Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Durvalumab · 1 trial · 1 indication
The primary endpoint of the safety run-in (phase Ib) is the recommended phase II dose (RP2D) defined by the highest dose per protocol without dose-limiting toxicity (DLT) according to a 3+3 design related to the intervention. A DLT is defined as the occurrence of an adverse event (AE) that is at least possibly related to the investigational product (IP) or investigational regimen (IR), with two exceptions: any grade of vitiligo or alopecia will not qualify as a DLT. The DLT assessment period is from the time of first dose of IP/IR and ends upon administration of the first dose of IP/IR on Cycle 2, Day 1 (28 day cycle). Toxicities will be scored according to CTC criteria version 5.0 (Published November 27th, 2017). All participants that cannot complete the combination therapy as planned due to directly related toxicity will be discussed in the Study Steering Committee and they will determine whether the patient is classified as having a DLT.
Response is defined as stable disease, partial or complete response according to Response Evaluation Criteria in Solid Tumors (RECIST 1.1), determined 6 months after start of combination therapy. If the number of responses is ≥ 4 out of 25 patients further research of this treatment regime is justified. Furthermore, the lower boundary of the 90% CI should be higher than 5% to justify further research of this treatment regime.
| Arm | Type | Description |
|---|---|---|
| Durvalumab and rintatolimod combination therapy | EXPERIMENTAL | 1500mg Durvalumab administered via IV infusion once every first day of a 28 day cycle for a total of maximum 12 cycles (12 infusions in total). 200-400mg Rintatolimod administered via IV infusion twice per week for a total of 6 weeks (12 infusions in total). |
| Name | Type | Description |
|---|---|---|
| Durvalumab | BIOLOGICAL | Human anti-PD-L1 antibody |
| Rintatolimod | DRUG | TLR-3 agonist, synthetic double-stranded ribonucleic acid (poly I:C12U) |
Inclusion Criteria: * Histologically or cytologically (Bethesda 5 or 6) confirmed metastatic pancreatic cancer, as indicated by a definite cytology/histology report. * Stable disease according to RECIST criteria version 1.1 after at least 8 cycles of chemotherapy (FOLFIRINOX). * Inclusion ≤ 6 weeks...
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Durvalumab is being studied for use in metastatic pancreatic cancer, specifically metastatic pancreatic ductal adenocarcinoma. It is an investigational monoclonal antibody being evaluated in a Phase 1 clinical trial in combination with the TLR-3 agonist rintatolimod for therapy efficacy in patients with this condition.
Durvalumab targets PD-L1, a protein that helps cancer cells evade the immune system. As an anti-PD-L1 immune checkpoint inhibitor, it works by blocking the interaction between PD-L1 on tumor cells and PD-1 on T cells, potentially enhancing the immune system's ability to fight cancer.
Durvalumab is being developed by AIM ImmunoTech Inc., a biopharmaceutical company traded on the stock exchange under the ticker symbol AIM. The company is conducting clinical research to evaluate the drug's potential in treating metastatic pancreatic cancer.
Durvalumab is in Phase 1 clinical development for metastatic pancreatic cancer. It is an investigational drug and has not been approved by regulatory authorities for this indication. The ongoing Phase 1 trial is currently recruiting patients to evaluate the safety and efficacy of the treatment.
Durvalumab is being evaluated in clinical trial NCT05927142, a Phase 1 study titled 'Combining Anti-PD-L1 Immune Checkpoint Inhibitor Durvalumab With TLR-3 Agonist Rintatolimod in Patients With Metastatic Pancreatic Ductal Adenocarcinoma for Therapy Efficacy.' The trial is recruiting 43 participants in the Netherlands and is open to adults aged 18 years and older.
Durvalumab is a monoclonal antibody that targets PD-L1. It is also known by its brand name Imfinzi, which is used in other cancer indications. However, in the context of this clinical trial, it is being investigated specifically for metastatic pancreatic cancer under the name Durvalumab.