Celecoxib + Durvalumab + Tremelimumab for Liver Cancer

Not yet recruiting at 3 trial locations

Overseen By Olumide B. Gbolahan, MBBS, MSc

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Emory University

Must not be taking: Warfarin, Heparin, DOACs, NSAIDs

Disqualifiers: Liver dysfunction, Thromboembolic events, Cardiovascular disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 14

Duration: 28 days per cycle, up to 2 years

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new combination of treatments for advanced or metastatic liver cancer. The study tests how well the mix of celecoxib (a pain reliever that may also stop tumor growth) and two immunotherapy drugs, durvalumab and tremelimumab, can help the immune system fight cancer. Patients with liver cancer that has spread and who have completed previous cancer treatments might be suitable candidates for this trial. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of people, offering participants a chance to contribute to important advancements in liver cancer treatment.

Will I have to stop taking my current medications?

The trial requires that you stop taking certain medications, such as warfarin, heparin products, direct acting anticoagulants (DOACs), and other non-steroidal anti-inflammatory drugs (NSAIDs). If you are stable on low dose aspirin (less than 325mg/day), you may continue taking it.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that using celecoxib, durvalumab, and tremelimumab together generally results in a manageable safety profile. In studies, about 19.1% of patients experienced significant side effects from durvalumab and tremelimumab. However, the likelihood of needing to stop treatment or encountering serious outcomes like death was low.

While some side effects may occur, they typically aren't severe enough to require stopping the treatment. Celecoxib is often used to relieve pain and swelling, with a well-known safety profile in other conditions. Overall, these findings provide reassurance about the safety of this treatment combination for liver cancer. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about the combination of celecoxib, durvalumab, and tremelimumab for liver cancer because it introduces a unique immunotherapeutic approach. Unlike standard treatments like surgery, ablation, or sorafenib, this combo harnesses the body's immune system to fight cancer cells. Durvalumab and tremelimumab are immune checkpoint inhibitors that block proteins used by cancer cells to evade immune detection, potentially enhancing the body's ability to attack tumors. Celecoxib, an anti-inflammatory drug, might enhance this effect by reducing inflammation that can help cancer grow. This innovative strategy could offer a new line of defense against liver cancer, providing hope for improved outcomes.

What evidence suggests that this trial's treatments could be effective for liver cancer?

In this trial, participants will receive a combination treatment of celecoxib, durvalumab, and tremelimumab to evaluate its potential effectiveness in treating advanced liver cancer. Research has shown that using durvalumab and tremelimumab together may help treat liver cancer, with studies finding that this combination can extend patient survival compared to traditional treatments like sorafenib. These drugs assist the immune system in identifying and attacking cancer cells. Even in patients with a poor prognosis, the treatment was generally safe. Celecoxib, which reduces inflammation and may inhibit tumor growth, is being added to determine if it enhances the effectiveness of the other two drugs. ^{1 3 4 6 7}

Who Is on the Research Team?

Olumide B. Gbolahan, MBBS, MSc

Principal Investigator

Emory University

Are You a Good Fit for This Trial?

This trial is for patients with advanced or metastatic hepatocellular cancer (liver cancer). Participants should have a type of liver cancer that has spread to nearby tissue, lymph nodes, or other body parts. Specific eligibility criteria are not provided but typically include factors like age, overall health status, and the extent of disease progression.

Inclusion Criteria

Radiologically measurable disease based on Response Evaluation Criteria in Solid Tumors version (RECIST) 1.1

Life expectancy > 12 weeks as determined by the investigator

Platelet count > 100,000 cells/ul

Exclusion Criteria

Contraindication to ICI per investigator discretion

Patients who are receiving any other investigational agents or an investigational device within 28 days before administration of first dose of study drugs

History of allergic reactions attributed to compounds of similar chemical or biologic composition to the agents used in study

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants receive celecoxib orally twice daily, durvalumab intravenously on day 1 of each cycle, and tremelimumab intravenously on day 1 of cycle 1 only. Cycles repeat every 28 days.

28 days per cycle, up to 2 years

1 visit per cycle (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment completion, with follow-up at 30 days and then every 12 weeks for up to 2 years.

Up to 2 years

Every 12 weeks (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Celecoxib
• Durvalumab
• Tremelimumab

Trial Overview The study tests celecoxib (a pain-reducing anti-inflammatory drug) combined with durvalaumab and tremellimumab (monoclonal antibodies for immunotherapy). The goal is to see if this combination can better attack the cancer by stopping tumor growth and aiding the immune system in fighting off the disease.

How Is the Trial Designed?

Group I: Treatment (celecoxib, durvalumab, tremelimumab) Experimental Treatment 7 Interventions

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.

Who Is Running the Clinical Trial?

Emory University

Lead Sponsor

Trials

1,735

Recruited

2,605,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07174570

Celecoxib, Durvalumab and Tremelimumab for the ... This phase II trial tests how well the combination of celecoxib with durvalaumab and tremellimumab works in treating patients with hepatocellular cancer ...

2. withpower.com withpower.com/trial/phase-2-carcinoma-hepatocellular-8-2025-453b6

Celecoxib + Durvalumab + Tremelimumab for Liver Cancer This phase II trial tests how well the combination of celecoxib with durvalaumab and tremellimumab works in treating patients with hepatocellular cancer ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11589085/

Early Clinical Outcomes of Durvalumab Plus ... Durvalumab plus tremelimumab may be effective and safe for unresectable hepatocellular carcinoma, even in patients who receive it as a later- ...

4. fda.gov fda.gov/drugs/resources-information-approved-drugs/fda-approves-tremelimumab-combination-durvalumab-unresectable-hepatocellular-carcinoma

FDA approves tremelimumab in combination with ... Tremelimumab plus durvalumab demonstrated a statistically significant and clinically meaningful improvement in OS compared to sorafenib ( ...

5. ecancer.org ecancer.org/en/video/12451-durvalumab-and-tremelimumab-show-manageable-safety-in-poor-prognosis-hcc

Durvalumab and tremelimumab show manageable safety ... Initial results show a 19.1% rate of significant adverse events, but treatment discontinuation and mortality rates remain low, indicating a ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40781661/

Adverse drug reaction to tremelimumab and durvalumab in ... Objective: This study sought to comprehensively evaluate the safety profile of tremelimumab and durvalumab in patients with hepatocellular ...

7. frontiersin.org frontiersin.org/journals/immunology/articles/10.3389/fimmu.2025.1657398/full

A real-world drug safety surveillance study from the FAERS ... A real-world drug safety surveillance study from the FAERS database of hepatocellular carcinoma patients receiving durvalumab in combination with tremelimumab.