At a glance
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A Phase 1b Biomarker-Driven Combination Trial of Copanlisib, Olaparib, and Durvalumab (MEDI4736) in Patients With Advanced Solid Tumors
In Brief
A Phase 1 clinical trial evaluating Biopsy Procedure, Biospecimen Collection, and 7 other interventions for Advanced Malignant Solid Neoplasm and 2 related conditions. Active but no longer recruiting, targeting 39 participants across 17 sites.
Signals
Detailed Summary
This phase Ib trial seeks to identify the side effects and best dose of the combination of copanlisib and olaparib when given together with durvalumab. The trial will evaluate how well the drug combinations work in treating patients with advanced cancers who have solid tumors that have spread from where they first started (primary site) to other places in the body (metastatic) or cannot be removed by surgery (unresectable). Copanlisib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. PARPs are proteins that help repair DNA mutations. PARP inhibitors, such as olaparib, can keep PARP from working, so tumor cells can't repair themselves and may stop growing. 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. The treatment combinations of copanlisib and olaparib or copanlisib, olaparib, and durvalumab may work better in treating patients with solid tumors compared to usual treatments such as surgery, radiation, or other chemotherapy drugs.
Study Details
Timeline
Arms & Interventions
See Detailed Description
Interventions
Undergo tumor biopsy
Undergo collection of blood samples
Undergo CT
Given IV
Given IV
Undergo ECHO
Undergo MRI
Given PO
Undergo x-ray