A Phase 3 randomized open-label multicenter controlled study to evaluate the efficacy and safety of zanidatamab in combination with physician s choice chemotherapy compared to trastuzumab in combination with physician s choice chemotherapy for the treatment of participants with metastatic HER2-positive breast cancer who have progressed on or are intolerant to previous trastuzumab deruxtecan treatment
This study tests a new treatment called zanidatamab against a standard treatment called trastuzumab. Both treatments will be given with chemotherapy chosen by the doctor for patients with metastatic HER2-positive breast cancer who have not done well on or cannot tolerate a previous treatment called T-DXd. To join the study, patients need to have had at least two lines of HER2-directed therapies before. Patients will be checked for HER2-positive status before being enrolled, and randomization will happen once they meet all the study criteria. Patients will be assigned randomly to one of the two treatments, with groups based on their past treatments and where they live. They will receive their treatment in 21-day cycles until their disease gets worse, they decide to leave the study, or other reasons to stop occur. The study will keep a close watch on how effective the treatments are, with patients getting regular scans to check their health.
A Phase 3 Randomized Open-label Study Comparing Efficacy and Safety of Sacituzumab Tirumotecan (sac-TMT MK-2870) as a Monotherapy and in Combination with Pembrolizumab (MK-3475) Versus Treatment of Physician s Choice in Participants With Previously Untreated Locally Recurrent Unresectable or Metastatic Triple-Negative Breast Cancer Expressing PD-L1 at CPS Less than 10 (TroFuse-011)
This is a Phase 3 study testing whether the study medicine sacituzumab tirumotecan ( sac-TMT, antibody-drug conjugate (ADC) targeting TROP2), given alone or with pembrolizumab (immunotherapy), can treat triple-negative breast cancer (TNBC) in patients whose tumor shows little to no PD-L1 expression (CPS
A Phase 3 Randomized Open-label Study of Rinatabart Sesutecan (Rina-S) versus Treatment of Investigator s Choice (IC) in Patients with Platinum Resistant Ovarian Cancer (GOG 3107)
This study is being done to compare a new treatment, Rina-S, to standard chemotherapy in patients with a type of ovarian cancer that no longer responds to platinum-based chemotherapy. Patients will be randomly assigned to get either Rina-S or one of four chemotherapy options chosen by their doctor. The study includes patients with different levels of a protein called FRa and different past treatments. To join, patients must have ovarian, peritoneal, or fallopian tube cancer and have already been treated with certain medicines, including platinum-based chemotherapy and other approved drugs if available. Patients will keep getting treatment until their cancer worsens, they have serious side effects, they decide to stop, or the study is ended. Doctors will check how well the treatment is working with regular scans and blood tests, and they will monitor side effects. A smaller group of patients will have extra heart tests to check if Rina-S affects the heart. A special safety team will review the study and can make changes or stop it if the treatment is too risky. Rina-S will be given through an IV every three weeks, while chemotherapy will follow usual dosing schedules.
A Phase 3 Randomized Open-Label Study to Compare the Efficacy and Safety of Anitocabtagene Autoleucel Versus Standard of Care Therapy in Participants With Relapsed/Refractory Multiple Myeloma
This study is testing the efficacy and potential side effects of a novel CAR-T cell treatment called anitocabtagene autoleucel (anito-cel). It is being compared to four standard treatments used for patients with multiple myeloma (MM, a type of blood cancer) that has returned or stopped responding to treatment. The patients in the study have already had 1 to 3 previous treatments. Patients will receive either anitocabtagene autoleucel or standard treatment. The patients will either get anitocabtagene autoleucel or one of the four standard treatments, which include: Pomalidomide, bortezomib, and dexamethasone (PVd); Daratumumab, pomalidomide, and dexamethasone (DPd); Carfilzomib, daratumumab, and dexamethasone (KDd); Carfilzomib and dexamethasone (Kd). If the patient is assigned to the standard treatment arm, they will receive the selected regimen for that specific arm. If the patient is assigned to the anitocabtagene autoleucel arm, the standard treatment regimen initially selected may be used as optional extra therapy (bridging therapy), if required per the investigator’s judgment.
A Phase 3 Randomized Open-Label Study to Evaluate the Efficacy and Safety of Tobevibart+Elebsiran Combination Therapy in Participants with Chronic HDV Infection (ECLIPSE 1)
The purpose this study is to learn more about chronic (long-term) hepatitis Delta virus (HDV) infection and whether the combinationof study drugs, tobevibart (VIR-3434) and elebsiran (VIR-2218), can treat this infection as well as how an immediate treatment with the combination of study drugs compare to a delayed treatment in people with chronic HDV infection who are on nucleos(t)ide reverse transcriptase inhibitor (NRTI) therapy.
