Corona

The primary purpose of the study is to assess how well amivantamab in combination with lazertinib or in combination with chemotherapy works (antitumor activity) in participants with epidermal growth factor receptor mutated (EGFRm) non-small cell lung cancer (NSCLC; that is one of the major types of lung cancer).

Researchers are evaluating the effectiveness of camizestrant compared to standard endocrine therapy in patients with early breast cancer that is estrogen receptor positive (ER+) and human epidermal growth factor receptor 2 negative (HER2-). These patients have an intermediate or high risk of cancer recurrence and have already completed local treatments such as surgery and possibly chemotherapy, alongside at least 2 years and up to 5 years of standard adjuvant endocrine therapy. The study is a Phase III, open-label trial designed to assess outcomes over a long term. Participants will be randomly assigned to receive either camizestrant, an oral selective estrogen receptor degrader, or one of several standard endocrine therapies including tamoxifen, anastrozole, letrozole, or exemestane, administered according to local approved guidelines. The treatment duration for both groups is planned to last 60 months. Eligible patients may have previously used CDK4/6 inhibitors, and the study will specifically include those with intermediate or high risk of recurrence as determined by clinical and biological markers. During the study, participants will be monitored for up to 10 years from the last patient's randomization to evaluate invasive breast cancer-free survival. Additional outcomes include invasive disease-free survival, distant relapse-free survival, overall survival, safety, and clinical outcome assessments. The study involves ongoing assessments of health status, treatment effects, and safety to determine the long-term benefits and risks of camizestrant compared to standard therapies.

Researchers are evaluating the safety, tolerability, and effectiveness of IMVT-1402 in adults with Cutaneous Lupus Erythematosus, including Subacute and Chronic forms. The study focuses on participants who have active disease and have not responded adequately to conventional treatments. This Phase 2b trial aims to better understand how IMVT-1402 performs compared to a placebo in this patient group. The study includes three treatment periods. In Period 1, participants are randomly assigned to receive either IMVT-1402 Dose 1 or a placebo injection once weekly for 12 weeks. In Period 2, all participants who finished the first period receive IMVT-1402 Dose 1 once weekly for 14 weeks. In Period 3, after completing Period 2, participants are re-randomized to receive either IMVT-1402 Dose 1 or Dose 2 weekly for 26 weeks. All treatments are given as subcutaneous injections. Participants will be involved for about 61 weeks total. Researchers will measure changes in disease severity using the Cutaneous Lupus Erythematosus Disease area and Severity Index (CLASI-A) score from the start to Week 12. Throughout the study, safety and tolerability will be monitored, along with other assessments to track disease activity and participant health.

Researchers are evaluating whether adding immunotherapy drugs brentuximab vedotin and nivolumab to standard chemotherapy, with or without radiation, can improve survival for patients aged 5 to 60 years with newly diagnosed stage I or II classical Hodgkin lymphoma. This phase III trial compares outcomes in groups based on their early response to initial chemotherapy, aiming to understand if immunotherapy can lead to better progression-free survival and overall survival compared to standard treatment alone. The study also looks at side effects, quality of life, and long-term health impacts across different patient groups. Participants first receive two cycles of standard ABVD chemotherapy every 28 days, followed by imaging to classify their response as rapid or slow early responders and their risk status as favorable or unfavorable. Based on these factors, patients are assigned to one of eight treatment arms that include either continued standard chemotherapy regimens or immunotherapy with brentuximab vedotin and nivolumab, sometimes combined with involved-site radiation therapy. Treatments are given intravenously or orally depending on the drugs, and cycles typically last 28 days. Imaging and blood samples are collected regularly throughout the study. Throughout the trial, participants undergo frequent scans such as FDG-PET, CT, MRI, and PET-CT to monitor their disease status. Blood samples and questionnaires assess treatment effects and quality of life. After completing treatment, patients have scheduled follow-up visits every 3 months for the first year, then every 6 months for two years, and annually up to 12 years to track long-term outcomes, side effects, and survival. The main measurements focus on progression-free survival, overall survival, treatment-related adverse events, and patient-reported experiences.

Researchers are evaluating the efficacy and safety of inavolisib combined with Phesgo compared to placebo with Phesgo as maintenance therapy in participants who have previously untreated HER2-positive advanced breast cancer with PIK3CA mutations. This Phase III, multicenter, randomized, double-blind, placebo-controlled study focuses on participants with locally advanced or metastatic breast cancer, aiming to understand the treatment impact after initial induction therapy. Participants will receive inavolisib orally once daily on Days 1 to 21 of each 21-day cycle, starting on Day 1 of Cycle 1 during maintenance treatment. Phesgo will be administered subcutaneously every three weeks on Day 1 of each cycle. The study includes an induction therapy phase where taxane-based chemotherapy is given after Phesgo. Optional endocrine therapy such as tamoxifen, aromatase inhibitors, or fulvestrant may be used based on the investigator's choice, with luteinizing hormone-releasing hormone agonists administered according to local guidelines. During the study, participants will be monitored for progression-free survival for up to approximately 40 months. Assessments include evaluation of heart function, organ function, and overall health status. Researchers will track the safety and effectiveness of the treatment combination through regular clinical evaluations and laboratory tests. The total duration includes maintenance treatment cycles and follow-up to measure outcomes and monitor safety.

