MelanomaPhase 2NCT00612664
Phase II, 2nd Line Melanoma - RAND Monotherapy
A Phase 2 study testing Anti-CD137 (4-1BB) (BMS-663513) in people with Melanoma, run by Bristol-Myers Squibb at 32 sites in 6 countries.
Trial summary
The main purpose of this study is to estimate the proportion of patients with a type of skin cancer called melanoma who are progression free, (that is, the cancer has not gotten substantially worse), when treated with Anti-CD137 (4-1BB) (BMS-663513) at 0.1 mg/kg, 1 mg/kg or 5 mg/kg every 3 weeks or 1 mg/kg every 6… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Melanoma
- What is being tested?
- Anti-CD137 (4-1BB) (BMS-663513)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 158 participants
- Where
- 32 sitesin 6 countries
- Study dates
- Mar 2008to Oct 2009
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects must have been previously treated with one line of systemic anti-cancer therapy (non-experimental or experimental) for metastatic disease, and relapsed, failed to respond (CR or PR) or did not tolerate that regimen. If the treatment has been administered as an adjuvant and/or neoadjuvant therapy, the subject must have documented disease progression from the last treatment and also received one additional line of systemic therapy for metastatic disease.
- Men and women, who are at least 18 years of age
Who cannot join
- Ocular or mucosal melanoma
- Complete surgical resection of all identifiable sites of disease
- Symptomatic brain metastasis. Subjects with signs or symptoms suggestive of brain metastasis are not eligible unless brain metastases are ruled out by computerized axial tomography (CT) scan or magnetic resonance imaging (MRI). Subjects with stable brain metastasis and those who were previously treated with radiotherapy or surgery must have no current evidence of symptomatic brain metastasis and are off steroid therapy for at least 4 weeks prior to randomization
Trial locations and contacts
32 sites in 6 countries.
32 sites in 6 countries
United States10 sites
Harry & Jeanette Weinberg Cancer Inst At Franklin Square
Baltimore, Maryland, 21237
Dana-Farber Cancer Inst
Boston, Massachusetts, 02115
Blumenthal Cancer Center, Carolinas Medical Center
Charlotte, North Carolina, 28204
University Of Texas
Houston, Texas, 77030
Indiana University Melvin And Bren Simon Cancer Center
Indianapolis, Indiana, 46202
The Angeles Clinic & Research Institute
Los Angeles, California, 90025
Yale University School Of Medicine
New Haven, Connecticut, 06520
Mem Sloan-Ket Can Ctr
New York, New York, 10021
Oncology Specialists, S.C.
Park Ridge, Illinois, 60068
Providence Portland Medical Center
Portland, Oregon, 97213
Germany7 sites
Local Institution
Homburg / Saar, 66421
Local Institution
Jena, 07740
Local Institution
Kiel, 24105
Local Institution
Mainz, 55131
Local Institution
Mannheim, 68167
Local Institution
Tübingen, 72076
Local Institution
Würzburg, 97080
France5 sites
Local Institution
Lille, 59037
Local Institution
Paris, 75010
Local Institution
Paris, 75651
Local Institution
Vandœuvre-lès-Nancy, 54511
Local Institution
Villejuif, 94805
Italy5 sites
Local Institution
Genove, 16132
Local Institution
Milan, 20141
Local Institution
Naples, 80131
Local Institution
Padova, 35128
Local Institution
Siena, 53100
Canada3 sites
Local Institution
Calgary, Alberta, T2N 4N2
Local Institution
Edmonton, Alberta, T6G 1Z2
Local Institution
Montreal, Quebec, H4J 1C5
Denmark2 sites
Local Institution
Aarhus C, 8000
Local Institution
Odense C, DK-5000
About this study
Official title: A Randomized, Multi-Dose, Open-Label, Phase II Study of BMS-663513 as a Second-Line Monotherapy in Subjects With Previously Treated Unresectable Stage III or IV Melanoma
The main purpose of this study is to estimate the proportion of patients with a type of skin cancer called melanoma who are progression free, (that is, the cancer has not gotten substantially worse), when treated with Anti-CD137 (4-1BB) (BMS-663513) at 0.1 mg/kg, 1 mg/kg or 5 mg/kg every 3 weeks or 1 mg/kg every 6 weeks
- Conditions
- Melanoma
- Being tested
- Anti-CD137 (4-1BB) (BMS-663513)
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anti-CD137 (4-1BB) (BMS-663513)Drug
IV solution, IV, until PD or toxicity
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Active comparator | 0.1 mg/kg every 3 weeks Receives: Drug: Anti-CD137 (4-1BB) (BMS-663513) |
| Arm 2 | Active comparator | 1 mg/kg every 3 weeks Receives: Drug: Anti-CD137 (4-1BB) (BMS-663513) |
| Arm 3 | Active comparator | 1 mg/kg every 6 weeks Receives: Drug: Anti-CD137 (4-1BB) (BMS-663513) |
| Arm 4 | Active comparator | 5 mg/kg every 3 weeks Receives: Drug: Anti-CD137 (4-1BB) (BMS-663513) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Radiographic imaging, photographic and clinical evaluation will be used for tumor assessment to determine 6-month progression-free survival rate
