Greer

Researchers are evaluating the long-term effects of aleniglipron, a drug taken orally, in adults with overweight or obesity who also have type 2 diabetes mellitus T2DM. This is a randomized, double-blind, placebo-controlled Phase 3 study designed to assess the drugs effectiveness, safety, and tolerability over an extended period. The study focuses on the management of weight and diabetes in this population. Participants will be randomly assigned to receive either aleniglipron or a placebo, all administered orally. The treatment period lasts for 76 weeks, during which participants will take multiple doses of the assigned medication. The study includes three different aleniglipron arms and one placebo arm, all aiming to evaluate weight change and diabetes control over time. Throughout the study, participants will undergo assessments to measure changes in body weight, waist circumference, HbA1c levels, blood pressure, and cholesterol levels. The primary outcome is the percent change in body weight from the start of the study to week 76. Secondary outcomes include the proportion of participants achieving various levels of weight loss and diabetes targets. The study also monitors safety and tolerability during the treatment period, which lasts approximately 76 weeks.

Researchers are evaluating pasritamig JNJ-78278343 combined with best supportive care BSC compared to placebo with BSC in men with metastatic castration-resistant prostate cancer mCRPC, a form of prostate cancer that has spread and no longer responds to hormone therapies. This Phase 3 randomized, double-blind study aims to assess overall survival, measuring how long participants live from the start of the study until death from any cause. Participants will be randomly assigned to receive either pasritamig or placebo through intravenous infusion. The dosing starts with step-up doses on Cycle 1 Day 1 and Day 8, followed by a target dose on Day 15. Subsequent cycles of treatment occur every 6 weeks, with Cycle 1 lasting 8 weeks and later cycles lasting 6 weeks each. All participants may also receive best supportive care, which includes treatments like radiation, steroids, pain medication, and other palliative procedures, at the physicians discretion. Treatment continues until disease progression, intolerable side effects, withdrawal, death, or end of study. During the study, participants will have regular assessments to monitor overall survival and other outcomes such as progression-free survival, symptomatic progression, skeletal-related events, and time to pain or fatigue worsening. Laboratory tests and monitoring for adverse events will occur up to 2 years and 8 months. Participants will receive ongoing evaluation to track treatment effects and safety throughout the trial duration, which spans until August 2028.

Researchers are studying two surgical procedures to reduce the risk of ovarian cancer in women with BRCA1 genetic mutations. This trial compares bilateral salpingectomy, which removes only the fallopian tubes, with bilateral salpingo-oophorectomy, which removes both fallopian tubes and ovaries. The goal is to find out if removing just the fallopian tubes with delayed ovary removal is nearly as effective as removing both from the start. Participants choose between two groups one undergoes bilateral salpingectomy with the option of later ovary removal, and the other undergoes bilateral salpingo-oophorectomy. Both groups have imaging tests like pelvic ultrasounds or pelvic MRIs during screening and provide blood samples throughout the study. Follow-up visits occur at multiple time points, including 10 to 60 days, 6 months, 12 months, 24 months, and then yearly for up to 20 years. During the study, researchers track if ovarian or related cancers develop and assess symptoms related to estrogen loss, quality of life, cancer-related distress, sexual function, menopausal symptoms, medical decision making, and any adverse events. Various questionnaires and imaging tests support these evaluations. Long-term safety and cancer risk reduction are monitored for up to two decades after surgery.

