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 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 Single-Arm Multiple-Dose Pharmacokinetic Comparability Trial Between TAK-881 and HYQVIA in Adults with Chronic Inflammatory Demyelinating Polyradiculoneuropathy
The MIgGRATE Study is a clinical study for adults with Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP) of an investigational drug called TAK-881. In this study, TAK-881 will be compared to an approved immunoglobulin G (IgG) treatment called HYQVIA®. The purpose of this study is to learn more about: How the body processes each of these study drugs What effects TAK-881 may have on CIDP How safe TAK-881 is and how the body tolerates it How the immune system reacts to TAK-881 The infusion experience with each of these study drugs
A Phase 3 Study of Dinutuximab Added to Intensive Multimodal Therapy for Children with Newly Diagnosed High-Risk Neuroblastoma
In this study, all patients will start with the same treatment using two drugs called topotecan and cyclophosphamide in the first cycle. After that, patents will be randomized to either Arm A or Arm B based on tumor status and disease staging. Patients in Arm A will get the standard therapy while the patients in Arm B will receive the standard therapy plus the study medicine called dinutuximab. As part of the standard treatment both arms include surgery and stem cell transplants. During the study patients will be closely monitored with imaging scans to assess their disease. The study will go on until therapy is complete or the disease worsens. Once therapy is complete, patients will continue to be followed closely for any signs of the disease returning.
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.