Malignant MelanomaPhase 2NCT01696045
Phase 2 Study of Ipilimumab in Children and Adolescents (12 to < 18 Years) With Previously Treated or Untreated, Unresectable Stage III or Stage lV Malignant Melanoma
A Phase 2 study testing Ipilimumab in people with Malignant Melanoma, run by Bristol-Myers Squibb at 32 sites in 8 countries.
Trial summary
The purpose of the study is to comply with the Pediatric Investigation Plan requirements of Ipilimumab Read more about this study
- Who is it for?
- Ages 12 to 17 years
- Conditions the study is for
- Malignant Melanoma
- What is being tested?
- Ipilimumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 32 sitesin 8 countries
- Study dates
- 12 Nov 2012to 31 Jul 2016
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 12 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 12 < 18 years of age
- Previously treated or untreated, unresectable Stage III or Stage IV malignant melanoma
- Karnofsky Performance Status (KPS) or Lansky Score ≥ 50
Who cannot join
- Primary Ocular Melanoma
- Prior therapy with a Cytotoxic T Lymphocyte Antigen 4 (CTLA-4) or Programmed death- 1 (PD-1) antagonist, or Programmed cell death- ligand 1 (PD-L1) or CD137 agonists
- Symptomatic brain metastases
- History of autoimmune diseases
Trial locations and contacts
32 sites in 8 countries.
32 sites in 8 countries
United States14 sites
Children'S Hospital Colorado
Aurora, Colorado, 80045
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215
The University Of Texas Md Anderson Cancer Center
Houston, Texas, 77030
James Whitcomb Riley Hospital For Children
Indianapolis, Indiana, 46202
Childrens Hospital Of La
Los Angeles, California, 90027
St. Jude Children'S Research Hospital
Memphis, Tennessee, 38105
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Children'S Hospital Of Orange County
Orange, California, 92868
Phoenix Children'S Hospital
Phoenix, Arizona, 85016
University Of Pittsburgh Medical Center Cancer Center
Pittsburgh, Pennsylvania, 15232
Mayo Clinic
Rochester, Minnesota, 55905
Primary Children'S Medical Center
Salt Lake City, Utah, 84113
University Of Utah
Salt Lake City, Utah, 84113
H. Lee Moffitt Cancer Center & Research Institute
Tampa, Florida, 33612
Germany5 sites
Local Institution
Dortmund, 44137
Local Institution
Erlangen, 91054
Local Institution
Hamburg, 20246
Local Institution
M?nster, 48149
Local Institution
Münster, 48149
France4 sites
Local Institution
Lyon, 69008
Local Institution
Marseille, 13385
Local Institution
Nantes, 44093
Local Institution
Villejuif, 94805
Mexico3 sites
Local Institution
Df, Mexico City, 06720
Local Institution
Leon, Guanajato, Guanajuato, 37000
Local Institution
México, D.F, 02990
United Kingdom3 sites
Local Institution
Bristol, Avon, BS2 8BJ
Local Institution
Newcastle, Northumberland, NE1 4LP
Local Institution
Sutton, Surrey, SM2 5PT
About this study
Official title: Phase 2 Study of Ipilimumab in Children and Adolescents (12 to < 18 Years) With Previously Treated or Untreated, Unresectable Stage III or Stage IV Malignant Melanoma
The purpose of the study is to comply with the Pediatric Investigation Plan requirements of Ipilimumab
- Conditions
- Malignant Melanoma
- Being tested
- Ipilimumab
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IpilimumabBiological
Also called Yervoy, BMS- 734016
| Study group | Role | What they receive |
|---|---|---|
| Ipilimumab 3 mg/kg | Experimental | Ipilimumab (3 mg/kg) was administered intravenously (IV) over 90 minutes on Day 1 of each 21-day cycle for 4 cycles. Receives: Biological: Ipilimumab |
| Ipilimumab 10 mg/kg | Experimental | Ipilimumab (10 mg/kg) was administered intravenously (IV) over 90 minutes on Day 1 of each 21-day cycle for 4 cycles. Receives: Biological: Ipilimumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival (OS) Rate at 1 Year
Overall Survival (OS) was defined as the time from the start of ipilimumab treatment date to death due to any cause. If a participant had not died, the participant was censored at the time of last contact (last known alive date). OS rates at 1 year were calculated from both Kaplan-Meier estimates and the proportion of participants alive at 1 year following start of treatment.
