Norwalk

Researchers are collecting long-term safety and effectiveness data for participants treated with ibrutinib, a first-in-class, orally taken medicine that targets Brutons tyrosine kinase. The study focuses on individuals who have already been treated with ibrutinib in prior studies and are continuing to benefit from the treatment. The goal is to provide ongoing access to ibrutinib while monitoring health outcomes over time. Participants will continue taking ibrutinib capsules once daily at the dose established in their previous study ranging from 140 mg to 560 mg until the doctor decides the treatment is no longer helping, the participant chooses to stop, or other specified reasons occur. Some participants may receive ibrutinib alone or in combination with nivolumab depending on their prior treatment. The study is open-label, meaning everyone knows the treatment being given. During the study, participants are regularly monitored for safety and disease changes through assessments and visits until they stop the study drug or move to other treatments. Researchers track side effects up to 30 days after the last dose and may analyze how the disease responds in combination with earlier study data. The study continues until all participants transition off study treatment or the sponsor ends the trial, ensuring ongoing care and data collection over time.

This research aims to screen for pancreatic cancer and its early signs in people aged 50 and older who have a strong family history or genetic risk for pancreatic cancer. The study focuses on using Magnetic Resonance Imaging and Magnetic cholangiopancreatography MRIMRCP to detect early-stage pancreatic cancer or precursor lesions. Blood samples will also be collected to help develop a blood-based screening test for pancreatic cancer. Participants will undergo annual MRIMRCP with IV gadolinium contrast and high-resolution imaging of the pancreas for up to 3 years, totaling four scans. Blood samples and a brief psychological survey will be collected every six months during this period. If any abnormalities appear on MRI, these will be reviewed by a multi-disciplinary tumor board and discussed with the participant. The study covers all MRI costs. Throughout the study, participants will be asked to complete surveys and provide blood samples for a bio-bank. The research team will monitor findings from MRI scans and blood tests regularly to detect early pancreatic cancer or precursor lesions. The study lasts up to three years and includes ongoing assessments to ensure participants health and safety during this time.

This research aims to explore the link between new-onset or worsening diabetes and the later development of pancreatic cancer. It focuses on individuals over 50 years old who have either been diagnosed with diabetes within the past year or have experienced deteriorating diabetes recently. The study uses Magnetic Resonance Imaging and Magnetic Cholangiopancreatography MRIMRCP to screen for early pancreatic cancer or its precursors, helping to identify risks earlier. Participants will undergo an MRI with contrast at the start of the study. Any abnormalities found will be reviewed by a team of specialists and discussed with the participant. Blood samples will be collected every six months for up to three years to create a bio-bank that supports developing a blood test for pancreatic cancer. Additional MRI scans may be done as needed based on expert recommendations. During the study, participants will complete a brief psychological survey and provide blood samples regularly. Researchers will monitor the presence of early pancreatic cancer or precursor lesions over three years. The study tracks the relative risk of pancreatic cancer among those with new or worsening diabetes. Participants must be willing to undergo MRI screening, provide informed consent, and attend all study visits during this period.

Researchers are evaluating the safety and effectiveness of a combination treatment called KarXT and KarX-EC for adults aged 55 to 90 who have agitation linked to Alzheimers Disease. This Phase 3 study aims to understand how this treatment may help manage agitation symptoms in this population, with careful monitoring of side effects and overall safety. Participants will receive either the KarXT plus KarX-EC treatment or a placebo, with doses given on specified days as capsules. The study is randomized and double-blind, meaning neither participants nor researchers know who receives the active treatment or placebo. The treatment period lasts 14 weeks, during which participants are closely observed. During the study, participants will undergo various assessments including the Cohen-Mansfield Agitation Inventory-International Psychogeriatric Association CMAI-IPA score to measure agitation changes at week 14. Additional evaluations include clinical global impressions, neuropsychiatric inventories, safety monitoring through lab tests, vital signs, body measurements, and assessment of side effects up to week 18. Caregivers will also report on participants status, and safety will be closely followed throughout the trial.

Researchers are evaluating the combination of disitamab vedotin and tucatinib in people with advanced or metastatic breast or gastric cancers that express the HER2 protein. These solid tumors, which start in organs like the breast or stomach, tend to grow quickly or spread, making treatment challenging. This Phase 2 clinical trial aims to test how safe and effective this combination therapy is, particularly for tumors that have HER2, which helps cancer cells grow faster and spread more easily. The study includes several phases a dose escalation phase to find the best dose of disitamab vedotin combined with tucatinib, followed by a dose optimization phase to assess safety and effectiveness at selected doses. After these phases, an expansion phase will evaluate this combination in four groups of participants with different HER2 expression levels and cancer types. Disitamab vedotin is given intravenously, while tucatinib is taken orally twice daily at 300 mg. Participants receive the combination therapy according to their assigned study group. During the trial, participants will undergo regular assessments including scans and lab tests to monitor tumor response and safety. The study will track side effects, dose changes, and overall treatment effects over several years, with some evaluations extending up to five years after treatment. Researchers will measure outcomes such as tumor response rate, duration of response, disease control, progression-free survival, and overall survival. Safety monitoring includes checking for adverse events and laboratory abnormalities throughout the study period.

