A Study of an Anti-KIR Antibody Lirilumab in Combination With an Anti-PD1 Antibody Nivolumab and Nivolumab Plus an Anti-CTLA-4 Ipilimumab Antibody in Patients With Advanced Solid Tumors

  • Interventional
  • Not Recruiting
  • NCT01714739
Eligibility Details Visit Clinicaltrials.gov

A Phase 1/2 Study of the Combination of Lirilumab (Anti-KIR) Plus Nivolumab (Anti-PD-1) or Lirilumab Plus Nivolumab and Ipilimumab in Advanced Refractory Solid Tumors

To assess the safety and tolerability and preliminary anti-tumor activity of lirilumab (BMS-986015) given in combination with nivolumab (BMS-936558) and to identify dose limiting toxicities (DLTs) and the maximally tolerated dose (MTD) of the combination. In addition, to assess the combinations of lirilumab and nivolumab or lirilumab and nivolumab plus ipilimumab (BMS-734016) in subjects with advanced (metastatic and/or unresectable) refractory solid tumors.

Gender
All

Age Group
18 Years and up

Accepting Healthy Volunteers?
No

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com.

        Inclusion Criteria:

         - During dose escalation, subjects with advanced solid tumors (except for primary CNS metastases) that have progressed following at least one standard regimen

         - During cohort expansion, subjects with various solid tumors that have received at least one and no more than 5 prior treatment regimens

         - Subjects must have measurable disease

         - Subject must consent to provide previously collected tumor tissue

         - Women and men ≥18 years of age with performance status of 0 or 1

         - At least 4 weeks since any previous treatment for cancer

        Exclusion Criteria:

         - Active or chronic autoimmune diseases

         - Uncontrolled or significant cardiovascular disease

         - Chronic hepatitis (except for subjects with hepatocellular carcinoma)

         - Active infection

         - Active Central nervous system (CNS) metastases

         - Human Immunodeficiency Virus/Acquired Immunodeficiency Syndrome((HIV/AIDS)

         - Positive test for Hepatitis B virus surface antigen or Hepatitis C antibody (except for subjects with hepatocellular carcinoma)

        Other protocol defined inclusion/exclusion criteria could apply

At a Glance

National Government IDNCT01714739

IRB#IRB12-1667

Lead SponsorBristol-Myers Squibb

Lead PhysicianThomas F. Gajewski

Collaborator(s)N/A

EligibilityAll
18 Years and up
Not Recruiting