Measured: 1 year following start of treatment (Assessed up to June 2016, approximately 38 months)
Percentage of Participants With Severe Immune-Mediated Adverse Reactions (imARs)
The percentage of participants with severe Immune-mediated Adverse Reactions (imARs) was determined by dividing the number of participants with grade 3 or worse imARs by the total number of treated participants and expressing this number as a percentage. imARs were AEs determined by the investigator to have an immune-mediated etiology, including inflammatory events associated with ipilimumab treatment.
Measured: From first dose to 90 days after last dose (Assessed up to June 2016, approximately 38 months)
Secondary outcomes (4)
Disease Control Rate (DCR)
Disease control rate was defined as the percentage of all treated participants with a best overall response of Complete Response (CR), Partial Response (PR), or Stable disease (SD), based on the investigator's assessment per mWHO Criteria.
CR= Complete disappearance of all non-index lesions. PR= Decrease, relative to baseline, of 50% or greater in the sum of the products of the two largest perpendicular diameters of all index lesions. SD= Does not meet criteria for complete or partial response, in the absence of progressive disease. PD= At least 25% increase in the sum of the products of all index lesions (taking as reference the smallest sum recorded at or following baseline) and/or the appearance of any new lesion(s).
Measured: From Day 1 of first subject, first treatment to Day 365 of last subject, first treatment (approximately 36 months)
Progression Free Survival
Progression-Free Survival was defined as the time from the start of ipilimumab treatment to disease progression or death, whichever occurs first. A participant who died without reported progression was considered to have progressed on their date of death. For participants who remained alive and had not progressed, PFS was censored on the date of the last tumor assessment.
Measured: From date of first treatment until disease progression or death (Assessed up to June 2016, approximately 38 months)
Best Overall Response Rate (BORR)
Best Overall Response Rate (BORR) was defined as the total number of participants with the best overall response of Complete Response (CR) or Partial Response (PR) divided by the total number of treated participants and expressed as a percentage.
CR= Complete disappearance of all non-index lesions. PR= Decrease, relative to baseline, of 50% or greater in the sum of the products of the two largest perpendicular diameters of all index lesions. SD= Does not meet criteria for complete or partial response, in the absence of progressive disease. PD= At least 25% increase in the sum of the products of all index lesions (taking as reference the smallest sum recorded at or following baseline) and/or the appearance of any new lesion(s).
Measured: From Day 1 of first subject, first treatment to Day 365 of last subject, first treatment (approximately 36 months)
Overall Survival Time
Overall Survival time was defined as the time from the start of ipilimumab treatment date to date of death due to any cause. Participants who had not died were censored at the time of last contact (last known alive date).
Measured: From date of first treatment to date of death (Assessed up to June 2016, approximately 38 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2012 (estimated)
- Study start12 Nov 2012
- Primary completion31 Jul 2016
- Study completion31 Jul 2016
Why it stopped: Slow accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Malignant 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 2
- Primary purpose
- Treatment
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 14 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
- NCT01696045
- Sponsor's protocol ID
- CA184-178
- Other IDs
- 2012-002249-39
- Status last verified
- Jul 2017
- First submitted
- 26 Sep 2012
- Last updated
- 29 Aug 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Geoerger B, Bergeron C, Gore L, Sender L, Dunkel IJ, Herzog C, Brochez L, Cruz O, Nysom K, Berghorn E, Simsek B, Shen J, Pappo A. Phase II study of ipilimumab in adolescents with unresectable stage III or IV malignant melanoma. Eur J Cancer. 2017 Nov;86:358-363. doi: 10.1016/j.ejca.2017.09.032. Epub 2017 Nov 5.
