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

Complete title: 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

Research Study Number       20120892
    
Principal Investigator       Laura Chow
    
Phase       I

Look up trial at NIH

Research Study Description

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.

Eligibility Criteria (must meet the following to participate in this study)

Ages Eligible for Study: 18 Years and older

Genders Eligible for Study: Both

- 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)

Other eligibility criteria may apply.

Exclusions (conditions that would prevent participation in this study)

- Uncontrolled brain metastases

- Certain prior drug treatments for the cancer

- Autoimmune disease

- Inadequate liver or kidney function

Other exclusion criteria may apply.



Research Study Number       20120892
    
Contact       Seattle Cancer Care Alliance Intake Office
    
Telephone       800-804-8824 / 206-288-1024
    
   

Keywords
Solid Tumors

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