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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

Conditions

Melanoma, skin

Trial Phase

Phase I

Trial Purpose and Description

Trial Purpose

Primary Objective:
In Part 1, the primary objectives are to determine the safety and tolerability of BMS-982470 when administered weekly and 3 times weekly in combination with BMS-936558 to subjects with advanced or metastatic solid tumors and to identify a maximum tolerated dose (MTD).
In Part 2, the primary objective is to further characterize the safety and tolerability of BMS-982470 administered weekly and 3 times weekly in combination with BMS-936558 in subjects with clear cell renal cell carcinoma (ccRCC) or non-small cell lung cancer (NSCLC).


Participation Guidelines

Age:
Gender:

Eligibility Criteria

Inclusion Criteria:

  • All subjects will have locally advanced or metastatic cancer resistant to standard treatment, for which no additional standard treatment is available, or for which the subject declines standard treatment, excluding cancer in the blood in Part 2 (Cohort Expansion), tumor types will be further restricted to clear cell renal cell carcinoma or non-small cell lung cancer
  • At least 1 non-irradiated lesion with measurable disease at baseline
  • Availability of an existing tumor biopsy sample (or consent to allow pre-treatment tumor biopsy if sample not available)

Exclusion Criteria:

  • Uncontrolled brain metastases
  • Certain prior drug treatments for the cancer
  • Autoimmune disease
  • Inadequate liver or kidney function
Sponsor:
Bristol-Myers Squibb Company
Dates:
06/26/2013
Last Updated:
Study HIC#:
1207010484