/2

Bevacizumab and ICIs + hSRT in Symptomatic Melanoma Brain Metastases

Melanoma Brain Metastases

Single arm phase I/II trial to evaluate the safety and efficacy of the combination of bevacizumab, with ipilimumab plus nivolumab, and hypofractionated stereotactic radiotherapy (hSRT) in patients with symptomatic melanoma brain metastases (MBM).

Начало: 31.05.2025 Край: 30.01.2026 Възраст: от 18 г. Лечение

Australia Melanoma and Skin Cancer Trials Limited NCT06163820

Набира участници Фаза 1/2

Study to Evaluate the Safety, Tolerability & Efficacy of TNG462 in Combination in PDAC & NSCLC Patients

PDAC PDAC - Pancreatic Ductal Adenocarcinoma NSCLC RAS Mutation +4

TNG462-C102 is a Phase 1/2, open-label, multicenter study designed to determine the safety, tolerability, PK, PD, and preliminary antineoplastic activity of oral TNG462 in combination with RMC-6236, RMC-9805, mFOLFIRINOX or gemcitabine/nab-paclitaxel. The study comprises a dose escalation phase and a dose expansion phase.

Начало: 31.05.2025 Край: 01.12.2027 Възраст: от 18 г.

United States Tango Therapeutics, Inc. NCT06922591

Набира участници Фаза 2

A Study Testing the Combination of Dasatinib or Imatinib to Chemotherapy Treatment With Blinatumomab for Children, Adolescents, and Young Adults With Philadelphia Chromosome Positive (Ph+) or ABL-Class Philadelphia Chromosome-Like (Ph-Like) B-cell Acute Lymphoblastic Leukemia (B-ALL)

B Acute Lymphoblastic Leukemia

This pilot trial assesses the effect of the combination of blinatumomab with dasatinib or imatinib and standard chemotherapy for treating patients with Philadelphia chromosome positive (Ph+) or ABL-class Philadelphia chromosome-like (Ph-like) B-Cell acute lymphoblastic leukemia (B-ALL). Blinatumomab is a bispecific antibody that binds to two different proteins-one on the surface of cancer cells and one on the surface of cells in the immune system. An antibody is a protein made by the immune system to help fight infections and other harmful processes/cells/molecules. Blinatumomab may bind to the cancer cell and a T cell (which plays a key role in the immune system's fighting response) at the same time. Blinatumomab may strengthen the immune system's ability to fight cancer cells by activating the body's own immune cells to destroy the tumor. Dasatinib and imatinib are in a class of medications called tyrosine kinase inhibitors. They work by blocking the action of an abnormal protein that signals cancer cells to multiply, which may help keep cancer cells from growing. Giving blinatumomab and dasatinib or imatinib in combination with standard chemotherapy may work better in treating patients with Ph+ or Ph-like ABL-class B-ALL than dasatinib or imatinib with chemotherapy.

Начало: 30.05.2025 Край: 01.12.2030 Възраст: 366–46 г. Лечение

Australia, Canada, Puerto Rico +1 National Cancer Institute (NCI) NCT06124157

Набира участници Фаза 1

PAS-004 in Adults Who Have Neurofibromatosis Type 1 With Plexiform Neurofibromas

NF1 Mutation Neurofibroma Plexiform Neurofibroma, Plexiform Neurofibromatosis Type 1 (NF1)-Related Plexiform Neurofibromas (PNs) +1

The main purpose of this clinical trial is to test PAS-004 in people with at least one symptomatic plexiform neurofibroma due to Neurofibromatosis Type 1 (NF1). The main questions it aims to answer are: * How well participants are able tolerate different doses of PAS-004, and * What side effects PAS-004 might have. This study will have two parts, Part A and Part B. The main goal of Part A of this study is to learn more about how participants tolerate different doses of PAS-004, and what side effects PAS-004 might have. What we learn from Part A of the study will help decide what doses of the study drug (PAS-004) should be used in Part B of the study, and if it is safe. In Part B, two different doses from Part A will be tested. The main goal of this part of the study is to keep studying any side effects of PAS-004 at those two dose levels, and to learn more about if the doses picked for this part of the study might have an effect on plexiform neurofibromas. Participants in Part A of the study who were taking doses selected for Part B may be able to continue on to Part B and keep taking the same dose of PAS-004 for 6 more months. Study participants in both parts will have regular visits to the study doctor and be asked to have tests and exams done to check on their health and safety, including blood draws and MRIs. Everyone participating in the study will take PAS-004 by mouth once a day during the study, in 28-day cycles. Participants will be asked to keep a diary to record their daily dose of study drug. Participants will continue on daily PAS-004 for up to 6 months, or until: * They decide to withdraw from the study, or * They experience unacceptable side effects, or * Their disease progresses, or another illness interferes with taking the study drug, or * The sponsor selects a dose level to study further in the next part of the study, or * The sponsor stops the study.

