An Investigational Immuno-therapy Study of BMS-986205 Given in Combination With Nivolumab and in Combination With Both Nivolumab and Ipilimumab in Cancers That Are Advanced or Have Spread

  • Interventional
  • Recruiting
  • NCT02658890
Eligibility Details Visit Clinicaltrials.gov

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

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.

Gender
All

Age Group
18 Years to 100 Years

Accepting Healthy Volunteers?
No

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

At a Glance

National Government IDNCT02658890

IRB#IRB16-1071

Lead SponsorBristol-Myers Squibb

Lead PhysicianMark J. Ratain

Collaborator(s)N/A

EligibilityAll
18 Years to 100 Years
Recruiting