Malignant MelanomaPhase 2NCT00135408
A Study of MDX-010 (BMS-734016) Administered With or Without Prophylactic Oral Budesonide
A Phase 2 study testing Ipilimumab+ Budesonide in people with Malignant Melanoma, run by Bristol-Myers Squibb at 10 sites in 6 countries.
Trial summary
The purpose of the study is to determine Efficacy, Safety and Tolerability of MDX-010 (BMS-734016) administered with or without Prophylactic Oral Budesonide. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malignant Melanoma
- What is being tested?
- Ipilimumab+ Budesonide
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 115 participants
- Where
- 10 sitesin 6 countries
- Study dates
- Dec 2005to 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologic or cytologic diagnosis of unresectable Stage III or IV malignant melanoma (excluding ocular melanoma)
- Flexible Sigmoidoscopy and colonic biopsy required
Who cannot join
- Patients with active, untreated central nervous system metastasis. Patients with autoimmune disease.
Trial locations and contacts
10 sites in 6 countries.
10 sites in 6 countries
United States4 sites
Study site
Charlotte, North Carolina
Study site
Los Angeles, California
Study site
San Francisco, California
Study site
Seattle, Washington
About this study
Official title: Randomized, Double-Blind, Placebo-Controlled Phase II Study Comparing the Safety of MDX-010 (BMS-734016) Administered With or Without Prophylactic Oral Budesonide (Entocort EC) in Patients With Previously Treated Unresectable Stage III or IV Malignant Melanoma
The purpose of the study is to determine Efficacy, Safety and Tolerability of MDX-010 (BMS-734016) administered with or without Prophylactic Oral Budesonide.
- Conditions
- Malignant Melanoma
- Being tested
- Ipilimumab+ Placebo, Ipilimumab+ Budesonide
- Keywords
- Unresectable Stage III or IV Malignant 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+ PlaceboDrug
Also called BMS-734016, (MDX-010)
Solution, Intravenous, 10 mg/kg, 3 weeks, 12 - 48 weeks depending on the response.
Ipilimumab+ BudesonideDrug
Also called BMS-734016, (MDX-010)
Solution/Capsule, Intravenous/Oral, 10 mg/kg + 9 mg, 3 weeks (Ipilimumab) + once daily until week 16 (Budesonide), 12 - 48 weeks depending on the response.
| Study group | Role | What they receive |
|---|---|---|
| A1 | Active comparator | Not described Receives: Drug: Ipilimumab+ Placebo |
| A2 | Active comparator | Not described Receives: Drug: Ipilimumab+ Budesonide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Grade 2,3,4 Diarrhea - patients on study drug.
Secondary outcomes (1)
Safety monitored w/follow-up period. Assess Best Objective response, Disease control rate, progression free survival, overall survival, duration/best objective response, Time/best objective response. PK, immunogenicity & pharmacodynamic analysis
Measured: at Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2005 (estimated)
- Study startDec 2005
- 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 (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
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 115 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Medarex
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00135408
- Sponsor's protocol ID
- CA184-007
- Status last verified
- Sep 2016
- First submitted
- 25 Aug 2005
- Last updated
- 28 Sep 2016
- 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 25667295
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Double-Blind, Placebo-Controlled Phase II Study Comparing the Safety of MDX-010 (BMS-734016) Administered With or Without Prophylactic Oral Budesonide (Entocort EC) in Patients With Previously Treated Unresectable Stage III or IV Malignant Melanoma
- ClinicalTrials.gov ID
- NCT00135408
- Acronym / sponsor ID
- CA184-007
- Conditions
- Malignant Melanoma
- Keywords
- Unresectable Stage III or IV Malignant Melanoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 115 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Collaborators
- Medarex
- Study start
- Dec 2005
- Primary completion
- Jul 2007 (actual)
- Study completion
- Jul 2007 (actual)
- First posted
- 26 Aug 2005 (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 the study is to determine Efficacy, Safety and Tolerability of MDX-010 (BMS-734016) administered with or without Prophylactic Oral Budesonide.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A1 | Active comparator | Drug: Ipilimumab+ Placebo |
| A2 | Active comparator | Drug: Ipilimumab+ Budesonide |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Histologic or cytologic diagnosis of unresectable Stage III or IV malignant melanoma (excluding ocular melanoma)
- Flexible Sigmoidoscopy and colonic biopsy required
Key exclusion criteria (1 listed)
- Patients with active, untreated central nervous system metastasis. Patients with 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 |
|---|---|---|
| Ipilimumab+ PlaceboAlso: BMS-734016, (MDX-010)Solution, Intravenous, 10 mg/kg, 3 weeks, 12 - 48 weeks depending on the response. | Drug | A1 |
| Ipilimumab+ BudesonideAlso: BMS-734016, (MDX-010)Solution/Capsule, Intravenous/Oral, 10 mg/kg + 9 mg, 3 weeks (Ipilimumab) + once daily until week 16 (Budesonide), 12 - 48 weeks depending on the response. | Drug | A2 |
Primary outcome
Rate of Grade 2,3,4 Diarrhea - patients on study drug.
1 secondary outcome
Safety monitored w/follow-up period. Assess Best Objective response, Disease control rate, progression free survival, overall survival, duration/best objective response, Time/best objective response. PK, immunogenicity & pharmacodynamic analysis
Time frame: at Week 24
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 28 Sep 2016.
- 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.
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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.
10 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 Ipilimumab+ Budesonide in people with Malignant Melanoma, run by Bristol-Myers Squibb at 10 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 1 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 28 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United States, Canada, Israel, Italy, Peru 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?
Rate of Grade 2,3,4 Diarrhea - patients on study drug.. 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 NCT00135408, 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 28 Sep 2016.