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Recruiting Phase 2 NCT03907475

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

Trial Parameters

Condition Locally Advanced Malignant Solid Neoplasm
Sponsor National Cancer Institute (NCI)
Study Type INTERVENTIONAL
Phase Phase 2
Enrollment 115
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2019-07-16
Completion 2026-06-01
Interventions
Biopsy ProcedureBiospecimen CollectionCapecitabine

Brief Summary

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.

Eligibility Criteria

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 medical necessity may be acceptable as the baseline sample if the samples were collected within 3 months prior to registration and the patient has not received any investigational or targeted treatment since that time. * A patient who cannot be safely biopsied may be considered for the study upon discussion with Principal Investigator. * Patients must have measurable disease, defined as at least one les

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