MelanomaPhase 2NCT00289640
Study of Ipilimumab (MDX-010) Monotherapy in Patients With Previously Treated Unresectable Stage III or IV Melanoma
A Phase 2 study testing ipilimumab (MDX-010, BMS-734016) and Ipilimumab in people with Melanoma, run by Bristol-Myers Squibb at 62 sites in 10 countries.
Trial summary
The purpose of this clinical research study is to compare the best overall response rate (BORR)(as per modified WHO criteria) in patients with previously treated, therapy-refractory, or -intolerant, Stage III (unresectable) or Stage IV melanoma receiving ipilimumab doses of 0.3, 3, and 10 mg/kg. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Melanoma
- What is being tested?
- ipilimumab (MDX-010, BMS-734016) and Ipilimumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 210 participants
- Where
- 62 sitesin 10 countries
- Study dates
- Apr 2006to Jul 2007
- Phase
- Phase 2
- 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients with previously treated, therapy-refractory or -intolerant, Stage III (unresectable) or Stage IV melanoma
Who cannot join
None listed.
Trial locations and contacts
62 sites in 10 countries.
62 sites in 10 countries
United States25 sites
Harry And Jeanette Weinberg Cancer Inst At Franklin Square
Baltimore, Maryland, 21237
Presbyterian Hospital
Charlotte, North Carolina, 28204
The Christ Hospital Cancer Center Research
Cincinnati, Ohio, 45219
Cleveland Clinic
Cleveland, Ohio, 44195
Ellis Fischel Cancer Center
Columbia, Missouri, 65203
Center For Oncology Research & Treatment, P.A.
Dallas, Texas, 75230
Mary Crowley Medical Research Center
Dallas, Texas, 75246
Cancer Centers Of The Carolinas
Greenville, South Carolina, 29615
American Health Network
Indianapolis, Indiana, 46202
Baptist Cancer Institute
Jacksonville, Florida, 32207
Wilshire Oncology Medical Group Inc
Laverne, California, 91750
University Of Louisville
Louisville, Kentucky, 40202
Mount Sinai Comprehensive Cancer Center
Miami Beach, Florida, 33140
Yale University School Of Medicine
New Haven, Connecticut, 06520
Memorial Sloan Kettering Cancer Center
New York, New York, 10021
Md Anderson Cancer Center Orlando
Orlando, Florida, 32806
Oncology Specialists, Sc
Park Ridge, Illinois, 60068
Providence Portland Medical Center
Portland, Oregon, 97213
Hubert H. Humphrey Cancer Center
Robbinsdale, Minnesota, 55422
St Joseph Oncology Inc
Saint Joseph, Missouri, 64507
Scripps Cancer Center
San Diego, California, 92121
The Angeles Clinic And Research Institution
Santa Monica, California, 90404
Washington University School Of Medicine
St Louis, Missouri, 63110
Arizona Cancer Center
Tucson, Arizona, 85724
Palm Beach Cancer Institute
West Palm Beach, Florida, 33401
France9 sites
Local Institution
Brest, Cedex, 29200
Local Institution
Clermont-Ferrand, 63058
Local Institution
Lyon, 69288
Local Institution
Lyon, 69373
Local Institution
Marseille, 13009
Local Institution
Paris, 75010
Local Institution
Rennes, 35042
Local Institution
Toulouse, 31059
Local Institution
Vandœuvre-lès-Nancy, 54511
Germany7 sites
Local Institution
Berlin, 12200
Local Institution
Essen, 45122
Local Institution
Heidelberg, 69115
Local Institution
Jena, 07740
Local Institution
Kiel, 24105
Local Institution
Mannheim, 68169
Local Institution
Würzburg, 97080
Australia4 sites
Local Institution
Brisbane, Queensland, 4101
Local Institution
Heidelberg, Victoria, 3084
Local Institution
Newcastle, New South Wales, 2300
Local Institution
Wodonga, Victoria, 3690
Brazil4 sites
Local Institution
Centro-Porto Alegre, Rio Grande do Sul, 90020
Local Institution
Jaú, São Paulo, 17210
Local Institution
Porto Alegre, Rio Grande do Sul, 90610
Local Institution
São Paulo, São Paulo, 01509
