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Completed

NCT Number: NCT01489059

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

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Key information

Conditions

Melanoma Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Germ Cell and Embryonal Neoplasms, Nerve Tissue Neuroectodermal Tumors Neuroendocrine Tumors Nevi and Melanomas Skin Diseases Skin Neoplasms Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Local Institution, San Juan, Puerto Rico

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

BMS-982470 (recombinant interleukin-21)

Biological

Solution, Intravenous, 10,30,50 μg/kg, daily for 5 days every 3 weeks (daily x 5), 16-20 weeks depending on response

Ipilimumab

Biological

Solution, Intravenous, 1,3,10 mg/kg, every 3 weeks, 16-20 weeks depending on response

Other names: Yervoy®

Primary outcomes

  1. 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

    Based on the dose-limiting toxicity (DLT) rate

  2. Part 2 (Cohort Escalation): Safety and tolerability of the MTD dose for each of the schedules

    Time frame: 84 days on treatment

    Based on medical review of AE reports and the results of vital sign measurements, physical examinations, medical history, and clinical laboratory tests

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. Trough observed serum concentration (Cmin) of BMS-982470 and Ipilimumab

    Time frame: 1 time point each 3-week Cycle

  7. 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

  8. 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

  9. 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

  10. 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

  11. Incidence of BMS-984270 and Ipilimumab Anti-Drug Antibodies

    Time frame: Up to 6 months following last dose

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
Dec 9, 2011
Registry last updated
Aug 29, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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