Gainesville

Researchers are evaluating AZD0120, a dual-targeted CAR-T therapy aimed at BCMA and CD19, compared with standard treatment regimens for participants with relapsed refractory multiple myeloma RRMM. This Phase III, randomized, open-label global study aims to assess how AZD0120 performs relative to established therapies including DKd, DPd, PVd, or Kd. The study focuses on participants who have received previous treatments and now require additional therapy due to disease progression. Participants will receive either AZD0120 or one of four standard regimens chosen by their investigator, including combinations of daratumumab, carfilzomib, pomalidomide, bortezomib, and dexamethasone. The treatment period and dosing depend on the assigned regimen, and the study compares these approaches over time. The trial is designed to measure progression-free survival and response rates to evaluate the benefits of AZD0120 compared to standard care. During the study, participants will undergo regular assessments to monitor disease status and treatment effects. These include laboratory tests to measure disease markers, imaging, and safety evaluations. The primary outcomes include progression-free survival over three years and minimal residual disease negativity at nine months. Secondary outcomes assess response rates and overall survival over several years. The study duration extends up to 2030 with ongoing monitoring and follow-up to collect comprehensive data on participant health and treatment impact.

The trial investigates the safety and effectiveness of a combination of two investigational kinase inhibitor drugs, avutometinib and defactinib, compared to standard treatments chosen by doctors for women with recurrent low-grade serous ovarian cancer LGSOC who have not responded to prior platinum-based therapy. The goal is to improve progression-free survival and evaluate overall survival, safety, quality of life, and disease symptoms in this patient group. Participants will receive either the combination of avutometinib taken orally twice weekly and defactinib taken orally twice daily on a 21 days on, 7 days off schedule per 28-day cycle, or one of four standard treatments selected by their doctor. These standard treatments include intravenous pegylated liposomal doxorubicin, intravenous paclitaxel, or oral anastrozole or letrozole, each given according to specified doses and schedules. Patients initially receiving standard treatments who experience disease progression may switch to the investigational combination. During the study, participants will have regular follow-up visits to monitor their health, side effects, and disease progression over up to 24 months for progression-free survival and up to 5 years for overall survival. Researchers will assess tumor response, adverse events, drug levels in blood, and quality of life using validated questionnaires. The study involves randomized assignment to treatment groups and includes ongoing assessments to understand the impact of therapies on cancer control and patient well-being.

Researchers are evaluating the combination of sonrotoclax plus zanubrutinib compared with zanubrutinib plus placebo in adults with relapsed or refractory mantle cell lymphoma MCL. This Phase 3 randomized, double-blind study aims to compare how well these treatments work and assess their safety in this patient population. The study is sponsored by BeOne Medicines and focuses on patients who have previously received 1 to 5 prior systemic therapies including anti-CD20 monoclonal antibody or chemoimmunotherapy. Participants will receive either sonrotoclax plus zanubrutinib or placebo plus zanubrutinib, both administered orally. The study has two groups one receiving the combination of sonrotoclax and zanubrutinib, and the other receiving zanubrutinib with placebo. Treatment continues as per protocol, and the study includes detailed assessments of response and safety over time. During the study, participants will be monitored for progression-free survival as the primary outcome, assessed by an independent review committee over approximately 41 months. Secondary outcomes include overall survival, response rates, duration of response, health-related quality of life, and adverse events up to around 58 months. Regular evaluations will be conducted to assess disease status, quality of life, and safety throughout the trial, which is planned to complete by 2032.

Researchers are evaluating the efficacy and safety of Adagrasib alone and in combination with pembrolizumab for patients with advanced or metastatic non-small cell lung cancer NSCLC that has a KRAS G12C mutation. The study includes a Phase 2 portion that assesses these treatments in patients with various PD-L1 tumor proportion scores TPS and a Phase 3 portion that compares Adagrasib plus pembrolizumab to pembrolizumab alone in patients with higher PD-L1 TPS 50%. The goal is to understand how these treatments work as first-line therapy in this patient population. Treatment involves Adagrasib administered orally twice daily BID either alone or combined with pembrolizumab, which is given intravenously at 200 mg every three weeks. Phase 2 includes three cohorts based on PD-L1 status and treatment type, while Phase 3 randomly assigns patients to receive either the combination or pembrolizumab alone. Patients with unresectable or metastatic squamous or nonsquamous NSCLC are included, with specific brain metastases criteria for Phase 3 participants. Participants will be monitored over periods of up to 22 months in Phase 2 and 36 months in Phase 3. Assessments include measuring treatment efficacy, safety, pharmacokinetics, quality of life, and tumor response using RECIST 1.1 criteria. Regular evaluations involve imaging, clinical exams, and patient-reported outcomes. The study aims to provide detailed information on treatment tolerability and effectiveness during and after therapy.