or
forgot password

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
Open (Enrolling)
Both
Neoplasms by Site

Thank you

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