Grand Island

Researchers are studying metastatic castration-resistant prostate cancer mCRPC to find new treatment options. This trial evaluates if the study medicine ifinatamab deruxtecan I-DXd or MK-2400 helps people live longer overall and experience slower cancer growth or spread compared to chemotherapy. The study is a Phase 3 trial comparing I-DXd with standard chemotherapy for mCRPC patients. Participants are randomly assigned to receive either I-DXd at 12 mgkg every 3 weeks through intravenous infusion or docetaxel chemotherapy at 75 mgm2 every 3 weeks combined with daily prednisone pills. Treatment continues until the disease progresses, unacceptable side effects occur, or treatment is stopped for other reasons. Premedication is given before each dose of I-DXd to help prevent nausea and vomiting. During the study, participants will have regular visits for treatment and monitoring. Researchers will assess overall survival and radiographic progression-free survival for up to about 36 months. Additional measures include response rates, time to pain progression, PSA progression, and adverse events. The study tracks safety, treatment effects, and quality of life over a long follow-up period to better understand the potential benefits and risks of I-DXd compared to chemotherapy.

Researchers are evaluating the safety and immune response of a second dose of the RSVpreF vaccine in pregnant women during later pregnancies. The study also aims to understand how long the protection lasts from a single dose given during a previous pregnancy by examining blood samples from nonpregnant participants who had the vaccine before. This Phase 3 trial involves pregnant participants and their unborn babies, as well as nonpregnant participants previously vaccinated. Pregnant participants are divided into two groups one group who previously received RSVpreF in a Pfizer trial will get a second dose, and another group will be randomly assigned to receive either RSVpreF or a placebo if no prior antibody data exists. Infants born to these participants will be followed for six months to monitor safety and antibody levels. Nonpregnant participants who received RSVpreF in an earlier trial will provide blood samples to assess the durability of their immune response without receiving additional vaccine doses. Participants will undergo safety monitoring including tracking local and systemic reactions, adverse events, and serious events during pregnancy and after birth for infants. Blood tests will measure neutralizing antibodies against RSV types A and B at birth, 3 months, and 6 months. The study includes consent procedures for both pregnant participants and infants, and nonpregnant participants will have scheduled visits for blood sample collection. The total study duration extends through infant follow-up and ongoing immune response assessments.

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 cyclin-dependent kinase 4 and 6 inhibitor CDK46i and letrozole compared to placebo plus CDK46i and letrozole in adults with endocrine-sensitive PIK3CA-mutated hormone receptor-positive HR, HER2-negative advanced breast cancer. This phase III, randomized, double-blind study focuses on participants who have measurable disease and meet specific hormone receptor and HER2 status criteria. Participants are randomly assigned to receive either oral inavolisib once daily along with letrozole and CDK46i or placebo once daily with letrozole and CDK46i. The CDK46i is given on a schedule of either Days 1-21 or Days 1-28 of each 28-day cycle. The study includes parallel groups to compare these treatment combinations over time. During the study, participants will be monitored for progression-free survival, overall survival, response rates, duration of response, clinical benefit, and changes in pain, physical function, and global health status. Safety will be assessed by tracking adverse events and patient-reported treatment side effects using questionnaires. The study will follow participants for up to seven years, with regular evaluations to track disease status and quality of life.

Researchers are evaluating the effects of a triple therapy inhaler combining budesonide, glycopyrronium, and formoterol fumarate BGF MDI 32014.49.6 g compared to a dual therapy inhaler with glycopyrronium and formoterol fumarate GFF MDI 14.49.6 g on heart and lung outcomes in adults with Chronic Obstructive Pulmonary Disease COPD who have a higher risk for heart and lung events. This Phase III study is randomized, double-blind, and conducted at multiple centers, focusing on participants with COPD and elevated cardiopulmonary risk. Participants will receive either the triple therapy inhaler or the dual therapy inhaler, both administered twice daily. The study compares these two inhalers over a period of up to three years, monitoring for serious cardiac or COPD events. The trial includes careful evaluation of various heart and lung-related health events during this period. During the study, participants will be closely monitored through regular visits, assessments, and tests to measure lung function, heart events, and COPD exacerbations. Researchers will track the time until the first severe cardiac or COPD event and evaluate other cardiovascular and respiratory outcomes over up to three years. Participants will also be assessed for their ability to properly use the inhaler and adherence to the study protocol throughout the trial.

