MelanomaPhase 2NCT01709162
Study to Compare the Effect of Ipilimumab Retreatment With That of Chemotherapy in Advanced Melanoma
A Phase 2 study testing Ipilimumab and Chemotherapy in people with Melanoma, run by Bristol-Myers Squibb at 17 sites in 5 countries.
Trial summary
The purpose of the study is to determine whether additional doses of ipilimumab have a positive effect on survival in the treatment of advanced melanoma that has progressed after successful initial treatment with ipilimumab. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Melanoma
- What is being tested?
- Ipilimumab and Chemotherapy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 17 sitesin 5 countries
- Study dates
- Mar 2013to Jul 2014
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologic diagnosis of unresectable stage III or IV metastatic melanoma
- Prior ipilimumab induction treatment (3 mg/kg)
- Documented disease control [Stable Disease ≥3 months or Partial Response/Complete Response] after ipilimumab induction
- Documented progressive disease following disease control
Who cannot join
- Patients with brain metastasis are excluded, unless they are free of neurologic symptoms related to metastatic brain lesions and do not receive systemic corticosteroid therapy for the purpose of reducing intracranial inflammation in the 10 days prior to beginning retreatment with ipilimumab
- Any intervening anticancer therapy between last dose of ipilimumab induction and ipilimumab retreatment on study
- Patients who experienced any grade 3 immune-related adverse event (irAE) (except for endocrinopathies where clinical symptoms were controlled with appropriate hormone replacement therapy) or any grade 4 toxicity during prior treatment with ipilimumab
- Patients with a prior irAE that has not improved to grade 1 or better at randomization
Trial locations and contacts
17 sites in 5 countries.
17 sites in 5 countries
United States7 sites
Lehigh Valley Hospital
Allentown, Pennsylvania, 18103
Rocky Mountain Cancer Centers
Aurora, Colorado, 80012
Birmingham Hematology & Oncology Associates Llc
Birmingham, Alabama, 35205
Texas Oncology Sammons Cancer Center
Dallas, Texas, 75246
Investigative Clinical Research Of Indiana, Llc
Indianapolis, Indiana, 46260
Comprehensive Cancer Center Of Nevada
Las Vegas, Nevada, 89148
Cancer Center Of Kansas
Wichita, Kansas, 67214
Germany5 sites
Local Institution
Cologne, 50937
Local Institution
Erfurt, 99089
Local Institution
Göttingen, 37075
Local Institution
Heidelberg, 69115
Local Institution
Kiel, 24105
France3 sites
Local Institution
Bordeaux, 33075
Local Institution
Nantes, 44093
Local Institution
Paris, 75010
About this study
Official title: A Randomized, Open-Label, Multicenter Phase II Study of Ipilimumab Retreatment Versus Chemotherapy for Subjects With Advanced Melanoma Who Progressed After Initially Achieving Disease Control With Ipilimumab Therapy
The purpose of the study is to determine whether additional doses of ipilimumab have a positive effect on survival in the treatment of advanced melanoma that has progressed after successful initial treatment with ipilimumab.
- Conditions
- Melanoma
- Being tested
- Ipilimumab, Chemotherapy
- 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
ChemotherapyDrug
| Study group | Role | What they receive |
|---|---|---|
| Ipilimumab, 3 mg/kg | Experimental | Participants received ipilimumab, 3 mg/kg, by intravenous infusion, every 3 weeks for a total of 4 doses or until disease progression, unacceptable toxicity, or withdrawal of consent Receives: Biological: Ipilimumab |
| Chemotherapy | Active comparator | Participants received the investigator's choice of chemotherapy, administered per package instructions. Receives: Drug: Chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival
Overall survival is defined for each patient as the time between randomization and death. If a patient has not died, he or she will be censored at the time of last contact (last known alive date)
Measured: From randomization to death or last known alive date, assessed up to 15.6 months
Secondary outcomes (2)
Disease Control Rate (DCR)
DCR is defined per arm as the total number of randomized participants with best overall response as complete response, partial response, or stable disease, divided by the total number of randomized participants in the arm. Bristol-Myers Squibb terminated this study early because the study would not meet its scientific objective in the predefined time frame. Thus, no participants were analyzed. Because the study ended before best overall response could be determined, no participants were analyzed.
