Full TitleA Phase I Study of Ipilimumab and Nivolumab in Advanced HIV-Associated Solid Tumors with Expansion Cohorts in HIV-Associated Solid Tumors and a Cohort of HIV-Associated Classical Hodgkin Lymphoma (AMC-095)
Nivolumab and ipilimumab are immunotherapy drugs that provoke a response of the immune system against cancer. In this study, researchers are assessing nivolumab alone and with ipilimumab in patients with advanced HIV-related solid tumors that cannot be successfully treated with standard therapies. Patients will receive nivolumab alone or one of several escalating doses of nivolumab in combination with ipilimumab. Patients with Hodgkin lymphoma will receive the standard dose of nivolumab for this disease. Both drugs are given intravenously (by vein).
Nivolumab is a form of immunotherapy. It boosts the body’s immune system by targeting 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 shut-down mechanism by activating PD-1, enabling them to escape attack by the body’s white blood cells. Nivolumab binds to and inactivates PD-1, enhancing the body’s ability to detect and destroy cancer cells.
Ipilimumab is also a form of immunotherapy. It is an antibody against CTLA-4, a molecule that controls a part of the immune system by shutting it down. Researchers believe that an antibody against CTLA-4 could stop it from turning off the immune system, and allow an immune response that may help the body to destroy cancer cells.
Ipilimumab and nivolumab are approved for treating melanoma. Nivolumab is also approved for treating several other types of cancer, including Hodgkin lymphoma. Their use in this study is considered investigational.
To be eligible for this study, patients must meet several criteria, including but not limited to the following:
- Patients must have an inoperable or metastatic HIV-related solid tumor that cannot be successfully treated with standard therapies.
- For patients with Hodgkin lymphoma, they must have cancer that persists or has come back despite at least one prior regimen of chemotherapy. and their CD4 counts must be over 100.
- At least 4 weeks must pass between the completion of prior therapies 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.