Safety Study of IL-21/Anti-PD-1 Combination in the Treatment of Solid Tumors

A Phase 1 Dose Escalation Study of BMS-982470 (Recombinant Interleukin-21, rIL-21) in Combination With BMS-936558 (Anti-PD-1) in Subjects With Advanced or Metastatic Solid Tumors

The purpose of this study is to determine whether the combination of the 2 drugs being investigated (IL-21 and anti-PD-1) is safe, and provide preliminary information on the clinical benefits of two different schedules of the combination.

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

Inclusion Criteria:

• All subjects will have locally advanced or metastatic solid tumors

• For Part 2 (Cohort Expansion):

  • Tumor types will be restricted to clear cell renal cell carcinoma (ccRCC), non-small cell lung cancer (NSCLC), and melanoma

• At least 1 lesion with measurable disease

• Only subjects with tumor samples that are PD-L1 positive or negative are eligible

Exclusion Criteria:

• Uncontrolled central nervous system (CNS) or leptomeningeal metastasis
• Inadequate liver or kidney function
• History of autoimmune Disease