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Found 13 Actively Recruiting clinical trials
Actively Recruiting
Researchers are evaluating the safety and effects of a medicine called disitamab vedotin for adults with advanced breast cancer that is hard to treat and has spread in the body. This study focuses on participants whose tumors express HER2 and who have received previous treatments for their advanced breast cancer. The goal is to understand how well this medicine works and its safety in these patients through a Phase 1b/2 open-label study. All participants will receive disitamab vedotin intravenously (IV) once every two weeks at the study clinic. They will continue the treatment until they or their doctor decide to stop, which could be due to cancer progression, side effects, or personal choice. During treatment, study visits occur every two weeks. After stopping treatment, participants will have follow-up visits about every six weeks, and later follow-up phone calls approximately every twelve weeks. Participants will undergo evaluations including assessments of their cancer response by the study doctors, following recognized criteria. The study team will monitor the participants for up to about two years or until their disease progresses or they pass away. This includes safety monitoring and collecting information about the medicine’s effects to determine its safety and effectiveness.
Actively Recruiting
Researchers are evaluating the effectiveness and safety of standard chemotherapy combined with bevacizumab, with or without the addition of INCA33890, as the first treatment option for patients with metastatic microsatellite stable colorectal cancer. This phase 3 randomized, double-blind study focuses on patients with stage IV colorectal adenocarcinoma that cannot be cured by surgery and who have not received prior systemic treatment for their metastatic disease. Participants will receive standard-of-care chemotherapy (FOLFOX) and bevacizumab both administered at protocol-defined doses. They will be randomly assigned to also receive either INCA33890 or a placebo, with dosing also defined by the study protocol. The treatments will be given as the initial therapy for metastatic disease, aiming to compare the outcomes between the groups receiving INCA33890 and those who do not. Throughout the study, participants will be monitored for progression-free survival for up to three years. Researchers will assess disease progression using measurable disease criteria and regularly evaluate participants' health status and organ function through laboratory tests. Safety and treatment response will be closely followed, with the goal of determining how well the treatments control the cancer without unacceptable side effects.
Actively Recruiting
Researchers are evaluating the study medicine PF-08046054 compared to the standard chemotherapy drug docetaxel in adults with non-small cell lung cancer (NSCLC) that has spread or cannot be removed with surgery or radiation. Participants must have PD-L1 expression on 1% or more of their tumor cells and have experienced cancer progression during or after treatment with PD-L1 or PD-1 inhibitors, platinum-based chemotherapy, and targeted therapies for those with known genetic mutations. The trial is a Phase 3 randomized study to better understand how well PF-08046054 works alone compared to docetaxel alone. Participants will be randomly assigned to receive either PF-08046054 or docetaxel. Those in the PF-08046054 group will get intravenous (IV) infusions twice every 21-day cycle, while those in the docetaxel group will receive one IV infusion every 21 days. The treatment period may last up to 5 years if their NSCLC responds to the therapy. No other treatments are combined during the study period. Throughout the study, participants will have regular clinic visits for evaluations and monitoring to see how they respond to the treatment. Researchers will collect information on overall survival over approximately 5 years. They will also monitor safety and disease progression during these visits to understand the long-term effects and benefits of the treatments.
Actively Recruiting
Researchers are evaluating a new medicine called PF-08634404 combined with chemotherapy for people aged 18 and older who have locally advanced or metastatic gastric, gastroesophageal junction, or esophageal adenocarcinoma. The study includes participants who have not received prior treatment for advanced or metastatic disease and are in good health based on medical tests. This research is designed as a Phase 2/3 trial to learn about safety, response, and compare this new treatment to an approved therapy called nivolumab plus chemotherapy. The study has two parts: the first part assesses the safety and response to PF-08634404 with chemotherapy, and the second part compares this combination to nivolumab with chemotherapy. Treatments are given intravenously in repeated cycles. Participants receive either PF-08634404 plus chemotherapy or nivolumab plus chemotherapy based on the study phase and group assignment. During the study, participants undergo regular evaluations including medical tests to monitor organ function and safety. Researchers will measure treatment response using RECIST 1.1 criteria, track adverse events, and assess progression-free survival and overall survival over approximately four years. Follow-up continues through 90 days after the last treatment to monitor side effects and overall health.
Actively Recruiting
Researchers are investigating a new atrioventricular interval modulation (AVIM) algorithm within a dual-chamber Medtronic Astra/Azure pacemaker to see how it affects blood pressure control in people with hypertension. This multinational, prospective, randomized, double-blind clinical trial aims to evaluate the safety and effectiveness of the AVIM therapy, which is added to standard antihypertensive drug treatment. The study includes adults who either need or already have an Astra/Azure pacemaker implanted and have high blood pressure. The study has three phases: a screening phase, a double-blind randomized phase lasting one year, and an unblinded phase lasting two years. Eligible participants will have the AVIM algorithm downloaded into their pacemaker and be randomly assigned to either have the AVIM therapy turned ON or OFF. All participants will continue their prescribed blood pressure medications throughout the study. The study compares the effects of activated versus deactivated AVIM therapy on blood pressure. Throughout the study, participants will undergo various assessments including blood pressure monitoring to measure changes in average 24-hour ambulatory systolic blood pressure from baseline at three months. Safety is closely monitored by tracking any serious adverse effects related to the device. The total participation includes long-term follow-up over three years to evaluate both efficacy and safety of the AVIM therapy in managing hypertension alongside standard treatments.
