A Phase 3 Study of Trastuzumab Deruxtecan (T-DXd) and Rilvegostomig versus Standard-of-Care Gemcitabine, Cisplatin, and Durvalumab for First Line Locally Advanced or Metastatic HER2-expressing Biliary Tract Cancer (DESTINY-BTC01)
| ClinicalTrials.gov Identifier |
| NCT06467357 |
| Institution Name |
| AstraZeneca AB |
| Full Institution Address |
|
Södertälje 151 85 Sweden |
| Institution Phone |
| 1-877-240-9479 |
| Institution Website |
| https://www.astrazenecaclinicaltrials.com/ |
| Additional Institutions |
|
A complete list of global study sites is listed on ClinicalTrials.gov (study ID NCT06467357) https://clinicaltrials.gov/study/NCT05503797 Please call the AstraZeneca Clinical Study Information Center for more information. You will be asked to provide the ClinicalTrials.gov Study ID NCT06467357 AstraZeneca Clinical Study Information Center Phone: 1-877-240-9479 Email: [email protected] |
| Principal Investigator |
| Please see below |
| Principal Investigator Phone |
| Please see below |
| Principal Investigator Email |
| Please see below |
| Additional Principal Investigators |
|
A complete list of global study sites is listed on ClinicalTrials.gov (study ID NCT06467357) https://clinicaltrials.gov/study/NCT06467357 Please call the AstraZeneca Clinical Study Information Center for more information. You will be asked to provide the ClinicalTrials.gov study ID NCT06467357 AstraZeneca Clinical Study Information Center Phone: 1-877-240-9479 Email: [email protected] |
| Study Coordinator |
| Please see below |
| Study Coordinator Phone |
| Please see below |
| Study Coordinator Email |
| Please see below |
| Additional Study Coordinators |
|
A complete list of global study sites is listed on ClinicalTrials.gov (study ID NCT06467357) https://clinicaltrials.gov/study/NCT06467357 Please call the AstraZeneca Clinical Study Information Center for more information. You will be asked to provide the ClinicalTrials.gov study ID NCT06467357 AstraZeneca Clinical Study Information Center Phone: 1-877-240-9479 Email: [email protected] |
| Study Overview |
|
This study is a global research trial for people with biliary tract cancer (which includes cancers of the bile ducts and gallbladder) that cannot be removed by surgery or has already spread. The study focuses on patients whose cancer expresses a high level of a protein called Human epidermal growth factor receptor 2 (HER2). This study is comparing the standard treatment (durvalumab in combination with gemcitabine and cisplatin chemotherapies with a new medicine combination, trastuzumab deruxtecan (T-DXd) and rilvegostomig, to find out if the new approach can help people live longer or keep their cancer under control for more time. Ultimately, the goal is to see if the new therapy is a safer and more effective option for people with this type of cancer. |
| Enrollment Information |
| 620 total patients (globally) |
| Study Start Date |
| 20240812 |
| Study End Date |
| 20290516 |
| Study Purpose |
| The purpose of this study is to explore if T-DXd alone or in combination with rilvegostomig compared to standard of care treatment with gemcitabine, cisplatin, and durvalumab is effective in treating patients for first line locally advanced or metastatic HER2-expressing biliary tract cancer. |
| Inclusion Criteria |
|
- be 18 years old or older and weigh at least 30 kg (about 66 pounds). - have biliary tract cancer (in the bile ducts or gallbladder) that cannot be removed by surgery or has spread and not have had treatment for cancer that has spread (some earlier treatments are allowed if enough time has passed). - have cancer that shows enough of a protein called HER2, proven by a recent tissue sample from their tumor. There are other criteria to participate, which your study healthcare team will explain, evaluate, and answer any questions you may have. |
| Exclusion Criteria |
|
- have already had certain cancer treatments such as other HER2 medicines or strong immune drugs. - have a different type of cancer called ampullary carcinoma. - have serious health, heart, gut, lung, or mental health problems that could make it unsafe to take part. - have cancer that has spread to the brain or spinal cord and is causing problems or needs treatment right now. There are other criteria which could prevent participation, which your study healthcare team will explain, evaluate, and answer any questions you may have. |
| Required Tests Prior to Study |
|
If you are interested in participating, the study site will provide an informed consent form, which lists required tests prior to beginning study treatment. Your study healthcare team will explain and answer any questions you may have. |
| Potential Side Effects |
|
If you are interested in participating, the study site will provide an informed consent form, which lists detailed potential side effects of the study medications. Your study healthcare team will explain and answer any questions you may have. |
| Financial Assistance Available |
| Yes |