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-L1PD-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 the BLB-201 vaccine, delivered intranasally, in infants and children aged 8 months to 5 years. This Phase 12a randomized, placebo-controlled trial includes participants who may have had prior respiratory syncytial virus RSV infection. The study aims to assess two different vaccine doses in this young population to better understand the vaccines effects and safety profile. Participants will receive either a low dose 106 PFU or a high dose 107 PFU of the BLB-201 vaccine or placebo. Some participants will receive one dose on Day 1, while others will receive two doses on Day 1 and Day 57. The vaccine and placebo are given by intranasal administration. The trial includes groups of both RSV seropositive and RSV seronegative infants and children. During the study, participants will be closely monitored for adverse events from Day 1 through Day 29, with specific attention to solicited events from Day 1 to Day 15. Medical history, physical exams, and laboratory tests will be conducted to evaluate health status and immune response. Parents or legal representatives will provide informed consent and confirm routine immunizations are up to date. The total study duration extends until the primary completion date in late 2028, with ongoing safety and immunogenicity assessments throughout this period.

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 23 study is divided into two parts Dose Confirmation and Efficacy Expansion. It aims to compare ZV combined with rituximab, gemcitabine, and oxaliplatin R-GemOx against R-GemOx alone, and ZV combined with bendamustine rituximab BR against BR alone, focusing on progression-free survival. Enrollment in the BR-related arms has been discontinued with no analysis planned for those arms.

Researchers are evaluating the safety, tolerability, and effectiveness of combining Imzokitug with Pumitamig and Platinum-Doublet Chemotherapy PDCT compared to Pumitamig and PDCT alone. The study focuses on adults with locally advanced or metastatic non-small cell lung cancer NSCLC who have not received previous systemic therapy for advanced or metastatic disease. This is a Phase 2 interventional trial assessing first-line treatments for this condition. Participants will receive either the combination of Imzokitug, Pumitamig, and PDCT or Pumitamig with PDCT alone. Treatment involves specified doses given on certain days, with tumor tissue samples required for analysis. The study is randomized and parallel in design, with multiple experimental arms. The primary treatment period extends up to approximately four years, during which the response to therapy will be closely monitored. Throughout the trial, participants will undergo evaluations including tumor assessments using RECIST v1.1 criteria to measure objective response rates. Safety will be monitored by documenting adverse events, serious adverse events, and treatment-related effects up to 90 days after the last treatment. Researchers will also track progression-free survival, overall survival, duration of response, and time to recurrence during the study and follow-up periods. The trial is sponsored by Bristol-Myers Squibb and aims to collect comprehensive data over several years.

Researchers are conducting a Phase III, randomized, open-label multicenter study to evaluate the effectiveness and safety of giredestrant compared with fulvestrant. Both drugs are combined with the investigators choice of a CDK46 inhibitor palbociclib, ribociclib, or abemaciclib in participants with estrogen receptor-positive ER, HER2-negative advanced breast cancer who have become resistant to prior adjuvant endocrine therapy. Participants will be randomly assigned to one of two groups one group will receive giredestrant 30 mg orally daily on Days 1-28 of each 28-day cycle, while the other will receive fulvestrant 500 mg intramuscularly on Days 1 and 15 of Cycle 1 and Day 1 of subsequent 28-day cycles. Both groups will also receive a CDK46 inhibitor chosen by the investigator, with dosing schedules depending on the specific inhibitor selected. Preperimenopausal women and men will receive a luteinizing hormone-releasing hormone LHRH agonist during treatment. Participants will be assessed for progression-free survival over up to 5 years, with additional measures including overall survival, response rates, duration of response, clinical benefit, and quality of life. Safety will be monitored through adverse event reporting, vital signs, and laboratory tests during treatment and up to 28 days after the last dose. The study is led by Hoffmann-La Roche and aims to provide detailed information on the treatments effects in this patient population.