Safety Study of IL-21/Ipilimumab Combination in the Treatment of Melanoma

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT01489059
First received: December 7, 2011
Last updated: January 23, 2014
Last verified: January 2014

December 7, 2011
January 23, 2014
December 2011
November 2014   (final data collection date for primary outcome measure)
  • Part1 (Dose Escalation): The Maximum tolerated dose (MTD) of BMS-982470 using 2 distinct schedules when administered in combination with Ipilimumab [ Time Frame: Within the first 63 days ] [ Designated as safety issue: Yes ]
    Based on the dose-limiting toxicity (DLT) rate
  • Part 2 (Cohort Escalation): Safety and tolerability of the MTD dose for each of the schedules [ Time Frame: 84 days on treatment ] [ Designated as safety issue: Yes ]
    Based on medical review of AE reports and the results of vital sign measurements, physical examinations, medical history, and clinical laboratory tests
Same as current
Complete list of historical versions of study NCT01489059 on ClinicalTrials.gov Archive Site
  • Efficacy of BMS-982470 in combination with Ipilimumab as measured by objective response [ Time Frame: Baseline (Day 1), End of Treatment (EOT) [3 weeks after last dose of Ipilimumab], 3 and 6 months Follow-up ] [ Designated as safety issue: No ]
  • Area under the serum concentration-time curve from time zero to the last quantifiable concentration [AUC(0-T)] of BMS-982470 and Ipilimumab [ Time Frame: 20 time points during Lead-In Cycle; Up to 11 time points during Cycle 3 ] [ Designated as safety issue: No ]
  • Area under the serum concentration-time curve in one dosing interval [AUC(TAU)] of BMS-982470 and Ipilimumab [ Time Frame: 20 time points during Lead-In Cycle; Up to 11 time points during Cycle 3 ] [ Designated as safety issue: No ]
  • Area under the serum concentration-time curve from time zero extrapolated to infinite time [AUC(INF)] of BMS-982470 and Ipilimumab [ Time Frame: 20 time points during Lead-In Cycle; Up to 11 time points during Cycle 3 ] [ Designated as safety issue: No ]
  • The maximum observed serum concentration (Cmax) of BMS-982470 and Ipilimumab [ Time Frame: 20 time points during Lead-In Cycle; Up to 11 time points during Cycle 3 ] [ Designated as safety issue: No ]
  • Trough observed serum concentration (Cmin) of BMS-982470 and Ipilimumab [ Time Frame: 1 time point each 3-week Cycle ] [ Designated as safety issue: No ]
  • The time of maximum observed serum concentration (Tmax) of BMS-982470 and Ipilimumab [ Time Frame: 20 time points during Lead-In Cycle; Up to 11 time points during Cycle 3 ] [ Designated as safety issue: No ]
  • Serum half-life (T-HALF) of BMS-982470 and Ipilimumab [ Time Frame: 20 time points during Lead-In Cycle; Up to 11 time points during Cycle 3 ] [ Designated as safety issue: No ]
  • Apparent total body clearance (CLT) of BMS-982470 and Ipilimumab [ Time Frame: 20 time points during Lead-In Cycle; Up to 11 time points during Cycle 3 ] [ Designated as safety issue: No ]
  • Apparent volume of distribution at steady state (Vss) of BMS-982470 and Ipilimumab [ Time Frame: 20 time points during Lead-In Cycle; Up to 11 time points during Cycle 3 ] [ Designated as safety issue: No ]
  • Incidence of BMS-984270 and Ipilimumab Anti-Drug Antibodies [ Time Frame: Up to 6 months following last dose ] [ Designated as safety issue: No ]
  • Efficacy of BMS-982470 in combination with Ipilimumab as measured by objective response [ Time Frame: Baseline (Day 1), End of Treatment (EOT) [3 weeks after last dose of Ipilimumab], 3 and 6 months Follow-up ] [ Designated as safety issue: No ]
  • Area under the serum concentration-time curve from time zero to the last quantifiable concentration [AUC(0-T)] of BMS-982470 and Ipilimumab [ Time Frame: Up to 6 months following last dose ] [ Designated as safety issue: No ]
  • Area under the serum concentration-time curve in one dosing interval [AUC(TAU)] of BMS-982470 and Ipilimumab [ Time Frame: Up to 6 months following last dose ] [ Designated as safety issue: No ]
  • Area under the serum concentration-time curve from time zero extrapolated to infinite time [AUC(INF)] of BMS-982470 and Ipilimumab [ Time Frame: Up to 6 months following last dose ] [ Designated as safety issue: No ]
  • The maximum observed serum concentration (Cmax) of BMS-982470 and Ipilimumab [ Time Frame: Up to 6 months following last dose ] [ Designated as safety issue: No ]
  • Trough observed serum concentration (Cmin) of BMS-982470 and Ipilimumab [ Time Frame: Up to 6 months following last dose ] [ Designated as safety issue: No ]
  • The time of maximum observed serum concentration (Tmax) of BMS-982470 and Ipilimumab [ Time Frame: Up to 6 months following last dose ] [ Designated as safety issue: No ]
  • Serum half-life (T-HALF) of BMS-982470 and Ipilimumab [ Time Frame: Up to 6 months following last dose ] [ Designated as safety issue: No ]
  • Apparent total body clearance (CLT) of BMS-982470 and Ipilimumab [ Time Frame: Up to 6 months following last dose ] [ Designated as safety issue: No ]
  • Apparent volume of distribution at steady state (Vss) of BMS-982470 and Ipilimumab [ Time Frame: Up to 6 months following last dose ] [ Designated as safety issue: No ]
  • Incidence of BMS-984270 and Ipilimumab Anti-Drug Antibodies [ Time Frame: Up to 6 months following last dose ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Safety Study of IL-21/Ipilimumab Combination in the Treatment of Melanoma
A Phase I Dose Escalation Study of BMS-982470 (Recombinant Interleukin 21, rIL-21) in Combination With Ipilimumab in Subjects With Unresectable Stage III or Stage IV Melanoma

