Monserrato

Researchers are studying treatments for locally advanced or metastatic colorectal cancer mCRC that cannot be removed by surgery and has a specific KRAS G12C gene mutation. This trial aims to evaluate if adding the targeted therapies calderasib and cetuximab to the standard chemotherapy regimen mFOLFOX6 can provide better outcomes compared to mFOLFOX6 with or without bevacizumab. The study focuses on the safety and tolerability of these combinations and whether they can help people live longer without their cancer growing or spreading. Participants will be assigned to one of two groups. One group will receive calderasib orally, cetuximab every two weeks, and mFOLFOX6 chemotherapy including oxaliplatin, leucovorin or levofolinate calcium, and 5-fluorouracil every two weeks. The other group will receive mFOLFOX6 chemotherapy with or without bevacizumab every two weeks, based on the investigators decision. Treatments will continue until certain stopping criteria are met. During the study, participants will be monitored for side effects and treatment tolerance, with regular assessments of cancer progression. Researchers will measure outcomes such as dose-limiting toxicities, adverse events, progression-free survival, and overall survival. Quality of life will also be evaluated through questionnaires. The study may last up to several years, with monitoring continuing for safety and effectiveness throughout the treatment period and follow-up.

Researchers are evaluating treatment options for patients with advanced HRD-positive high-grade ovarian cancer, fallopian tube cancer, primary peritoneal cancer, and clear cell carcinoma of the ovary who have no remaining tumor after primary tumor debulking surgery. This phase II, multicenter, randomized, open-label study aims to compare the recurrence-free survival between patients receiving 3 cycles versus 6 cycles of carboplatin plus paclitaxel chemotherapy, followed by maintenance therapy with niraparib. Participants are randomly assigned to one of two treatment groups one group receives 3 cycles of carboplatin plus paclitaxel chemotherapy followed by niraparib maintenance therapy, while the other group receives 6 cycles of the same chemotherapy followed by niraparib maintenance. Niraparib maintenance therapy starts at a dose of 200 mg or 300 mg once daily and continues until disease progression, unacceptable side effects, or other stopping criteria. Tumor assessments using CT or MRI scans are done at specific intervals, and the tumor marker CA-125 is measured every 12 weeks. Clinical visits for blood tests and toxicity monitoring occur regularly during chemotherapy and niraparib maintenance. During the study, participants will attend clinical visits for safety monitoring, including adverse event tracking, blood counts, physical exams every 12 weeks, and serum pregnancy tests for women of childbearing potential. Tumor evaluations occur 9 to 12 weeks after starting therapy and then every 6 months. The study will follow patients for up to 8 years to measure recurrence-free survival and other outcomes such as overall survival, quality of life, and safety. About 640 patients will be recruited across approximately 60 sites in six European countries over 36 months.

Researchers are evaluating elacestrant compared to standard endocrine therapies in adults with node-positive, Estrogen Receptor-positive ER, HER2-negative early breast cancer who are at high risk of cancer returning. The study focuses on those who have had prior endocrine therapy and aims to measure how well elacestrant may prevent invasive breast cancer recurrence over five years. Participants are randomly assigned to receive either 345 mg of elacestrant daily for five years or continue their prior standard endocrine therapy, which may include an aromatase inhibitor anastrozole, letrozole, or exemestane or tamoxifen. The trial is open-label, meaning both participants and researchers know which treatment is given. During the study, participants will have regular assessments to monitor cancer recurrence, survival, side effects, and quality of life. Evaluations include questionnaires on health status and physical functioning at baseline, six months, and annually for up to five years. Safety is tracked through adverse event reporting up to five years plus 28 days. The total participation duration can last up to five years with ongoing monitoring and data collection.

Researchers are evaluating the safety and effectiveness of the drugs eltrekibart and mirikizumab in adults with moderately to severely active ulcerative colitis UC, a chronic inflammatory bowel disease. This Phase 2 study aims to find out how these treatments work alone or in combination to improve UC symptoms and health. The study is sponsored by Eli Lilly and Company and will last about 4 to 5 years, including screening. Participants will be randomly assigned to receive one of several treatments eltrekibart with a placebo, mirikizumab with a placebo, both drugs together, or placebo alone. The study is double-blinded, meaning neither the participants nor the researchers know which treatment is given to ensure unbiased results. The treatment period includes dosing with the study drugs or placebo, and participants will be monitored for safety and response. Participants will be involved in the trial for around 69 weeks, including a screening period of up to 35 days before starting treatment. Throughout the study, they will undergo assessments to measure clinical remission, response, endoscopic improvement, and quality of life using questionnaires. Blood samples will be taken to study drug levels, and researchers will monitor safety and disease activity regularly. The main outcome is the percentage of participants achieving clinical remission at Week 12, with additional measures assessed up to Week 52.

Researchers are evaluating trastuzumab deruxtecan T-DXd as a treatment for adult patients with advanced HER2-positive gastric or gastroesophageal junction GEJ adenocarcinoma who have previously received a trastuzumab-based regimen. This study aims to assess the real-world effectiveness of T-DXd, patient characteristics, treatment patterns, and safety in this population. It also includes data collection on patients receiving conventional therapies for exploratory comparison. This is a non-interventional observational study where patients receive T-DXd or conventional therapies as part of routine clinical care according to approved guidelines SmPC. No investigational drugs are given. The study tracks patients starting T-DXd as a second-line or later treatment and collects data on other therapies such as chemotherapy and immunotherapy used in clinical practice. Participants will be followed for up to approximately 2 years from baseline to monitor outcomes including time to next treatment, changes in treatment, physician-reported safety events, use of prophylactic treatments, and quality of life using validated questionnaires. Data on physician visits, treatment discontinuation, and safety events will also be collected to understand treatment tolerability and patient experience in a real-world setting.

