SCCA Clinical Studies: Phase 1 Program
Nivolumab (anti-PD1)/IL-21 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
|Closed||Neoplasms by Site||Phase I||NCT01629758|
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)
- All subjects will have locally advanced or metastatic cancer, 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
- Received at least one prior chemotherapy regimen
- 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)
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
Last UpdatedApril 11, 2014
See this trial at ClinicalTrials.gov
Access protocol and consent forms at Fred Hutchinson Cancer Research Center
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