Grand Forks

Researchers are investigating new treatments for people with high-risk, early-stage breast cancer, specifically targeting triple-negative breast cancer (TNBC) and hormone receptor (HR)-low positive/HER2-negative breast cancer. These types have little or no HER2 protein and involve hormones like estrogen or progesterone. The study aims to evaluate if the addition of sacituzumab tirumotecan (sac-TMT), a targeted therapy, combined with pembrolizumab and chemotherapy can improve outcomes compared to pembrolizumab with chemotherapy alone. Participants receive treatments including sacituzumab tirumotecan, pembrolizumab, and chemotherapy drugs such as carboplatin and paclitaxel, all given by intravenous infusion. Rescue medications like antihistamines, acetaminophen, dexamethasone, or steroid mouthwash may be used as needed. The study is randomized and open-label, comparing sac-TMT followed by chemotherapy plus pembrolizumab to chemotherapy and pembrolizumab without sac-TMT. During the study, researchers will monitor participants up to about 30 weeks to assess the percentage of people with no remaining cancer cells at surgery. They will also follow participants for up to approximately 92 months to track event-free survival, meaning time without cancer growth, spread, or return. Participants will undergo imaging, clinical assessments, and laboratory tests to evaluate treatment effects and safety throughout the study.

This is a Phase III, two-arm, randomized, double-blind, global, multicenter study assessing the efficacy and safety of rilvegostomig compared to pembrolizumab, both in combination with platinum-based doublet chemotherapy, as a first-line (1L) treatment for patients with squamous metastatic non-small cell lung cancer (mNSCLC) whose tumors express PD-L1 (tumor cells (TC) ≥ 1%).

This research aims to compare intismeran autogene combined with pembrolizumab versus placebo with pembrolizumab as an additional treatment after surgery for people with stage II, IIIA, or IIIB (with nodal involvement) non-small cell lung cancer (NSCLC) that has been fully removed with clear margins. The study is a phase 3 trial investigating whether the combination including intismeran autogene improves disease-free survival compared to the placebo combination. Participants will receive either intismeran autogene by intramuscular injection plus pembrolizumab by intravenous infusion or a placebo injection plus pembrolizumab. The treatments are given after surgery and standard platinum-based chemotherapy. No more than 24 weeks can pass from surgery to the first pembrolizumab dose. The study evaluates these treatments as adjuvant therapy to reduce cancer recurrence. During the trial, researchers will monitor participants for disease-free survival for up to approximately 78 months. Participants undergo regular assessments including medical evaluations to track cancer status and treatment effects. The study excludes those with prior neoadjuvant therapy, certain infections, or other cancer treatments that might interfere. Safety and long-term outcomes are carefully observed throughout the study period.

Researchers are evaluating cancer directed therapy given at home versus in the clinic for patients with advanced cancer that may have spread to nearby tissue, lymph nodes, or distant parts of the body. This Phase 2 trial aims to reduce the physical, emotional, social, and financial burdens patients face by comparing traditional clinic-based care to home-based treatment with virtual support. The study focuses on improving patient quality of life, treatment compliance, and reducing distress, particularly for marginalized groups. Participants start by receiving at least one cycle of standard-of-care cancer treatment in the clinic. They are then randomized to either continue treatment at home for about 24 weeks or stay in the clinic for 8 weeks before switching to home treatment for approximately 16 weeks. Home care includes drug administration, lab tests, and monitoring by a home health nurse provider with remote oversight from a specialized Command Center. Patients also receive biometric devices and a tablet for video visits with the Mayo Clinic care team. During the study, participants complete questionnaires about their experience, treatment preference, comfort with home infusions, and quality of life. Researchers assess safety through monitoring adverse events and track hospital visits or emergency room use over six months. After treatment, patients are followed for one year to evaluate overall survival, cost of care, and treatment administration. The primary outcome is the patient-reported rating of Cancer Connected Access and Remote Expertise after 8 weeks.

Researchers are establishing the Caris Biorepository to collect and store high-quality biological specimens along with clinical and demographic data. This resource aims to support research studies focused on advancing precision medicine and improving patient care, especially in areas related to cancer, early detection of cancer, and minimal residual disease. The biorepository is designed to securely share valuable biospecimen information and clinical outcomes to help develop targeted treatments and improve healthcare. The Caris Biorepository will gather specimens prospectively from multiple sources and maintain molecular integrity and clinical relevance of these samples. It will provide access to this information for researchers both within Caris Life Sciences and external collaborators such as government agencies, academic institutions, and industry partners. The project supports drug development, clinical research trials, publications, and healthcare policy development by bridging the gap between human specimens and associated clinical data. Participants in this research will provide biospecimens and clinical data, with the biorepository managing access and use of these materials over time. The study focuses on developing a high-quality collection of human samples and associated data for up to 35 years, supporting various research purposes. Outcomes include ensuring specimen integrity and releasing specimens for testing while maintaining detailed clinical information to facilitate future medical discoveries and improvements in patient outcomes.

