Safety and Effects of Durvalumab Combined With Chemotherapy for Advanced Solid Tumors

What this Trial Is About

Researchers are evaluating the safety and effects of durvalumab combined with chemotherapy in patients with advanced solid tumors that have spread to other parts of the body. This phase II trial aims to understand how durvalumab, an immunotherapy drug, may help the immune system attack cancer cells while assessing changes in the tumor environment and genetic factors related to treatment response. The study also explores whether changes in cell-free DNA relate to treatment outcomes. Participants are assigned to one of seven treatment groups receiving durvalumab alone or combined with various chemotherapy drugs such as gemcitabine hydrochloride, pegylated liposomal doxorubicin hydrochloride, capecitabine, carboplatin, paclitaxel, or nab-paclitaxel. Treatments are administered intravenously or orally in repeated cycles every 21 or 28 days depending on the arm. Throughout the trial, patients undergo computed tomography CT scans, tissue biopsies, blood sample collections, and some receive echocardiography. After completing study treatment, monthly follow-up occurs for three months. Participants will be closely monitored with regular scans and laboratory tests to evaluate side effects and tumor response. Biopsies and blood samples are collected at screening and during the trial to study immune changes and genetic markers. The main outcome measured is the incidence of adverse events during treatment cycles. Safety and preliminary antitumor activity are assessed, and patients are followed for three months after treatment ends to monitor ongoing effects and recovery.

Durvalumab in Combination With Chemotherapy in Treating Patients With Advanced Solid Tumors, DURVA+ Trial