Grand Island

Researchers are evaluating a new medicine called ifinatamab deruxtecan (I-DXd) for treating men with metastatic castration-resistant prostate cancer (mCRPC). The study aims to find out if people receiving I-DXd live longer overall and have longer periods without cancer growth or spread compared to those receiving chemotherapy. This is a Phase 3, open-label trial sponsored by Merck Sharp & Dohme LLC. Participants in the study will be randomly assigned to receive either I-DXd at a dose of 12 mg/kg every 3 weeks or a combination of docetaxel chemotherapy (75 mg/m² every 3 weeks) with daily prednisone. I-DXd is given by intravenous infusion every 3 weeks until the disease progresses or side effects prevent continued treatment. Premedication is given before I-DXd to help prevent nausea and vomiting. During the study, participants will be closely monitored for overall survival and radiographic progression-free survival for up to about 36 months. Researchers will also assess several other outcomes including response rates, time to progression, pain progression, prostate-specific antigen changes, and side effects. Safety and treatment tolerability will be tracked throughout, and participants’ health will be regularly evaluated with scans and other tests.

Researchers are studying the safety and immune response of giving a second dose of the RSVpreF vaccine during later pregnancies, as well as how long protection lasts from a single dose given in an earlier pregnancy. The study involves pregnant participants and their unborn babies, along with nonpregnant participants who received the vaccine before, to understand vaccine effects and immune duration. The trial is a Phase 3 study sponsored by Pfizer focused on respiratory syncytial virus (RSV) infection. The study includes three groups: Cohort 1 consists of pregnant participants who previously received RSVpreF in a Pfizer trial and will get a second dose; Cohort 2 includes pregnant participants who received RSVpreF commercially or in a prior trial, randomized to receive either RSVpreF or a placebo; Cohort 3 involves nonpregnant participants who had RSVpreF during a previous pregnancy and will provide blood samples to assess lasting immunity without receiving new vaccine doses. Infants born to vaccinated pregnant participants are monitored for safety and antibody levels for six months. Participants will attend visits for vaccinations, blood tests, and health monitoring. Pregnant participants are observed for reactions and side effects from the day of vaccination through weeks afterward. Infants are followed from birth up to six months to assess adverse events and antibody presence. The main outcomes include reports of vaccine reactions, adverse events, and the level of RSV antibodies at birth and up to six months. Nonpregnant participants provide blood samples to measure immune response persistence over time. The total study duration extends until February 2028.

Researchers are evaluating changes in bone mineral density in premenopausal women with heavy menstrual bleeding caused by uterine fibroids or moderate-to-severe pain from endometriosis. This Phase 3B, open-label study looks at the effects of continuous treatment with a relugolix combination tablet for up to 48 months (4 years), followed by a 1-year period to monitor bone health after stopping treatment. Participants will take a daily oral relugolix combination tablet containing relugolix 40 mg, estradiol 1 mg, and norethindrone acetate 0.5 mg for 4 years. Bone mineral density will be measured every 6 months using dual-energy X-ray absorptiometry (DXA). Some women who have completed a previous related study may join to complete 3 years of treatment. After treatment ends, bone density will be checked again at 6 months and 12 months during the follow-up year. Women in the study will have regular visits for bone density scans and health assessments, including physical and gynecological exams, lab tests, and vital signs. Researchers will track changes in bone density at the spine, hip, and femoral neck throughout treatment and follow-up. They will also monitor for any fractures or adverse events during the 4 years of treatment and the 1-year post-treatment period. Total participation can last up to 5 years including the follow-up.

Researchers are evaluating the effectiveness and safety of combining inavolisib with a CDK4/6 inhibitor and letrozole compared to a placebo combined with a CDK4/6 inhibitor and letrozole. This study focuses on participants with endocrine-sensitive PIK3CA-mutated hormone receptor-positive, HER2-negative advanced breast cancer. The trial is a Phase III, multicenter, randomized, double-blind, placebo-controlled study sponsored by Hoffmann-La Roche. Participants are assigned to one of two groups: one receiving oral inavolisib daily along with letrozole and a CDK4/6 inhibitor, and the other receiving a placebo with letrozole and a CDK4/6 inhibitor. The CDK4/6 inhibitor is given either on Days 1-21 or Days 1-28 of each 28-day cycle. Treatment will continue as per the study protocol while monitoring responses and safety. During the trial, participants will have measurable disease evaluated regularly using RECIST v1.1 criteria. Researchers will monitor progression-free survival from randomization up to seven years, alongside other outcomes such as overall survival, response rates, duration of response, and quality of life measures including pain and physical function. Safety will be assessed through adverse event tracking and patient-reported outcomes throughout the follow-up period.

Researchers are evaluating the effects of a triple therapy inhaler combining budesonide, glycopyrronium, and formoterol fumarate (BGF MDI 320/14.4/9.6 bcg) on heart and lung outcomes in people with chronic obstructive pulmonary disease (COPD) who have a higher risk of heart and lung problems. This Phase III study compares this triple therapy to a dual therapy inhaler containing glycopyrronium and formoterol fumarate (GFF MDI 14.4/9.6 bcg). The trial is randomized, double-blind, and conducted at multiple centers to assess which treatment better affects cardiopulmonary outcomes.

