Neoplasms by SitePhase 1NCT01629758
Safety Study of IL-21/Anti-PD-1 Combination in the Treatment of Solid Tumors
A Phase 1 study testing Denenicokin and Nivolumab in people with Neoplasms by Site, run by Bristol-Myers Squibb at 5 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neoplasms by Site
- What is being tested?
- Denenicokin and Nivolumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 5 sitesUnited States
- Study dates
- Jun 2012to Dec 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
- 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
Who cannot join
- Uncontrolled central nervous system (CNS) or leptomeningeal metastasis
- Inadequate liver or kidney function
- History of autoimmune Disease
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Sidney Kimmel Comprehensive Cancer Center At Johns Hopkins
Baltimore, Maryland, 21231
Yale University School Of Medicine
New Haven, Connecticut, 06520
Oncology Research Associates, Pllc D/B/A
Scottsdale, Arizona, 85258
Seattle Cancer Care Alliance
Seattle, Washington, 98109
Moffitt Cancer Center
Tampa, Florida, 33612
About this study
Official title: 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.
- Conditions
- Neoplasms by Site
- Being tested
- Denenicokin, Nivolumab
- Medical subject headings
- Neoplasms by Site
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DenenicokinBiological
Also called BMS-982470, rIL-21(recombinant interleukin 21)
NivolumabBiological
Also called BMS-936558, Anti-PD-1 (Anti-Programmed-Death-1), MDX-1106
| Study group | Role | What they receive |
|---|---|---|
| Part 1-Arm A: BMS-982470 (weekly x 4) + BMS-936558 | Experimental | 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 Receives: Biological: Denenicokin; Biological: Nivolumab |
| Part 1-Arm B: BMS-982470 (3 times/week) + BMS-936558 | Experimental | 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 Receives: Biological: Denenicokin; Biological: Nivolumab |
| Part 2-Arm A: BMS-982470 (weekly x 4) + BMS-936558 | Experimental | 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 Receives: Biological: Denenicokin; Biological: Nivolumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety, as measured by the rate of adverse events and serious adverse events
Measured: Approximately up to 4.5 years
Secondary outcomes (2)
Efficacy as measured by tumor assessment (RECIST)
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)
Measured: 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)
Immunogenicity as measured by incidence of specific antidrug antibodies (ADA) to BMS-98470 and BMS-936558
Measured: Up to 2 years + 100 days post-treatment follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2012 (estimated)
- Study startJun 2012
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neoplasms by SiteStudies 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
- 33 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
- NCT01629758
- Sponsor's protocol ID
- CA220-008
- Status last verified
- Feb 2015
- First submitted
- 26 Jun 2012
- Last updated
- 6 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT01629758
- Acronym / sponsor ID
- CA220-008
- Conditions
- Neoplasms by Site
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- Jun 2012
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 28 Jun 2012 (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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Part 1-Arm A: BMS-982470 (weekly x 4) + BMS-936558 | Experimental | Biological: Denenicokin, Biological: NivolumabDose 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 |
| Part 1-Arm B: BMS-982470 (3 times/week) + BMS-936558 | Experimental | Biological: Denenicokin, Biological: NivolumabDose 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 |
| Part 2-Arm A: BMS-982470 (weekly x 4) + BMS-936558 | Experimental | Biological: Denenicokin, Biological: NivolumabCohort 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- All subjects will have locally advanced or metastatic solid tumors
- For Part 2 (Cohort Expansion):
- At least 1 lesion with measurable disease
- Only subjects with tumor samples that are PD-L1 positive or negative are eligible
Key exclusion criteria (3 listed)
- Uncontrolled central nervous system (CNS) or leptomeningeal metastasis
- Inadequate liver or kidney function
- History of 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 |
|---|---|---|
| DenenicokinAlso: BMS-982470, rIL-21(recombinant interleukin 21) | Biological | Part 1-Arm A: BMS-982470 (weekly x 4) + BMS-936558, Part 1-Arm B: BMS-982470 (3 times/week) + BMS-936558, Part 2-Arm A: BMS-982470 (weekly x 4) + BMS-936558 |
| NivolumabAlso: BMS-936558, Anti-PD-1 (Anti-Programmed-Death-1), MDX-1106 | Biological | Part 1-Arm A: BMS-982470 (weekly x 4) + BMS-936558, Part 1-Arm B: BMS-982470 (3 times/week) + BMS-936558, Part 2-Arm A: BMS-982470 (weekly x 4) + BMS-936558 |
Primary outcome
Safety, as measured by the rate of adverse events and serious adverse events
Time frame: Approximately up to 4.5 years
2 secondary outcomes
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)
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
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 6 Mar 2015.
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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
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Denenicokin and Nivolumab in people with Neoplasms by Site, run by Bristol-Myers Squibb at 5 sites in United States.
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 5 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 6 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. 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?
Safety, as measured by the rate of adverse events and serious adverse events (time frame: Approximately up to 4.5 years). 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 6 Mar 2015; AzTrials last refreshed its copy on 7 Nov 2026.