The purpose of this study is to determine whether the combination of interleukin-21 (IL-21) and Ipilimumab in subjects with melanoma is safe, and provide preliminary information on the clinical benefits of the combination compared with Ipilimumab alone

Allocation: Part 1 Dose Escalation Phase: Non-randomized; Part 2 Cohort Expansion Phase: Randomized

Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Melanoma
  • Biological: BMS-982470 (recombinant interleukin-21)
    Solution, Intravenous, 10,30,50 μg/kg, daily for 5 days every 3 weeks (daily x 5), 16-20 weeks depending on response
  • Biological: BMS-982470 (recombinant interleukin-21)
    Solution, Intravenous, 30,100,150 μg/kg, weekly, 16-20 weeks depending on response
  • Biological: BMS-982470 (recombinant interleukin-21)
    Solution, Intravenous, Maximum tolerated dose from Part 1, daily for 5 days every 3 weeks (daily x 5), 12-16 weeks depending on response
  • Biological: BMS-982470 (recombinant interleukin-21)
    Solution, Intravenous, Maximum tolerated dose from Part 1, Weekly, 12-16 weeks depending on response
  • Biological: Ipilimumab
    Solution, Intravenous, 1,3,10 mg/kg, every 3 weeks, 16-20 weeks depending on response
    Other Name: Yervoy®
  • Biological: Ipilimumab
    Solution, Intravenous, Maximum tolerated dose from Part 1, every 3 weeks, 12-16 weeks depending on response
    Other Name: Yervoy®
  • Biological: Ipilimumab
    Solution, Intravenous, 3mg/kg, Every 3 weeks, 12-16 weeks depending on response
    Other Name: Yervoy®
  • Experimental: Part 1 - Arm 1: BMS-982470 (Daily x 5) + Ipilimumab
    Dose Escalation
    Interventions:
    • Biological: BMS-982470 (recombinant interleukin-21)
    • Biological: Ipilimumab
  • Experimental: Part 1 - Arm 2: BMS-982470 (Weekly) + Ipilimumab
    Dose Escalation
    Interventions:
    • Biological: BMS-982470 (recombinant interleukin-21)
    • Biological: Ipilimumab
  • Experimental: Part 2 - Arm 1: BMS-982470 (Daily x 5) + Ipilimumab
    Cohort Expansion
    Interventions:
    • Biological: BMS-982470 (recombinant interleukin-21)
    • Biological: Ipilimumab
  • Experimental: Part 2 - Arm 2: BMS-982470 (Weekly) + Ipilimumab
    Cohort Expansion
    Interventions:
    • Biological: BMS-982470 (recombinant interleukin-21)
    • Biological: Ipilimumab
  • Active Comparator: Part 2 - Arm 3: Ipilimumab monotherapy
    Cohort Expansion
    Intervention: Biological: Ipilimumab
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
150
November 2014
November 2014   (final data collection date for primary outcome measure)

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

Inclusion Criteria:

  • Unresectable Stage III or Stage IV melanoma
  • Part 1 Dose Escalation: Prior melanoma treatment allowed except for the following: ipilimumab, BMS-982470 (rIL-21), anti-Programmed Death-1 (anti-PD-1), anti-programmed death-ligand 1 (anti-PD-L1), anti-PD-L2 or anti-CD137
  • Part 2 Cohort expansion: Prior treatment for melanoma is not allowed, except for adjuvant therapy with interferon alpha or melanoma vaccines which are permitted
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Measurable disease by computed tomography (CT) or magnetic resonance imaging (MRI)
  • Normal liver function tests

Exclusion Criteria:

  • Part 1 Dose escalation: subjects with ≤ 2 brain metastases of stable size, ≥ 4 weeks post-radiation treatment, and off steroids are allowed
  • Part 2 Cohort expansion: subjects with known or suspected brain metastases and uveal melanoma are excluded
  • Autoimmune disease
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Puerto Rico
 
NCT01489059
CA220-007
No
Bristol-Myers Squibb
Bristol-Myers Squibb
Not Provided
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
Bristol-Myers Squibb
January 2014

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