Начало: 30.05.2025 Край: 01.12.2027 Възраст: от 18 г. Лечение

Australia, South Korea, United States Pasithea Therapeutics Corp. NCT06961565

Набира участници Фаза 3

A Study of BGB-16673 Compared to Investigator's Choice in Participants With Relapsed/Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma Previously Exposed to Covalent Bruton Tyrosine Kinase (BTK) Inhibitors

Chronic Lymphocytic Leukemia Small Lymphocytic Lymphoma

The purpose of this study is to investigate the efficacy and safety of BGB-16673 compared with investigator's choice (bendamustine plus rituximab or high-dose methylprednisolone plus rituximab) in participants with relapsed/refractory (R/R) chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) previously exposed to covalent Bruton tyrosine kinase inhibitor(s) (cBTKi).

Начало: 29.05.2025 Край: 30.11.2029 Възраст: от 18 г.

China, Taiwan BeOne Medicines NCT06970743

Набира участници Фаза 3

A Study of Retatrutide (LY3437943) in Participants Who Have Obesity or Overweight and Chronic Low Back Pain

Obesity Overweight Chronic Low Back Pain (CLBP)

The main purpose of this study is to evaluate the efficacy and safety of retatrutide in relieving chronic low back pain in participants who have obesity or overweight. Participation in the study will last about 80 weeks.

Начало: 29.05.2025 Край: 01.09.2027 Възраст: от 18 г.

Argentina, Canada, Mexico +2 Eli Lilly and Company NCT07035093

Набира участници Фаза 1

Study of GS-3242 in Participants With HIV-1; Substudy-05

HIV-1-infection

This study is part of a master study. The goal of master protocol (GS-US-544-5905, NCT05585307) is to learn how novel antiretrovirals (medicines that stop the virus from multiplying) affect the human immunodeficiency virus-1 (HIV-1) infection in people living with HIV (PWH). Substudy GS-US-544-5905-05 is to learn more about the study drug GS-3242 in PWH.

Начало: 29.05.2025 Край: 01.02.2027 Възраст: 18–65 г. Лечение

Mexico, Thailand, United States Gilead Sciences NCT07001319

Набира участници Фаза 2

A Clinical Study of Intismeran Autogene (V940) and Pembrolizumab (MK-3475) in People With Melanoma (V940-012/INTerpath-012)

Malignant Melanoma

Researchers want to learn if intismeran autogene with pembrolizumab can stop advanced melanoma from growing or spreading. Melanoma is a type of skin cancer. Advanced means the cancer has spread to other parts of the body and cannot be removed with surgery. A standard (or usual) treatment for advanced melanoma is immunotherapy. Immunotherapy is a treatment that helps the immune system fight cancer. Intismeran autogene is a study treatment designed to help a person's immune system attack their specific cancer. Pembrolizumab is an immunotherapy. The goal of this study is to learn if people who receive intismeran autogene with pembrolizumab live longer without the cancer growing or spreading than people who receive placebo with pembrolizumab. A placebo looks like the study treatment but has no study treatment in it. Using a placebo helps researchers better understand the effects of a study treatment.

Начало: 29.05.2025 Край: 05.09.2031 Възраст: от 18 г. Лечение

Australia, Canada, France +8 Merck Sharp & Dohme LLC NCT06961006

Набира участници Фаза 3

A Study to Investigate the Treatment Effect of Subcutaneous Injections of Pentosan Polysulfate Sodium Compared With Placebo in Adult Participants With Knee Osteoarthritis Pain.

Osteoarthritis, Knee

The purpose of this study is to measure the change in pain and function with subcutaneous injections of pentosan polysulfate sodium (PPS) compared with subcutaneous injections of placebo in participants with knee OA pain. Study details include: * The study duration will be up to 64 weeks. * The treatment duration will be 6 weeks. * The visit frequency will be twice weekly during treatment. * The visit/contact frequency will be every 4-6 weeks during the 52-week Follow-up period. * Approximately 466 participants will be enrolled into this study.

Начало: 29.05.2025 Край: 01.07.2027 Възраст: от 18 г. Лечение

Australia, United States Paradigm Biopharmaceuticals Ltd. NCT06917404

Набира участници

U-CaVIT Versus Standard of Care for Prevention of Atonic Postpartum Hemorrhage After Cesarean Section in High-risk Women.