Researchers are evaluating the safety, side effects, and optimal dose of cabozantinib combined with standard chemotherapy in patients newly diagnosed with osteosarcoma. This phase IIIII trial aims to compare the effects of adding cabozantinib, a kinase inhibitor that may slow tumor growth, to the usual chemotherapy drugs methotrexate, doxorubicin, and cisplatin. The study focuses on patients under 40 years old with high-grade osteosarcoma, including both localized and metastatic cases. Participants receive treatment in two main phases. The feasibility phase now closed tested cabozantinib with chemotherapy in metastatic patients with resectable tumors, using cycles of oral cabozantinib and intravenous chemotherapy drugs over several months. The ongoing efficacy phase randomly assigns patients to either standard chemotherapy alone or chemotherapy combined with cabozantinib, with treatment divided into induction, consolidation, and maintenance cycles lasting 35 or 28 days each. Imaging scans, blood samples, and surgery are part of the treatment and evaluation process. During the study, participants undergo regular assessments including X-rays, CT scans, MRI, PET or bone scans, and blood sample collection at diagnosis and throughout treatment. Researchers monitor event-free survival, overall survival, symptom burden, and side effects reported by patients. The trial lasts up to 5 years after treatment to assess long-term outcomes, gather tumor and blood samples for further biological studies, and evaluate the impact of cabozantinib addition on patient health and response.

Researchers are evaluating whether a medicine called BI 3034701 can help adults living with obesity or overweight lose weight. The study includes adults aged 18 to 74 years who have a body mass index BMI of 30 or more, or a BMI of 27 or more with at least one weight-related health problem. People with type 2 diabetes are not allowed to participate. The study is a phase II treatment trial sponsored by Boehringer Ingelheim. Participants are randomly assigned to one of seven groups, with six groups receiving different doses of BI 3034701 and one group receiving a placebo that looks like the medicine but contains no active drug. Each participant receives two injections under the skin every week for 42 weeks. Alongside the injections, all participants receive counseling to help improve their diet and encourage regular exercise. The study lasts about 10 months for each participant. During the study, participants visit the study site 15 times where their body weight is regularly measured and laboratory tests are performed. They also complete questionnaires about their well-being and keep diaries of their food intake and physical activity. Researchers monitor health status and any side effects throughout the trial. The main measure of success is the percentage change in body weight after 42 weeks of treatment, with additional measures including weight loss milestones, waist size, and blood pressure changes.

This trial investigates monitoring and treatment options for patients with low risk and standard risk metastatic germ cell tumors, which are cancers that start in the cells that produce sperm or eggs. The study aims to find out if active surveillance after surgical removal of low risk tumors can maintain high survival rates, and whether carboplatin or cisplatin chemotherapy works better for treating standard risk tumors in children, adolescents, and young adults. Patients with low risk tumors undergo observation after surgery and may transfer to a standard risk treatment arm if the tumor recurs. Those with standard risk tumors are randomly assigned to receive one of two chemotherapy regimens one containing carboplatin, bleomycin, and etoposide, or the other containing cisplatin, bleomycin, and etoposide. Treatments are given intravenously in cycles every 21 days for up to 3 or 4 cycles depending on the group. Throughout the study, patients have imaging scans, blood tests, tumor biopsies, and pulmonary function tests to monitor response and side effects. Participants are followed closely during treatment and afterward with regular check-ups including CT, MRI, and chest X-rays, as well as blood sample collections. Follow-up visits occur every 2 months for the first year, then every 3-6 months up to 2 years, every 6 months for years 3 to 5, and annually up to 10 years. Researchers measure overall survival, event-free survival, hearing loss, body composition, tumor markers, and patient-reported outcomes related to hearing and neuropathy. This long-term monitoring helps assess the effects and safety of chemotherapy and surveillance strategies.

