MelanomaPhase 1NCT01489059
Safety Study of IL-21/Ipilimumab Combination in the Treatment of Melanoma
A Phase 1 study testing BMS-982470 (recombinant interleukin-21) and Ipilimumab in people with Melanoma, run by Bristol-Myers Squibb at 9 sites in 2 countries.
Trial summary
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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Melanoma
- What is being tested?
- BMS-982470 (recombinant interleukin-21) and Ipilimumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 9 sitesin 2 countries
- Study dates
- Dec 2011to Jun 2014
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
9 sites in 2 countries.
9 sites in 2 countries
United States8 sites
Md Anderson Can Cnt
Houston, Texas, 77030
Indiana University Health Melvin And Bren Simon Cancer Center
Indianapolis, Indiana, 46202
Ucla Hematology/Oncology.
Los Angeles, California, 90095
University Of Louisville Medical Center, Inc., Dba
Louisville, Kentucky, 40202
Portland Providence Medical Center
Portland, Oregon, 97213
Oncology Research Associates, Pllc D/B/A
Scottsdale, Arizona, 85258
Seattle Cancer Care Alliance
Seattle, Washington, 98109
H. Lee Moffitt Cancer Center & Research Inst, Inc
Tampa, Florida, 33612
About this study
Official 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
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
Read the detailed description
Allocation: Part 1 Dose Escalation Phase: Non-randomized; Part 2 Cohort Expansion Phase: Randomized
- Conditions
- Melanoma
- Being tested
- BMS-982470 (recombinant interleukin-21), Ipilimumab
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
BMS-982470 (recombinant interleukin-21)Biological
Solution, Intravenous, 30,100,150 μg/kg, weekly, 16-20 weeks depending on response
BMS-982470 (recombinant interleukin-21)Biological
Solution, Intravenous, Maximum tolerated dose from Part 1, daily for 5 days every 3 weeks (daily x 5), 12-16 weeks depending on response
BMS-982470 (recombinant interleukin-21)Biological
Solution, Intravenous, Maximum tolerated dose from Part 1, Weekly, 12-16 weeks depending on response
IpilimumabBiological
Also called Yervoy®
Solution, Intravenous, 1,3,10 mg/kg, every 3 weeks, 16-20 weeks depending on response
IpilimumabBiological
Also called Yervoy®
Solution, Intravenous, Maximum tolerated dose from Part 1, every 3 weeks, 12-16 weeks depending on response
IpilimumabBiological
Also called Yervoy®
Solution, Intravenous, 3mg/kg, Every 3 weeks, 12-16 weeks depending on response
| Study group | Role | What they receive |
|---|---|---|
| Part 1 - Arm 1: BMS-982470 (Daily x 5) + Ipilimumab | Experimental | Dose Escalation Receives: Biological: BMS-982470 (recombinant interleukin-21); Biological: Ipilimumab |
| Part 1 - Arm 2: BMS-982470 (Weekly) + Ipilimumab | Experimental | Dose Escalation Receives: Biological: BMS-982470 (recombinant interleukin-21); Biological: Ipilimumab |
| Part 2 - Arm 1: BMS-982470 (Daily x 5) + Ipilimumab | Experimental | Cohort Expansion Receives: Biological: BMS-982470 (recombinant interleukin-21); Biological: Ipilimumab |
| Part 2 - Arm 2: BMS-982470 (Weekly) + Ipilimumab | Experimental | Cohort Expansion Receives: Biological: BMS-982470 (recombinant interleukin-21); Biological: Ipilimumab |
| Part 2 - Arm 3: Ipilimumab monotherapy | Active comparator | Cohort Expansion Receives: Biological: Ipilimumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Part1 (Dose Escalation): The Maximum tolerated dose (MTD) of BMS-982470 using 2 distinct schedules when administered in combination with Ipilimumab
Based on the dose-limiting toxicity (DLT) rate
Measured: Within the first 63 days
Part 2 (Cohort Escalation): Safety and tolerability of the MTD dose for each of the schedules
Based on medical review of AE reports and the results of vital sign measurements, physical examinations, medical history, and clinical laboratory tests
Measured: 84 days on treatment
Secondary outcomes (11)
Efficacy of BMS-982470 in combination with Ipilimumab as measured by objective response
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 1 time point each 3-week Cycle
The time of maximum observed serum concentration (Tmax) of BMS-982470 and Ipilimumab
Measured: 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
Measured: 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
Measured: 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
Measured: 20 time points during Lead-In Cycle; Up to 11 time points during Cycle 3
Incidence of BMS-984270 and Ipilimumab Anti-Drug Antibodies
Measured: Up to 6 months following last dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2011 (estimated)
- Study startDec 2011
- Primary completionJun 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MelanomaStudies of the same condition, open and under way.
