Stony Brook

The trial investigates the use of volrustomig in participants with unresected locally advanced head and neck squamous cell carcinoma (LA-HNSCC) who have not shown disease progression after receiving definitive concurrent chemoradiotherapy (cCRT). The study aims to evaluate the efficacy and safety of volrustomig compared to observation in this patient population. Participants have tumors that express PD-L1 and the study is conducted as a Phase III, randomized, open-label, multi-center global trial. Participants are assigned to receive either volrustomig as sequential therapy following cCRT or to an observation group. The treatment period involves monitoring participants who have completed definitive cCRT but remain unresected and have no evidence of metastatic disease. The study focuses on participants with Stage III, IVA, or IVB LA-HNSCC according to AJCC criteria, who have not undergone tumor resection before cCRT and have not been treated with radiotherapy alone. During the study, participants are regularly evaluated for progression-free survival, with follow-up lasting up to approximately 8 years to assess long-term outcomes. Researchers will monitor safety and disease progression closely. The overall participation duration includes screening, treatment or observation, and extended follow-up to capture both efficacy and safety data over time.

This research involves both pediatric and adult patients with various blood-related cancers and other disorders affecting the blood and immune system. It focuses on using unlicensed cryopreserved cord blood units (CBUs) for transplantation, aiming to study how well these unlicensed CBUs support recovery after transplant. The study also looks at important outcomes such as infection transmission, infusion reactions, survival rates, and graft-versus-host disease. Participants will receive transplants using these unlicensed cord blood units as part of a multicenter access and distribution protocol. The study is conducted at multiple U.S. transplant centers under the care of transplant physicians. The transplantation process involves administering these CBUs to patients with hematologic malignancies and other relevant conditions. Patients will be monitored for neutrophil recovery at 60 and 100 days post-transplant to assess engraftment success. Researchers will also evaluate infection rates, serious infusion reactions, survival one year after transplant, and incidences of acute and chronic graft-versus-host disease. Platelet recovery will be tracked as well. The study involves regular assessments to follow patients’ health and transplant outcomes over time.

Researchers are evaluating the safety and tolerability of NKX019, an investigational allogeneic CD19-directed CAR natural killer (CAR NK) cell therapy, in adults with active lupus nephritis or primary membranous nephropathy. This Phase 1/2 open-label, multi-center, non-randomized study also explores preliminary efficacy, pharmacokinetics, and pharmacodynamics of NKX019 in people with these autoimmune diseases. Participants have conditions that have persisted despite standard treatments and meet specific disease activity and biopsy criteria. Participants undergo a dose escalation phase using a 3+3 design to identify recommended doses. Each treatment cycle includes lymphodepletion with fludarabine and cyclophosphamide (Flu/Cy), though some may receive cyclophosphamide alone if cytopenic, followed by three doses of NKX019. The study monitors safety during and after treatment, and additional participants may be enrolled across indications once doses are established. During the study, participants receive medical evaluations including safety assessments for treatment-emergent adverse events and dose-limiting toxicities. Researchers assess disease activity, laboratory markers, and immunologic responses. Monitoring continues from the first NKX019 dose until 30 days after the last treatment. The study spans adults aged 18 to 70 years with specific autoimmune kidney diseases meeting detailed inclusion and exclusion criteria to ensure safety and appropriate participation.

Researchers are evaluating the safety and tolerability of NKX019, an investigational allogeneic CD19-directed CAR natural killer (CAR NK) cell therapy, in participants with autoimmune diseases such as systemic sclerosis, idiopathic inflammatory myopathies, and antineutrophil cytoplasmic antibody-associated vasculitis. This Phase 1/2, open-label, multi-center, non-randomized study uses a dose escalation and dose expansion design to assess preliminary efficacy, pharmacokinetics, pharmacodynamics, and immunogenicity of NKX019 in these immune-mediated conditions. The study uses a "3+3" dose escalation design to determine recommended doses for further study. Participants receive a cycle that starts with lymphodepletion using fludarabine and cyclophosphamide (Flu/Cy), or cyclophosphamide alone if they are cytopenic, followed by three doses of NKX019. The trial includes multiple cohorts to enroll additional participants across different autoimmune disease indications and monitors treatment effects and safety throughout. Participants undergo screening and receive treatments under close observation. Researchers monitor safety outcomes including dose-limiting toxicities during the first 28 days after the initial NKX019 dose and treatment-emergent adverse events from the first dose until 30 days after the last treatment. The study collects data on clinical responses, laboratory tests, and immune effects throughout the treatment and follow-up periods, with participant involvement spanning screening, treatment, and safety monitoring phases.