Researchers are evaluating whether adding the immunotherapy drug durvalumab to the usual chemotherapy regimen can improve outcomes for patients with MammaPrint High 2 Risk MP2 stage II-III hormone receptor positive, HER2 negative breast cancer. This phase III trial focuses on comparing breast cancer event-free survival and other measures between patients receiving chemotherapy alone and those receiving chemotherapy with durvalumab. Immunotherapy may help enhance the bodys immune response against cancer, while chemotherapy works to stop tumor growth in various ways. Participants are first tested for MP2 status using MammaPrint on previously collected tissue. Those with MP2 results are randomized into two groups. One group receives paclitaxel intravenously on days 1 and 8 every 14 days for six cycles, followed by doxorubicin and cyclophosphamide intravenously every 14 days for four cycles. The other group receives the same chemotherapy schedule combined with durvalumab given intravenously over 60 minutes on specific cycles. Mammography and optional tumor tissue and blood sample collections occur during the study. During the study, participants undergo assessments including mammography, tumor biopsies, blood tests, and quality-of-life questionnaires. Researchers measure outcomes such as event-free survival, response rates, relapse-free survival, overall survival, treatment side effects, and patient-reported fatigue and physical health. After treatment completion, participants are followed for up to 10 years to monitor long-term outcomes and survival. Specimens are also banked for future research.

Researchers are investigating treatments for patients with stage IV or recurring non-small cell lung cancer who have previously received platinum chemotherapy and immunotherapy. This phase IIIII trial compares the effects of adding cemiplimab, an immune system-stimulating monoclonal antibody, to the usual combination of docetaxel and ramucirumab. The goal is to see if adding cemiplimab helps the immune system better attack tumor cells and improves survival outcomes. Participants are randomly assigned to one of two groups. One group receives docetaxel and ramucirumab along with dexamethasone, while the other group receives these same treatments plus cemiplimab. Treatments are given in cycles every 21 days, with infusions lasting from 30 minutes to an hour depending on the drug. Patients undergo regular blood sample collections and imaging scans such as CT or MRI throughout the study. During the trial, participants are monitored for overall survival, disease progression, tumor response, and side effects. After completing treatment, follow-up visits occur every 3 to 6 months for up to 3 years. Blood tests and imaging help assess treatment effects and safety. Researchers also collect and store blood and tissue samples to support future studies.

Researchers are studying adults newly diagnosed with breast, colorectal, melanoma, non-Hodgkin lymphoma, or non-small cell lung cancer who are planning to receive systemic cancer therapies such as chemotherapy and immune checkpoint inhibitors ICIs. The study aims to understand how cannabis and cannabinoid use relates to cancer-related symptoms over one year. This observational research includes patients treated in community oncology clinics and is sponsored by Wake Forest University Health Sciences. Participants complete surveys and allow medical record reviews throughout the study. The study tracks cannabis and cannabinoid use as well as perceived benefits, harms, and adverse effects monthly for 12 months following enrollment. An optional sub-study is available at select sites for patients with non-small cell lung cancer receiving specific chemotherapy with ICIs. During the study, participants fill out monthly surveys about their symptoms and cannabis use. Researchers also review medical records to assess cancer-related symptoms and treatment progress. The main measure is cancer-related symptoms assessed monthly for up to one year. Secondary measures include cannabis use patterns and adverse effects. Participation involves ongoing survey completion and record review, with the total study duration lasting 12 months post-enrollment.

The BEATRIX study focuses on healthy pregnant women aged 49 or younger between 24 and 36 weeks of pregnancy to evaluate the safety and immune response of a group B streptococcus GBS vaccine. Researchers aim to understand how this vaccine works in pregnant women and their babies, assessing various safety measures and immune responses related to GBS. This study is a Phase 3, randomized, placebo-controlled, double-blinded trial sponsored by Pfizer. Participants will receive a single injection of either the GBS vaccine or a placebo saline. After birth, a subset of infants will receive routine vaccines according to each countrys immunization schedule, including vaccines for diphtheria, pneumococcal disease, and others. Some infants will have blood samples taken after completing their primary and toddler vaccine doses to evaluate immune responses. Pregnant participants will visit the study site at least three to four times, with some visits possibly conducted by phone, and may stay involved for up to 14 months, including six months after delivery. Their babies will be followed for about 12 months, with a subset participating for up to 19 months. Researchers will monitor local and systemic reactions, adverse events, and antibody levels in both mothers and infants to assess safety and immunogenicity of the vaccine throughout the study period.