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
Phase 1
18 Years
N/A
18 Years
N/A
Open (Enrolling)
Both
Neoplasms by Site
Both
Neoplasms by Site
Trial Information
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
Allocation: Part 1 Dose Escalation: Nonrandomized Trial; Part 2 Cohort Expansion:
Randomized Trial
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
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Safety, as measured by the rate of adverse events and serious adverse events
Outcome Time Frame:
Approximately up to 4.5 years
Safety Issue:
Yes
Principal Investigator
Bristol-Myers Squibb
Investigator Role:
Study Director
Investigator Affiliation:
Bristol-Myers Squibb
Authority:
United States: Food and Drug Administration
Study ID:
CA220-008
NCT ID:
NCT01629758
Start Date:
June 2012
Completion Date:
September 2015
Related Keywords:
- Neoplasms by Site
- Neoplasms
- Neoplasms by Site
Name | Location |
|---|---|
| Seattle Cancer Care Alliance | Seattle, Washington 98109 |
| Moffitt Cancer Center | Tampa, Florida 33612 |
| Johns Hopkins Sidney Kimmel Comprehensive Cancer Center | Baltimore, Maryland 21231 |
| Oncology Research Associates, Pllc D/B/A | Scottsdale, Arizona 85258 |
