Full TitleIIT: Phase II Study to Assess the Efficacy of Durvalumab (MEDI4736) and Tremelimumab Plus Radiotherapy or Ablation in Patients with Metastatic Colorectal Cancer
Durvalumab and tremelimumab are immunotherapy drugs. They boost the power of the immune system to recognize and kill cancer cells by inhibiting proteins that normally put the brakes on the immune response. Durvalumab targets the PD-L1 protein, while tremelimumab inhibits the CTLA-4 protein.
In this study, researchers are assessing the safety and effectiveness of giving these two drugs to patients who are also receiving radiation therapy or ablation for metastatic colorectal cancer. The study also aims to determine if combining immunotherapy with radiation or ablation may further enhance the immune response against cancer.
Durvalumab is approved for treating advanced bladder cancer; its use in this study is considered investigational. Tremelimumab is an investigational drug. Both medications are given intravenously (by vein).
To be eligible for this study, patients must meet several criteria, including but not limited to the following:
- Patients must have metastatic colorectal cancer and plan to receive radiation therapy or ablation.
- At least 4 weeks must pass between the completion of previous treatment and entry into 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 call 646-888-4187.