South Africa4 sites
Local Institution
Cape Town, Western Cape, 7506
Local Institution
Johannesburg, Gauteng, 2199
Local Institution
Pretoria, Gauteng, 0041
Local Institution
Pretoria, Gauteng, 0181
Belgium3 sites
Local Institution
Brussels, 1070
Local Institution
Brussels, 1090
Local Institution
Brussels, 1200
Canada3 sites
Local Institution
Calgary, Alberta, T2N 4N2
Local Institution
Edmonton, Alberta, T6G 1Z2
Local Institution
Kingston, Ontario, K7L 5P9
Czechia2 sites
Local Institution
Olomouc, 775 20
Local Institution
Prague, 128 08
About this study
Official title: A Randomized, Double-Blind, Multi-center, Phase II Fixed Dose Study of Multiple Doses of Ipilimumab (MDX-010) Monotherapy in Patients With Previously Treated Unresectable Stage III or IV Melanoma
The purpose of this clinical research study is to compare the best overall response rate (BORR)(as per modified WHO criteria) in patients with previously treated, therapy-refractory, or -intolerant, Stage III (unresectable) or Stage IV melanoma receiving ipilimumab doses of 0.3, 3, and 10 mg/kg. The safety of this product will also be evaluated.
- Conditions
- Melanoma
- Being tested
- ipilimumab (MDX-010, BMS-734016), Ipilimumab
- Keywords
- Stage III (unresectable), Stage IV melanoma
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ipilimumab (MDX-010, BMS-734016)Drug
IV solution, IV, 0.3mg/kg, Q 3 wks for 12 wks then Q 12 wks, 48+ weeks depending on response.
IpilimumabDrug
IV solution, IV, 3 mg/kg, Q 3 wks for 12 wks then Q 12 wks, 48+ weeks depending on response.
IpilimumabDrug
IV solution, IV, 10 mg/kg, Q 3 wks for 12 wks then Q 12 wks, 48+ weeks depending on response.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: ipilimumab (MDX-010, BMS-734016) |
| 2 | Experimental | Not described Receives: Drug: Ipilimumab |
| 3 | Experimental | Not described Receives: Drug: Ipilimumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
estimate BORR in patients with previously treated, therapy-refractory or -intolerant, Stage III (unresectable) or Stage IV melanoma receiving ipilimumab doses of 0.3, 3, and 10 mg/kg.
Secondary outcomes (6)
estimate progression free survival rate at Week 12 assessment and other timepoints
estimate disease control rate at various time points
estimate overall survival
estimate survival rate at one year
evaluate health-related quality of life
obtain pharmacokinetic samples for population PK analysis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2006 (estimated)
- Study startApr 2006
- Primary completionJul 2007
- Study completionJul 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 210 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Medarex
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00289640
- Sponsor's protocol ID
- CA184-022
- Status last verified
- Jan 2009
- First submitted
- 9 Feb 2006
- Last updated
- 2 Mar 2010
- Results posted
- No
Publications
Schadendorf D, Hodi FS, Robert C, Weber JS, Margolin K, Hamid O, Patt D, Chen TT, Berman DM, Wolchok JD. Pooled Analysis of Long-Term Survival Data From Phase II and Phase III Trials of Ipilimumab in Unresectable or Metastatic Melanoma. J Clin Oncol. 2015 Jun 10;33(17):1889-94. doi: 10.1200/JCO.2014.56.2736. Epub 2015 Feb 9.
PubMed 25667295Wolchok JD, Neyns B, Linette G, Negrier S, Lutzky J, Thomas L, Waterfield W, Schadendorf D, Smylie M, Guthrie T Jr, Grob JJ, Chesney J, Chin K, Chen K, Hoos A, O'Day SJ, Lebbe C. Ipilimumab monotherapy in patients with pretreated advanced melanoma: a randomised, double-blind, multicentre, phase 2, dose-ranging study. Lancet Oncol. 2010 Feb;11(2):155-64. doi: 10.1016/S1470-2045(09)70334-1. Epub 2009 Dec 8.