Researchers are evaluating a phase II trial to test the effect of combining pembrolizumab, an immunotherapy drug, with radiation therapy after chemotherapy in patients with muscle invasive bladder cancer. The goal is to see if this combination can prevent the need for surgery to remove the bladder. Standard care involves chemotherapy before surgery to shrink or eliminate the tumor. Pembrolizumab may help the immune system attack the cancer, while radiation therapy uses high-energy x-rays to kill cancer cells and shrink tumors. Participants receive photon beam radiation therapy once daily from Monday to Friday for up to 20 treatments. Pembrolizumab is given through an intravenous infusion on the first day of each 21-day cycle, continuing for up to 18 cycles or about one year, unless the disease progresses or side effects become unacceptable. Patients also undergo transurethral resection of bladder tumor (TURBT) before starting treatment. Imaging tests like CT, MRI, or PET scans, along with cystoscopy and sample collections of urine and blood, are performed throughout the study. During the study, researchers monitor participants’ health with scans, biopsies, and questionnaires about symptoms related to gastrointestinal, urinary, and sexual function. They measure bladder intact event-free survival within three years, local recurrence, metastasis-free survival, overall survival, and the rate of needing surgery to remove the bladder. After treatment, patients are followed every 26 weeks for two years and then annually up to five years. The study also collects samples for future research and tracks treatment side effects carefully.

Researchers are studying stage IIIB-IV non-small cell lung cancer (NSCLC) to better predict and improve responses to first-line PD1 or PD-L1-based immunotherapy using biomarkers. This phase II trial aims to develop biomarkers that can identify patients who may not respond well to initial immunotherapy and to guide the choice of second-line treatments based on genetic mutations. The study also evaluates the safety and effectiveness of second-line treatments, including immunotherapy and targeted therapies, for patients whose cancer progresses after first-line therapy. Participants initially receive PD(L)1-based immunotherapy every 3 weeks, with or without chemotherapy, for up to 12 to 24 months. Depending on their response and circulating tumor DNA (ctDNA) levels, patients may either stop or continue immunotherapy under different randomized study arms. If disease progresses, patients enter the second part of the trial where they receive treatments such as tremelimumab with durvalumab or adagrasib with bevacizumab, based on specific genetic mutations. Some patients may participate in future treatment arms as they become available. Throughout the study, participants undergo regular blood sample collections, tumor biopsies (in Part 1), and imaging tests such as CT, MRI, or PET scans. Additional fluid samples like cerebrospinal fluid, ascites, and pleural fluid may be collected during routine care. After completing treatment, patients are followed for up to two years with scheduled visits every three to six months to monitor progression-free survival and other health outcomes.

Researchers are evaluating a phase III trial comparing two treatment approaches for women with locally advanced cervical cancer that has spread to nearby tissues or lymph nodes. The study aims to see if adding induction chemotherapy with carboplatin, paclitaxel, and pembrolizumab before standard chemotherapy, radiation, and pembrolizumab maintenance can improve progression-free survival. This trial also investigates overall survival, treatment toxicity, treatment timing, and the role of biomarkers in predicting outcomes. Participants are randomly assigned to one of two groups. One group receives standard chemoradiation with cisplatin and pembrolizumab followed by pembrolizumab maintenance. The other group receives induction therapy with carboplatin, paclitaxel, and pembrolizumab, followed by chemoradiation with cisplatin and pembrolizumab, and then pembrolizumab maintenance. Radiation therapy includes external beam radiation and brachytherapy, given over several weeks. Treatments continue unless the cancer progresses or unacceptable side effects occur. Throughout the study, participants undergo various scans such as PET, CT, chest x-rays, and MRI, along with blood sample collections. After completing treatment, participants are followed every 3 months for 2 years, then every 6 months for 3 years to monitor cancer progression or survival. The primary outcome measured is progression-free survival up to 7 years. Additional assessments include treatment safety, biomarker studies, and radiation quality reviews.

Researchers are evaluating two blood tests, the Haystack assay and the Signatera4 assay, to detect minimal residual disease (MRD) and early cancer recurrence in patients with stage II-IV colorectal cancer (CRC) that can be removed by surgery. Early detection of cancer return after surgery is important as it may improve chances for curative treatments. The Signatera assay is currently used but may not be very sensitive, while early data suggests the Haystack test might detect recurrence earlier. Participants will have archival tissue and blood samples collected before surgery for MRD testing with both Haystack and Signatera assays. After surgery, blood samples will be taken again between 3 to 10 weeks, then every 3 months for 2 years, and every 6 months from years 3 to 5. These samples will be tested with both assays to monitor for cancer return. Some exploratory tests may also be done with other assays under development. This study includes patients undergoing surgery with or without additional therapies. During the study, patients will provide blood samples at scheduled intervals and allow access to archival tissue for personalized MRD testing. Researchers will measure the rate of MRD detected by both tests up to 5 years after surgery. Follow-up includes monitoring for cancer recurrence through blood testing compared to imaging results. The study aims to determine which assay detects recurrence earlier and more accurately, helping guide future surveillance strategies.

Researchers are evaluating the safety and effectiveness of lumateperone in treating irritability associated with Autism Spectrum Disorder (ASD) in children and adolescents aged 5 to 17 years. This Phase 3, multicenter, randomized, double-blind, placebo-controlled study includes participants diagnosed with ASD and confirmed irritability symptoms using standard diagnostic tools. The study consists of three phases: a screening period lasting up to 14 days to check eligibility, a 6-week double-blind treatment period where participants will be randomly assigned to receive either a high dose of lumateperone, a low dose of lumateperone, or a placebo once daily, and a 1-week safety follow-up period after the last dose to monitor participants' well-being. During the study, participants will be monitored for changes in irritability using the Aberrant Behavior Checklist - Irritability subscale at week 6. Safety evaluations will occur during the follow-up visit approximately one week post-treatment. Throughout the trial, assessments will include clinical evaluations and caregiver reports to track symptoms and any side effects, ensuring participant safety over the approximately seven-week participation period.