Measured: Every 3 months for approximately 3.5 years after start of randomization and then every 6 months until confirmed and documented progressive disease
Best Overall Response Rate (BORR)
BORR is defined per arm as the total number of randomized patients with a best overall response of complete response or partial response, divided by the total number of randomized patients in the arm. Bristol-Myers Squibb terminated this study early because the study would not meet its scientific objective in the predefined timeframe. Because the study ended before best overall response for all patients was defined, no participant data was analyzed.
Measured: Every 3 months for approximately 3.5 years after start of randomization and then every 6 months until confirmed and documented progressive disease
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2012 (estimated)
- Study startMar 2013
- Primary completionJul 2014
- Study completionJul 2014
Why it stopped: Discontinued early due to enrollment challenges and changes in treatment standards
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.
- 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
- 31 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
- NCT01709162
- Sponsor's protocol ID
- CA184-243
- Other IDs
- 2012-003291-38
- Status last verified
- Sep 2015
- First submitted
- 12 Oct 2012
- Last updated
- 30 Nov 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-Label, Multicenter Phase II Study of Ipilimumab Retreatment Versus Chemotherapy for Subjects With Advanced Melanoma Who Progressed After Initially Achieving Disease Control With Ipilimumab Therapy
- ClinicalTrials.gov ID
- NCT01709162
- Acronym / sponsor ID
- CA184-243
- Conditions
- Melanoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Discontinued early due to enrollment challenges and changes in treatment standards
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- Mar 2013
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 18 Oct 2012 (estimated)
- Results
- Posted 30 Nov 2015
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 whether additional doses of ipilimumab have a positive effect on survival in the treatment of advanced melanoma that has progressed after successful initial treatment with ipilimumab.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ipilimumab, 3 mg/kg | Experimental | Biological: IpilimumabParticipants received ipilimumab, 3 mg/kg, by intravenous infusion, every 3 weeks for a total of 4 doses or until disease progression, unacceptable toxicity, or withdrawal of consent |
| Chemotherapy | Active comparator | Drug: ChemotherapyParticipants received the investigator's choice of chemotherapy, administered per package instructions. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Histologic diagnosis of unresectable stage III or IV metastatic melanoma
- Prior ipilimumab induction treatment (3 mg/kg)
- Documented disease control [Stable Disease ≥3 months or Partial Response/Complete Response] after ipilimumab induction
- Documented progressive disease following disease control
Key exclusion criteria (4 listed)
- Patients with brain metastasis are excluded, unless they are free of neurologic symptoms related to metastatic brain lesions and do not receive systemic corticosteroid therapy for the purpose of reducing intracranial inflammation in the 10 days prior to beginning retreatment with ipilimumab
- Any intervening anticancer therapy between last dose of ipilimumab induction and ipilimumab retreatment on study
- Patients who experienced any grade 3 immune-related adverse event (irAE) (except for endocrinopathies where clinical symptoms were controlled with appropriate hormone replacement therapy) or any grade 4 toxicity during prior treatment with ipilimumab
- Patients with a prior irAE that has not improved to grade 1 or better at 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 |
|---|---|---|
| IpilimumabAlso: Yervoy, BMS-734016 | Biological | Ipilimumab, 3 mg/kg |
| Chemotherapy | Drug | Chemotherapy |
Primary outcome
Overall Survival
Time frame: From randomization to death or last known alive date, assessed up to 15.6 months
Overall survival is defined for each patient as the time between randomization and death. If a patient has not died, he or she will be censored at the time of last contact (last known alive date)
2 secondary outcomes
Disease Control Rate (DCR)
Time frame: Every 3 months for approximately 3.5 years after start of randomization and then every 6 months until confirmed and documented progressive disease
Best Overall Response Rate (BORR)
Time frame: Every 3 months for approximately 3.5 years after start of randomization and then every 6 months until confirmed and documented progressive disease
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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
17 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ipilimumab and Chemotherapy in people with Melanoma, run by Bristol-Myers Squibb at 17 sites in 5 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 4 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 30 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in United States, Germany, France, Austria, Italy. 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 30 Nov 2015). 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 (time frame: From randomization to death or last known alive date, assessed up to 15.6 months). 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 30 Nov 2015.