Tremelimumab + Durvalumab for Liver Cancer
Trial Summary
What is the purpose of this trial?
This is a single-arm, phase II study of patients with advanced liver cancer or hepatocellular carcinoma (HCC) who are eligible for first-line treatment with T300+D. The invesitgators hypothesize that T300+D will be safe and tolerated in CP-B patients with HCC. HCC mostly affects disadvantaged populations with higher rates among racial/ethnic minorities, who are often not included in clinical trials (i.e., Hispanics, Blacks, underserved, low socioeconomic status) and present with more severe disease. Given there is not much data in the US patient cohort, this study provides a chance to gain that knowledge.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications. However, you cannot use any immunosuppressive medication within 14 days before starting the trial drugs, except for certain low-dose steroids and specific types of steroid treatments.
What data supports the effectiveness of the drug combination of Tremelimumab and Durvalumab for liver cancer?
The combination of Tremelimumab and Durvalumab has been shown to improve overall survival in patients with liver cancer that cannot be removed by surgery, as demonstrated in the HIMALAYA study. This study found that patients receiving this drug combination lived longer on average compared to those receiving another treatment called sorafenib.12345
Is the combination of Tremelimumab and Durvalumab safe for humans?
The combination of Tremelimumab and Durvalumab has been studied for safety in various cancers, including liver cancer. Common side effects include rash, fatigue, diarrhea, itching, muscle pain, and abdominal pain. Serious side effects occurred in about 32.6% of patients, which is higher compared to using Durvalumab alone.12367
What makes the drug combination of Tremelimumab and Durvalumab unique for liver cancer?
The combination of Tremelimumab and Durvalumab is unique for liver cancer because it uses a dual immunotherapy approach, where Tremelimumab blocks CTLA-4 (a protein that downregulates the immune system) and Durvalumab blocks PD-L1 (a protein that helps cancer cells evade the immune system), enhancing the body's ability to fight cancer. This combination has shown improved overall survival compared to the standard treatment with sorafenib in patients with inoperable liver cancer.12378
Research Team
Sukeshi P Arora, MD
Principal Investigator
The University of Texas Health Science Center at San Antonio
Eligibility Criteria
This trial is for adults with advanced liver cancer or hepatocellular carcinoma who are fit for first-line treatment. It's especially aimed at those often underrepresented in trials, like racial/ethnic minorities and individuals from low socioeconomic backgrounds. Participants must have a specific level of liver impairment known as Child-Pugh-B cirrhosis.Inclusion Criteria
Exclusion Criteria
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Priming dose of tremelimumab 300 mg IV once with durvalumab 1500 mg IV on Day 1 of each 4-week cycle. Patients will stay on study treatment until evidence of disease progression, unacceptable toxicity, or death.
Follow-up
Participants are monitored for safety and effectiveness after treatment. A repeat CT/MRI scan will be performed after 2 cycles to evaluate response. Serum tumor marker AFP and CT/MRI scans will be repeated at least every 2 cycles.
Treatment Details
Interventions
- Tremelimumab and Durvalumab (Checkpoint Inhibitor)
Find a Clinic Near You
Who Is Running the Clinical Trial?
The University of Texas Health Science Center at San Antonio
Lead Sponsor
AstraZeneca
Industry Sponsor