Summary

for people ages 12 years and up (full criteria)
at UCLA
study started
estimated completion

Description

Summary

The purpose of this study is to determine whether nivolumab plus ipilimumab or nivolumab alone is effective and safe in the treatment of solid tumors with High Tumor Mutational Burden (TMB-H)

Official Title

A Randomized, Open-Label, Phase 2 Study of Nivolumab in Combination With Ipilimumab or Nivolumab Monotherapy in Participants With Advanced or Metastatic Solid Tumors of High Tumor Mutational Burden (TMB-H)

Keywords

Pan Tumor TMB-H Nivolumab Ipilimumab Nivolumab Monotherapy

Eligibility

For people ages 12 years and up

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:

  • 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

Locations

  • Local Institution not yet accepting patients
    Los Angeles California 90095-7349 United States
  • Local Institution not yet accepting patients
    Los Angeles California 90095-7349 United States
  • Local Institution not yet accepting patients
    Los Angeles California 90095-7349 United States
  • Local Institution not yet accepting patients
    Los Angeles California 90095-7349 United States
  • Local Institution not yet accepting patients
    Los Angeles California 90095-7349 United States
  • Local Institution not yet accepting patients
    Los Angeles California 90095 United States
  • John Wayne Cancer Center accepting new patients
    Santa Monica California 90404 United States
  • Local Institution withdrawn
    Orange California 92868 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Bristol-Myers Squibb
Links
BMS Clinical Trial Information
BMS Clinical Trial Patient Recruiting
Investigator Inquiry Form
FDA Safety Alerts and Recalls
ID
NCT03668119
Phase
Phase 2
Study Type
Interventional
Last Updated