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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT01629758
First received: June 26, 2012
Last updated: March 5, 2015
Last verified: February 2015
June 26, 2012
March 5, 2015
June 2012
December 2014   (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 ]
Same as current
Complete list of historical versions of study NCT01629758 on ClinicalTrials.gov Archive Site
  • Efficacy as measured by tumor assessment (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) ]
    Based on 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)
  • 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 ]
  • 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) ]
    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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
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.
Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Neoplasms by Site
  • Biological: Denenicokin
    Other Names:
    • BMS-982470
    • rIL-21(recombinant interleukin 21)
  • Biological: Nivolumab
    Other Names:
    • BMS-936558
    • 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: Denenicokin
    • Biological: Nivolumab
  • 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: Denenicokin
    • Biological: Nivolumab
  • 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: Denenicokin
    • Biological: Nivolumab
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
33
December 2014
December 2014   (Final data collection date for primary outcome measure)

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

  • All subjects will have locally advanced or metastatic solid tumors
  • For Part 2 (Cohort Expansion):

    • Tumor types will be restricted to clear cell renal cell carcinoma (ccRCC), non-small cell lung cancer (NSCLC), and melanoma
  • At least 1 lesion with measurable disease
  • Only subjects with tumor samples that are PD-L1 positive or negative are eligible

Exclusion Criteria:

  • Uncontrolled central nervous system (CNS) or leptomeningeal metastasis
  • Inadequate liver or kidney function
  • History of autoimmune Disease
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01629758
CA220-008
No
Not Provided
Not Provided
Bristol-Myers Squibb
Bristol-Myers Squibb
Not Provided
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
Bristol-Myers Squibb
February 2015

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