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Found 29 Actively Recruiting clinical trials
Actively Recruiting
Researchers are evaluating new treatment options for advanced renal cell carcinoma (RCC), focusing on ways to control cancer growth and spread. This study compares the effects of combining two targeted therapies, belzutifan and zanzalintinib, to belzutifan alone in people with advanced RCC who have previously received certain therapies. The goal is to see if the combination can help patients live longer overall and without their cancer worsening. Participants will receive oral tablets of belzutifan combined either with zanzalintinib or a placebo that looks like zanzalintinib. This is a Phase 3, randomized, double-blind study, meaning neither the participants nor the researchers know which treatment is being given until the study ends. The study focuses on people with advanced RCC who have progressed after prior treatments involving PD-1/L1 and VEGF-TKI therapies. Throughout the study, participants will be monitored for how long they live without their cancer progressing (progression-free survival) for up to about 30 months and overall survival for up to about 50 months. Researchers will conduct evaluations to assess the cancer's response and monitor safety. Participation involves regular assessments, and the total monitoring period can last up to several years to gather important information about the treatments' effects and tolerability.
Actively Recruiting
Researchers are evaluating treatments for breast cancer that is hormone receptor-positive (HR+) and human epidermal growth factor receptor 2-negative (HER2-), specifically in cases where the cancer is either locally advanced and cannot be removed by surgery or has spread to other parts of the body (metastatic). The study aims to determine if patritumab deruxtecan (also called HER3-DXd or MK-1022) helps patients live longer overall or without the cancer growing compared to chemotherapy or trastuzumab deruxtecan. This is a Phase 3 clinical trial focusing on this particular type of breast cancer. Participants receive one of several treatments: patritumab deruxtecan through intravenous infusion, chemotherapy options like paclitaxel or nab-paclitaxel via IV, oral capecitabine tablets, liposomal doxorubicin via IV, or trastuzumab deruxtecan via IV infusion. The study compares the effects of patritumab deruxtecan alone to the treatment chosen by the physician. Treatments are administered according to standard dosing schedules during the trial. During the study, participants are monitored for how long they live without the cancer progressing (up to about 45 months) and overall survival (up to about 85 months). Researchers assess disease status through imaging and other evaluations. Participants have regular check-ups to monitor health, treatment effects, and any side effects. The study tracks treatment response and safety over the extended follow-up period to understand the benefits and risks of the therapies.
Actively Recruiting
Researchers are evaluating sotatercept as a potential treatment for pulmonary arterial hypertension (PAH), a condition where blood vessels in the lungs thicken and narrow, causing high blood pressure in the lungs and overworking the heart. PAH symptoms include difficulty breathing and reduced ability to be active. Current standard treatments address symptoms but do not stop disease progression. This Phase 3 study focuses on the long-term safety and tolerability of sotatercept when added to standard PAH therapy. Participants in this long-term follow-up study receive sotatercept through subcutaneous injections every three weeks. Only individuals who completed prior sotatercept PAH studies without early discontinuation may join. This study continues the observation and assessment of participants over an extended period to learn about the effects and safety of sotatercept combined with background PAH treatments. During the study, participants will be regularly monitored for adverse events, treatment discontinuations, and the presence of anti-drug antibodies for up to approximately 90 months. Laboratory tests will evaluate blood components such as platelets, hemoglobin, creatinine, bilirubin, and liver enzymes. Changes from baseline in body weight, blood pressure, and electrocardiogram readings will also be tracked. The study involves adherence to visit schedules and compliance with study procedures to ensure comprehensive long-term safety data collection.
Actively Recruiting
This research aims to assess the effectiveness and safety of eloralintide in adults with moderate to severe obstructive sleep apnea who are also obese or overweight. The study is organized under a master protocol called YDAO, which supports two separate studies: YSA1 for participants who are unable or unwilling to use Positive Airway Pressure (PAP) therapy, and YSA2 for those who have been using PAP therapy for at least three months and intend to continue it during the study. This is a Phase 3 randomized, double-blind, placebo-controlled trial focused on this specific population. Participants will receive either eloralintide or a placebo, both given by subcutaneous injection once weekly. They will be assigned to one of two groups based on their current PAP therapy use: those not using PAP (YSA1) and those continuing PAP (YSA2). The study treatment and observation will last about 76 weeks, allowing detailed evaluation over time. During the study, participants will undergo assessments including polysomnography to measure the apnea-hypopnea index (AHI) and body weight changes from baseline to week 64. Researchers will monitor weight, sleep apnea severity, and safety throughout the trial. The long participation period includes screening, treatment, and follow-up to capture comprehensive data on eloralintide’s effects and tolerability.
Actively Recruiting
This trial investigates whether eptinezumab can reduce the number of migraine days in children and teenagers aged 6 to 17 with episodic migraine. The study focuses on pediatric participants who have had migraine headaches for at least six months, aiming to evaluate the preventive treatment potential of this medication. This is a Phase 3 randomized, double-blind, placebo-controlled study designed to assess both the effectiveness and safety of eptinezumab given intravenously. Participants will receive either eptinezumab or a placebo, both administered as a solution through an infusion. The study includes a screening period where migraine and headache frequency are recorded using an electronic diary. The main measurement is the change from baseline in the average number of monthly migraine days over the first 12 weeks of treatment. During the study, participants and their caregivers will complete headache diaries to track migraine occurrences. Researchers will monitor migraine frequency and evaluate safety throughout the trial. The primary outcome is the difference in migraine days per month compared to the start of the study, assessed over the 12-week treatment period. This study helps understand how well eptinezumab may prevent episodic migraine in the pediatric population.
