Summary

for people ages 18-100 (full criteria)
at La Jolla, California and other locations
study started
estimated completion:

Description

Summary

The purpose of the study is to determine safety and effectiveness of experimental medication BMS-986205 when combined with Nivolumab and in combination with both Nivolumab and Ipilimumab in patients with cancers that are advanced or have spread. Pharmacokinetics and pharmacodynamics of BMS-986205 when combined with Nivolumab and in combination with Nivolumab and Ipilimumab in this patient population will also be assessed.

Official Title

A Phase 1/2a Study of BMS-986205 Administered in Combination With Nivolumab (Anti-PD-1 Monoclonal Antibody) and in Combination With Both Nivolumab and Ipilimumab (Anti-CTLA-4 Monoclonal Antibody) in Advanced Malignant Tumors

Keywords

Advanced Cancer Melanoma Non-Small Cell Lung Cancer Carcinoma, Non-Small-Cell Lung Nivolumab Antibodies, Monoclonal BMS-986205 Ipilimumab

Eligibility

For people ages 18-100

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

Inclusion Criteria:

  • During dose escalation, subjects with advanced solid tumors that have progressed following at least one standard regimen
  • During cohort expansion, subjects with advanced cancer that either have received at least one prior therapy or are treatment naive, depending on the specified tumor type
  • Subjects must have measurable disease
  • Subject must consent to provide previously collected tumor tissue and a tumor biopsy during screening.
  • At least 4 weeks since any previous treatment for cancer
  • Must be able to swallow pills or capsules
  • Eastern Cooperative Oncology Group(ECOG) Performance Status 0-1

Exclusion Criteria:

  • Active or chronic autoimmune diseases
  • Uncontrolled or significant cardiovascular disease
  • History of any chronic Hepatitis, active Hepatitis B or C, human immunodeficiency virus (HIV), or acquired immune deficiency syndrome (AIDS)
  • Chronic hepatitis: Positive test for Hepatitis B virus surface antigen or Hepatitis C antibody (except for subjects with hepatocellular carcinoma)
  • Active central nervous system (CNS) metastases and CNS metastases as the only sites of disease
  • Active infection

Other protocol defined inclusion/exclusion criteria could apply

Locations

  • UCSD Moores Cancer Center accepting new patients
    La Jolla California 92093-0698 United States
  • Local Institution withdrawn
    Phoenix Arizona 85054 United States
  • University of Arizona Cancer Center accepting new patients
    Tucson Arizona 85724 United States
  • Local Institution accepting new patients
    Vancouver British Columbia V5Z 4E6 Canada
  • Cross Cancer Institute accepting new patients
    Edmonton Alberta T6G 1Z2 Canada

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Bristol-Myers Squibb
Links
FDA Safety Alerts and Recalls
BMS Clinical Trial Patient Recruiting
Investigator Inquiry Form
ID
NCT02658890
Phase
Phase 1/2
Study Type
Interventional
Last Updated
July 23, 2018