Yorongos

Researchers are investigating new treatments for high-risk, early-stage breast cancer, specifically targeting two types triple-negative breast cancer TNBC and hormone receptor-low positiveHER2-negative breast cancer. These cancers are characterized by low or no HER2 protein and low hormone receptor presence. The study aims to evaluate if adding sacituzumab tirumotecan sac-TMT to pembrolizumab and chemotherapy can better reduce cancer cells in tumors and lymph nodes and improve the length of time patients live without cancer progression compared to pembrolizumab with chemotherapy alone. Participants in this trial receive one of two treatment plans. One group gets sacituzumab tirumotecan intravenously every two weeks plus pembrolizumab every three weeks for 12 weeks, followed by pembrolizumab with carboplatin and paclitaxel for another 12 weeks. After 3 to 6 weeks, surgery and optional radiation therapy take place, followed by pembrolizumab for about 28 weeks. Participants with remaining disease may receive additional treatments chosen by their doctors, including olaparib, capecitabine, doxorubicin, epirubicin, or cyclophosphamide. The other group receives chemotherapy drugs carboplatin and paclitaxel with pembrolizumab initially, then pembrolizumab with cyclophosphamide and doxorubicin or epirubicin, followed by surgery, optional radiation, and pembrolizumab for about 28 weeks, with similar additional options for residual disease. During the study, participants undergo core needle biopsies, receive intravenous infusions of study drugs, and have surgery and possible radiation therapy. Researchers assess outcomes such as the percentage of participants with no detectable cancer cells at surgery pathological complete response, event-free survival up to about 92 months, and overall survival up to nearly 10 years. Quality of life and side effects are monitored through questionnaires and adverse event tracking. The study lasts several years, with various assessments throughout treatment and follow-up periods to gather comprehensive data on treatment effects and safety.

Researchers are evaluating the safety and effectiveness of zilovertamab vedotin ZV combined with standard treatments for people with relapsed or refractory diffuse large B-cell lymphoma rrDLBCL. This Phase 23 study is divided into two parts Dose Confirmation and Efficacy Expansion. It aims to compare ZV combined with rituximab, gemcitabine, and oxaliplatin R-GemOx against R-GemOx alone, and ZV combined with bendamustine rituximab BR against BR alone, focusing on progression-free survival. Enrollment in the BR-related arms has been discontinued with no analysis planned for those arms.

Researchers are evaluating whether adding zilovertamab vedotin to a standard treatment regimen can help people with previously untreated diffuse large B-cell lymphoma DLBCL live longer without the cancer growing or spreading. This phase 3 randomized study compares the combination of zilovertamab vedotin with rituximab plus cyclophosphamide, doxorubicin, and prednisone R-CHP against the standard regimen of rituximab plus cyclophosphamide, doxorubicin, vincristine, and prednisone R-CHOP. The trial is sponsored by Merck Sharp & Dohme LLC and aims to improve treatment outcomes for people with this type of lymphoma. Participants receive treatment in cycles lasting 21 days, for up to 6 cycles approximately 4 months. One group receives zilovertamab vedotin plus rituximab or a rituximab biosimilar, cyclophosphamide, doxorubicin, and prednisone or prednisolone or methylprednisolone, while the comparison group receives rituximab or biosimilar, cyclophosphamide, doxorubicin, vincristine, and prednisone or prednisolone or methylprednisolone. Both groups may receive 2 additional cycles of rituximab or biosimilar if they have high-risk DLBCL. All infusions are given intravenously on Day 1 of each cycle, with prednisone or similar drugs taken orally on Days 1-5 of each cycle. Throughout the study, participants are closely monitored for progression-free survival up to about 50 months, as well as other outcomes such as overall survival, response to treatment, adverse events, and quality of life changes. Assessments include clinical evaluations during treatment and follow-up periods, with safety monitoring continuing for up to 9 months. This comprehensive follow-up helps researchers understand the effects and tolerability of the treatments over time.

Researchers are conducting an observational study to evaluate the quality of care for patients with soft-tissue sarcoma, gastrointestinal stromal tumor GIST, and bone sarcoma. The study compares outcomes such as relapse-free survival, overall survival, and amputation rates between expert and non-expert centers. Expert pathology peer reviews and translational research on tumor samples from four sarcoma subtypes are included to explore biomarkers and develop preclinical models. The study includes both retrospective data from January 2012 to June 2019 and prospective data from July 2019 to January 2022. Data collected involves clinical and treatment information registered in a shared database. Quality indicators assessed include biopsy methods, imaging studies, multidisciplinary team discussions, surgical margins, re-resections, radiotherapy use, and molecular status assessments for GIST. Tumor samples will be analyzed by expert centers for diagnosis differences and biomarker research. Participants will provide informed consent and clinical data will be collected and analyzed over approximately three years. The study measures various quality and outcome indicators such as biopsy rates, imaging, surgical margins, survival rates, and amputation frequencies. Tumor tissue samples will be used for genetic and protein analyses, with some fresh samples used to create models for further research. Patients may withdraw consent at any time without affecting their care or participation in data collection.

Researchers are comparing the combination of sacituzumab tirumotecan and pembrolizumab to pembrolizumab alone for people with metastatic non-small cell lung cancer NSCLC who have high PD-L1 expression 50% or more. The study aims to see if the combination improves overall survival compared to pembrolizumab by itself. This is a Phase 3 clinical trial focusing on first-line treatment in this patient group. Participants receive either sacituzumab tirumotecan plus pembrolizumab or pembrolizumab alone. Sacituzumab tirumotecan is given by intravenous infusion on Days 1, 15, and 29 of each 6-week cycle, while pembrolizumab is given by intravenous infusion every 6 weeks for up to 18 cycles. Supportive medications such as diphenhydramine, acetaminophen, dexamethasone, and H2 antagonists are used before some infusions to manage side effects. Participants who complete the first pembrolizumab course and show disease progression may be eligible for additional pembrolizumab cycles. Throughout the trial, participants will have regular assessments including scans and evaluations to measure overall survival and other outcomes such as progression-free survival, tumor response, and quality of life. Researchers will also monitor symptoms like cough, chest pain, and breathing difficulties. Safety is closely followed over up to approximately 77 months, with detailed data collected on adverse events and treatment discontinuation. The total participation duration can last several years depending on individual progress and treatment response.