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

This study is currently recruiting participants.
Verified March 2013 by Bristol-Myers Squibb
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT01629758
First received: June 26, 2012
Last updated: March 28, 2013
Last verified: March 2013
History of Changes

June 26, 2012
March 28, 2013
June 2012
September 2015   (final data collection date for primary outcome measure)
Safety, as measured by the rate of adverse events and serious adverse events [ Time Frame: Approximately up to 4.5 years ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01629758 on ClinicalTrials.gov Archive Site
  • Efficacy as measured by tumor assessment (irRECIST and RECIST) [ Time Frame: Week 6 of for the first 4 cycles, Week 6 of alternate cycle starting with cycle 6, End of Treatment (2 years) and approximately every 12 weeks during follow-up (approximately 1 year) ] [ Designated as safety issue: No ]
    Based on immune-related Response Evaluation Criteria for Solid Tumors (irRECIST) 1.1 and Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 using Best overall response (BOR), Objective response rate (ORR), Duration of Response (DOR), Progression-Free Survival Rate (PFSR),
  • Maximum observed plasma concentration (Cmax) of BMS-982470 and BMS-936558 will be derived from serum concentration versus time data [ Time Frame: Up to 42 timepoints within the first 12 weeks ] [ Designated as safety issue: No ]
  • Trough observed plasma concentration (Cmin) of BMS-982470 and BMS-936558 will be derived from serum concentration versus time data [ Time Frame: Up to 42 timepoints within the first 12 weeks ] [ Designated as safety issue: No ]
  • Time of maximum observed plasma concentration (Tmax) of BMS-982470 and BMS-936558 will be derived from serum concentration versus time data [ Time Frame: Up to 42 timepoints within the first 12 weeks ] [ Designated as safety issue: No ]
  • Area under the plasma concentration-time curve from time zero extrapolated to infinite time [AUC(INF)] of BMS-982470 will be derived from serum concentration versus time data [ Time Frame: Up to 42 timepoints within the first 12 weeks ] [ Designated as safety issue: No ]
  • Area under the concentration-time curve in one dosing interval [AUC(TAU)] of BMS-982470 and BMS-936558 will be derived from serum concentration versus time data [ Time Frame: Up to 42 timepoints within the first 12 weeks ] [ Designated as safety issue: No ]
  • Plasma half-life (T-HALF) of BMS-982470 will be derived from serum concentration versus time data [ Time Frame: Up to 42 timepoints within the first 12 weeks ] [ Designated as safety issue: No ]
  • Total body clearance (CLT) of BMS-982470 will be derived from serum concentration versus time data [ Time Frame: Up to 42 timepoints within the first 12 weeks ] [ Designated as safety issue: No ]
  • Volume of distribution at steady-state (Vss) of BMS-982470 and BMS-936558 will be derived from serum concentration versus time data [ Time Frame: Up to 42 timepoints within the first 12 weeks ] [ Designated as safety issue: No ]
  • Accumulation index; ratio of AUC(TAU) at steady-state to AUC(TAU) after the first dose (AI) of BMS-982470 and BMS-936558 will be derived from serum concentration versus time data [ Time Frame: Up to 42 timepoints within the first 12 weeks ] [ Designated as safety issue: No ]
  • Immunogenicity as measured by incidence of specific antidrug antibodies (ADA) to BMS-98470 and BMS-936558 [ Time Frame: Up to 2 years + 100 days post-treatment follow-up ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Safety Study of IL-21/Anti-PD-1 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

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.

Allocation: Part 1 Dose Escalation: Nonrandomized Trial; Part 2 Cohort Expansion: Randomized Trial
Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Neoplasms by Site
  • Biological: BMS-982470
    Other Name: rIL-21(recombinant interleukin 21)
  • Biological: BMS-936558
    Other Names:
    • Anti-PD-1 (Anti-Programmed-Death-1)
    • MDX-1106
  • Experimental: Part 1-Arm A: BMS-982470 (weekly x 4) + BMS-936558
    Dose Escalation BMS-982470 10, 30, 50, 75 or 100 µg/kg Solution, Intravenous, During each 6 week cycle: weekly x 4 (i.e during weeks 1 through 4), Up to 2 years + BMS-936558 3 mg/kg Solution, Intravenous, During each 6 week cycle: every other week (i.e during weeks 1, 3, and 5), Up to 2 years
    Interventions:
    • Biological: BMS-982470
    • Biological: BMS-936558
  • Experimental: Part 1-Arm B: BMS-982470 (3 times/week)) + BMS-936558
    Dose Escalation BMS-982470 10, 30, 50, 75 or 100 µg/kg Solution, Intravenous, During each 6 week cycle: 3 times/week during weeks 1 and 3, Up to 2 years + BMS-936558 3 mg/kg Solution, Intravenous, During each 6 week cycle: every other week (i.e during weeks 1, 3, and 5), Up to 2 years
    Interventions:
    • Biological: BMS-982470
    • Biological: BMS-936558
  • Experimental: Part 2-Arm A: BMS-982470 (weekly x 4) + BMS-936558
    Cohort Expansion BMS-982470 (dose selected in Part 1) Solution, Intravenous, During each 6 week cycle: weekly x 4 (i.e during weeks 1 through 4), Up to 2 years + BMS-936558 3 mg/kg Solution, Intravenous, During each 6 week cycle: every other week (i.e during weeks 1, 3, and 5), Up to 2 years
    Interventions:
    • Biological: BMS-982470
    • Biological: BMS-936558
  • Experimental: Part 2-Arm B: BMS-982470 (3 times/week) + BMS-936558
    Cohort Expansion BMS-982470 (dose selected in Part 1) Solution, Intravenous, During each 6 week cycle: 3 times/week during weeks 1 and 3, Up to 2 years + BMS-936558 3 mg/kg Solution, Intravenous, During each 6 week cycle: every other week (i.e during weeks 1, 3, and 5), Up to 2 years
    Interventions:
    • Biological: BMS-982470
    • Biological: BMS-936558
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
165
September 2015
September 2015   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: For participation information at a USA site use a phone number below. For site information outside the USA please email: Clinical.Trials@bms.com
Contact: First line of email MUST contain NCT# & Site#. Only trial sites that are recruiting have contact information at this time.
United States
 
NCT01629758
CA220-008
No
Bristol-Myers Squibb
Bristol-Myers Squibb
Not Provided
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
Bristol-Myers Squibb
March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP