Rice Lake

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 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 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.

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.

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.

This trial evaluates treatment approaches for patients with locally advanced nasal and paranasal sinus squamous cell carcinoma that can be removed by surgery. It compares chemotherapy given before surgery and radiation therapy to surgery and radiation therapy alone. The study aims to assess organ preservation rates, overall survival, and progression-free survival, along with the accuracy of imaging predictions and the effects of tobacco use on treatment outcomes and patient symptoms. Participants are randomly assigned to one of two treatment groups. One group undergoes standard surgery followed by image-guided intensity-modulated radiation therapy IMRT and may receive cisplatin or carboplatin chemotherapy during radiation if certain risk factors are present. The other group receives up to three courses of chemotherapy with docetaxel and cisplatin or carboplatin before surgery, followed by the same radiation and chemotherapy approach. Chemotherapy is administered intravenously, and radiation is given daily for 30 treatments over several weeks. During the study, participants have imaging scans such as MRI and PETCT before and after chemotherapy to evaluate tumor status and organ preservation. After treatment, patients are monitored with follow-up visits every three months for up to two years, then every six months up to five years. The research team collects laboratory tests, questionnaires, and clinical assessments to measure survival outcomes, organ preservation, treatment side effects, and patient-reported symptoms throughout the study period.

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.

This trial studies adults with malignant peritoneal mesothelioma, comparing standard treatment alone to standard treatment combined with immunotherapy using atezolizumab. It aims to determine if adding atezolizumab to chemotherapy and bevacizumab improves response rates and survival. The study also explores safety, metabolic responses, surgical outcomes, and blood-based biomarkers related to treatment effects. Participants are randomly assigned to one of two groups. One group receives a combination of atezolizumab, bevacizumab, carboplatin, and pemetrexed intravenously every 21 days for up to four cycles, followed by cytoreductive surgery and HIPEC within 4 to 8 weeks. Those not eligible for surgery continue maintenance treatment with atezolizumab and bevacizumab. The other group receives bevacizumab, carboplatin, and pemetrexed on the same schedule, followed by surgery and HIPEC or maintenance bevacizumab with or without atezolizumab. Throughout the study, participants undergo CT and PET scans and provide blood and tissue samples for analysis. After completing treatment, patients are followed every six months for up to three years to assess outcomes including response rates, survival, safety, and pathological effects. The study measures these outcomes using imaging criteria and clinical evaluations to understand treatment benefits and risks.

Researchers are collecting and storing tissue and blood samples from patients with various types of cancer to help create better models for studying cancer and testing new cancer drugs. This observational study focuses on patients with hematopoietic and lymphatic system neoplasms, malignant solid tumors, metastatic malignant solid tumors, and recurrent malignant solid tumors. The goal is to procure biological tissues and materials to develop preclinical cancer models for future laboratory analysis. During the study, tumor tissue and blood samples are collected during medical procedures required for the patients cancer treatment. These samples are then preserved using methods such as xenograft models, where tissues are transplanted to another species, or in vitro cell cultures. This process allows for future scientific study without additional invasive procedures beyond routine clinical care. Participants will be involved in routine clinical procedures during which tissue and blood samples are collected. Researchers will store these specimens and monitor their use in creating cancer models over a period of up to five years. The main outcome measured is the successful procurement and storage of tissue and blood specimens for research purposes. Participation will continue as long as samples can be collected during clinical management, with no additional treatment or interventions required specifically for this study.

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.