Locust Grove

Researchers are evaluating the effectiveness and safety of combining standard chemotherapy and bevacizumab with or without the drug INCA33890 for the first treatment of metastatic microsatellite stable colorectal cancer. This is a Phase 3 randomized trial focusing on patients with stage IV colorectal adenocarcinoma that cannot be cured by surgery. Participants receive either INCA33890 or a placebo, both given alongside bevacizumab and FOLFOX chemotherapy at doses defined by the study protocol. Treatment is administered as part of the first-line therapy for metastatic disease, with participants randomly assigned to one of the two groups. During the study, participants will be regularly monitored through imaging and clinical assessments to measure progression-free survival for up to three years. Additional outcomes include overall survival, response to treatment, side effects, and quality of life measures up to four years. Safety and treatment effects will be closely followed throughout the trial period.

Researchers are evaluating treatments for adults with locally advanced or metastatic urothelial carcinoma bladder cancer who have progressed after prior therapy with enfortumab vedotin EV plus pembrolizumab. This global, multicenter, randomized, open-label Phase 23 trial compares a new drug, Datopotamab Deruxtecan Dato-DXd combined with either carboplatin or cisplatin, against the standard gemcitabine combined with carboplatin or cisplatin. The study aims to identify the recommended dose for Phase 3 and assess preliminary safety and efficacy during Part A, followed by a larger Phase 3 evaluation. Participants in Part A receive Dato-DXd at doses of 4 mgkg or 6 mgkg with platinum chemotherapy every three weeks. In Part B, participants receive the selected recommended dose of Dato-DXd or gemcitabine, each combined with either carboplatin or cisplatin, administered intravenously every three weeks. The specific platinum drug and dosing schedule are based on eligibility and investigator judgment, including options for split-dose cisplatin in certain cases. During the trial, participants undergo regular assessments including imaging scans to monitor tumor response, safety evaluations, and laboratory tests. The primary outcomes include overall response rate in Phase 2 and progression-free survival and overall survival in Phase 3, tracked up to approximately 34 to 38 months. Participants are followed throughout treatment and for a period afterward to evaluate treatment effects and safety under medical supervision.