Actively Recruiting
Researchers are evaluating TORL-1-23 in a Phase 2 study for women with advanced platinum-resistant epithelial ovarian cancer, including primary peritoneal and fallopian tube cancers expressing Claudin 6. This study aims to assess the safety and effectiveness of TORL-1-23 given as a single treatment in those whose disease has progressed despite prior platinum-based therapies. Eligible participants must have confirmed high-grade ovarian or related cancers and tumors positive for CLDN6 expression. The treatment involves intravenous infusions of TORL-1-23 at doses of 2.4 mg/kg, 3.0 mg/kg, or 3.4 mg/kg on Day 1 of every 3-week cycle. Additionally, participants receive a 6.0 mg subcutaneous injection of Pegfilgrastim on Day 4 of each cycle to support white blood cell counts. Treatment continues until disease progression or other criteria are met, and the study's total duration is about 40 months. Participants will be closely monitored from the first dose through the study duration with assessments at predefined intervals to measure disease response and safety. Evaluations include imaging scans to measure tumor size, laboratory tests for organ function, heart monitoring with ECG, and regular clinical exams. Researchers will track the therapy's effects on tumor progression and side effects to understand the overall benefit and safety of TORL-1-23 in this patient group.
Actively Recruiting
Researchers are evaluating how factors like age, gender, other medical conditions, and the type of immunotherapy affect the development of side effects in patients with malignant solid tumors receiving immune checkpoint inhibitor (ICI) therapy. The study aims to develop and validate a risk prediction model for serious immune-related side effects during the first year of ICI treatment. Additional goals include tracking the occurrence of various side effects, quality of life, patient-reported symptoms, and treatment patterns over 12 months, along with studying biological markers that may predict side effect risk. Participants will have tissue samples collected at the start of their cancer treatment and will complete questionnaires at baseline and at weeks 4, 12, 24, and 52. Blood samples may also be collected at multiple times during the study. The study focuses on patients receiving standard-of-care ICI therapy for solid tumors, without combination chemotherapy or other non-ICI treatments. During the study, participants will complete patient-reported outcome forms and health questionnaires to assess side effects and quality of life. Researchers will monitor the occurrence of severe immune-related side effects over 52 weeks and evaluate biological markers from blood and tissue samples. The study also assesses the use of electronic methods for collecting patient data. Total participation includes assessments over approximately one year following treatment start.
Actively Recruiting
Researchers are establishing the International Registry to Improve Outcomes in Men with Advanced Prostate Cancer (IRONMAN), a study enrolling at least 5,000 men with advanced prostate cancer, including metastatic hormone-sensitive prostate cancer (mHSPC) and metastatic castration-resistant prostate cancer (M0/M1 CRPC). This international cohort will collect data from patients across various countries including Australia, Barbados, Brazil, Canada, and others to better understand differences in care and treatment across academic and community settings worldwide. Participants will receive standard care treatments for metastatic prostate cancer as determined by local practices. The study will collect detailed data at enrollment and during follow-up for a minimum of five years. Blood samples and, when feasible, tumor tissue will be collected at enrollment, at treatment changes, and at one-year follow-up to help identify molecular markers related to treatment response and resistance. During participation, patients will complete patient-reported outcome measures (PROMs) at enrollment and every three months. Physicians will provide questionnaires at enrollment, treatment changes, one-year follow-up, and treatment discontinuation. Researchers will track overall survival, adverse events, comorbidities, treatment changes, and patient quality of life to identify optimal treatment sequences and outcomes for men with advanced prostate cancer.
Actively Recruiting
Researchers are conducting a global, multi-center, non-randomized observational trial to evaluate the PulseSelect™ PFA System in adults with recurrent symptomatic paroxysmal or persistent atrial fibrillation who have not responded to at least one Class I or III antiarrhythmic drug. The study aims to observe safety and effectiveness outcomes over a 36-month period following the ablation procedure. Participants will undergo an ablation procedure using the commercially available PulseSelect™ PFA System according to each hospital's standard of care. After the procedure, study visits are scheduled at 3, 6, 12, 24, and 36 months, with required 24-hour Holter monitoring at 6, 12, 24, and 36 months to assess heart rhythm. During the study, researchers will track freedom from atrial fibrillation and monitor for any device or procedure-related adverse events, especially within the first 6 months post-ablation. Participants will be followed for up to 36 months to evaluate long-term outcomes and safety of the PulseSelect™ PFA System.
Actively Recruiting
Researchers are evaluating the safety, tolerability, and characteristics of a drug called Rina-S in people with various advanced solid tumors that have spread or cannot be removed by surgery. This includes cancers such as ovarian, endometrial, breast, non-small cell lung cancer, and mesothelioma. The study is a Phase 1/2 trial designed to assess how the drug works and its effects on these cancers. Participants will receive intravenous infusions of Rina-S alone or in combination with other drugs like Carboplatin, Bevacizumab, or Pembrolizumab. The study is divided into multiple parts focusing on different tumor types and treatment combinations, including monotherapy and combination therapy cohorts. Treatments continue until disease progression, unacceptable side effects, or other reasons for stopping treatment. During the study, participants will undergo various assessments including safety monitoring for side effects and dose-limiting toxicities, tumor response evaluations using imaging criteria, and heart monitoring with electrocardiograms for some participants. Researchers will track treatment-emergent adverse events for up to about one year. Participants remain involved through treatment cycles and follow-up evaluations to understand the drug's effects and safety profile.
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