National Cancer Institute (NCI)
This phase II trial studies the side effects of durvalumab when given together with chemotherapy in treating patients with solid tumors that have spread to other places in the body (advanced). Immunotherapy with monoclonal antibodies, such as durvalumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Chemotherapy drugs, such as gemcitabine hydrochloride, pegylated liposomal doxorubicin hydrochloride, capecitabine, carboplatin, paclitaxel, and nab-paclitaxel work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving chemotherapy with durvalumab may improve how immune cells respond and attack tumor cells.
PRIMARY OBJECTIVE: I. To determine the safety of adding durvalumab to standard chemotherapy regimens. SECONDARY OBJECTIVES: I. Determine the changes that occur in the immune microenvironment in response to chemotherapy and assess how these changes alter the pharmacodynamic effects of a checkpoint inhibitor. II. Investigate whether the response to immunotherapy correlates with patients' genetic aberrations and/or the activation status of tumor-infiltrating and circulating T cells. III. Explore the relationship between immune status of the tumor and overall tumor mutational load. IV. Asses…
Inclusion Criteria: * Patients with histologically documented metastatic or locally advanced (not amenable to surgery) solid tumors whose disease has progressed following at least one line of standard therapy and/or no standard of treatment exists that has been shown to prolong survival. * If anti-PD-1 or one of the 6 chemotherapy agents is standard-of-care, prior therapy with the agent would not be required. * Patient must have tumor amenable to biopsy and be willing to undergo a tumor biopsy. * Flash frozen tissue collected as part of another study or from a procedure performed due to…
Undergo tissue biopsy
Undergo blood sample collection
Given PO
Given IV
Undergo CT
Given IV
Undergo ECHO
Given IV
Given IV
Given IV
Given IV
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