Researchers are evaluating the effectiveness and safety of Datopotamab Deruxtecan (Dato-DXd) with or without durvalumab compared to the investigator's choice chemotherapy combined with pembrolizumab in patients who have PD-L1 positive locally recurrent inoperable or metastatic triple-negative breast cancer (TNBC). This Phase III, randomized, open-label, international study aims to see if adding durvalumab to Dato-DXd can help patients live longer without their cancer worsening or simply live longer compared to standard chemotherapy with pembrolizumab. The study also examines how the treatments and cancer impact patients' quality of life. Participants will be randomly assigned to one of three treatment groups: Dato-DXd plus durvalumab, Dato-DXd alone, or investigator's choice chemotherapy (paclitaxel, nab-paclitaxel, or gemcitabine plus carboplatin) combined with pembrolizumab. All treatments are given by intravenous infusion. The study design includes stratification based on geographic location, disease-free interval history, and prior PD-1/PD-L1 treatment for early-stage TNBC. During the study, participants will have regular assessments to monitor their disease status using RECIST 1.1 criteria and undergo imaging reviewed by blinded independent central review. Researchers will track progression-free survival, quality of life, safety, and other health measures over an anticipated period of up to 33 months. Participants must provide tumor samples for PD-L1 testing, and safety monitoring will continue throughout the study.

Researchers are evaluating the efficacy and safety of utidelone combined with capecitabine in patients who have HER2-negative breast cancer with brain metastases. This is a pivotal Phase II multicenter clinical trial that aims to assess both intracranial and systemic treatment effects in this patient population. The study focuses on comparing utidelone alone and utidelone with capecitabine to determine their impacts on brain metastases and overall disease control. Participants will receive utidelone intravenously once daily for five consecutive days every 21 days. In combination treatment groups, capecitabine is taken orally twice daily for days 1 to 14 of each 21-day cycle. Different dosing regimens of utidelone (25 or 30 mg/m2) combined with a fixed capecitabine dose (1000 mg/m2) are evaluated. Treatment cycles repeat every 21 days, and patients may receive multiple cycles as part of the study. During the study, participants will undergo regular assessments including brain MRI scans to measure intracranial tumor response according to RECIST 1.1 criteria over 12 months. Researchers will monitor safety, side effects, and systemic disease progression. Patients’ blood and organ function will be checked to ensure treatment tolerance. The main outcome is the intracranial objective response rate after treatment, with ongoing monitoring to evaluate both efficacy and safety throughout the study period.

Researchers are evaluating an investigational drug called linvoseltamab in adults at moderate risk of developing multiple myeloma. This includes patients with precancerous conditions known as High-Risk Monoclonal Gammopathy of Undetermined Significance (HR-MGUS) and Non-High-Risk Smoldering Multiple Myeloma (NHR-SMM). The study aims to understand how well linvoseltamab can eliminate abnormal plasma cells and improve laboratory signs related to these conditions. It is a Phase 2 dose-ranging and interception study focused on these specific patient groups. Participants receive linvoseltamab as directed by the study protocol. The treatment schedule and dosing details are determined per protocol to assess the drug's effects and safety. The study does not mention comparator groups, focusing solely on evaluating linvoseltamab. The study includes a safety observation period lasting 35 days to monitor adverse events and a long-term follow-up of up to 5.5 years to assess the achievement of complete response. During the study, participants are regularly monitored for side effects and treatment-emergent adverse events. Researchers measure how often these events occur and their severity during the 35-day safety period. They also evaluate whether participants achieve a complete response, as determined by the investigator, over up to 5.5 years. Blood tests and laboratory evaluations are conducted to track drug levels and immune responses, including antibody formation against linvoseltamab. The study involves ongoing safety and effectiveness assessments throughout the participation period.

