MelanomaPhase 1NCT00803374
Combination of Anti-CD137 & Ipilimumab in Patients With Melanoma
A Phase 1 study testing AntiCD137 and Ipilimumab in people with Melanoma, run by Bristol-Myers Squibb at 7 sites in United States.
Trial summary
The purpose of this study is to determine if BMS-663513 administered in combination with ipilimumab to patients with advanced malignant melanoma is safe and tolerable Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Melanoma
- What is being tested?
- AntiCD137 and Ipilimumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 7 sitesUnited States
- Study dates
- Nov 2010to Jan 2013
- 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
- Histologically or cytologically confirmed malignant melanoma
- Stage III (unresectable) or Stage IV disease which may have been treated with up to one prior cytotoxic chemotherapy and/or up to 3 other therapeutic regimens
- Willing to undergo up to 3 biopsies of an accessible lesion
Who cannot join
- Active/symptomatic brain metastases
- Primary ocular melanoma or primary tumor of unknown origin
- Concurrent autoimmune disease
- Previous treatment with a CD137 agonist or CTLA-4 inhibitor
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Local Institution
Boston, Massachusetts, 02114
Local Institution
Boston, Massachusetts, 02115
Local Institution
Boston, Massachusetts, 02215
Local Institution
Los Angeles, California, 90025
Local Institution
New Haven, Connecticut, 06520
Local Institution
New York, New York, 10021
Local Institution
Tampa, Florida, 33612
About this study
Official title: A Phase I, Multiple Ascending Dose Study of BMS-663513 (Anti CD137) in Combination With Ipilimumab (BMS-734016/Anti-CTLA-4) in Subjects With Unresectable Stage III or Stage IV Melanoma
The purpose of this study is to determine if BMS-663513 administered in combination with ipilimumab to patients with advanced malignant melanoma is safe and tolerable
- Conditions
- Melanoma
- Being tested
- AntiCD137, Ipilimumab
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AntiCD137Drug
Also called BMS-663513
Infusion, IV, 0.1 mg/kg, Q3 weeks for 12 weeks then Q12 weeks, 12+ weeks depending on response
AntiCD137Drug
Also called BMS-663513
Infusion, IV, 0.3 mg/kg, Q3 weeks for 12 weeks then Q12 weeks, 12+ weeks depending on response
AntiCD137Drug
Also called BMS-663513
Infusion, IV, 1.0 mg/kg, Q3 weeks for 12 weeks then Q12 weeks, 12+ weeks depending on response
AntiCD137Drug
Also called BMS-663513
Infusion, IV, 3.0 mg/kg, Q3 weeks for 12 weeks then Q12 weeks, 12+ weeks depending on response
AntiCD137Drug
Also called BMS-663513
Infusion, IV, 10 mg/kg, Q3 weeks for 12 weeks then Q12 weeks, 12+ weeks depending on response
IpilimumabDrug
Also called BMS-734016, MDX-010
Infusion, IV, 10 mg/kg, Q3 weeks for 12 weeks then Q12, 12+ weeks depending on response
| Study group | Role | What they receive |
|---|---|---|
| 0.1 mg/kg | Experimental | Not described Receives: Drug: AntiCD137; Drug: Ipilimumab |
| 0.3 mg/kg | Experimental | Not described Receives: Drug: AntiCD137; Drug: Ipilimumab |
| 1.0 mg/kg | Experimental | Not described Receives: Drug: AntiCD137; Drug: Ipilimumab |
| 3.0 mg/kg | Experimental | Not described Receives: Drug: AntiCD137; Drug: Ipilimumab |
| 10 mg/kg | Experimental | Not described Receives: Drug: AntiCD137; Drug: Ipilimumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evidence of safety and tolerability as determined by analysis of adverse event reports and results of vital sign measurements, physical examinations, and clinical laboratory tests
Measured: During the course of the each subject's treatment and up to 70 days after his or her last dose of study medication is received
Secondary outcomes (1)
Evidence of clinical improvement in tumor burden confirmed by CT or MRI
Measured: Weeks 12, 18, 24, 30, 36, 42, 48, and every 12 weeks thereafter
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2008 (estimated)
- Study startNov 2010
- Primary completionJul 2012 (estimated)
- Study completionJan 2013 (estimated)
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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00803374
- Sponsor's protocol ID
- CA186-007
- Status last verified
- Nov 2011
- First submitted
