Easton

Researchers are evaluating the combination of adagrasib, pembrolizumab, and platinum-doublet chemotherapy compared to placebo plus pembrolizumab and platinum-doublet chemotherapy in adults with previously untreated, locally advanced or metastatic non-squamous non-small cell lung cancer NSCLC carrying the KRAS G12C mutation. This Phase 3 trial aims to assess the efficacy, safety, and tolerability of these treatment combinations in this specific patient group. Participants will receive either adagrasib plus pembrolizumab combined with platinum-doublet chemotherapy or placebo plus pembrolizumab and platinum-doublet chemotherapy. Treatments involve specified doses administered on scheduled days, with the chemotherapy consisting of carboplatin or cisplatin along with pemetrexed. Participants are randomly assigned to one of the two study groups and treatments are blinded to ensure unbiased assessment. Throughout the study, participants will undergo regular evaluations including imaging scans to measure tumor response and progression-free survival, as well as assessments of overall survival. Safety is closely monitored by recording adverse events for up to 90 days after the last dose. Quality of life and symptom assessments are also conducted using validated questionnaires. The study duration includes follow-up for up to seven years to gather comprehensive data on treatment outcomes and participant health.

Researchers are evaluating the combination of pazopanib with or without abexinostat in patients who have locally advanced unresectable or metastatic renal cell carcinoma RCC. This Phase 3, randomized, double-blind, placebo-controlled study aims to compare the effects of pazopanib plus abexinostat versus pazopanib plus placebo. The study focuses on progression-free survival and other outcomes to understand the potential benefits and risks of adding abexinostat to pazopanib treatment for this condition. Participants will be randomly assigned in a 21 ratio to receive either pazopanib plus abexinostat or pazopanib plus a placebo. Pazopanib is taken daily by mouth throughout each 28-day treatment cycle, while abexinostat or its matching placebo is taken twice daily on specific days within each cycle. If disease progression occurs, patients initially receiving placebo may switch to the combination of pazopanib plus abexinostat. Treatment continues until disease progression, unacceptable side effects, withdrawal, or study closure. Participants will undergo screening within 28 days before starting treatment to confirm eligibility. They will be monitored regularly during treatment cycles with assessments including imaging scans and evaluations of side effects using standard criteria. Outcome measures include progression-free survival, overall survival, response rates, duration of response, and changes in quality of life scores. Follow-up will continue for up to approximately four years, with ongoing safety and efficacy evaluations throughout the study period.

Researchers are investigating the effects of crizanlizumab compared to a placebo in adolescents and adults with Sickle Cell Disease who experience frequent vaso-occlusive crises VOCs. This Phase III, randomized, double-blind study involves patients aged 12 years and older who have had 4 to 12 VOCs managed by healthcare professionals in the past year. The study evaluates the safety and effectiveness of crizanlizumab with or without standard hydroxyureahydroxycarbamide therapy. Participants are randomly assigned in a 21 ratio to receive either crizanlizumab at a dose of 5 mgkg or a placebo, both given alongside standard care. The treatment is administered intravenously as a concentrate for infusion. The study is stratified by hydroxyurea use and geographical region to ensure balanced groups. The main treatment period lasts for one year. During the study, participants will attend regular visits for treatment and monitoring. Researchers will assess the number of healthcare-managed VOCs, including those treated in person or via remote consultation, and measure various other outcomes such as time to first VOC, VOC duration, antibody development to crizanlizumab, adverse events, and changes in hemoglobin levels. Safety and efficacy will be observed over two years, with detailed documentation of VOC events and other health assessments throughout participation.

Researchers are evaluating the safety and effectiveness of an experimental drug combination, fianlimab and cemiplimab, compared to the approved combination of relatlimab and nivolumab Opdualag in adults with advanced or metastatic melanoma, a serious type of skin cancer. This Phase 3 study aims to understand how well these treatments work and what side effects they may cause. The study also investigates how much of the study drugs are present in the blood over time and whether the body produces antibodies against these drugs. Participants are randomly assigned to receive either the experimental combination of fianlimab plus cemiplimab given intravenously every three weeks or the approved combination of relatlimab plus nivolumab given intravenously every four weeks. The study compares these two treatments in parallel groups. Treatments are administered during the study period, and participants are monitored regularly to assess the effects and safety of the medications. During the trial, participants undergo assessments including tumor measurements following standardized criteria to evaluate response to treatment. The study also monitors for adverse events, laboratory abnormalities, and the presence of anti-drug antibodies. The main outcome measure is the objective response rate, evaluated over up to 72 months. Participants are followed for safety and effectiveness throughout this period, which may last several years in total.

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.

This research aims to compare two methods of monitoring pancreatic cysts and to identify biomarkers that may help detect the risk of these cysts turning into pancreatic cancer. The study evaluates whether more frequent monitoring or less frequent monitoring leads to better patient outcomes and explores various blood and imaging biomarkers for improved risk prediction. Participants are observed through two different surveillance approaches that were previously randomized but are now closed to new enrollment. One approach involves lower intensity monitoring with MRI, CT, or endoscopic ultrasound EUS scans spaced out over years, while the other involves higher intensity monitoring with more frequent imaging based on cyst size. Throughout the study, patients may also provide blood samples and undergo biopsies, fine needle aspirations, or surgery as needed. Participants are followed up regularly for five years from registration, with imaging and blood tests at intervals depending on their assigned monitoring method. Researchers collect data on clinical features, anxiety, quality of life, financial distress, healthcare costs, and outcomes such as the development of concerning pancreatic cyst features or pancreatic cancer. The study uses these measures to assess the effectiveness of monitoring strategies and the predictive value of biomarkers.

