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Studying a Combination of Immunotherapies and Biomarker for Advanced Solid Tumors

Studying a Combination of Immunotherapies and Biomarker for Advanced Solid Tumors

Clinicaltrials.gov identifier:

Breast, Ovarian, Pancreatic, Prostate, Colorectal, Endometrial

Study Contact Information:

Please contact the sites directly. If there is no contact information, email Clinical.Trials@bms.com

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.

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. 

Study Sites

  • California
    • Santa Monica: John Wayne Cancer Institute
      • Contact: Dr. Steven O'Day at: 310-449-5224  
  • Colorado
    • Denver: Rocky Mountain Cancer Center
      • Contact: Allen Cohn at: 303-388-4876
  • Minnesota
    • Minneapolis: Minnesota Oncology and Hematology
      • Contact: Tim Larson, MD at: 
  • New York
    • Johnson City: Broome Cancer Center
      • Contact: Ronald Harris, MD at: (607) 763-6850
  • North Carolina
    • Durham: Duke University Cancer Center
      • Contact: Niharika Mettu, DM at: 
  • Oregon
    • Portland: Oregon Health & Science University
      • Contact: Dr. Matthew Taylor at: 503-418-9324
  • Puerto Rico
    • San Juan: Fundacion de Investigacion
      • Contact: Dr. Mirelis Acosta Rivera: 787-722-1248      
  • Texas
    • Dallas: Texas Oncology, Dallas
      • Contact: Dr. Kristi McIntyre at: 214-739-4175
    • Houston: MD Anderson Cancer Center
      • Contact: Aung Naing at: 713-792-3245
    • Tyler: Texas Oncology, Tyler
      •  Contact: Donald Richards at: 903-579-9800
This Study is Open To:
  • Clinical study CA209-848 is enrolling patients diagnosed with the following types of metasatic cancer which is no longer responsive to standard therapy or for whom no standard therapy is available:
    • breast
    • colorectal
    • esophageal
    • gastric
    • hepatocellular 
    • ovarian
    • pancreatic
    • prostate
    • uterine
    • other cancers
  • Participants must have available tumor tissue and blood for Tumor Mutation Burden (TMB) testing.
  • Patients must have a certain amount of mutations in their tumor, (TMB-High). 
  • Participants must have measurable disease for response assessment Exclusion Criteria:

For a full list of eligibility, visit BMS Study Connect.

This Study is Not Open To:
  • Participants with melanoma, non-small cell lung cancer (NSCLC), renal cell carcinoma (RCC) or hematological cancer as primary site of disease are not eligible.
  • Participants who have previously received certain immunotherapies, or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways are not eligible. 
  • Patients must not have received treatment with any chemotherapy, radiation therapy, biologics for cancer, or investigational therapy within 28 days of first administration of study treatment.

For a full list of exclusion criteria, visit BMS Study Connect.