Full TitleCV202103: A Phase 1b/2 Study of BMS-813160 in Combination with Chemotherapy or Nivolumab in Patients with Advanced Solid Tumors
BMS813160 is an investigational immunotherapy drug. It works by blocking signals that may suppress the immune system, thereby helping the immune system to recognize and fight cancer cells. In this study, researchers are finding the highest dose of BMS813160 that can be given safely in combination with chemotherapy or nivolumab immunotherapy in patients with metastatic colorectal cancer or pancreatic cancer.
Patients will be assigned to one of three treatment groups:
- Patients with previously untreated metastatic colorectal cancer will receive BMS813160 plus standard colorectal cancer chemotherapy.
- Patients with previously untreated metastatic pancreatic cancer will receive BMS813160 plus standard pancreatic cancer chemotherapy.
- Patients with metastatic pancreatic or colorectal cancer that has continued to grow despite one or two prior regimens of chemotherapy will receive BMS813160 plus nivolumab.
Nivolumab targets a protein on white blood cells called PD-1. PD-1 normally maintains the balance of the immune system by shutting it down at the right time. Some cancers take advantage of this mechanism by expressing PD-L1, enabling them to escape attack by the body’s white blood cells. Nivolumab blocks PD-1, enhancing the body’s ability to detect and destroy cancer cells.
BMS813160 is taken orally (by mouth). The chemotherapy and nivolumab treatments in this study are given intravenously (by vein).
To be eligible for this study, patients must meet several criteria, including but not limited to the following:
- Patients in the first two treatment groups must have metastatic pancreatic cancer or metastatic colorectal cancer and may not have received prior treatment for advanced disease.
- Patients in the third treatment group must have metastatic pancreatic cancer that has continued to grow despite one prior regimen of chemotherapy or metastatic colorectal cancer (with a genetic alteration called mismatch repair deficiency) that has continued to grow despite one or two prior regimens of chemotherapy.
- At least 4 weeks must pass between the completion of prior 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 and to inquire about eligibility for this study, please contact Dr. Anna Varghese at 646-888-4308.