| ClinicalTrials.gov Identifier |
| NCT06109779 |
| Principal Investigator |
| AstraZeneca Clinical Study Information Center |
| Principal Investigator Phone |
| 1--877-240-9479 |
| Principal Investigator Email |
| information.center@astrazeneca.com |
| Study Coordinator |
| AstraZeneca Clinical Study Information Center |
| Study Coordinator Phone |
| 1-877-240-9479 |
| Study Coordinator Email |
| information.center@astrazeneca.com |
| Study Overview |
| The ARTEMIDE-Biliary01 study is looking at an immunotherapy called rilvegostomig. We want to find out whether rilvegostomig, given together with standard chemotherapy, may further delay or lower the chances of BTC coming back after surgery. Previous studies have shown that a type of treatment called immunotherapy may also be an effective adjuvant therapy. Immunotherapy helps the immune system find and attack cancer cells. This study will be conducted in patients with BTC who are free of disease after surgery.
Everyone in this study will also get chemotherapy as part of standard-of-care treatment for BTC. Chemotherapy is often recommended after surgery to delay or lower the chances of BTC coming back. This is called adjuvant therapy. These chemotherapies are all commonly used treatments for BTC . Your study doctor will decide which chemotherapy is best for you, based on your condition, medical history, and medical guidelines in your country.
To find out more about how safe and effective rilvegostomig is, we will compare it with a placebo. Neither you nor you study doctor will know if you are receiving rilvegostomig or placebo.
Clinicaltrials.gov link: https://clinicaltrials.gov/study/NCT06109779?intr=Rilvegostomig&rank=8#study-overview
CCF webinar: https://www.youtube.com/watch?v=SL3MzEh1qJA |
| Enrollment Information |
| 750 |
| Study Start Date |
| 20231204 |
| Study End Date |
| 20300930 |
| Study Purpose |
| A global study to assess the efficacy and tolerability of rilvegostomig compared to placebo in combination with investigator's choice of chemotherapy in participants with BTC after surgical resection with curative intent. |
| Inclusion Criteria |
| Key criteria
-Histologically confirmed adenocarcinoma of the biliary tract (intrahepatic or extrahepatic cholangiocarcinoma (CCA) or muscle invasive gallbladder cancer (GBC)) after macroscopically complete resection (R0 or R1)
-Provision of a tumor sample collected at surgical resection.
-Randomization within 12 weeks after resection with adequate healing and removal of drains.
-Confirmed to be disease-free by imaging within 28 days prior to randomization.
-Eastern Cooperative Oncology Group performance status of 0 or 1 |
| Exclusion Criteria |
| Key Criteria
- Participants with locally-advanced, unresectable, or metastatic disease at initial diagnosis.
- Ampullary cancer, neuroendocrine, mixed neuroendocrine and non-neuroendocrine neoplasms and nonepithelial tumors.
- Any anti-cancer therapy for BTC prior to surgery
- Active or prior documented autoimmune or inflammatory disorders or any severe or uncontrolled systemic disease
- Current or prior use of immunosuppressive medication within 14 days before the first dose
- Thromboembolic event within 3 months
- Active HBV or HCV infection unless treated. |
| Required Tests Prior to Study |
| - Physical exam, vital signs, blood and urine tests, tumor scans, tests on stored tumor sample taken during surgery, heart tests, and pregnancy tests (if needed), |
| Potential Side Effects |
| Potential side effects include may be those that are associated with the chemotherapy your investigator has selected for you.
Potential side effects of the rilvegostomig may be those that are associated with how the drug is expected to work in the body, especially through its effect on the immune system. In some cases, these may be severe. If enrolled in the study you will receive a list of these side effects in the informed consent form. |
| Financial Assistance Available |
| Yes |