Postpartum Hemorrhage (Primary) Hemorrhage Postpartum Complication Delivery ,Complications,Maternal +3

This pilot study aims to assess performance, safety and feasibility of U-CaVIT method (Uro-Catheter Vacuum Induced Tamponade), using the Rüsch® Brillant Silicone Balloon Catheter, an urological catheter, for the prevention of atonic PPH in high-risk women undergoing cesarean delivery. The U-CaVIT method has been implemented at the Department of Obstetrics at university hospital of Zurich (USZ) due to temporary supply issues with the Bakri® Balloon Catheter. The Rüsch® Balloon Catheter is used in case of uterine atony when standard first-line uterotonic treatments have failed or in some cases as add-on therapy in non-atonic PPH. In the meantime, the use of U-CaVIT has become standard practice at the USZ for the treatment of atonic PPH, appearing to be user-friendly, clinically effective according to treating physicians, well tolerated by the treated women and cost-saving compared to the previously used Bakri® Balloon.

Начало: 28.05.2025 Край: 01.11.2026 Възраст: от 18 г.

Switzerland Christian Haslinger NCT07019623

Набира участници

Suicide Preventive Psychosocial Treatment for Youths

Suicide Attempt Suicidal and Self-injurious Behavior Suicide Attempted Suicide, Attempted

Suicide is the leading cause of death amongst 10-18-year-olds in Sweden. Suicide attempts are the strongest predictor of subsequent death by suicide, often lead to inpatient care, and are associated with substantial societal costs, making suicide attempts a critical target in psychiatric intervention research. Although youths attempting suicide are typically assessed and treated for potential comorbid psychiatric conditions, there is currently no trans-diagnostic evidence-based treatment specifically targeting suicidal behavior. To fill this gap, the Safe Alternatives for Teens and Youths (SAFETY) was developed. SAFETY is a transdiagnostic family-based cognitive-behavioral suicide prevention program that has shown promise but more studies are needed. The overall objective of this project is to evaluate the efficacy, durability, and cost-effectiveness of the SAFETY intervention, a scalable suicide prevention intervention that can be offered immediately following a youth suicide attempt, in a fully powered single-blind randomized controlled superiority trial. Our primary hypothesis is that the SAFETY intervention will be superior to Enhanced Treatment As Usual (enhanced with the evidence-based intervention safety planning) in reducing the proportion of suicide reattempts. Moreover, we predict that these improvements will be maintained for up to 60 months post-treatment. Finally, we expect that SAFETY will be cost-effective compared to the control intervention, both at the primary endpoint and in the longer term.

Начало: 28.05.2025 Край: 01.09.2032 Възраст: 10–17 г.

Sweden Karolinska Institutet NCT06931639

Набира участници

Impacts of Cash Transfers on Child Neurodevelopment (Auxilio Brasil)

Inflammation HPA CBCL Family Relations

This study examines the impact of Auxilio Brasil (AB), a cash transfer program to mothers of school-age children, on resource-deprived populations in Brazil and its protective effects on child neurodevelopment and mental health. The investigators will conduct a randomized clinical trial (RCT) among those already receiving AB in which 300 families will be randomized in a 1:1 ratio to receive either a high ($40/month) or low ($2/month) supplemental transfer for 2 years. Three hundred children (index child participants; 7-10 years old) will be enrolled across both study arms. Additionally, up to 150 siblings ("sibling participants;" 7-10 years old) will be enrolled. Eligible families who decide to participate will sign a study-specific informed consent (mother) and assent (child) form. The UNIFESP team will conduct the respective assessments at baseline, approximately 8- and 16- months, 24-months and approximately 6-months post-RCT. Aim 1: Determine the impact of high vs low cash transfers on children's exposure to adversities (ACEs) and neurodevelopment. Aim 2: Determine the impact of cash transfers on children's inflammatory markers and HPA activity/cortisol. Exploratory Aim: The investigators will explore (i) whether sex/gender of the children moderates the pathways in the above mediation model; and (ii) whether cash transfer-related effects persist 6 months post-RCT.

Начало: 28.05.2025 Край: 31.01.2029 Възраст: 23–45 г.

Brazil, United States New York State Psychiatric Institute NCT05477901

Набира участници Фаза 1/2

A Study to Evaluate KRIYA-825 (VV-14295) in Adults With Geographic Atrophy Secondary to Age-related Macular Degeneration

Geographic Atrophy Secondary to Age-related Macular Degeneration

The goal of this study is to evaluate how safe and tolerable KRIYA-825 (VV-14295) is and to determine how effective it is in reducing the growth of geographic atrophy (GA) lesions in the treated eye in patients with GA secondary to age-related macular degeneration (AMD).

