Repurposing Celecoxib to Overcome Resistance to Immunotherapy in Advanced HCC (RECON Study)
Emory University
Summary
This phase II trial tests how well the combination of celecoxib with durvalaumab and tremellimumab works in treating patients with hepatocellular cancer (liver cancer) that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced) or that has spread from where it first started (primary site) to other places in the body (metastatic). Celecoxib belongs to the family of drugs called nonsteroidal anti-inflammatory agents and is used to reduces pain. Celecoxib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Immunotherapy with monoclonal antibodies, such as durvalumab and tremelimumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving celecoxib with durvalaumab and tremellimumab may better treat patients with advanced or metastatic liver cancer.
Description
PRIMARY OBJECTIVE: I. To evaluate the efficacy of the combination of celecoxib, and durvalumab+ tremelimumab in advanced hepatocellular carcinoma (HCC). SECONDARY OBJECTIVES: I. To evaluate the activity of the combination of celecoxib, and durvalumab+ tremelimumab in advanced HCC. II. To evaluate the safety and feasibility of the combination of celecoxib, and durvalumab+ tremelimumab in advanced HCC. TERTIARY/EXPLORATORY: I. To evaluate biomarkers associated with the efficacy of the combination of celecoxib, and durvalumab+ tremelimumab in advanced HCC. OUTLINE: Patients receive celeco…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Histologically or cytologically confirmed hepatocellular cancer (HCC) planned for treatment at gastrointestinal clinics of Emory University's Winship Cancer Institute or Grady Cancer Center * Radiologically measurable disease based on Response Evaluation Criteria in Solid Tumors version (RECIST) 1.1 * Age ≥ 18 years * Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 (Karnofsky ≥ 60%) * Platelet count \> 100,000 cells/ ul (within 28 days of cycle 1 day 1, at the discretion of the investigator) * Hemoglobin (Hb) \> 9g/dl (within 28 days of cycle 1 day 1, at…
Interventions
- DrugCelecoxib
Receive by mouth (PO).
- BiologicalDurvalumab
Receive intravenously (IV).
- BiologicalTremelimumab
Given intravenously (IV).
- ProcedureBiospecimen Collection
Undergo blood sample collection
- ProcedureComputed Tomography
Undergo Computed Tomography (CT).
- ProcedureMagnetic Resonance Imaging
Undergo Magnetic Resonance Imaging (MRI).
- ProcedureBiopsy Procedure
Locations (4)
- Grady Health SystemAtlanta, Georgia
- Emory University Hospital MidtownAtlanta, Georgia
- Emory University Hospital/Winship Cancer InstituteAtlanta, Georgia
- Emory Saint Joseph's HospitalAtlanta, Georgia