- More trials run by Bristol-Myers SquibbThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01489059
- Sponsor's protocol ID
- CA220-007
- Status last verified
- Aug 2014
- First submitted
- 7 Dec 2011
- Last updated
- 29 Aug 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT01489059
- Acronym / sponsor ID
- CA220-007
- Conditions
- Melanoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- Dec 2011
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 9 Dec 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
Allocation: Part 1 Dose Escalation Phase: Non-randomized; Part 2 Cohort Expansion Phase: Randomized
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Part 1 - Arm 1: BMS-982470 (Daily x 5) + Ipilimumab | Experimental | Biological: BMS-982470 (recombinant interleukin-21), Biological: IpilimumabDose Escalation |
| Part 1 - Arm 2: BMS-982470 (Weekly) + Ipilimumab | Experimental | Biological: BMS-982470 (recombinant interleukin-21), Biological: IpilimumabDose Escalation |
| Part 2 - Arm 1: BMS-982470 (Daily x 5) + Ipilimumab | Experimental | Biological: BMS-982470 (recombinant interleukin-21), Biological: IpilimumabCohort Expansion |
| Part 2 - Arm 2: BMS-982470 (Weekly) + Ipilimumab | Experimental | Biological: BMS-982470 (recombinant interleukin-21), Biological: IpilimumabCohort Expansion |
| Part 2 - Arm 3: Ipilimumab monotherapy | Active comparator | Biological: IpilimumabCohort Expansion |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Part 1 - Arm 1: BMS-982470 (Daily x 5) + Ipilimumab |
| BMS-982470 (recombinant interleukin-21)Solution, Intravenous, 30,100,150 μg/kg, weekly, 16-20 weeks depending on response | Biological | Part 1 - Arm 2: BMS-982470 (Weekly) + Ipilimumab |
| 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 | Part 2 - Arm 1: BMS-982470 (Daily x 5) + Ipilimumab |
| BMS-982470 (recombinant interleukin-21)Solution, Intravenous, Maximum tolerated dose from Part 1, Weekly, 12-16 weeks depending on response | Biological | Part 2 - Arm 2: BMS-982470 (Weekly) + Ipilimumab |
| IpilimumabAlso: Yervoy®Solution, Intravenous, 1,3,10 mg/kg, every 3 weeks, 16-20 weeks depending on response | Biological | Part 1 - Arm 1: BMS-982470 (Daily x 5) + Ipilimumab, Part 1 - Arm 2: BMS-982470 (Weekly) + Ipilimumab |
| IpilimumabAlso: Yervoy®Solution, Intravenous, Maximum tolerated dose from Part 1, every 3 weeks, 12-16 weeks depending on response | Biological | Part 2 - Arm 1: BMS-982470 (Daily x 5) + Ipilimumab, Part 2 - Arm 2: BMS-982470 (Weekly) + Ipilimumab |
| IpilimumabAlso: Yervoy®Solution, Intravenous, 3mg/kg, Every 3 weeks, 12-16 weeks depending on response | Biological | Part 2 - Arm 3: Ipilimumab monotherapy |
Primary outcome
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
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
11 secondary outcomes
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
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
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
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
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
Trough observed serum concentration (Cmin) of BMS-982470 and Ipilimumab
Time frame: 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
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
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
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
Incidence of BMS-984270 and Ipilimumab Anti-Drug Antibodies
Time frame: Up to 6 months following last dose
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bristol-Myers Squibb study director
Bristol-Myers Squibb
9 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BMS-982470 (recombinant interleukin-21) and Ipilimumab in people with Melanoma, run by Bristol-Myers Squibb at 9 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Aug 2014.