MelanomaPhase 3NCT02545075
A Comparative Study in Chinese Subjects With Chemotherapy Naïve Stage IV Melanoma Receiving Ipilimumab (3 mg/kg) vs. Dacarbazine
A Phase 3 study testing Ipilimumab and Dacarbazine in people with Melanoma, run by Bristol-Myers Squibb at 8 sites in China.
Trial summary
The purpose of this study is to determine whether Ipilimumab will extend the life of chinese patients with Chemotherapy Naive Stage IV Melanoma more than Dacarbazine as well as to examine safety in this patient population. 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 Dacarbazine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 182 participants
- Where
- 8 sitesChina
- Study dates
- 31 Oct 2015to 19 Apr 2019
- Phase
- Phase 3
- 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
- Chinese males and females ≥ 18 years of age
- Histologic diagnosis of malignant melanoma
- Chemotherapy naive Stage IV melanoma (AJCC 2010)
- Life expectancy of ≥ 16 weeks
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Who cannot join
- Evidence of brain metastases on brain imaging
- Primary ocular or mucosal melanoma
- Any other malignancy from which the patient has been disease-free for less than 5 years
- BRAF status cannot be determined by Screening test
- Human Immunodeficiency Virus (HIV) positive or hepatitis B surface antigen (HBsAg) positive, or active Hepatitis C infection
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
China8 sites
Local Institution
Beijing, 100142
Local Institution
Changchun, Jilin, 130021
Local Institution
Hanghzou, Zhejiang
Local Institution
Kunming
Local Institution
Nanjing, Jiangsu, 210000
Local Institution
Shanghai, 200032
Local Institution
Tianjin, Tianjin Municipality, 300060
Local Institution
Xi’an, Shanxi, 710038
About this study
Official title: A Randomized, Open-Label, Two-arm, Comparative Study in Chinese Subjects With Chemotherapy Naïve Stage IV Melanoma Receiving Ipilimumab (3 mg/kg) vs. Dacarbazine
The purpose of this study is to determine whether Ipilimumab will extend the life of chinese patients with Chemotherapy Naive Stage IV Melanoma more than Dacarbazine as well as to examine safety in this patient population.
- Conditions
- Melanoma
- Being tested
- Ipilimumab, Dacarbazine
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IpilimumabDrug
Also called MDX-010
DacarbazineDrug
Also called DTIC
| Study group | Role | What they receive |
|---|---|---|
| Ipilimumab | Experimental | Intravenously (IV) 3 mg/kg every 3 weeks (at week 1,4,7,10) and thereafter (q3w/4 doses) at the time of progression Receives: Drug: Ipilimumab |
| Dacarbazine | Experimental | IV solution 250 mg/m2 (Day 1-5, every 3weeks/at week 1, 4, 7, 10,13,16,19,22) Receives: Drug: Dacarbazine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Two-Years Survival Rate
Two-year survival rate is defined as the probability that a subject is alive at 2 years following the randomization date and will be estimated via the Kaplan-Meier (KM) method.
Measured: 24 months
Secondary outcomes (7)
One-Year Survival Rate
Survival rate at 1 year is defined as the probability that a subject is alive at 1 year following the randomization date and will be estimated via the Kaplan-Meier (KM) method.
Measured: Approximately 43 months
Overall Survival (OS)
OS is defined for each subject as the time between randomization date and the date of death (of any cause).
Measured: Approximately 43 months
Progression Free Survival ( PFS)
PFS is defined for each subject as the time between randomization date and the date of progression or death, whichever occurs first.
Measured: Approximately 43 months
Disease Control Rate ( DCR )
Primary DCR is defined as the number of subjects in the arm with Best Overall Response (BOR) of complete response (CR), partial response (PR), or stable disease (SD), divided by the total number of randomized subjects in the arm.
Measured: Approximately 43 months
Best Overall Response Rate ( BORR )
BORR definition is defined as the number of subjects in the arm with a BOR of CR or PR, divided by the total number of randomized subjects in the arm.
