Full TitleWO39608: A Phase Ib/II, Open-Label, Multicenter, Randomized Umbrella Study Evaluating the Efficacy and Safety of Multiple Immunotherapy-Based Treatment Combinations in Patients with Metastatic Pancreatic Ductal Adenocarcinoma (Morpheus-Pancreatic Cancer)
The standard treatment for pancreatic cancer that has spread despite prior therapy is chemotherapy, but typically the cancer continues to grow. In this study, researchers are comparing the safety and effectiveness of multiple immunotherapy treatments for patients with metastatic pancreatic cancer. Immunotherapies boost the power of the immune system to find and kill cancer cells.
In Stage 1 of this study, patients will be randomly assigned to one of these treatment groups:
- Standard chemotherapy (control group)
- Atezolizumab plus cobimetinib
- Atezolizumab plus PEGPH20
- Atezolizumab plus BL-8040
Atezolizumab is designed to improve the immune system’s ability to recognize and destroy cancer cells by blocking PD-L1, a protein made by some cancers. Cobimetinib works by inhibiting MEK, a protein which fuels cancer growth. BL-8040 alters the movement of immune cells and could increase the body’s immune response against cancer. PEGPH20 breaks down a specific tissue component called hyaluronan, which is found in large amounts in pancreatic cancer; breaking down hyaluronan may increase the activity of atezolizumab.
If tumor growth continues during Stage 1, a patient may be able to switch to another study treatment in Stage 2 of the study. Researchers will determine what treatments will be offered in Stage 2 after observing the responses to the treatments in Stage 1.
To be eligible for this study, patients must meet several criteria, including but not limited to the following:
- Patients must have metastatic pancreatic cancer that has continued to grow despite no more than one prior regimen of therapy with 5-fluorouracil or gemcitabine.
- Patients may not have previously received immunotherapy drugs.
- Patients must recover from the serious side effects of prior treatment before entering the study.
- Patients must be physically well enough that they are fully ambulatory, capable of all self care, and are capable of all but physically strenuous activities. As an example, patients must be well enough that they would be able to carry out office work or light housework.
- This study is for patients age 18 and older.
For more information about this study and to inquire about eligibility, please contact Dr. Eileen O’Reilly at 646-888-4182.