- 4 Dec 2008
- Last updated
- 21 Nov 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Multiple Ascending Dose Study of BMS-663513 (Anti CD137) in Combination With Ipilimumab (BMS-734016/Anti-CTLA-4) in Subjects With Unresectable Stage III or Stage IV Melanoma
- ClinicalTrials.gov ID
- NCT00803374
- Acronym / sponsor ID
- CA186-007
- Conditions
- Melanoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- Nov 2010
- Primary completion
- Jul 2012 (estimated)
- Study completion
- Jan 2013 (estimated)
- First posted
- 5 Dec 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 purpose of this study is to determine if BMS-663513 administered in combination with ipilimumab to patients with advanced malignant melanoma is safe and tolerable
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| 0.1 mg/kg | Experimental | Drug: AntiCD137, Drug: Ipilimumab |
| 0.3 mg/kg | Experimental | Drug: AntiCD137, Drug: Ipilimumab |
| 1.0 mg/kg | Experimental | Drug: AntiCD137, Drug: Ipilimumab |
| 3.0 mg/kg | Experimental | Drug: AntiCD137, Drug: Ipilimumab |
| 10 mg/kg | Experimental | Drug: AntiCD137, Drug: Ipilimumab |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Histologically or cytologically confirmed malignant melanoma
- Stage III (unresectable) or Stage IV disease which may have been treated with up to one prior cytotoxic chemotherapy and/or up to 3 other therapeutic regimens
- Willing to undergo up to 3 biopsies of an accessible lesion
Key exclusion criteria (4 listed)
- Active/symptomatic brain metastases
- Primary ocular melanoma or primary tumor of unknown origin
- Concurrent autoimmune disease
- Previous treatment with a CD137 agonist or CTLA-4 inhibitor
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 |
|---|---|---|
| AntiCD137Also: BMS-663513Infusion, IV, 0.1 mg/kg, Q3 weeks for 12 weeks then Q12 weeks, 12+ weeks depending on response | Drug | 0.1 mg/kg |
| AntiCD137Also: BMS-663513Infusion, IV, 0.3 mg/kg, Q3 weeks for 12 weeks then Q12 weeks, 12+ weeks depending on response | Drug | 0.3 mg/kg |
| AntiCD137Also: BMS-663513Infusion, IV, 1.0 mg/kg, Q3 weeks for 12 weeks then Q12 weeks, 12+ weeks depending on response | Drug | 1.0 mg/kg |
| AntiCD137Also: BMS-663513Infusion, IV, 3.0 mg/kg, Q3 weeks for 12 weeks then Q12 weeks, 12+ weeks depending on response | Drug | 3.0 mg/kg |
| AntiCD137Also: BMS-663513Infusion, IV, 10 mg/kg, Q3 weeks for 12 weeks then Q12 weeks, 12+ weeks depending on response | Drug | 10 mg/kg |
| IpilimumabAlso: BMS-734016, MDX-010Infusion, IV, 10 mg/kg, Q3 weeks for 12 weeks then Q12, 12+ weeks depending on response | Drug | 0.1 mg/kg, 0.3 mg/kg, 1.0 mg/kg, 10 mg/kg, 3.0 mg/kg |
Primary outcome
Evidence of safety and tolerability as determined by analysis of adverse event reports and results of vital sign measurements, physical examinations, and clinical laboratory tests
Time frame: During the course of the each subject's treatment and up to 70 days after his or her last dose of study medication is received
1 secondary outcome
Evidence of clinical improvement in tumor burden confirmed by CT or MRI
Time frame: Weeks 12, 18, 24, 30, 36, 42, 48, and every 12 weeks thereafter
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2011.
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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
7 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 AntiCD137 and Ipilimumab in people with Melanoma, run by Bristol-Myers Squibb at 7 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 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: withdrawn, as of the sponsor's last update on 21 Nov 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 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 was withdrawn before enrolling participants, so there are no results.
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?
Evidence of safety and tolerability as determined by analysis of adverse event reports and results of vital sign measurements, physical examinations, and clinical laboratory tests (time frame: During the course of the each subject's treatment and up to 70 days after his or her last dose of study medication is received). 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 21 Nov 2011.