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

Unique to Me: Realize What's Inside

Clinicaltrials.gov identifier:
NCT03668119

Study Contact Information:

Please contact the sites directly. If there is no contact information, email [email protected]

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Overview
Who Can Join
Details
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About this Study

This study is researching  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 "" (TMB) can help doctors tell how well patients will respond to  drugs.

NOTE: This study is no longer enrolling.

Type of Study

This is a , two-arm study. 

  • This is a  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. 

This Study is Open To:

NOTE: This study is no longer enrolling.

This Study is NOT Open To:

NOTE: This study is no longer enrolling.

What the Study Involves

  • 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 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 or CT scans to see how their cancer is responding to treatment.
  • Patients may withdraw from the study at any time. 

Study Contact Information:

Please contact the sites directly. If there is no contact information, email [email protected]

Clinicaltrials.gov identifier:
NCT03668119

Study Contact Information:

Please contact the sites directly. If there is no contact information, email [email protected]

PRINTER FRIENDLY PAGE