MelanomaNCT03205722
The Effectiveness of Nivolumab Monotherapy as First-Line Therapy in Adults With Advanced Melanoma in Germany
An observational study of Melanoma, run by Bristol-Myers Squibb.
Trial summary
A retrospective, observational study based on chart reviews for patients with advanced melanoma treated with nivolumab monotherapy prescribed as first-line therapy between June 2015 and June 2016, conducted in a representative sample of sites in Germany. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Melanoma
- What is being tested?
- Non-Interventional
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 5 Jan 2018to 30 Jul 2018
- Phase
- Observational
- 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
Study population: all patients diagnosed with advanced melanoma who were initiated with nivolumab monotherapy as their first-line therapy in Germany between June 2015 and June 2016.
Who may be able to join
- Adult patients with a primary diagnosis of advanced melanoma (histologically confirmed stage III [unresectable] or stage IV skin, ocular, or mucosal melanoma)
- Newly initiated with nivolumab monotherapy as their first-line therapy for previously untreated advanced melanoma between June 2015 and June 2016
- At least 18 years of age at time of treatment decision
Who cannot join
- Patients with a current primary diagnosis of a cancer other than advanced melanoma ie, a cancer other than melanoma that requires systemic or other treatment
- Patients currently included in an interventional clinical trial for his/her locally advanced or metastatic melanoma. Patients who have completed their participation in an interventional trial; or who are not receiving study drug anymore and who are only followed-up for overall survival can be enrolled. In case of a blinded study, the treatment arm (ie, type of administered treatment) needs to be known.
- Patients < 18 years of age at time of treatment initiation
- Other protocol defined inclusion/exclusion criteria could apply
About this study
Official title: The Effectiveness of Nivolumab (OPDIVO®) Monotherapy as First-Line Therapy in Adults With Advanced (Unresectable or Metastatic) Melanoma: An Early Retrospective, Observational Study in Germany
A retrospective, observational study based on chart reviews for patients with advanced melanoma treated with nivolumab monotherapy prescribed as first-line therapy between June 2015 and June 2016, conducted in a representative sample of sites in Germany.
- Conditions
- Melanoma
- Being tested
- Non-Interventional
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-InterventionalOther
Non-Interventional
| Study group | Role | What they receive |
|---|---|---|
| Melanoma patients with 1st-line Nivo treatment | Non-Interventional. Patients with advanced melanoma treated with nivolumab monotherapy prescribed as first-line therapy between June 2015 and June 2016. Receives: Other: Non-Interventional |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival (OS)
OS for adult patients with advanced (unresectable or metastatic) melanoma treated with nivolumab monotherapy as first-line therapy from date of advanced diagnosis, and from the start of treatment with nivolumab over the first 23 months after treatment initiation, overall.
Measured: Approximately 23 months
Secondary outcomes (18)
OS from date of advanced diagnosis
Measured: Approximately 23 months
progression-free survival (PFS)
Measured: Approximately 23 months
best overall response rate (BORR)
Measured: Approximately 23 months
best overall response (BOR)
Measured: Approximately 23 months
Distribution of Best Overall Response (BOR) by Severity of melanoma at initiation of treatment
Measured: Approximately 23 months
Best Overall Response (BOR) in patients greater than or equal to 65 years old
Measured: Approximately 23 months
Best Overall Response (BOR) in Eastern Cooperative Oncology Group (ECOG) performance status greater than or equal to 2
Measured: Approximately 23 months
Distribution of Best Overall Response (BOR) by Mutational status
Measured: Approximately 23 months
Best Overall Response (BOR) in Patients with brain metastases
Measured: Approximately 23 months
Distribution of Best Overall Response (BOR) by Melanoma subtype
Measured: Approximately 23 months
Distribution of incidence of Adverse Events (AEs)
Measured: Approximately 23 months
Distribution of severity of Adverse Events (AEs)
Measured: Approximately 23 months
Distribution of management of Adverse Events (AEs)
Measured: Approximately 23 months
Distribution of socio-demographic characteristics in adult patients with advanced melanoma treated with nivolumab monotherapy as first-line therapy
Socio-demographic characteristics (Gender, Height, Weight, Age) will be summarized using descriptive statistics
Measured: Approximately 23 months
Distribution of clinical characteristics in adult patients with advanced melanoma treated with nivolumab monotherapy as first-line therapy
Clinical characteristics (Initial Diagnosis of melanoma, Histological subtypes, Performance status, Comorbidities, history of cancer) will be summarized using descriptive statistics
Measured: Approximately 23 months
Distribution of Treatment Patterns
Details on Prior and Evolution of Current Treatment Patterns will be summarized using descriptive statistics.
