Multiple Ascending Dose (MDX1105-01)
NCT00729664 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 281
Last updated 2015-09-07
Summary
Collection of survival data, evaluation of PDL-1 expression in tumors, and evaluation of PD-L1 receptor occupancy in peripheral blood has been added.
Conditions
- Cancer, Multiple Indications
Interventions
- BIOLOGICAL
-
Anti-PDL-1 antibody
Solution, Intravenous, 0.1 mg/kg, Every 14 days, 3 doses per each cycle of 42 days, 16 cycles/48 doses depending on response
- BIOLOGICAL
-
Anti-PDL-1 antibody
Solution, Intravenous, 0.3 mg/kg, Every 14 days, 3 doses per each cycle of 42 days, 16 cycles/48 doses depending on response
- BIOLOGICAL
-
Anti-PDL-1 antibody
Solution, Intravenous, 1 mg/kg, Every 14 days, 3 doses per each cycle of 42 days, 16 cycles/48 doses depending on response
- BIOLOGICAL
-
Anti-PDL-1 antibody
Solution, Intravenous, 3 mg/kg, Every 14 days, 3 doses per each cycle of 42 days, 16 cycles/48 doses depending on response
- BIOLOGICAL
-
Anti-PDL-1 antibody
Solution, Intravenous, 10 mg/kg, Every 14 days, 3 doses per each cycle of 42 days, 16 cycles/48 doses depending on response
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
Bristol-Myers Squibb · Bristol-Myers Squibb
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2009-02-28
- Primary Completion
- 2015-07-31
- Completion
- 2015-07-31
Countries
- United States
Study Locations
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