Researchers are evaluating a treatment approach for early-stage hormone-sensitive, HER-2 negative breast cancer with an Oncotype recurrence score of 18 or less. This Phase III trial compares breast conservation surgery with endocrine therapy alone against breast conservation surgery with both radiation and endocrine therapy. The goal is to see if skipping radiation after lumpectomy is not worse in preventing cancer recurrence in the same breast. Participants will be randomly assigned to one of two groups. One group will receive radiation therapy to the breast plus at least five years of endocrine therapy with drugs such as Tamoxifen, Anastrozole, Letrozole, or Exemestane. The other group will receive endocrine therapy only for at least five years without radiation. Radiation must start within 12 weeks of surgery if assigned. Endocrine therapy dosing and schedule are determined by the treating doctor. During the study, participants will have regular follow-ups up to five years to monitor cancer recurrence in the breast and elsewhere, survival, and breast preservation. Assessments will include clinical exams, imaging like mammograms or MRI, and pathology reviews. The main outcome is time to invasive or noninvasive breast tumor recurrence within five years. Some measures will continue through an average of 15 years, including breast conservation rates. Safety and overall health will be monitored throughout and after treatment.

Researchers are evaluating the effectiveness of Daromun, a neoadjuvant intratumoral treatment, combined with surgery and adjuvant therapy compared to surgery and adjuvant therapy alone in patients with Stage IIIB, IIIC, or IIID melanoma. The study aims to determine if Daromun can significantly improve recurrence-free survival RFS in these patients. This is a Phase 3, open-label, randomized, controlled, multi-center trial involving 186 participants. Participants will be randomly assigned to one of two groups Arm 1 will receive Daromun injections directly into melanoma lesions once weekly for up to four weeks, followed by surgery within four weeks and then adjuvant therapy. Arm 2 will undergo surgery within four weeks after randomization followed by adjuvant therapy. Post-surgery adjuvant therapies are decided by the investigator and may include immunotherapy or targeted treatments. Throughout the study, participants will be followed for up to five years to assess recurrence-free survival, with additional survival data collected up to six years after randomization. Safety assessments include monitoring adverse events, laboratory tests, electrocardiograms, echocardiograms, physical exams, and vital signs. Tumor response will be evaluated during surgery. Participants will attend scheduled visits for treatment, monitoring, and follow-up to evaluate both the primary and secondary outcomes.

Researchers are studying premenopausal women with early-stage breast cancer that is estrogen receptor-positive and HER2-negative, focusing on tumors with specific gene recurrence scores. The trial aims to find out if adding chemotherapy to ovarian function suppression plus endocrine therapy improves invasive breast cancer-free survival compared to ovarian function suppression plus endocrine therapy alone. This Phase III trial addresses the need for better treatments in younger women, given their higher risk and past conflicting study results on ovarian suppression and chemotherapy. Participants are randomly assigned to one of two groups one receiving ovarian function suppression combined with an aromatase inhibitor for five years, and the other receiving adjuvant chemotherapy followed by the same ovarian function suppression and aromatase inhibitor regimen. Choices for the aromatase inhibitor and gonadotropin releasing hormone agonist are made by the investigator, with options including drugs such as goserelin, leuprolide, or triptorelin. Endocrine treatment beyond five years is at the investigators discretion, and bilateral oophorectomy may be used instead of ovarian suppression if preferred. During the study, participants are monitored over 11 years from randomization, with measurements including invasive breast cancer-free survival as the primary outcome. Secondary outcomes include disease-free survival, overall survival, recurrence intervals, menopausal symptoms, and pain during aromatase inhibitor therapy. Safety and treatment effects are assessed through regular evaluations, and participants continue to be followed long term to understand the impact of treatments on their breast cancer outcomes.

Researchers are evaluating two different doses of quizartinib as maintenance therapy for adults with FLT3-ITD positive acute myeloid leukemia AML who are in their first complete remission and have not undergone allogeneic hematopoietic stem cell transplantation. This Phase 2 clinical trial aims to assess the safety and effectiveness of these doses in helping maintain remission in this specific group of AML patients. The study also includes a Holter sub-study to examine how rapid heart rate changes might affect the heart safety of quizartinib. Participants are randomly assigned to receive either a higher or lower oral daily dose of quizartinib. The trial has two parallel treatment groups, each receiving one of the two dose levels. The maintenance therapy starts within 60 days after the last consolidation cycle of prior treatment. The study is open-label, meaning both participants and researchers know the dose being administered. Throughout the study, participants will be monitored for serious treatment-emergent adverse events from the first dose until 30 days after the last dose, with follow-up up to 87 months. Researchers will also track overall survival and relapse-free survival during this time. Participants will undergo regular evaluations, including physical exams, blood tests, and heart monitoring, to assess safety and treatment effects over the long term.