Celecoxib, Durvalumab and Tremelimumab for the Treatment of Patients With Advanced or Metastatic Liver Cancer

Part of paid clinical trials in Atlanta, Georgia.

Sponsor
Emory University
Study ID
NCT07174570
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Advanced Hepatocellular Carcinoma
  • Metastatic Hepatocellular Carcinoma
  • Stage III Hepatocellular Carcinoma AJCC v8
  • Stage IV Hepatocellular Carcinoma AJCC v8

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Celecoxib — DRUG
    Receive by mouth (PO).
  • Durvalumab — BIOLOGICAL
    Receive intravenously (IV).
  • Tremelimumab — BIOLOGICAL
    Given intravenously (IV).
  • Biospecimen Collection — PROCEDURE
    Undergo blood sample collection
  • Computed Tomography — PROCEDURE
    Undergo Computed Tomography (CT).
  • Magnetic Resonance Imaging — PROCEDURE
    Undergo Magnetic Resonance Imaging (MRI).
  • Biopsy Procedure — PROCEDURE
    Undergo tissue biopsy.

Study Details

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.

Key Dates

Start date
Jan 2, 2026
Status verified
Jan 2026
Primary completion
Nov 13, 2026
Completion
Nov 13, 2027

Study Design

Enrollment
39 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (celecoxib, durvalumab, tremelimumab)
    Patients receive celecoxib PO BID on days 1-28 of each cycle, durvalumab IV over 30 minutes on day 1 of each cycle and tremelimumab IV over 30 minutes on day 1 of cycle 1 only. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo blood sample collection, CT or MRI throughout the study. Patients may undergo tissue biopsy during screening.

Primary Outcome Measure

Progression-Free Survival (PFS) [ Time Frame: Time between the date of registration and the first date of documented progression, regardless of discontinuation of study drug, or death due to any cause, whichever occurs first, assessed up to 2 years ]

Central Contacts

Locations (4)

FacilityCityStateZIPSite coordinators
Emory Saint Joseph's HospitalAtlantaGeorgia30342
Kathleen Coleman
[email protected]
404-251-1278
Olumide B. Gbolahan, MBBS, MSc (PRINCIPAL_INVESTIGATOR)
Emory University Hospital MidtownAtlantaGeorgia30308
Kathleen Coleman
[email protected]
404-251-1278
Olumide B. Gbolahan, MBBS, MSc (PRINCIPAL_INVESTIGATOR)
Emory University Hospital/Winship Cancer InstituteAtlantaGeorgia30322
Kathleen Coleman
[email protected]
404-251-1278
Olumide B. B. Gbolahan, MBBS, MSc (PRINCIPAL_INVESTIGATOR)
Grady Health SystemAtlantaGeorgia30303
Kathleen Coleman
[email protected]
404-251-1278
Olumide B. Gbolahan,, MBBS, MSc (PRINCIPAL_INVESTIGATOR)

Find similar trials in Atlanta, GA

By research site
Emory Saint Joseph's Hospital· Atlanta, GAEmory University Hospital Midtown· Atlanta, GAEmory University Hospital/Winship Cancer Institute· Atlanta, GAGrady Health System· Atlanta, GA

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