Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Durvalumab · 1 trial · 4 indications
An objective response is defined as a complete response (CR) or partial response (PR). Disease status will be assessed using Response Evaluation Criteria in Solid Tumors (RECIST) version (v).1.1 criteria. ORR is defined as the proportion of evaluable patient who experience a CR or PR divided by the total number of evaluable patients. The final ORR point estimate and corresponding 95% confidence interval will be reported.
| Arm | Type | Description |
|---|---|---|
| Treatment (regorafenib, durvalumab) | EXPERIMENTAL | Patients receive regorafenib PO QD on days 1-21 and durvalumab IV on day 1. Treatment repeats every 28 days for a maximum of 2 years from registration or until decision to proceed to surgery, disease progression, excessive toxicity, or patient withdrawal. |
| Name | Type | Description |
|---|---|---|
| Durvalumab | BIOLOGICAL | Given IV |
| Regorafenib | DRUG | Given PO |
Inclusion Criteria: * Age \>= 18 years at time of study entry * Body weight \> 30 kg * Patients must have hepatocellular carcinoma (HCC) diagnosis confirmed by histology/cytology or clinically by American Association for Study of liver Diseases (AASLD) criteria in cirrhotic patients * Measurable di...
Durvalumab is a monoclonal antibody being studied for the treatment of Stage IB Hepatocellular Carcinoma AJCC v8. It is currently in Phase 2 clinical development for this indication, with an active trial evaluating its use in high-risk liver cancer patients.
Durvalumab is a monoclonal antibody that belongs to the -mab (antibody) target class. It is being investigated for its role in treating hepatocellular carcinoma, specifically in the setting of Stage IB disease, as part of a Phase 2 clinical trial.
Durvalumab is being developed by United Therapeutics Corporation, which trades under the ticker UTHR. The company is conducting a Phase 2 clinical trial to evaluate the drug in patients with Stage IB Hepatocellular Carcinoma AJCC v8.
Durvalumab is in Phase 2 clinical development for the treatment of Stage IB Hepatocellular Carcinoma AJCC v8. The ongoing trial is active but not recruiting, and it is an uncontrolled, biomarker-selected study with a small enrollment of 4 patients.
Durvalumab is being studied in the clinical trial NCT05194293, titled 'Regorafenib and Durvalumab for the Treatment of High-Risk Liver Cancer.' This Phase 2 trial is active but not recruiting, and it includes patients with Stage IB, II, III, and IIIA Hepatocellular Carcinoma AJCC v8 in the United States.
Durvalumab is a distinct monoclonal antibody being developed by United Therapeutics Corporation. It is being evaluated in combination with regorafenib in a Phase 2 trial for high-risk liver cancer, specifically Stage IB Hepatocellular Carcinoma AJCC v8.