Measured: Approximately 43 months
Duration of Response ( DoR)
DoR definition for the response evaluable subjects whose BOR is CR or PR is defined as the time between the date of response of CR or PR (whichever occurs first) and the first date of progressive disease (PD) or the date of death (whichever occurs first).
Measured: Approximately 43 months
Duration of Stable Disease ( DoSD )
Primary duration of stable disease (DoSD) definition for the randomized subjects whose BOR is SD is defined as the time between the randomization date and the first date of PD or the date of death (whichever occurs first)."
Measured: Approximately 43 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2015 (estimated)
- Study start31 Oct 2015
- Primary completion19 Apr 2019
- Study completion19 Apr 2019
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 182 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
- NCT02545075
- Sponsor's protocol ID
- CA184-248
- Status last verified
- May 2020
- First submitted
- 25 Aug 2015
- Last updated
- 19 May 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-Label, Two-arm, Comparative Study in Chinese Subjects With Chemotherapy Naïve Stage IV Melanoma Receiving Ipilimumab (3 mg/kg) vs. Dacarbazine
- ClinicalTrials.gov ID
- NCT02545075
- Acronym / sponsor ID
- CA184-248
- Conditions
- Melanoma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 182 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 31 Oct 2015 (actual)
- Primary completion
- 19 Apr 2019 (actual)
- Study completion
- 19 Apr 2019 (actual)
- First posted
- 9 Sep 2015 (estimated)
- Results
- Posted 19 May 2020
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 whether Ipilimumab will extend the life of chinese patients with Chemotherapy Naive Stage IV Melanoma more than Dacarbazine as well as to examine safety in this patient population.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ipilimumab | Experimental | Drug: IpilimumabIntravenously (IV) 3 mg/kg every 3 weeks (at week 1,4,7,10) and thereafter (q3w/4 doses) at the time of progression |
| Dacarbazine | Experimental | Drug: DacarbazineIV solution 250 mg/m2 (Day 1-5, every 3weeks/at week 1, 4, 7, 10,13,16,19,22) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Chinese males and females ≥ 18 years of age
- Histologic diagnosis of malignant melanoma
- Chemotherapy naive Stage IV melanoma (AJCC 2010)
- Life expectancy of ≥ 16 weeks
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Key exclusion criteria (5 listed)
- Evidence of brain metastases on brain imaging
- Primary ocular or mucosal melanoma
- Any other malignancy from which the patient has been disease-free for less than 5 years
- BRAF status cannot be determined by Screening test
- Human Immunodeficiency Virus (HIV) positive or hepatitis B surface antigen (HBsAg) positive, or active Hepatitis C infection
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: MDX-010 | Drug | Ipilimumab |
| DacarbazineAlso: DTIC | Drug | Dacarbazine |
Primary outcome
Two-Years Survival Rate
Time frame: 24 months
Two-year survival rate is defined as the probability that a subject is alive at 2 years following the randomization date and will be estimated via the Kaplan-Meier (KM) method.
7 secondary outcomes
One-Year Survival Rate
Time frame: Approximately 43 months
Overall Survival (OS)
Time frame: Approximately 43 months
Progression Free Survival ( PFS)
Time frame: Approximately 43 months
Disease Control Rate ( DCR )
Time frame: Approximately 43 months
Best Overall Response Rate ( BORR )
Time frame: Approximately 43 months
Duration of Response ( DoR)
Time frame: Approximately 43 months
Duration of Stable Disease ( DoSD )
Time frame: Approximately 43 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- BMS clinical trial educational resourceLink provided by the sponsor.
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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
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Ipilimumab and Dacarbazine in people with Melanoma, run by Bristol-Myers Squibb at 8 sites in China.
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 5 inclusion and 5 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 19 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in China. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 19 May 2020). 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?
Two-Years Survival Rate (time frame: 24 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 19 May 2020.