PubMed 20004617
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Multi-center, Phase II Fixed Dose Study of Multiple Doses of Ipilimumab (MDX-010) Monotherapy in Patients With Previously Treated Unresectable Stage III or IV Melanoma
- ClinicalTrials.gov ID
- NCT00289640
- Acronym / sponsor ID
- CA184-022
- Conditions
- Melanoma
- Keywords
- Stage III (unresectable), Stage IV melanoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 210 participants (estimated)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Collaborators
- Medarex
- Study start
- Apr 2006
- Primary completion
- Jul 2007 (actual)
- Study completion
- Jul 2007 (actual)
- First posted
- 10 Feb 2006 (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 clinical research study is to compare the best overall response rate (BORR)(as per modified WHO criteria) in patients with previously treated, therapy-refractory, or -intolerant, Stage III (unresectable) or Stage IV melanoma receiving ipilimumab doses of 0.3, 3, and 10 mg/kg. The safety of this product will also be evaluated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: ipilimumab (MDX-010, BMS-734016) |
| 2 | Experimental | Drug: Ipilimumab |
| 3 | Experimental | Drug: Ipilimumab |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with previously treated, therapy-refractory or -intolerant, Stage III (unresectable) or Stage IV melanoma
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| ipilimumab (MDX-010, BMS-734016)IV solution, IV, 0.3mg/kg, Q 3 wks for 12 wks then Q 12 wks, 48+ weeks depending on response. | Drug | 1 |
| IpilimumabIV solution, IV, 3 mg/kg, Q 3 wks for 12 wks then Q 12 wks, 48+ weeks depending on response. | Drug | 2 |
| IpilimumabIV solution, IV, 10 mg/kg, Q 3 wks for 12 wks then Q 12 wks, 48+ weeks depending on response. | Drug | 3 |
Primary outcome
estimate BORR in patients with previously treated, therapy-refractory or -intolerant, Stage III (unresectable) or Stage IV melanoma receiving ipilimumab doses of 0.3, 3, and 10 mg/kg.
6 secondary outcomes
estimate progression free survival rate at Week 12 assessment and other timepoints
estimate disease control rate at various time points
estimate overall survival
estimate survival rate at one year
evaluate health-related quality of life
obtain pharmacokinetic samples for population PK analysis
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 2 Mar 2010.
- Derived from this study: PubMed 25667295Schadendorf D, Hodi FS, Robert C, Weber JS, Margolin K, Hamid O, Patt D, Chen TT, Berman DM, Wolchok JD. Pooled Analysis of Long-Term Survival Data From Phase II and Phase III Trials of Ipilimumab in Unresectable or Metastatic Melanoma. J Clin Oncol. 2015 Jun 10;33(17):1889-94. doi: 10.1200/JCO.2014.56.2736. Epub 2015 Feb 9.
- Derived from this study: PubMed 20004617Wolchok JD, Neyns B, Linette G, Negrier S, Lutzky J, Thomas L, Waterfield W, Schadendorf D, Smylie M, Guthrie T Jr, Grob JJ, Chesney J, Chin K, Chen K, Hoos A, O'Day SJ, Lebbe C. Ipilimumab monotherapy in patients with pretreated advanced melanoma: a randomised, double-blind, multicentre, phase 2, dose-ranging study. Lancet Oncol. 2010 Feb;11(2):155-64. doi: 10.1016/S1470-2045(09)70334-1. Epub 2009 Dec 8.
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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.
The record lists no contact. Use the official record to reach the sponsor.
62 sites in 10 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ipilimumab (MDX-010, BMS-734016) and Ipilimumab in people with Melanoma, run by Bristol-Myers Squibb at 62 sites in 10 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 1 inclusion and 0 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 2 Mar 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 62 sites in United States, France, Germany, Australia, Brazil and 5 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?
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?
estimate BORR in patients with previously treated, therapy-refractory or -intolerant, Stage III (unresectable) or Stage IV melanoma receiving ipilimumab doses of 0.3, 3, and 10 mg/kg.. 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 NCT00289640, which also lists 2 linked publications.
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 2 Mar 2010.