Last updated on January 2020

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


Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: Pan Tumor
  • Age: Between 12 - 100 Years
  • Gender: Male or Female

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

  • Participants with a refractory, metastatic, or unresectable histologically or cytologically confirmed solid malignant tumor with TMB-H who are refractory to standard local therapies, or for which no standard treatment is available.
  • Available tumor tissue and blood for TMB testing
  • Participants must have measurable disease for response assessment

Exclusion Criteria:

  • Women with positive pregnancy test at enrollment or prior administration of study medication
  • Participants with melanoma, non-small cell lung cancer (NSCLC), renal cell carcinoma (RCC) or hematological malignancy as primary site of disease
  • Participants who received prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways
  • Treatment with any chemotherapy, radiation therapy, biologics for cancer, or investigational therapy within 28 days of first administration of study treatment

Other protocol defined inclusion/exclusion criteria could apply

Recruitment Status: Open


Brief Description Eligibility Contact Research Team


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