Measured: every 6 weeks starting at week 12 after randomization
Secondary outcomes (7)
Safety profiles
Measured: throughout the study
Disease response rate
Measured: end of study
Disease control rate
Measured: end of study
1-year survival
Measured: end of study
Pharmacokinetics
Measured: throughout the study
Pharmacodynamics
Measured: throughout the study
Biomarkers
Measured: throughout the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2008 (estimated)
- Study startMar 2008
- Primary completionOct 2009
- Study completionOct 2009
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 158 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
- NCT00612664
- Sponsor's protocol ID
- CA186-006
- Status last verified
- Sep 2015
- First submitted
- 30 Jan 2008
- Last updated
- 12 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Multi-Dose, Open-Label, Phase II Study of BMS-663513 as a Second-Line Monotherapy in Subjects With Previously Treated Unresectable Stage III or IV Melanoma
- ClinicalTrials.gov ID
- NCT00612664
- Acronym / sponsor ID
- CA186-006
- Conditions
- Melanoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 158 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- Mar 2008
- Primary completion
- Oct 2009 (actual)
- Study completion
- Oct 2009 (actual)
- First posted
- 12 Feb 2008 (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 main purpose of this study is to estimate the proportion of patients with a type of skin cancer called melanoma who are progression free, (that is, the cancer has not gotten substantially worse), when treated with Anti-CD137 (4-1BB) (BMS-663513) at 0.1 mg/kg, 1 mg/kg or 5 mg/kg every 3 weeks or 1 mg/kg every 6 weeks
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Active comparator | Drug: Anti-CD137 (4-1BB) (BMS-663513)0.1 mg/kg every 3 weeks |
| Arm 2 | Active comparator | Drug: Anti-CD137 (4-1BB) (BMS-663513)1 mg/kg every 3 weeks |
| Arm 3 | Active comparator | Drug: Anti-CD137 (4-1BB) (BMS-663513)1 mg/kg every 6 weeks |
| Arm 4 | Active comparator | Drug: Anti-CD137 (4-1BB) (BMS-663513)5 mg/kg every 3 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Subjects must have been previously treated with one line of systemic anti-cancer therapy (non-experimental or experimental) for metastatic disease, and relapsed, failed to respond (CR or PR) or did not tolerate that regimen. If the treatment has been administered as an adjuvant and/or neoadjuvant therapy, the subject must have documented disease progression from the last treatment and also received one additional line of systemic therapy for metastatic disease.
- Men and women, who are at least 18 years of age
Key exclusion criteria (3 listed)
- Ocular or mucosal melanoma
- Complete surgical resection of all identifiable sites of disease
- Symptomatic brain metastasis. Subjects with signs or symptoms suggestive of brain metastasis are not eligible unless brain metastases are ruled out by computerized axial tomography (CT) scan or magnetic resonance imaging (MRI). Subjects with stable brain metastasis and those who were previously treated with radiotherapy or surgery must have no current evidence of symptomatic brain metastasis and are off steroid therapy for at least 4 weeks prior to randomization
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 |
|---|---|---|
| Anti-CD137 (4-1BB) (BMS-663513)IV solution, IV, until PD or toxicity | Drug | Arm 1, Arm 2, Arm 3, Arm 4 |
Primary outcome
Radiographic imaging, photographic and clinical evaluation will be used for tumor assessment to determine 6-month progression-free survival rate
Time frame: every 6 weeks starting at week 12 after randomization
7 secondary outcomes
Safety profiles
Time frame: throughout the study
Disease response rate
Time frame: end of study
Disease control rate
Time frame: end of study
1-year survival
Time frame: end of study
Pharmacokinetics
Time frame: throughout the study
Pharmacodynamics
Time frame: throughout the study
Biomarkers
Time frame: throughout the study
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 12 Oct 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
32 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Anti-CD137 (4-1BB) (BMS-663513) in people with Melanoma, run by Bristol-Myers Squibb at 32 sites in 6 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 2 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 12 Oct 2015. 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, Italy, Canada and 1 more country. 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?
Radiographic imaging, photographic and clinical evaluation will be used for tumor assessment to determine 6-month progression-free survival rate (time frame: every 6 weeks starting at week 12 after randomization). 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 12 Oct 2015.