Researchers are evaluating whether combining tucatinib with trastuzumab and mFOLFOX6 works better than standard treatments for people with HER2 positive colorectal cancer that has spread or cannot be removed by surgery. This Phase 3 study also aims to learn about the side effects that may occur when taking this combination of drugs. Participants have metastatic or unresectable colorectal cancer and are randomly assigned to different treatment groups. Participants are randomly placed in one of two study groups. One group receives tucatinib taken orally twice daily along with trastuzumab given intravenously every 3 weeks and mFOLFOX6 chemotherapy every 2 weeks. The other group receives standard care, which may be mFOLFOX6 alone or combined with bevacizumab or cetuximab, both given intravenously on different schedules. Tissue samples and biopsies are collected before treatment to confirm HER2 positivity and other markers. During the study, participants will have regular evaluations including imaging scans to measure cancer progression, blood tests, and assessments of side effects and quality of life. Progression-free survival is the primary outcome measured for up to about 3 years, with other outcomes like overall survival and response rate also tracked. Safety monitoring continues for about one year after the last treatment. The study lasts several years, with ongoing follow-up to understand long-term effects and benefits.

This research focuses on adults with moderate-to-severe Crohns Disease CD, a chronic inflammatory condition of the digestive tract. It aims to evaluate how effective two approved drugs, upadacitinib and risankizumab, are as second-line treatments for CD in real-world clinical settings. Approximately 250 participants prescribed either drug by their physicians will be enrolled across 25 sites in Italy. Participants will receive either upadacitinib or risankizumab as part of their usual medical care, following local prescribing guidelines. The study includes a retrospective phase looking back up to 2 years before enrollment and a prospective phase where participants will be observed for up to 18 months after starting the medication. Both groups will be followed from their first dose throughout the study period. During this time, participants will not experience any additional study-related burden beyond their routine care. Researchers will review clinical records and monitor outcomes such as the percentage of participants achieving corticosteroid-free remission at 12 months. The study aims to gather real-world data on these treatments effectiveness and safety over time, with no extra visits or procedures required beyond standard practice.

Researchers are evaluating Afimkibart RO7790121 for people with moderately to severely active Crohns disease. This Phase III clinical trial aims to assess the effectiveness and safety of both induction and maintenance therapy using this drug compared to a placebo. The study is designed as a double-blind, placebo-controlled trial across multiple centers. Participants will be randomly assigned to one of three groups receiving either Afimkibart via intravenous infusion followed by subcutaneous injection or matching placebo treatments. The study involves continuous treatment through induction and maintenance phases to compare outcomes at weeks 12 and 52. The trial includes a placebo group to provide a comparison for evaluating Afimkibarts effects. During the study, participants will have regular visits for assessments including clinical remission rates, endoscopic response, symptomatic remission, stool frequency, abdominal pain, and quality of life questionnaires. Researchers will monitor various outcomes over 52 weeks and track adverse events for up to 70 weeks after baseline. This long-term follow-up helps evaluate both the treatments impact and safety throughout the trial period.

Researchers are evaluating the efficacy and safety of tulisokibart in participants with moderately to severely active Crohns disease. This program includes two studies Study 1 involves both induction and maintenance treatment phases, while Study 2 focuses only on induction treatment. The main goal is to determine if one or more doses of tulisokibart are more effective than placebo in achieving clinical remission and endoscopic response at various time points up to Week 52. Participants are randomly assigned to receive different dosing regimens of tulisokibart or placebo. These regimens include high or low doses administered intravenously followed by subcutaneous injections, or subcutaneous injections alone. Some participants may continue in an extension phase receiving subcutaneous doses after completing their original treatment arm if they meet specific requirements. The studies use a double-blind design to compare tulisokibarts effects against placebo. During the trial, participants undergo regular assessments to measure clinical remission, endoscopic response, and other health outcomes using tools like the Crohns Disease Activity Index and stool frequency with abdominal pain scores. Safety evaluations include monitoring adverse events and treatment discontinuations. The studies last up to 52 weeks for Study 1 and 12 weeks for Study 2, with multiple visits to assess treatment effects and participant health under medical supervision.

Researchers are studying adult patients with generalized myasthenia gravis gMG who are positive for acetylcholine receptor AChR antibodies. The study aims to gather real-world evidence from Italian clinical practice on how efgartigimod alfa affects clinical outcomes and patient-reported experiences in those treated for gMG. This observational study will follow patients over a total duration of up to 23 months. The study involves collecting primary data at a baseline visit and follow-up visits at 6 and 12 months after baseline. Researchers will also gather secondary data from medical charts covering the 12 months before baseline, including details on MG-related therapies, exacerbations, hospitalizations, and the patients medical history. The treatment with efgartigimod alfa is decided independently by the treating physician as part of routine care, not influenced by study participation. Participants will be monitored through clinical assessments and questionnaires measuring changes in MG-Activities of Daily Living MG-ADL scores and the percentage achieving minimal symptom expression MSE up to 12 months. Additional measures include quality of life, fatigue, anxiety and depression, sleep quality, and caregiver burden scores tracked over the same period. The study collects comprehensive data to understand disease experience and treatment impact, with safety and outcomes evaluated throughout the 23-month period.