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Also known as Durvalumab, Durvalumab (Cohort 1-3), Durvalumab (MEDI4736), durvalumab
Durvalumab/ML · 1 trial · 1 indication
The study is exploratory and cannot be statistically powered for comparisons. Median progression-free survival (PFS) time is chosen as the clinically meaningful outcome. Survival estimates will be calculated using the Kaplan-Meier method. For information, the reference PFS time in patients with non-metastatic LAPC treated with gemcitabine monotherapy is about 6 months. Results will be presented descriptively.
| Arm | Type | Description |
|---|---|---|
| MIMIPAC | EXPERIMENTAL | Intervention: MIS-MWA plus immunotherapy using the combination of durvalumab with tremelimumab |
| Name | Type | Description |
|---|---|---|
| Durvalumab 50 MG/ML | DRUG | Combination of Durvalumab (fixed dose of 1500 mg) and Tremelimumab (fixed dose of 75 mg) will be given 2 weeks before surgery. Minimally invasive surgical microwave ablation (MIS-MWA) of the pancreatic tumor will be performed two weeks after the first dose of Durvalumab and Tremelimumab After 4 doses of Durvalumab and Tremelimumab, only Durvalumab 1500mg is provided q4w until disease progression. Systemic gemcitabine will be started 6 weeks after MIS-MWA. Gemcitabine will be given at a dose of 1000 mg /m² body surface, once a week for 3 weeks, followed with a week of rest. |
| Tremelimumab | DRUG | Combination of Durvalumab (fixed dose of 1500 mg) and Tremelimumab (fixed dose of 75 mg) will be given 2 weeks before surgery. Minimally invasive surgical microwave ablation (MIS-MWA) of the pancreatic tumor will be performed two weeks after the first dose of Durvalumab and Tremelimumab After 4 doses of Durvalumab and Tremelimumab, only Durvalumab 1500mg is provided q4w until disease progression. Systemic gemcitabine will be started 6 weeks after MIS-MWA. Gemcitabine will be given at a dose of 1000 mg /m² body surface, once a week for 3 weeks, followed with a week of rest. |
| Gemcitabine | DRUG | Combination of Durvalumab (fixed dose of 1500 mg) and Tremelimumab (fixed dose of 75 mg) will be given 2 weeks before surgery. Minimally invasive surgical microwave ablation (MIS-MWA) of the pancreatic tumor will be performed two weeks after the first dose of Durvalumab and Tremelimumab After 4 doses of Durvalumab and Tremelimumab, only Durvalumab 1500mg is provided q4w until disease progression. Systemic gemcitabine will be started 6 weeks after MIS-MWA. Gemcitabine will be given at a dose of 1000 mg /m² body surface, once a week for 3 weeks, followed with a week of rest. |
| Minimally Invasive Surgical Microwave Ablation (MIS-MWA) | PROCEDURE | Minimally invasive surgical microwave ablation (MIS-MWA) of the pancreatic tumor will be performed two weeks after the first dose of Durvalumab and Tremelimumab |
Inclusion Criteria: * Patients with unresectable non-metastatic Locally Advanced Pancreatic Cancer (LAPC) defined according to NCCN guidelines Version 2.2017 * Histologically proven adenocarcinoma of the pancreas located in the head, body or tail * LAPC tumor greatest diameter maximum 5 cm * Male o...
Durvalumab is an investigational antibody being studied for multiple cancers, including triple negative breast neoplasms, extensive-stage small cell lung cancer, invasive bladder cancer, metastatic non-small cell lung cancer, and non-small cell lung cancer. It is currently in Phase 3 clinical development and is not FDA approved.
Durvalumab is a monoclonal antibody (mab) that targets PD-L1, a protein that helps cancer cells evade the immune system. By blocking PD-L1, durvalumab aims to enhance the body's immune response against tumors. This mechanism is being evaluated across several oncology indications.
Durvalumab is developed by AstraZeneca PLC, a global biopharmaceutical company listed on the stock exchange under the ticker AZN. AstraZeneca is conducting multiple clinical trials to evaluate durvalumab as a potential treatment for various solid tumors.
Durvalumab is in Phase 3 clinical development for extensive-stage small cell lung cancer and other indications. It is an investigational drug, meaning it has not yet received FDA approval. Several Phase 3 trials are ongoing or completed, with a total of 8 clinical trials registered.
Durvalumab is being studied in 8 clinical trials, including NCT03043872 (CASPIAN), a Phase 3 trial combining durvalumab with tremelimumab and chemotherapy in untreated extensive-stage small cell lung cancer. Other trials include NCT03446547, NCT04449861, and NCT04712903, all evaluating durvalumab in lung cancer settings.
Durvalumab is also known as Durvalumab/Tremelimumab Combination Therapy, referring to its use in combination with tremelimumab. It is also referred to as Durvalumab (MEDI4736), Durvalumab + Chemotherapy, and SC durvalumab + rHu. These names describe different regimens or formulations of the same drug.