Yauco

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 evaluating INCB123667 compared to the investigators choice of chemotherapy in adults with platinum-resistant ovarian cancer characterized by cyclin E1 overexpression. This Phase 3 trial aims to assess treatment outcomes in participants who have specific tumor types and prior treatment histories. The study focuses on participants with high-grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer who meet detailed criteria for platinum resistance and prior therapies. Participants are randomly assigned to receive either INCB123667 as an oral tablet or chemotherapy selected by the investigator following protocol guidelines. The chemotherapy options are defined by the study protocol, and both treatments are given at protocol-defined doses. The trial includes two experimental treatment groups and does not use masking or blinding. Treatment continues with monitoring over a period of up to two years. Throughout the study, participants undergo regular assessments including tumor measurements by RECIST criteria, safety evaluations for adverse events, and quality of life questionnaires such as the EORTC QLQ-Core 30 and EQ-5D-5L. Researchers will monitor progression-free survival and overall survival as primary outcomes, along with response rates and treatment tolerability. The total study duration for participants may extend up to two years, with close follow-up to evaluate treatment effects and safety.