MelanomaNCT03732560
A Comparison of Nivolumab-based Treatments in a Real-world PD-L1 Positive Metastatic Melanoma Population in the US
An observational study of Melanoma, run by Bristol-Myers Squibb at 1 site in United States.
Trial summary
The goal of this study is to describe patient characteristics, treatment outcomes and adverse events for patients with metastatic melanoma testing positive for PD-L1 expression treated first line (1L) with either nivolumab and ipilimumab in combination (NIVO + IPI) or nivolumab (NIVO) monotherapy 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
- 600 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Jul 2018to 25 Mar 2021
- 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: Adult metastatic melanoma patients with a positive PD-L1 expression level (above 1%) treated with nivolumab or nivolumab+ipilimumab in the first line setting in the US between Oct 1, 2015 and July 1, 2017
Who may be able to join
- Adults 18 years or older
- First advanced of diagnosis of metastatic/Stage IV) melanoma
- Tested for PD-L1 expression with a tumor proportion score (TPS) greater than or equal to 1% (Phase 1 data collection)
- Initiating a first line of therapy during the index period between October 1, 2015 through July 1, 2017
- Medical history available for medical chart abstraction from date of diagnosis through most recent or current therapy (defined as end of data collection period)
Who cannot join
- Patients enrolled in a cancer treatment-related clinical trial prior to first line therapy initiation for metastatic/Stage IV) melanoma
- Other protocol defined inclusion/exclusion criteria could apply
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Retrospective Observational Study Comparing Nivolumab + Ipilimumab Combination vs. Nivolumab Monotherapy as First Line Treatment of Metastatic PD-L1 Positive Melanoma in the US
The goal of this study is to describe patient characteristics, treatment outcomes and adverse events for patients with metastatic melanoma testing positive for PD-L1 expression treated first line (1L) with either nivolumab and ipilimumab in combination (NIVO + IPI) or nivolumab (NIVO) monotherapy
- 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 |
|---|---|---|
| Patients undergoing treatment with nivolumab and ipilimumab | Not described Receives: Other: Non-Interventional | |
| Patients undergoing treatment with nivolumab | Not described Receives: Other: Non-Interventional |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival (OS) from Advanced Diagnosis
Measured: Minimum follow up 1 year
Secondary outcomes (11)
Progression Free Survival (PFS) from Advanced Diagnosis
Measured: Minimum follow up 1 year
Overall Survival (OS) from 1L Therapy Initiation
Measured: Minimum follow up 1 year
Progression Free Survival (PFS) from Index Date
Measured: Minimum follow up 1 year
Objective Response Rate (ORR)
Measured: Minimum follow up 1 year
Best Therapy Response
Best response (complete response, CR or partial response, PR) will be measured from the start of index treatment to progression or recurrence. Outcome will be reported as the percent of patients achieving best response from the total population of patients in a study arm.
Measured: Minimum follow up 1 year
Time to Best Therapy Response
Measured: Minimum follow up 1 year
Time to Loss of Peak Response
Measured: Minimum follow up 1 year
Response Evaluation Criteria in Solid Tumors (RECIST)
Measured: Minimum follow up 1 year
Immune-related Response Evaluation Criteria in Solid Tumors (iRECIST) criteria
Measured: Minimum follow up 1 year
Incidence of AE's
Measured: Minimum follow up 1 year
Incidence of SAE's
Measured: Minimum follow up 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2018
- Study start31 Jul 2018
- Primary completion25 Mar 2021
- Study completion25 Mar 2021
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
- 600 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
- NCT03732560
- Sponsor's protocol ID
- CA209-8RW
- Status last verified
- Dec 2022
- First submitted
- 5 Nov 2018
- Last updated
- 8 Dec 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Retrospective Observational Study Comparing Nivolumab + Ipilimumab Combination vs. Nivolumab Monotherapy as First Line Treatment of Metastatic PD-L1 Positive Melanoma in the US
- ClinicalTrials.gov ID
- NCT03732560
- Acronym / sponsor ID
- CA209-8RW
- Conditions
- Melanoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 600 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 31 Jul 2018 (actual)
- Primary completion
- 25 Mar 2021 (actual)
- Study completion
- 25 Mar 2021 (actual)
- First posted
- 6 Nov 2018 (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.
The goal of this study is to describe patient characteristics, treatment outcomes and adverse events for patients with metastatic melanoma testing positive for PD-L1 expression treated first line (1L) with either nivolumab and ipilimumab in combination (NIVO + IPI) or nivolumab (NIVO) monotherapy
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients undergoing treatment with nivolumab and ipilimumab | – | Other: Non-Interventional |
| Patients undergoing treatment with nivolumab | – | Other: Non-Interventional |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult metastatic melanoma patients with a positive PD-L1 expression level (above 1%) treated with nivolumab or nivolumab+ipilimumab in the first line setting in the US between Oct 1, 2015 and July 1, 2017
Key inclusion criteria (5 listed)
- Adults 18 years or older
- First advanced of diagnosis of metastatic/Stage IV) melanoma
- Tested for PD-L1 expression with a tumor proportion score (TPS) greater than or equal to 1% (Phase 1 data collection)
- Initiating a first line of therapy during the index period between October 1, 2015 through July 1, 2017
- Medical history available for medical chart abstraction from date of diagnosis through most recent or current therapy (defined as end of data collection period)
Key exclusion criteria (2 listed)
- Patients enrolled in a cancer treatment-related clinical trial prior to first line therapy initiation for metastatic/Stage IV) melanoma
- 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 | Patients undergoing treatment with nivolumab, Patients undergoing treatment with nivolumab and ipilimumab |
Primary outcome
Overall Survival (OS) from Advanced Diagnosis
Time frame: Minimum follow up 1 year
11 secondary outcomes
Progression Free Survival (PFS) from Advanced Diagnosis
Time frame: Minimum follow up 1 year
Overall Survival (OS) from 1L Therapy Initiation
Time frame: Minimum follow up 1 year
Progression Free Survival (PFS) from Index Date
Time frame: Minimum follow up 1 year
Objective Response Rate (ORR)
Time frame: Minimum follow up 1 year
Best Therapy Response
Time frame: Minimum follow up 1 year
Time to Best Therapy Response
Time frame: Minimum follow up 1 year
Time to Loss of Peak Response
Time frame: Minimum follow up 1 year
Response Evaluation Criteria in Solid Tumors (RECIST)
Time frame: Minimum follow up 1 year
Immune-related Response Evaluation Criteria in Solid Tumors (iRECIST) criteria
Time frame: Minimum follow up 1 year
Incidence of AE's
Time frame: Minimum follow up 1 year
Incidence of SAE's
Time frame: Minimum follow up 1 year
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 8 Dec 2022.
- BMS Clinical Trial InformationLink provided by the sponsor.
- FDA Safety Alerts and RecallsLink provided by the sponsor.
Related trials for Melanoma
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingPhase 1
IL-17 Blockade to Decrease irAEs (REPLAY)
Metastatic Melanoma
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
RecruitingPhase 1
A Feasibility Study Utilizing Immune Recall to Increase Response to Checkpoint Therapy
Melanoma
Active, not recruitingPhase 1/2
A Study of Dapansutrile Plus Pembrolizumab in Patients With PD-1 Refractory Advanced Melanoma
Melanoma
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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Melanoma, run by Bristol-Myers Squibb at 1 site 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 5 inclusion and 2 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 8 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
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?
Overall Survival (OS) from Advanced Diagnosis (time frame: Minimum follow up 1 year). 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 8 Dec 2022.