Greer

Researchers are evaluating pasritamig (JNJ-78278343), a T cell redirecting agent targeting human kallikrein 2, combined with best supportive care (BSC) for men with metastatic castration-resistant prostate cancer (mCRPC). This advanced cancer stage has spread beyond the prostate and no longer responds to hormone treatments. The study compares pasritamig plus BSC to a placebo plus BSC to assess overall survival in patients who have exhausted other life-prolonging therapies. Participants receive pasritamig or placebo through intravenous infusions starting with step-up doses on Cycle 1 Day 1 and Day 8, followed by the target dose on Day 15. Subsequent doses occur every 6 weeks in 6-week cycles, except the first cycle which lasts 8 weeks. All participants may receive best supportive care, including palliative radiation, steroids, pain medications, bone agents, and procedures, as determined by their doctors. Treatment continues until disease progression, intolerable side effects, death, withdrawal, or study end. During the study, participants undergo regular assessments to monitor overall survival and other outcomes like progression-free survival, symptom progression, skeletal events, pain, fatigue, and adverse events. These evaluations may include imaging, laboratory tests, and quality of life questionnaires over approximately 2 years and 8 months. Safety and treatment effects will be closely followed throughout the trial.

Researchers are evaluating two surgical procedures to reduce the risk of ovarian cancer in women with BRCA1 gene mutations. This trial compares bilateral salpingectomy, which removes the fallopian tubes, with bilateral salpingo-oophorectomy, which removes both fallopian tubes and ovaries. The study aims to see if the less extensive surgery is nearly as effective at lowering cancer risk and assesses effects on quality of life, menopausal symptoms, sexual function, and medical decision making. Participants choose between two groups: one undergoing bilateral salpingectomy with possible delayed removal of ovaries, and the other undergoing immediate removal of both fallopian tubes and ovaries. Before surgery, patients have pelvic or transvaginal ultrasounds or pelvic MRIs and blood samples collected. Follow-up visits occur at 10 to 60 days, 6, 12, and 24 months after surgery, then annually for up to 20 years. During the study, researchers will monitor the development of ovarian, primary peritoneal, or fallopian tube cancers over 20 years. They will also assess quality of life, cancer-related distress, menopausal and estrogen deprivation symptoms, sexual dysfunction, medical decision making, and adverse events up to 24 months after surgery. Blood samples and tissue are collected for future research. The long-term follow-up helps understand both cancer risk and patient well-being after surgery.

Researchers are evaluating how well active surveillance helps doctors monitor patients with low-risk germ cell tumors after surgical removal. The study also compares chemotherapy treatments using carboplatin versus cisplatin in pediatric, adolescent, and young adult patients with metastatic standard risk germ cell tumors. It aims to determine overall survival, event-free survival, and side effects such as hearing loss among these patients. The study includes patients with low-risk stage I ovarian immature teratoma or stage I non-seminoma or seminoma germ cell tumors who undergo observation. Patients with standard risk tumors are randomly assigned to receive one of four chemotherapy regimens combining bleomycin, etoposide, carboplatin, or cisplatin, given intravenously on specific days over cycles repeating every 21 days. Treatments continue for up to 3 or 4 cycles if no disease progression or unacceptable side effects occur. Throughout treatment and observation, patients undergo imaging scans, blood sample collection, tumor biopsies if needed, and pulmonary function tests. Participants will be followed with regular imaging and blood tests to monitor tumor response and recurrence, including CT, MRI, and chest x-rays. Follow-up visits occur every 2 months for the first year, then every 3 to 6 months through year 2, every 6 months for years 3 to 5, and annually up to 10 years. The study also assesses hearing outcomes, body composition, tumor marker decline, neuropathy, and serum microRNA over time to better understand treatment effects and patient quality of life.

Researchers are evaluating whether adding the immunotherapy drug durvalumab to the usual chemotherapy treatment can improve outcomes for adults with MammaPrint High 2 Risk (MP2) stage II-III hormone receptor positive, HER2 negative breast cancer. This phase III trial compares standard chemotherapy alone to chemotherapy combined with durvalumab. Previous evidence suggests patients with this specific cancer profile may respond better to chemotherapy and immunotherapy, so this study aims to see if durvalumab helps prevent cancer from returning. Participants are first screened with MammaPrint testing on tumor tissue to confirm MP2 status. Those eligible are then randomly assigned to one of two treatment groups. One group receives paclitaxel intravenously on days 1 and 8 every 14 days for 6 cycles, followed by doxorubicin and cyclophosphamide every 14 days for 4 cycles. The other group receives the same chemotherapy schedule plus durvalumab intravenously during specific cycles. Mammography is done during screening, and optional tumor tissue and blood samples are collected throughout the study. During the trial, participants undergo regular assessments including mammograms, tissue biopsies, and blood tests to monitor response and safety. Researchers measure event-free survival, pathologic complete response, residual cancer burden, distant relapse-free survival, and overall survival for up to 10 years after treatment. Quality of life is also evaluated through questionnaires during and after treatment. Participants are followed long-term to track outcomes and side effects.

