Troy

Researchers are evaluating treatments for patients with BRAF-V600 mutant melanoma that has spread to the brain. This phase II trial compares two combinations encorafenib, binimetinib, and nivolumab versus ipilimumab and nivolumab. The study aims to determine which approach is more effective at shrinking and controlling brain metastases, and it also examines survival, response rates, and treatment safety. Patients are randomly assigned to one of two treatment groups. One group takes encorafenib daily by mouth, binimetinib twice daily by mouth, and receives nivolumab through an intravenous IV infusion every 28 days. The other group receives nivolumab IV every cycle and ipilimumab IV over 30 minutes during the first four cycles, with cycles repeating every 21 days initially, then every 28 days. Treatment continues unless disease worsens or side effects become unacceptable. Participants undergo brain MRI scans before enrollment and throughout the study to assess tumor response using specific criteria. After completing treatment, patients are followed every six months for two years, then yearly up to three years. The study collects tissue, blood, spinal fluid, and stool samples for future research. Researchers monitor progression-free survival as the main outcome, along with overall survival, response rates, and treatment side effects.

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 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 evaluating the addition of nivolumab to the usual treatment of paclitaxel and ramucirumab compared to paclitaxel and ramucirumab alone in patients with advanced stomach or esophageal adenocarcinoma. This phase IIIII trial aims to see if nivolumab improves progression-free survival and overall survival in these patients. Nivolumab is an immunotherapy monoclonal antibody that may help the immune system attack cancer, while ramucirumab may prevent tumor blood vessel growth, and paclitaxel stops cancer cells from dividing. Participants are randomly assigned to one of two groups. One group receives nivolumab intravenously on day 1 of each 28-day cycle, combined with ramucirumab on days 1 and 15, and paclitaxel on days 1, 8, and 15. The other group receives only ramucirumab and paclitaxel on the same schedule without nivolumab. Treatment cycles continue unless the disease worsens or side effects become unacceptable. During the study, patients undergo CT scans and MRI imaging, and may optionally provide blood samples. Throughout the trial, participants are monitored with regular imaging and optional blood tests. After treatment ends, patients have follow-up visits at 30, 60, and 90 days, then every six months for up to three years. Researchers assess progression-free survival, overall survival, response rates, disease control, safety, and quality of life using questionnaires and patient-reported symptoms. This comprehensive monitoring helps evaluate treatment effects and patient well-being over time.

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 the effects of adding olaparib, a PARP inhibitor, after surgery and chemotherapy in patients with pancreatic cancer that has been surgically removed and who have mutations in BRCA1, BRCA2, or PALB2 genes. This phase II trial aims to see if olaparib can improve relapse-free survival compared to placebo. The study also evaluates overall survival and differences in outcomes based on mutation type and prior chemotherapy treatment. Participants are randomly assigned to receive either olaparib or a placebo orally twice daily in 28-day cycles for up to 12 cycles, unless the disease progresses or side effects occur. During the treatment, patients will have CT or MRI scans and blood samples taken regularly. After treatment, participants will be followed up at 30 days, every 4 months for the first year, then every 6 months for up to 10 years. Throughout the study, patients will undergo imaging and blood tests to monitor their health and detect any recurrence of cancer. The main outcome measured is the time from randomization to disease recurrence or death. Researchers will also track overall survival for up to 10 years. Safety will be monitored, and participants will be observed regularly after treatment to assess long-term effects and disease status.

This research aims to evaluate the combination of two drugs, cabozantinib and nivolumab, in treating advanced melanoma or squamous cell head and neck cancer that may have spread locally or to distant parts of the body. The study focuses on how these drugs affect tumor growth and the immune systems ability to fight cancer. It also investigates how quickly patients can be grouped based on tumor biomarkers, specifically tumor mutational burden and tumor inflammation signature, to understand differences in treatment responses. Participants receive nivolumab through intravenous infusion on the first day of each 28-day cycle and take cabozantinib orally every day. Treatment cycles continue for up to two years unless the disease progresses or side effects become unacceptable. During the study, patients undergo CT or MRI scans and blood sample collections. Tumor biopsies are taken during screening and may be repeated during follow-up. After treatment ends, participants are monitored every 12 weeks for one year and then every six months for up to three years. Throughout the trial, participants are assessed with imaging scans and blood tests to monitor cancer status and treatment effects. Researchers measure the time to receive biomarker results and evaluate tumor response rates. They also track safety, disease control, progression-free survival, and overall survival over the two years of treatment. Specimens are banked for future research. Participants remain under observation for several years after treatment to gather long-term data on outcomes and safety.

Researchers are evaluating treatments for older adults aged 70 and above with advanced stage IIIB-IV non-small cell lung cancer that expresses PD-L1 in 1-49% of tumor cells. This phase III trial compares the effects of adding chemotherapy to immunotherapy with pembrolizumab against pembrolizumab alone. The study aims to assess improvements in overall survival, progression-free survival, response rates, toxicity, quality of life, and explore geriatric assessment factors and gut microbiome correlations. Participants are randomly assigned to one of two groups. Arm A receives pembrolizumab intravenously every 21 days for four cycles, followed by maintenance pembrolizumab every 21 or 42 days for up to two years. Arm B receives the same pembrolizumab schedule plus one of several chemotherapy regimens, including combinations of pemetrexed, carboplatin, nab-paclitaxel, or paclitaxel administered intravenously on different schedules for four cycles, followed by pembrolizumab maintenance. Imaging with MRI, CT, and PET scans is performed at baseline and throughout the trial. During the study, participants undergo regular assessments including imaging scans to monitor disease status, blood tests, and quality of life questionnaires. After treatment completion, follow-up visits occur every three months for up to two years and then every six months up to five years. Researchers measure overall survival as the primary outcome and also track progression-free survival, response rates, adverse events, and patient-reported quality of life. Safety and tolerability are closely monitored along with exploratory analyses of chemotherapy dose intensity and microbiome factors.

Researchers are collecting blood and tissue samples from people with and without cancer to help evaluate new tests that could detect cancer early. This study aims to create a set of blinded blood samples from both cancer and non-cancer patients to validate these tests, focusing on multiple cancer types and stages. The goal is to improve early cancer detection through laboratory research. Participants complete a questionnaire at the start and provide blood samples at registration and again 12 months later. Those diagnosed with cancer may also have tissue samples collected at these times. The study includes patients with various cancer types and stages, as well as individuals without cancer, with some allowing enrollment before full cancer confirmation under specific conditions. During the study, researchers review the collected samples and questionnaire data to assess test performance by tumor type and clinical stage at diagnosis. Participants are followed for one year after completing the study. Key measurements include the provision of a blinded reference set of cancer versus non-cancer blood samples to support future clinical trials focused on blood-based multi-cancer early detection.

This research aims to establish a national biorepository by collecting research data and samples from patients who experience side effects from immunotherapy treatments used in cancer care. It focuses on patients who have serious immune-related reactions, rare infections, or accelerated tumor growth after receiving immuno-oncology therapies. The goal is to help researchers better predict, prevent, and treat these side effects in the future. Participants will have tissue and blood samples collected within 72 hours after confirmation of a serious immune-related side effect and again one month later. For patients experiencing colitis, stool samples may also be collected. Alongside sample collection, medical records will be reviewed for up to one year. This study is observational and involves no experimental treatments. During the study, participants will provide biospecimens at two time points and allow access to their medical records for a year. Researchers will analyze these samples and clinical data to build a resource for future studies on immune-related adverse events. The main outcome is the establishment of this biorepository, which will be maintained for up to one year after enrollment.