Начало: 28.05.2025 Край: 15.12.2027 Възраст: 55–80 г. Лечение

Canada, New Zealand Kriya Therapeutics, Inc. NCT06765980

Набира участници Фаза 2

A Study to Assess Adverse Events and Change in Disease Activity in Participants With Platinum-Resistant Advanced High-Grade Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancers With High Folate Receptor-Alpha Expression Treated With Intravenously (IV) Infused Mirvetuximab Soravtansine

Advanced High-Grade Epithelial Ovarian Primary Peritoneal Fallopian Tube Cancers High Folate Receptor-Alpha Expression +1

Cancer is a condition where cells in a specific part of body grow and reproduce uncontrollably. The purpose of this study is to assess the safety and efficacy of for Mirvetuximab Soravtansine in participants with platinum-resistant advanced high-grade epithelial ovarian, primary peritoneal, or fallopian tube cancer (platinum-resistant ovarian cancer) (PROC) whose tumors express a high level of folate receptor alpha (FRα). Mirvetuximab Soravtansine (MIRV) is an investigational antibody drug conjugate designed to selectively kill cancer cells. The antibody (protein) part of MIRV targets tumors by delivering a cell-killing drug to cancer cells carrying a protein called folate receptor alpha (FRα). There are 2 cohorts in this study, the Randomized Phase 2 Cohort and the Hepatic Impairment Cohort. In the Randomized Phase 2 Cohort, participants are placed in 1 of 2 groups, called treatment arms. Each treatment arm receives MIRV on a different schedule (on day 1 every 21 days or on days 1 and 15 every 28 days). The Hepatic Impairment Cohort is designed to determine the starting dose of MIRV in patients with moderately abnormal liver function. Around 110 participants will be enrolled in the study at approximately 75 sites worldwide. The total study duration will be approximately 24 months. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic and may require frequent medical assessments, blood tests, and scans.

Начало: 28.05.2025 Край: 01.03.2028 Възраст: от 18 г. Лечение

Australia, Belgium, South Korea +3 AbbVie NCT06682988

Набира участници Фаза 2

A Study to Assess the Effectiveness and Safety of Pacritinib in Patients With VEXAS Syndrome (PAXIS)

VEXAS VEXAS Syndrome

This trial is to assess the effectiveness and safety of pacritinib in patients with VEXAS (i.e., Vacuoles in myeloid progenitors, E1 ubiquitin-activating enzyme, X-linked, autoinflammatory manifestations, and somatic) syndrome. 78 participants will be enrolled, randomized to either pacritinib dose A, pacritinib dose B + placebo, or placebo. Randomization will be stratified by prescribed GC dose on the day of randomization.

Начало: 28.05.2025 Край: 22.05.2028 Възраст: от 18 г.

Canada, France, Germany +5 Swedish Orphan Biovitrum NCT06782373

Набира участници Фаза 3

Study to Assess the Efficacy and Safety of IMVT-1402 in Participants With Mild to Severe Generalized Myasthenia Gravis

Generalized Myasthenia Gravis

The purpose of the study is to assess the efficacy, safety and tolerability of IMVT-1402 in adult participants with mild to severe generalized myasthenia gravis.

Начало: 27.05.2025 Край: 01.12.2028 Възраст: 18–80 г.

Czechia, Denmark, Georgia +10 Immunovant Sciences GmbH NCT07039916

Набира участници Фаза 2

A Study of Long-acting Antibodies Alone and in Combinations for Moderate to Severe Ulcerative Colitis

Ulcerative Colitis Inflammatory Bowel Diseases Colitis Colitis, Ulcerative

This is a Phase 2, multicenter, proof-of-concept platform study in adult participants with moderately to severely active ulcerative colitis (UC). The primary goal of the study is to assess the efficacy and safety of multiple interventions following intravenous (IV) induction and subcutaneous (SC) maintenance treatment.

Начало: 27.05.2025 Край: 01.03.2028 Възраст: от 18 г. Лечение

Australia, Austria, Belgium +26 Spyre Therapeutics, Inc. NCT07012395

Набира участници Фаза 1

Evaluating the Safety and Tolerability of Orally Administered DF-003 in ROSAH Syndrome Patients

ROSAH

The purpose of this study is to evaluate the safety and tolerability of DF-003 in retinal dystrophy, optic nerve edema, splenomegaly, anhidrosis, and migraine headache (ROSAH) syndrome patients.

Начало: 27.05.2025 Край: 01.05.2026 Възраст: 18–65 г. Лечение

Australia, United States Shanghai Yao Yuan Biotechnology Ltd. (also known as Dru NCT06395285

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