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 II/III 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 evaluating an Internet-based pain coping skills program combined with enhanced usual care to see if it improves pain severity and pain interference in adult cancer survivors with persistent cancer-related pain. This study also looks at other effects such as opioid medication use, quality of life, pain management confidence, fatigue, sleep, emotional distress, positive feelings, pain impact, cognitive problems, and cognitive performance. The study enrolls 250 participants who have been treated for invasive cancer and are experiencing ongoing pain. Participants are randomly assigned to one of two groups. One group receives access to an 8-session online pain coping program plus pain education alongside their usual care, which they complete within 10 weeks and can revisit during that time. After the study ends, they retain access to the program. The other group receives pain education only at their initial clinic visit and will be offered access to the online program after completing the 6-month follow-up assessment. Each participant is involved in the study for about 9 months, from randomization through final follow-up at week 34. Researchers will assess changes in pain severity and interference primarily from baseline to 10 weeks, with additional follow-ups at 22 and 34 weeks. They will also monitor opioid use, quality of life, and pain management self-efficacy. Participants complete various questionnaires and assessments throughout, and adherence to the online program is tracked. The study aims to better understand how this Internet-based approach may help manage cancer-related pain.

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.

Researchers are evaluating the safety and immune response of a group B streptococcus (GBS) vaccine in healthy pregnant women and their babies. The study is a phase 3, randomized, placebo-controlled, double-blinded trial aiming to understand how the vaccine works in pregnancy and the infant's early life. The focus is on pregnant participants aged 49 or younger between 24 and 36 weeks of gestation with no major fetal abnormalities and negative tests for HIV, syphilis, and hepatitis B. Participants will receive a single injection of either the GBS6 vaccine or a saline placebo. The study also involves vaccines for infants, including combinations protecting against diphtheria, tetanus, pertussis, hepatitis B, polio, Haemophilus influenzae type b, and pneumococcal strains, given according to each country's immunization schedule. Pregnant participants are followed for up to 14 months, including 6 months after delivery. A subset of infants will have additional follow-up for up to 19 months receiving standard vaccines with blood samples taken after primary and booster doses. Participants will attend 3 to 4 visits, some by telephone, for safety and immune response assessments. Researchers will monitor local and systemic reactions, adverse events, and serious adverse events in mothers and infants for up to one year after birth. Key measures include antibody levels against GBS serotypes and vaccine effectiveness predictions based on infant antibody concentrations. Infant immunity to other vaccines is also compared between groups. This careful monitoring provides safety and immune response data throughout the study duration.

Researchers are evaluating the effectiveness of computerized cognitive training methods to help breast cancer survivors who experience cognitive difficulties related to cancer and its treatments. This trial focuses on breast cancer survivors with non-metastatic disease who report cognitive problems after their cancer therapy, aiming to address the long-lasting challenges that affect their work and health. The study is a Phase III, double-blind, randomized controlled trial comparing two types of cognitive training methods. Participants will be assigned to one of two groups. The first group will use global stimulation games featuring non-speeded, strategy-based exercises like solitaire, sudoku, and word search that do not adapt to the player's skill. The second group will use neuroplasticity games designed to improve cognitive functions such as attention, working memory, processing speed, and executive function, with exercises that adapt to the user's performance. The training involves eight exercises tailored to address cognitive concerns common among breast cancer survivors. During the study, participants will be monitored over 12 weeks post-randomization for self-reported cognitive impairment, with further assessments extending to 36 weeks. Researchers will collect data through cognitive tests, questionnaires, and behavioral tracking within the programs to measure changes in cognitive performance. The trial will also evaluate the safety and adherence to the training programs, with the total participation period lasting up to 36 weeks from randomization.

Researchers are collecting blood and tissue samples from patients with and without cancer to evaluate tests that might help detect cancer early. This observational study aims to create a blinded reference set of blood samples from both cancer and non-cancer patients to validate blood-based multi-cancer early detection tests. The study also assesses test performance at the time of initial cancer diagnosis by tumor type and clinical stage. Participants complete a questionnaire at the start of the study and provide blood samples at registration and again 12 months later. Patients diagnosed with cancer may also provide tissue samples at these same time points. The study collects samples to support the development and validation of early detection assays, with no treatment interventions involved. During the study, participants fill out questionnaires and provide blood and possibly tissue samples. Researchers follow up with participants one year after study completion. The main outcome is the creation of a blinded reference set of blood samples to test early cancer detection methods. The study monitors test performance based on cancer type and stage, with all evaluations completed within one year of enrollment.