Measured: Approximately 23 months
Distribution of Healthcare Resource Utilization
Healthcare Resource Utilization will be summarized using descriptive statistics
Measured: Approximately 23 months
Duration of nivolumab treatment
Measured: Approximately 23 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2017
- Study start5 Jan 2018 (estimated)
- Primary completion30 Jul 2018 (estimated)
- Study completion30 Jul 2018 (estimated)
Why it stopped: Business objectives have changed
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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 0 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
- NCT03205722
- Sponsor's protocol ID
- CA209-939
- Status last verified
- Apr 2018
- First submitted
- 29 Jun 2017
- Last updated
- 9 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Nivolumab (OPDIVO®) Monotherapy as First-Line Therapy in Adults With Advanced (Unresectable or Metastatic) Melanoma: An Early Retrospective, Observational Study in Germany
- ClinicalTrials.gov ID
- NCT03205722
- Acronym / sponsor ID
- CA209-939
- Conditions
- Melanoma
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Business objectives have changed
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 5 Jan 2018 (estimated)
- Primary completion
- 30 Jul 2018 (estimated)
- Study completion
- 30 Jul 2018 (estimated)
- First posted
- 2 Jul 2017 (actual)
- 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.
A retrospective, observational study based on chart reviews for patients with advanced melanoma treated with nivolumab monotherapy prescribed as first-line therapy between June 2015 and June 2016, conducted in a representative sample of sites in Germany.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Melanoma patients with 1st-line Nivo treatment | – | Other: Non-InterventionalNon-Interventional. Patients with advanced melanoma treated with nivolumab monotherapy prescribed as first-line therapy between June 2015 and June 2016. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- all patients diagnosed with advanced melanoma who were initiated with nivolumab monotherapy as their first-line therapy in Germany between June 2015 and June 2016.
Key inclusion criteria (3 listed)
- Adult patients with a primary diagnosis of advanced melanoma (histologically confirmed stage III [unresectable] or stage IV skin, ocular, or mucosal melanoma)
- Newly initiated with nivolumab monotherapy as their first-line therapy for previously untreated advanced melanoma between June 2015 and June 2016
- At least 18 years of age at time of treatment decision
Key exclusion criteria (4 listed)
- Patients with a current primary diagnosis of a cancer other than advanced melanoma ie, a cancer other than melanoma that requires systemic or other treatment
- Patients currently included in an interventional clinical trial for his/her locally advanced or metastatic melanoma. Patients who have completed their participation in an interventional trial; or who are not receiving study drug anymore and who are only followed-up for overall survival can be enrolled. In case of a blinded study, the treatment arm (ie, type of administered treatment) needs to be known.
- Patients < 18 years of age at time of treatment initiation
- Other protocol defined inclusion/exclusion criteria could apply
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 |
|---|---|---|
| Non-InterventionalNon-Interventional | Other | Melanoma patients with 1st-line Nivo treatment |
Primary outcome
Overall Survival (OS)
Time frame: Approximately 23 months
OS for adult patients with advanced (unresectable or metastatic) melanoma treated with nivolumab monotherapy as first-line therapy from date of advanced diagnosis, and from the start of treatment with nivolumab over the first 23 months after treatment initiation, overall.
18 secondary outcomes
OS from date of advanced diagnosis
Time frame: Approximately 23 months
progression-free survival (PFS)
Time frame: Approximately 23 months
best overall response rate (BORR)
Time frame: Approximately 23 months
best overall response (BOR)
Time frame: Approximately 23 months
Distribution of Best Overall Response (BOR) by Severity of melanoma at initiation of treatment
Time frame: Approximately 23 months
Best Overall Response (BOR) in patients greater than or equal to 65 years old
Time frame: Approximately 23 months
Best Overall Response (BOR) in Eastern Cooperative Oncology Group (ECOG) performance status greater than or equal to 2
Time frame: Approximately 23 months
Distribution of Best Overall Response (BOR) by Mutational status
Time frame: Approximately 23 months
Best Overall Response (BOR) in Patients with brain metastases
Time frame: Approximately 23 months
Distribution of Best Overall Response (BOR) by Melanoma subtype
Time frame: Approximately 23 months
Distribution of incidence of Adverse Events (AEs)
Time frame: Approximately 23 months
Distribution of severity of Adverse Events (AEs)
Time frame: Approximately 23 months
Distribution of management of Adverse Events (AEs)
Time frame: Approximately 23 months
Distribution of socio-demographic characteristics in adult patients with advanced melanoma treated with nivolumab monotherapy as first-line therapy
Time frame: Approximately 23 months
Distribution of clinical characteristics in adult patients with advanced melanoma treated with nivolumab monotherapy as first-line therapy
Time frame: Approximately 23 months
Distribution of Treatment Patterns
Time frame: Approximately 23 months
Distribution of Healthcare Resource Utilization
Time frame: Approximately 23 months
Duration of nivolumab treatment
Time frame: Approximately 23 months
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 9 Apr 2018.
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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
Questions about this trial
What is this clinical trial studying?
An observational study of Melanoma, run by Bristol-Myers Squibb.
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 9 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
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.
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?
Overall Survival (OS) (time frame: Approximately 23 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 9 Apr 2018.