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

August 28, 2014 updated by: Bristol-Myers Squibb

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
42

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Puerto Rico
      • San Juan, Puerto Rico, 00927
        • Local Institution
  • United States
    • Arizona
      • Scottsdale, Arizona, United States, 85258
        • Oncology Research Associates, Pllc D/B/A
    • California
      • Los Angeles, California, United States, 90095
        • Ucla Hematology/Oncology.
    • Florida
      • Tampa, Florida, United States, 33612
        • H. Lee Moffitt Cancer Center & Research Inst, Inc
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Indiana University Health Melvin and Bren Simon Cancer Center
    • Kentucky
      • Louisville, Kentucky, United States, 40202
        • University Of Louisville Medical Center, Inc., Dba
    • Oregon
      • Portland, Oregon, United States, 97213
        • Portland Providence Medical Center
    • Texas
      • Houston, Texas, United States, 77030
        • Md Anderson Can Cnt
    • Washington
      • Seattle, Washington, United States, 98109
        • Seattle Cancer Care Alliance

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Part 1 - Arm 1: BMS-982470 (Daily x 5) + Ipilimumab
Dose Escalation
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 Names:
  • Yervoy®
Biological: Ipilimumab
Solution, Intravenous, Maximum tolerated dose from Part 1, every 3 weeks, 12-16 weeks depending on response
Other Names:
  • Yervoy®
Biological: Ipilimumab
Solution, Intravenous, 3mg/kg, Every 3 weeks, 12-16 weeks depending on response
Other Names:
  • Yervoy®
Experimental: Part 1 - Arm 2: BMS-982470 (Weekly) + Ipilimumab
Dose Escalation
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 Names:
  • Yervoy®
Biological: Ipilimumab
Solution, Intravenous, Maximum tolerated dose from Part 1, every 3 weeks, 12-16 weeks depending on response
Other Names:
  • Yervoy®
Biological: Ipilimumab
Solution, Intravenous, 3mg/kg, Every 3 weeks, 12-16 weeks depending on response
Other Names:
  • Yervoy®
Experimental: Part 2 - Arm 1: BMS-982470 (Daily x 5) + Ipilimumab
Cohort Expansion
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 Names:
  • Yervoy®
Biological: Ipilimumab
Solution, Intravenous, Maximum tolerated dose from Part 1, every 3 weeks, 12-16 weeks depending on response
Other Names:
  • Yervoy®
Biological: Ipilimumab
Solution, Intravenous, 3mg/kg, Every 3 weeks, 12-16 weeks depending on response
Other Names:
  • Yervoy®
Experimental: Part 2 - Arm 2: BMS-982470 (Weekly) + Ipilimumab
Cohort Expansion
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 Names:
  • Yervoy®
Biological: Ipilimumab
Solution, Intravenous, Maximum tolerated dose from Part 1, every 3 weeks, 12-16 weeks depending on response
Other Names:
  • Yervoy®
Biological: Ipilimumab
Solution, Intravenous, 3mg/kg, Every 3 weeks, 12-16 weeks depending on response
Other Names:
  • Yervoy®
Active Comparator: Part 2 - Arm 3: Ipilimumab monotherapy
Cohort Expansion
Biological: Ipilimumab
Solution, Intravenous, 1,3,10 mg/kg, every 3 weeks, 16-20 weeks depending on response
Other Names:
  • Yervoy®
Biological: Ipilimumab
Solution, Intravenous, Maximum tolerated dose from Part 1, every 3 weeks, 12-16 weeks depending on response
Other Names:
  • Yervoy®
Biological: Ipilimumab
Solution, Intravenous, 3mg/kg, Every 3 weeks, 12-16 weeks depending on response
Other Names:
  • Yervoy®

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
Within the first 63 days
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
84 days on treatment

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
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
Baseline (Day 1), End of Treatment (EOT) [3 weeks after last dose of Ipilimumab], 3 and 6 months Follow-up
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
20 time points during Lead-In Cycle; Up to 11 time points during Cycle 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
20 time points during Lead-In Cycle; Up to 11 time points during Cycle 3
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
20 time points during Lead-In Cycle; Up to 11 time points during Cycle 3
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
20 time points during Lead-In Cycle; Up to 11 time points during Cycle 3
Trough observed serum concentration (Cmin) of BMS-982470 and Ipilimumab
Time Frame: 1 time point each 3-week Cycle
1 time point each 3-week Cycle
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
20 time points during Lead-In Cycle; Up to 11 time points during Cycle 3
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
20 time points during Lead-In Cycle; Up to 11 time points during Cycle 3
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
20 time points during Lead-In Cycle; Up to 11 time points during Cycle 3
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
20 time points during Lead-In Cycle; Up to 11 time points during Cycle 3
Incidence of BMS-984270 and Ipilimumab Anti-Drug Antibodies
Time Frame: Up to 6 months following last dose
Up to 6 months following last dose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Bristol-Myers Squibb

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2011

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2014

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2014

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 7, 2011

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 7, 2011

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 9, 2011

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 29, 2014

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 28, 2014

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CA220-007

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Drug Interventions

Conditions

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Locations

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