Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Durvalumab · 2 trials · 6 indications
Progression-Free Survival (PFS) is defined as the duration of time from start of treatment to time of disease progression or death, whichever occurs first.
Will be reported with 95% exact confidence interval.
| Arm | Type | Description |
|---|---|---|
| Durvalumab + zanzalintinib | EXPERIMENTAL | Participants will receive treatment regimen of durvalumab and zanzalintinib. Each treatment cycle is 28 days. Participants will continue to receive treatment until disease progression, death, or other reasons for withdrawal. |
| Treatment (Y-90, tremelimumab, durvalumab, zanzalintinib) | EXPERIMENTAL | CYCLE 1: Patients receive tremelimumab IV and durvalumab IV, over 60 minutes, on day 1. 7-14 days later patients undergo transarterial radioembolization with Y-90 in the absence of disease progression or unacceptable toxicity. 7 days to 12 weeks later patients proceed to cycle 2. CYCLE 2-12: Patients receive durvalumab IV, over 30-60 minutes, on day 1 and zanzalintinib PO QD on days 1-28 of each cycle. Cycles repeat every 28 days for 12 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo angiogram during screening and undergo SPECT, CT scan or MRI, and blood and urine sample collection throughout the study. Patients optionally undergo tumor biopsy throughout the study. |
| Name | Type | Description |
|---|---|---|
| Durvalumab | DRUG | Participants will receive 1500 mg durvalumab through intravenous (IV) administration over a period of 60 minutes on Day 1 of each 28-day cycle. |
| Zanzalintinib | DRUG | Participants will receive 60 mg durvalumab orally on Days 1-28 of each 28-day cycle. |
| Angiogram | PROCEDURE | Undergo angiogram |
| Biopsy Procedure | PROCEDURE | Undergo tumor biopsy |
| Biospecimen Collection | PROCEDURE | Undergo blood and urine sample collection |
| Computed Tomography | PROCEDURE | Undergo CT scan |
| Magnetic Resonance Imaging | PROCEDURE | Undergo MRI |
| Single Photon Emission Computed Tomography | PROCEDURE | Undergo SPECT |
| Tremelimumab | BIOLOGICAL | Given IV |
| Yttrium-90 Microsphere Radioembolization | PROCEDURE | Given via transartieral radioembolization procedure |
Inclusion Criteria: * Participants must have radiographically or histologically or cytologically confirmed hepatocellular cancer. Participants must have advanced cancer (metastatic or unresectable) requiring systemic therapy. * Participants must be treated with tremelimumab plus durvalumab and have...
Durvalumab is being studied for the treatment of hepatocellular carcinoma, including locally advanced and unresectable forms of the disease. It is an investigational antibody being evaluated in combination with other agents in clinical trials for patients with advanced liver cancer.
Durvalumab is a monoclonal antibody that targets PD-L1, a protein that helps cancer cells evade the immune system. By blocking PD-L1, Durvalumab may enhance the immune system's ability to fight cancer cells.
Durvalumab is being developed by Exelixis, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol EXEL. The company is investigating the drug in combination with other therapies for hepatocellular carcinoma.
Durvalumab is currently in Phase 2 clinical trials for the treatment of hepatocellular carcinoma. The drug is investigational and has not yet been approved for this indication, as it is still undergoing clinical development.
Durvalumab is being evaluated in two Phase 2 trials. NCT07226063 studies maintenance therapy with zanzalintinib and durvalumab in advanced hepatocellular cancer. NCT07511504 combines Y-90 radioembolization, durvalumab, tremelimumab, and zanzalintinib for unresectable and locally advanced hepatocellular carcinoma.
Durvalumab is the generic name for the drug marketed as Imfinzi. In the clinical trials for hepatocellular carcinoma, the drug is referred to as durvalumab, which is the same active ingredient as Imfinzi.