This is an open label, multi center, Phase 1 dose escalation and dose expansion study of mevrometostat (PF-06821497) administered orally BID as a single agent or in combination with SOC to patients with CRPC, SCLC, and FL. The study consists of three parts (Part 1, Part 2, and Part 3) along with the Japan and China monotherapy cohorts. Part 1 and Part 2 are closed for enrollment. Part 1 tested monotherapy in 3 cohorts (Parts 1A, 1B, and 1C); Part 2 tested combination therapy in Parts 2A (dose escalation), 2B and 2C (does expansion). Part 3 consists of the Bioequivalence (BE) and drug-drug interaction (DDI) substudies and are open for enrollment. The BE substudy will test between 2 mevrometostat formulation to confirm that they work in the body the same way. The DDI substudy will evaluate the effect of a strong CYP3A4 (an enzyme in your body that breaks down/ removes drugs) inhibitor on the PK of mevrometostat; a strong CYP3A4 inhibitor may slow down the breakdown/ removal of drugs in your body. The Sponsor may choose to delay or discontinue any cohorts or substudies.

Researchers are evaluating the safety and effectiveness of a combination treatment using carboplatin and mirvetuximab soravtansine in adult women with advanced-stage serous epithelial ovarian, fallopian tube, or primary peritoneal cancer that expresses folate receptor alpha FRb1. This single-arm Phase 2 study focuses on patients with stage III or IV disease who have measurable tumors and high FRb1 expression. The investigational drug mirvetuximab soravtansine is designed to target and kill cancer cells carrying this receptor. Participants will receive intravenous infusions of mirvetuximab soravtansine combined with carboplatin on the first day of each 21-day cycle. Bevacizumab may also be given based on the investigators decision. This treatment will continue for 6 to 9 cycles over the course of the study, which is expected to last approximately three years. During the study, participants will attend regular hospital or clinic visits for medical assessments, blood tests, and scans to monitor their response to treatment and any side effects. Researchers will evaluate tumor response through imaging and other measures over up to three years, also tracking disease control, progression-free survival, and symptom changes. Safety will be closely monitored throughout the study period.

Researchers are evaluating the safety and effectiveness of plixorafenib in people with advanced or metastatic solid tumors, including primary central nervous system tumors, that have specific BRAF gene alterations. The study focuses on participants with BRAF fusions or rare BRAF V600 mutations in tumors like melanoma, thyroid cancer, or recurrent CNS tumors. This is a Phase 2 trial aiming to understand how well plixorafenib works in these cancer types. Participants receive plixorafenib as oral tablets continuously in 3-week cycles. The dose may be increased as tolerated and treatment continues until the disease progresses, unacceptable side effects occur, or other reasons lead to stopping. The study includes different groups based on tumor types and BRAF mutation status, including unresectable solid or CNS tumors with BRAF fusions, recurrent CNS tumors with BRAF V600E mutations, and advanced rare non-CNS solid tumors with BRAF V600E mutations. During the trial, participants will have scans and tests before starting treatment to assess tumor changes. Researchers will monitor tumor response, duration of response, progression-free survival, overall survival, and treatment side effects for up to four years. Blood samples will be taken to study how the drug is processed in the body. Participants will be closely followed throughout the study to evaluate the drugs effects and safety.

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 the effectiveness of the Change4Better C4B mobile app in reducing the severity of problem gambling compared to standard treatment as usual TAU. This study is a 6-month randomized clinical trial involving individuals with gambling disorder who are enrolled in or seeking treatment at outpatient facilities affiliated with Bettor Choice Gambling Treatment Programs or Kindbridge Behavioral Health. The study aims to assess the feasibility and efficacy of adding the C4B app, which is based on cognitive behavioral therapy, as a support tool alongside routine outpatient treatment. Participants will be randomly assigned to one of two groups one group will receive standard TAU, which includes individual or group therapy sessions tailored to their needs and usually lasts about one hour per week for 12 weeks. The other group will receive TAU plus access to the C4B mobile app, which teaches skills to manage gambling behaviors and cognitive distortions. Participants using the app will be instructed by staff on how to use it and encouraged to spend about 8 hours over 12 weeks completing modules and practicing exercises. Monthly follow-up continues for an additional 12 weeks, during which the app remains accessible. During the study, participants will be monitored for changes in gambling symptom severity from baseline to 6 months. Researchers will track app engagement through measures such as days used, topics completed, practice exercises, weekly usage, and total time spent. Participants will continue receiving usual outpatient care, and data will be collected through assessments and follow-ups conducted by the Yale research team. The total study duration for each participant is 6 months, starting from randomization.