Researchers are evaluating the safety and effectiveness of Vagus Nerve Stimulation (VNS) Therapy as an additional treatment compared to no stimulation in people with treatment-resistant depression. This prospective, multi-center, randomized, controlled, blinded trial focuses on reducing depressive symptoms over 12 months using multiple depression rating scales. The study follows guidelines from the Centers for Medicare and Medicaid Services regarding evidence development for this treatment. Participants receive implantation of the VNS device, which delivers stimulation to the vagal nerve. After a minimum two-week period post-implantation, participants are randomly assigned to either active VNS treatment or no stimulation control, with outcomes observed for 12 months. Following this randomized phase, all participants enter an open-label extension where those in the control group receive active stimulation. Additional subjects may join this open-label study for up to five years to further assess long-term effects. Throughout the study, participants undergo regular assessments including the Montgomery Åsberg Depression Rating Scale (MADRS), WHO Disability Assessment Schedule, Health Outcome Scale, Clinical Global Impressions Scale, and Suicidality Tracking Scale. Researchers monitor response rates, remission times, duration of effects, and adverse events from implantation through 12 months. This comprehensive evaluation includes safety monitoring and functional outcome measures to understand the impact of VNS therapy on depression and related disabilities.

Researchers are evaluating ziltivekimab as a treatment for people living with heart failure and inflammation. This Phase 3 study compares ziltivekimab to a placebo in participants with heart failure who have mild to preserved ejection fraction and systemic inflammation. The study aims to assess the effect of ziltivekimab on cardiovascular death, heart failure hospitalization, or urgent heart failure visits over a period of up to 4 years. Participants will receive monthly injections of either ziltivekimab or a placebo using a pre-filled syringe or a pen-injector. The study medication is administered subcutaneously once a month for up to 4 years. The trial includes up to 20 clinic visits during which participants will be monitored and assessed. During the study, participants will use a study app on their phone to record all injections and complete questionnaires. Researchers will monitor participants for key outcomes like cardiovascular events and heart failure episodes from the time of randomization until the end of the study. Safety and health status will be regularly evaluated throughout the study period, which may last up to 48 months.

Researchers are evaluating the effectiveness of pembrolizumab combined with sacituzumab govitecan-hziy compared to the standard chemotherapy treatments in patients with locally advanced or metastatic urothelial cancer. This Phase III trial focuses on cancers that have spread to nearby tissues, lymph nodes, or other parts of the body. The study aims to compare overall survival and other outcomes such as progression-free survival, response rates, clinical benefits, duration of response, and treatment toxicity between the two treatment approaches. Quality of life and fatigue are also assessed as secondary measures. Participants are randomly assigned to one of two treatment groups. One group receives standard of care chemotherapy, which may include carboplatin or cisplatin combined with gemcitabine, or alternatively docetaxel or paclitaxel, administered intravenously in cycles every 21 days for up to six cycles, unless the disease progresses or side effects become unacceptable. The other group receives sacituzumab govitecan-hziy intravenously on days 1 and 8, along with pembrolizumab intravenously on day 1 of each 21-day cycle, continuing for up to 35 cycles or two years, unless there is disease progression or unacceptable toxicity. Throughout the study, participants undergo regular blood sample collections and imaging scans using computed tomography or magnetic resonance imaging to monitor their condition. Quality of life questionnaires are also completed to assess symptoms and fatigue over time. After treatment ends, patients are followed up 30 days later and then annually for up to five years to evaluate long-term outcomes and safety. The main outcome measured is overall survival from the time of randomization up to five years.