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Also known as Durvalumab, Durvalumab (Cohort 1-3), Durvalumab (MEDI4736), durvalumab
Durvalumab, Tremelimumab and, FOLFOX · 1 trial · 1 indication
Criteria RECIST 1.1
| Arm | Type | Description |
|---|---|---|
| Durvalumab + Tremelimumab + FOLFOX | OTHER | * Durvalumab for 12 months * Tremelimumab for up to 4 doses/cycles * FOLFOX |
| Name | Type | Description |
|---|---|---|
| Durvalumab, Tremelimumab and ,FOLFOX | DRUG | Study will be performed in 2 step: STEP 1 (phase Ib) will assess the safety of the combination of Durvalumab 750mg q2w + tremelimumab 75mg q4w + FOLFOX during the 2 first cycles of treatment (1 month) STEP 2 (phase II) will assess the efficacy of the combination of Durvalumab 750mg q2w + tremelimumab 75mg q4w + FOLFOX |
Inclusion Criteria: 1. Written informed consent and any locally-required authorization obtained from the subject prior to performing any protocol-related procedures, including screening evaluations 2. Male or female age more than 18 years 3. Performance status of 0 or 1 according to the ECOG and WH...
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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.