A Phase 3 Randomized Placebo-Controlled Clinical Study to Evaluate the Efficacy and Safety of MK-0616 in Reducing Major Adverse Cardiovascular Events in Participants at High Cardiovascular Risk
The purpose of this research study is to test an experimental drug called MK-0616 in adults who are at high risk for serious illness, death, or other health emergencies associated with high cholesterol. These are called major cardiovascular events. This study is being done to learn more about the safety and effectiveness of the drug MK-0616 in reducing the risk of major cardiovascular events in people who are at high risk for these events. PCSK9 plays a key role in cholesterol homeostasis by regulating levels of LDL receptors, which are responsible for the uptake of cholesterol into cells. Inhibition of PCSK9 prevents the interaction of PCSK9 with LDL receptors. This results in greater numbers of LDL receptors available on the cell surface to remove LDL cholesterol from the blood. Discovered and developed by Merck, MK-0616 is an investigational, potentially first oral PCSK9 inhibitor designed to lower low density lipoprotein (LDL) cholesterol.
A Phase 3 Randomized Placebo-Controlled Double-Blind Multicenter Trial of Selinexor in Maintenance Therapy After Systemic Therapy for Patients with P53 Wild-Type Advanced or Recurrent Endometrial Carcinoma (GOG 3083)
The purpose of this research study is to further evaluate the safety and effectiveness of selinexor for maintenance in patients with TP53 wild-type endometrial cancer.
A Phase 3 Randomized Study Comparing Teclistamab in Combination with Daratumumab SC and Lenalidomide (Tec-DR) and Talquetamab in Combination with Daratumumab SC and Lenalidomide (Tal-DR) versus Daratumumab SC Lenalidomide and Dexamethasone (DRd) in Participants with Newly Diagnosed Multiple Myeloma Who are Either Ineligible or not Intended for Autologous Stem Cell Transplant as Initial Therapy.
This is a phase 3 study to test medicines named Teclistamab (Tec-DR) and Talquetamabin (Tal-DR) together with standard treatment called Daratumumab SC, Lenalidomide, and Dexamethasone (DRd) in patients who are newly diagnosed with blood cancer and are ineligible or not intended to get Stem Cell Transplant as the first treatment. Patients will be grouped to receive either Tec-DR, Tal-DR or DRd drugs. All patients will have blood samples taken to see how well patient's body is handling this treatment. Doctors will closely monitor patients who has received the study medicines for any side effects, to see if these medicines are safe and well tolerated, examine the results of blood work, do the vital sign measurements and physical examination. The patients will be followed up to 30 days (+7 days) after the last dose of study treatment or before the start of a new treatment, whichever comes first.
A Phase 3 Study to Evaluate the Efficacy and Safety of Pegozafermin in Subjects with Compensated Cirrhosis due to Metabolic Dysfunction-Associated Steatohepatitis (MASH)
The purpose of this study is to learn about the safety, effectiveness, and long-term outcomes of the research drug, pegozafermin, for patients with compensated cirrhosis due to MASH when compared to a placebo.
A Phase 3 Superiority Study Comparing the Safety and Efficacy of SNP-ACTH (1-39) Gel compared to Rituximab and FDA approved biosimilars in Adults with Primary Membranous Nephropathy (PMN) in a Two-Phase Adaptive Trial Design
This trial is recruiting individuals with Primary Membranous Nephropathy (PMN) - a kidney-specific, autoimmune disease in which your body's defense system turns against you and harms your body. PMN presents with increased protein in the urine. Currently, rituximab is recommended to treat PMN. In this study, SNP-ACTH (1-39) Gel will be evaluated as the study drug because other synthetic ACTH (Adrenocorticotropic hormone) therapies had been shown to be efficacious in PMN treatment as ACTH is suggested to directly protect kidneys (more specifically, podocytes of the kidneys) while modulating the over-active immune system of the body. The active ingredient of the study drug is an ACTH hormone that’s similar to the ACTH hormone in the body, but it’s synthesized in a laboratory and combined with gelatin (of porcine origin) for a more sustained release formulation. Cerium Pharmaceuticals, Inc. is funding this research study. The overall trial is divided into two Phases: Phase 3a (this ICF applies to the 3a only) Phase 3b (a separate ICF will be provided for the 3b) The purpose of this overall research study is: For Phase 3a: To determine the optimum dose of SNP-ACTH (1-39) Gel in subjects with PMN. For Phase 3b: To test the safety and effectiveness of SNP-ACTH (1-39) Gel relative to rituximab in subjects with PMN. SNP-ACTH (1-39) Gel of Cerium Pharmaceuticals, Inc. is a study drug product. It has not been approved by the United States Food and Drug Administration (FDA) for marketing in the USA for the treatment of PMN. Other long-acting ACTH therapies are used in the USA or other countries for the treatment of PMN. Currently, rituximab therapy is suggested as a starting treatment for reduction of the activation of the immune system against the body for high risk PMN subjects.