Researchers are evaluating alisertib as a single treatment in patients with small cell lung cancer (SCLC) that has progressed after prior therapies. This Phase 2 study focuses on patients who have already received at least one platinum-based chemotherapy and an anti-PD-L1/PD-1 immunotherapy, with allowance for up to two prior treatment regimens in total. The study aims to identify specific biomarker groups that may respond best to alisertib and to assess its effectiveness, safety, and how the body processes the drug. Participants will receive alisertib tablets orally in doses of 50 mg, 60 mg, or 70 mg twice daily for seven days within each 21-day treatment cycle. The dosing amount depends on protocol amendments and is given on a schedule of days 1 to 7 of each cycle. This treatment continues under close monitoring to evaluate patient response and side effects. During the study, participants will be regularly evaluated for response to treatment, including measures such as tumor shrinkage and disease control, lasting up to 36 months after the first dose. Researchers will also assess progression-free survival and overall survival within biomarker-defined groups and the overall enrolled population. Safety is monitored by tracking adverse events from the start of treatment through 28 days after the last dose. Patients will be followed for up to three years to gather comprehensive data on treatment outcomes and safety.

Researchers are evaluating the safety, tolerability, and immune response of an intranasal vaccine called BLB-201, which is designed to protect against respiratory syncytial virus (RSV) infection. This Phase 1/2a randomized, placebo-controlled trial includes infants aged 8 to 24 months and children aged 18 to 59 months, some of whom may have had prior RSV infection. The study aims to understand how different doses affect these young participants. Participants receive one or two doses of BLB-201 at either a low dose (10^6 PFU) or a high dose (10^7 PFU) given through the nose. Some children receive a placebo, which is a harmless saline solution, to compare effects. The doses are given on Day 1, and for some groups, a second dose is given on Day 57. The study includes groups based on age and prior RSV exposure to assess responses across different participant types. Throughout the trial, participants are closely monitored for any side effects from Day 1 to Day 29, including both expected and unexpected events. The study team also evaluates how well the vaccine triggers the immune system. Caregivers provide consent and ensure their child attends all scheduled visits. The entire study runs until late 2028, allowing researchers to gather thorough safety and immune response data over time.

Researchers are evaluating the safety and effectiveness of zilovertamab vedotin (ZV) combined with standard treatments for people with relapsed or refractory diffuse large B-cell lymphoma (rrDLBCL). This Phase 2/3 study aims to see if adding ZV to rituximab, gemcitabine, and oxaliplatin (R-GemOx) improves progression-free survival compared to R-GemOx alone. The study is divided into two parts: Dose Confirmation (Part 1) and Efficacy Expansion (Part 2). Cohort B involving ZV plus bendamustine rituximab (BR) was discontinued and will not be analyzed for efficacy.

Researchers are evaluating the safety and effectiveness of giredestrant compared to fulvestrant, both combined with a CDK4/6 inhibitor, in adults with estrogen receptor-positive (ER+), HER2-negative advanced breast cancer who have developed resistance to prior adjuvant endocrine therapy. This Phase III, randomized, open-label study focuses on participants whose cancer is locally advanced or metastatic and not curable by surgery or other treatments. Participants are randomly assigned to one of two groups. The experimental group receives giredestrant 30 mg orally once daily in 28-day cycles plus an investigator's choice of a CDK4/6 inhibitor (palbociclib, ribociclib, or abemaciclib). The control group receives fulvestrant 500 mg by injection on specified days in 28-day cycles plus a chosen CDK4/6 inhibitor. Pre/perimenopausal women and men also receive an LHRH agonist during treatment. Treatment continues until disease progression or unacceptable side effects occur. During the study, participants will undergo evaluations including confirmation of ESR1 mutation status, disease measurement according to RECIST criteria, and monitoring of adverse events, vital signs, and laboratory tests. Researchers will assess progression-free survival, overall survival, response rates, pain severity, physical functioning, and quality of life over up to 5 years. Safety monitoring extends to 28 days after treatment ends, with ongoing data collection on clinical outcomes and treatment effects.

Researchers are evaluating the effectiveness and safety of combining sonrotoclax with zanubrutinib compared to zanubrutinib with placebo in adults who have relapsed or refractory mantle cell lymphoma (MCL). This phase 3 randomized, double-blind study aims to determine if sonrotoclax plus zanubrutinib can improve outcomes for patients who have received prior treatments including anti-CD20 monoclonal antibodies or chemoimmunotherapy. The trial is sponsored by BeOne Medicines and includes patients with measurable disease and adequate organ function. Participants are randomly assigned to one of two groups: one receives sonrotoclax plus zanubrutinib taken orally, and the other receives a placebo plus zanubrutinib, also taken orally. Treatment continues under blinded conditions to compare the effects of the study drug combination versus placebo. The study includes multiple outcome measures such as progression-free survival, overall survival, response rates, and quality of life assessments over periods ranging from about 41 to 92 months. During the trial, participants will undergo regular assessments including tumor evaluations, laboratory tests, and quality of life questionnaires using specific tools like the EORTC-QLQ-NHL-HG29 and EORTC-QLQ-C30. Safety is closely monitored from the first dose until 30 days after the last dose. The study spans several years, allowing researchers to track long-term outcomes and treatment-emergent side effects while participants continue follow-up visits according to the study schedule.