A Study of Nivolumab Combined With Ipilimumab and Nivolumab Alone in Patients With Advanced or Metastatic Solid Tumors of High Tumor Mutational Burden

About this Study

This study is researching immunotherapy drugs for treating advanced cancers. The researchers are studying whether treatment with a combination of the drugs nivolumab plus ipilimumab is safe and effective compared with nivolumab alone.  

This study is also researching whether a tumor test called "tumor mutational burden" (TMB) can help doctors tell how well patients will respond to immunotherapy drugs.

NOTE: This study is no longer enrolling.

Type of Study

This is a randomized, two-arm study. 

• This is a randomized study, which means that participants will be placed into one of the two treatment groups by chance. Neither patients nor the research doctor will choose the group participants are placed in. 
  • One group of patients will be assigned to receive both nivolumab and ipilimumab.
  • The second group will receive nivolumab alone.  

What the Study Entails

• Patients who are interested in participating will have tissue and blood tests to see if they are eligible.
• Eligible patients will be assigned to receive one or both immunotherapy agents for up to 24 months depending on response to the treatments.
  • One group of patients will be assigned to receive both nivolumab and ipilimumab intravenously.
  • The second group will receive nivolumab alone intravenously.
• Patients may have additional tissue samples taken over the course of the study.
• Patients will undergo additional MRI or CT scans to see how their cancer is responding to treatment.
• Patients may withdraw from the study at any time.