Researchers are evaluating the Freenome Multiomics Blood Test as a tool to help detect lung cancer earlier in people at high risk. This prospective, multi-center observational study involves participants eligible for standard lung cancer screening using a low-dose computed tomography (LDCT) scan. The study collects blood samples and compares the test's results with routine screening to see how well the blood test detects lung cancer over time. Participants who qualify and consent will have 50 ml of blood drawn for analysis by Freenome or its designee. Blood collection is done within 30 days of consent, and ideally on the same day as the LDCT screening, but up to 45 days after blood collection is allowed for the scan. The study collects detailed clinical and demographic information, including medical history, lifestyle, family history, and exposure risks, along with diagnostic and follow-up imaging and pathology reports related to lung cancer diagnosis. Participants will be followed for at least 24 months from their initial screening CT scan or until early study exit due to withdrawal or death. The researchers will monitor the sensitivity and specificity of the blood test in detecting lung cancer during this period. All clinical data, imaging, lab tests, and outcomes related to lung cancer diagnosis will be carefully recorded and analyzed to evaluate the blood test's performance.

Researchers are collecting blood and tissue samples from people with and without cancer to study and evaluate tests that could help detect cancer early. The goal is to create a blinded reference set of samples to validate blood-based tests for early detection of multiple types of cancer, including leukemia, lymphoma, breast, lung, and others. The study also aims to assess how well these tests perform at the time of initial cancer diagnosis, considering different tumor types and cancer stages. Participants complete a baseline questionnaire and provide blood samples at registration and again 12 months later. Those diagnosed with cancer may also provide tissue samples at these times. The study includes patients aged 40 to 75 years, with cancer diagnoses at various stages or individuals without cancer. Special procedures are in place for patients with high suspicion of certain cancers before confirmation. During the study, researchers collect detailed information through questionnaires, blood draws, and tissue sampling to analyze test accuracy. Participants are monitored for up to one year after registration to follow outcomes. The primary measure is providing this blinded set of blood samples to help validate future cancer detection tests, supporting research that could improve early diagnosis and treatment.

Researchers are evaluating how to best recommend chemotherapy for patients with colon cancer after surgery by using the presence or absence of circulating tumor DNA (ctDNA) in the blood. This approach aims to identify microscopic residual tumor cells and may provide better risk prediction for cancer recurrence compared to traditional methods. The trial focuses on patients with Stage IIB, IIC, or III colon cancer who have undergone complete tumor removal. Participants will have their tumor tissue and blood tested centrally using the Signatera assay to determine ctDNA status. Patients without detectable ctDNA may avoid chemotherapy, while those with detectable ctDNA are considered at higher risk and will be randomly assigned to receive different chemotherapy regimens, including mFOLFOX6, CAPOX, or mFOLFIRINOX, given intravenously or orally over periods ranging from 3 to 6 months. The study includes initial screening, treatment, and possible second randomization for patients whose ctDNA status changes during monitoring. During the study, participants will undergo various assessments including blood tests, imaging scans, and performance evaluations to monitor their health and response to therapy. Researchers will track the time to ctDNA positivity and disease-free survival for up to 3 and 5 years, respectively. Safety and treatment effects will be closely observed throughout the study duration, ensuring thorough follow-up and monitoring for all participants.

Researchers are evaluating whether breast conservation surgery combined with endocrine therapy can achieve a similar rate of invasive or non-invasive ipsilateral breast tumor recurrence (IBTR) compared to breast conservation surgery followed by breast radiation and endocrine therapy in patients with Stage I, hormone sensitive, HER2-negative breast cancer with an Oncotype recurrence score of 18 or less. This Phase III trial builds on the established role of radiation after lumpectomy, aiming to identify if radiation can be safely omitted in certain low-risk patients to reduce treatment burden and side effects. Participants receive either breast radiation plus endocrine therapy or endocrine therapy alone. Radiation therapy involves external beam radiation to the whole breast with or without a boost, partial breast irradiation, or accelerated partial breast irradiation, starting within 12 weeks after the last breast surgery. Endocrine therapy is given for a minimum of 5 years, with the specific drug choice and schedule determined by the treating physician. Endocrine therapy may begin before, during, or after radiation therapy, depending on the treatment group. Throughout the study, participants undergo regular assessments including imaging such as mammograms or MRI within six months before enrollment, and clinical evaluations to monitor tumor recurrence. The main outcome measured is the time to invasive or non-invasive ipsilateral breast tumor recurrence over five years. Safety, adherence to therapy, and recovery from surgery are also monitored. The total participation period includes at least five years to evaluate long-term recurrence rates.

Researchers are evaluating treatments for amblyopia in children aged 4 to 7 years. The study compares watching dichoptic movies or shows using the Luminopia virtual reality headset for 1 hour per day, 6 days per week, to traditional eye patching for 2 hours per day, 7 days per week. This Phase 3 trial aims to determine if the Luminopia treatment is not worse than patching in improving vision in the weaker eye over 26 weeks. Participants will be randomly assigned to either the Luminopia headset group or the patching group. Clinical assessments occur at 13 and 26 weeks after starting treatment. At 26 weeks, those initially assigned to patching who show less improvement may choose to try Luminopia therapy and continue follow-up visits at 39 and 52 weeks. Other participants will end the study at 26 weeks. During the study, children will have their vision tested at scheduled visits to measure changes in distance visual acuity in the amblyopic eye. Researchers will monitor treatment adherence and safety. The total participation can last up to 52 weeks for some children, with primary outcomes assessed at 26 weeks to evaluate vision improvement.