PubMed 29100190
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2 Study of Ipilimumab in Children and Adolescents (12 to < 18 Years) With Previously Treated or Untreated, Unresectable Stage III or Stage IV Malignant Melanoma
- ClinicalTrials.gov ID
- NCT01696045
- Acronym / sponsor ID
- CA184-178
- Conditions
- Malignant Melanoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slow accrual
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 12 Nov 2012 (actual)
- Primary completion
- 31 Jul 2016 (actual)
- Study completion
- 31 Jul 2016 (actual)
- First posted
- 28 Sep 2012 (estimated)
- Results
- Posted 1 Aug 2017
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 the study is to comply with the Pediatric Investigation Plan requirements of Ipilimumab
Study design
- Primary purpose
- Treatment
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ipilimumab 3 mg/kg | Experimental | Biological: IpilimumabIpilimumab (3 mg/kg) was administered intravenously (IV) over 90 minutes on Day 1 of each 21-day cycle for 4 cycles. |
| Ipilimumab 10 mg/kg | Experimental | Biological: IpilimumabIpilimumab (10 mg/kg) was administered intravenously (IV) over 90 minutes on Day 1 of each 21-day cycle for 4 cycles. |
Who may qualify
- Ages
- 12 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 12 < 18 years of age
- Previously treated or untreated, unresectable Stage III or Stage IV malignant melanoma
- Karnofsky Performance Status (KPS) or Lansky Score ≥ 50
Key exclusion criteria (4 listed)
- Primary Ocular Melanoma
- Prior therapy with a Cytotoxic T Lymphocyte Antigen 4 (CTLA-4) or Programmed death- 1 (PD-1) antagonist, or Programmed cell death- ligand 1 (PD-L1) or CD137 agonists
- Symptomatic brain metastases
- History of autoimmune diseases
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 |
|---|---|---|
| IpilimumabAlso: Yervoy, BMS- 734016 | Biological | Ipilimumab 10 mg/kg, Ipilimumab 3 mg/kg |
Primary outcome
Overall Survival (OS) Rate at 1 Year
Time frame: 1 year following start of treatment (Assessed up to June 2016, approximately 38 months)
Overall Survival (OS) was defined as the time from the start of ipilimumab treatment date to death due to any cause. If a participant had not died, the participant was censored at the time of last contact (last known alive date). OS rates at 1 year were calculated from both Kaplan-Meier estimates and the proportion of participants alive at 1 year following start of treatment.
Percentage of Participants With Severe Immune-Mediated Adverse Reactions (imARs)
Time frame: From first dose to 90 days after last dose (Assessed up to June 2016, approximately 38 months)
The percentage of participants with severe Immune-mediated Adverse Reactions (imARs) was determined by dividing the number of participants with grade 3 or worse imARs by the total number of treated participants and expressing this number as a percentage. imARs were AEs determined by the investigator to have an immune-mediated etiology, including inflammatory events associated with ipilimumab treatment.
4 secondary outcomes
Disease Control Rate (DCR)
Time frame: From Day 1 of first subject, first treatment to Day 365 of last subject, first treatment (approximately 36 months)
Progression Free Survival
Time frame: From date of first treatment until disease progression or death (Assessed up to June 2016, approximately 38 months)
Best Overall Response Rate (BORR)
Time frame: From Day 1 of first subject, first treatment to Day 365 of last subject, first treatment (approximately 36 months)
Overall Survival Time
Time frame: From date of first treatment to date of death (Assessed up to June 2016, approximately 38 months)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 29100190Geoerger B, Bergeron C, Gore L, Sender L, Dunkel IJ, Herzog C, Brochez L, Cruz O, Nysom K, Berghorn E, Simsek B, Shen J, Pappo A. Phase II study of ipilimumab in adolescents with unresectable stage III or IV malignant melanoma. Eur J Cancer. 2017 Nov;86:358-363. doi: 10.1016/j.ejca.2017.09.032. Epub 2017 Nov 5.
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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
32 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ipilimumab in people with Malignant Melanoma, run by Bristol-Myers Squibb at 32 sites in 8 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 3 inclusion and 4 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: stopped early, as of the sponsor's last update on 29 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 32 sites in United States, Germany, France, Mexico, United Kingdom and 3 more countries. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 Aug 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Overall Survival (OS) Rate at 1 Year (time frame: 1 year following start of treatment (Assessed up to June 2016, approximately 38 months)). 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?
On the ClinicalTrials.gov record for NCT01696045, which also lists 1 linked publication.
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 2017.