Actively Recruiting
This research aims to evaluate the safety and effectiveness of iza-bren, a bi-specific antibody-drug conjugate targeting EGFR and HER3 with a topoisomerase inhibitor, compared to the treatment of physician's choice (paclitaxel, nab-paclitaxel, carboplatin plus gemcitabine, or capecitabine). The study focuses on patients with previously untreated, locally advanced, recurrent inoperable, or metastatic triple-negative breast cancer (TNBC) or estrogen receptor (ER)-low, HER2-negative breast cancer who are not eligible for anti-PD(L)1 or endocrine therapies. The trial is conducted in two phases, phase 2 and phase 3, to thoroughly assess these treatments.
Actively Recruiting
Researchers are evaluating the effects of the drug orforglipron compared with a placebo on cardiovascular outcomes in adults who have atherosclerotic cardiovascular disease (ASCVD) and/or chronic kidney disease (CKD). This is a Phase 3, randomized, double-blind, placebo-controlled study designed to investigate major adverse cardiovascular events over a long period. Participants will receive either orforglipron or a placebo orally. The study is event-driven and will continue until the occurrence of major cardiovascular events or up to about 5 years. The treatments are administered without revealing to participants which group they are in to ensure unbiased results. During the study, participants will be monitored for the time to the first occurrence of a major cardiovascular event. Researchers will collect data from baseline through the end of the study, which lasts approximately 5 years. Regular assessments will help evaluate the safety and effects of the treatments on cardiovascular health in this population.
Actively Recruiting
Psoriatic arthritis (PsA) is a chronic inflammatory condition that affects the joints and skin in people with psoriasis. This study aims to evaluate how well zasocitinib (TAK-279) works in adults with active PsA, considering their prior treatment experiences with specific medications. The study is a Phase 3 trial that compares zasocitinib to a placebo in participants who have or have not been treated with biologic medicines. Participants will receive either zasocitinib tablets or a matching placebo. The study is randomized, double-blind, and placebo-controlled. Treatment will continue with monitoring over a period of up to 60 weeks to assess the effects and safety of zasocitinib. During the study, participants will undergo assessments of joint and skin symptoms, including tender and swollen joint counts and evaluations of psoriatic skin lesions. Researchers will measure how many participants achieve a significant improvement in their arthritis symptoms by Week 16. Safety and response will be monitored throughout the study period, with detailed follow-up visits and evaluations to understand the treatment's impact over time.
Actively Recruiting
Researchers are evaluating the effectiveness and safety of the drug BMS-986365 compared to the investigator's choice of therapy in men with metastatic castration-resistant prostate cancer. This Phase 3 study aims to measure the length of time participants live without radiographic disease progression, using established criteria for bone and soft tissue cancer progression. The study focuses on patients who have already been treated with androgen receptor pathway inhibitors and have metastatic prostate cancer confirmed by imaging. Participants will be randomly assigned to receive either one of two dose levels of BMS-986365 or the investigator's choice of treatment, which may include Docetaxel plus Prednisone/Prednisolone, Abiraterone plus Prednisone/Prednisolone, or Enzalutamide. The study has two parts: initially, participants are assigned to one of three groups including two BMS-986365 doses or comparator therapy, followed by a second part where they are randomized to either the selected BMS-986365 dose or the comparator treatment. During the study, participants will be monitored for disease progression through scans and evaluations using Response Evaluation Criteria in Solid Tumors and Prostate Cancer Clinical Trials Working Group criteria, with follow-up lasting up to four years. Safety and treatment effects will be assessed regularly, and participants' symptoms and quality of life will be closely observed. This long-term follow-up helps researchers understand the treatment's impact on cancer progression and patient well-being.
Actively Recruiting
Researchers are evaluating the safety and effectiveness of a new combination treatment using BMS-986489 (a fixed dose combination of BMS-986012 and Nivolumab) alongside Carboplatin and Etoposide compared to the current standard treatment with Atezolizumab plus Carboplatin and Etoposide. This study focuses on adults with extensive-stage small cell lung cancer and is conducted as a phase 3 randomized, double-blind, multicenter trial. The goal is to find out which combination works better as a first-line therapy for this advanced lung cancer. Participants will receive either BMS-986489 combined with Carboplatin and Etoposide or Atezolizumab combined with Carboplatin and Etoposide. Each drug will be given at specified doses on certain days according to the study protocol. The study compares these two treatment approaches to see their effects and safety when used as initial therapy for extensive-stage small cell lung cancer. During the study, participants will be closely monitored over a period of up to 5 years to assess overall survival. Researchers will use imaging techniques like CT scans or MRIs to measure tumor response and will evaluate participants' health and ability to perform normal activities. Safety and side effects will also be tracked throughout the study to ensure participant well-being.
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