MelanomaNCT05714371
Retrospective Assessment of Adverse Events-related Healthcare Resource Utilization and Costs of Immune Checkpoint Inhibitor and Targeted Therapy for Adjuvant Treatment of Melanoma
An observational study of Melanoma, run by Novartis Pharmaceuticals at 1 site in United States.
Trial summary
This was a retrospective cohort study using the PharMetrics database. The analysis was conducted using the most recent 5 years of data from the database, January 1, 2015, to October 30, 2020. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Melanoma
- What is being tested?
- Nivolumab, Ipilimumab + nivolumab and Pembrolizumab
- How many people
- 618 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Oct 2021to 27 Jan 2022
- 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: This was a retrospective, noninterventional cohort study
Who may be able to join
- Patients with at least one diagnosis of malignant melanoma of skin anytime from the start of data collection until the start of study period.
- Patients with a procedure of first lymph node dissection or nodal basin ultrasound surveillance, per the National Comprehensive Cancer Network (NCCN) guidelines version 2.2020. The first lymph node dissection / nodal basin ultrasound surveillance signified that the patient was eligible to receive systemic treatment as adjuvant therapy.
- The first lymph node dissection or nodal basin ultrasound surveillance (index adjuvant date) must have had a diagnosis of malignant melanoma of skin within 6 months, to ensure that the dissection was related to melanoma.
- Patients with at least pharmacy or medical claim for the study drugs within 1 year on and after index date. The index date was the date of first prescription of study drug, IO (i.e., nivolumab, ipilimumab + nivolumab, pembrolizumab) or dabrafenib + trametinib.
- At least 18 years of age at the time of adjuvant treatment initiation.
- Patients with at least 6 months of continuous enrollment prior to the index date.
- Patients with at least 6 months of continuous enrollment after the index date.
- If necessary, there were additional criteria of absence of secondary malignancy (including metastatic site).
Who cannot join
- Patients with a diagnosis of non-melanoma primary malignancy during the 6 months pre-index period.
- Patients with chemotherapy or interferon alpha before index date.
- Patients with pregnancy any time during the study period.
Trial locations and contacts
1 site in 1 country.
United States1 site
Novartis Pharmaceuticals
East Hanover, New Jersey, 07936
About this study
This was a retrospective cohort study using the PharMetrics database. The analysis was conducted using the most recent 5 years of data from the database, January 1, 2015, to October 30, 2020. Included patients were followed for outcome evaluation from the index date (first prescription of treatment, immunotherapy [IO], or targeted therapy [TT] following diagnosis of non-metastatic malignant melanoma and evidence of first lymph node resection), until the first occurrence or end of continuous eligibility or end of the study period.
- Conditions
- Melanoma
- Being tested
- Nivolumab, Ipilimumab + nivolumab, Pembrolizumab, Dabrafenib + trametinib
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NivolumabDrug
Patients receiving nivolumab
Ipilimumab + nivolumabDrug
Patients receiving ipilimumab + nivolumab
PembrolizumabDrug
Patients receiving pembrolizumab
Dabrafenib + trametinibDrug
Dabrafenib + trametinib
| Study group | Role | What they receive |
|---|---|---|
| Immunotherapy (IO) | Patients receiving IO Receives: Drug: Nivolumab; Drug: Ipilimumab + nivolumab; Drug: Pembrolizumab | |
| Targeted therapy (TT) | Patients receiving TT Receives: Drug: Dabrafenib + trametinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients on first systemic adjuvant therapy with adverse avents (AEs)
Measured: Up to approximately 5 years
Secondary outcomes (5)
Number of patients with AEs following first systemic adjuvant therapy completion/discontinuation.
Measured: Up to approximately 5 years
Healthcare resource utilization (HCRU) associated with AEs on first systemic adjuvant therapy
Measured: Up to approximately 5 years
Healthcare costs associated with AEs on first systemic adjuvant therapy
Measured: Up to approximately 5 years
HCRU associated with AEs following first systemic adjuvant therapy completion/discontinuation
Measured: Up to approximately 5 years
Healthcare costs associated with AEs following first systemic adjuvant therapy completion/discontinuation
Measured: Up to approximately 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2023
- Study start2 Oct 2021
- Primary completion27 Jan 2022
- Study completion27 Jan 2022
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 Novartis PharmaceuticalsThe 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
- 618 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05714371
- Sponsor's protocol ID
- CTMT212AUS57
- Status last verified
- Jan 2023
- First submitted
- 27 Jan 2023
- Last updated
- 6 Feb 2023
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Assessment of Adverse Events-related Healthcare Resource Utilization and Costs of Immune Checkpoint Inhibitor and Targeted Therapy for Adjuvant Treatment of Melanoma
- ClinicalTrials.gov ID
- NCT05714371
- Acronym / sponsor ID
- CTMT212AUS57
- Conditions
- Melanoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 618 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 2 Oct 2021 (actual)
- Primary completion
- 27 Jan 2022 (actual)
- Study completion
- 27 Jan 2022 (actual)
- First posted
- 6 Feb 2023 (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.
This was a retrospective cohort study using the PharMetrics database. The analysis was conducted using the most recent 5 years of data from the database, January 1, 2015, to October 30, 2020. Included patients were followed for outcome evaluation from the index date (first prescription of treatment, immunotherapy [IO], or targeted therapy [TT] following diagnosis of non-metastatic malignant melanoma and evidence of first lymph node resection), until the first occurrence or end of continuous eligibility or end of the study period.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Immunotherapy (IO) | – | Drug: Nivolumab, Drug: Ipilimumab + nivolumab, Drug: PembrolizumabPatients receiving IO |
| Targeted therapy (TT) | – | Drug: Dabrafenib + trametinibPatients receiving TT |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This was a retrospective, noninterventional cohort study
Key inclusion criteria (8 listed)
- Patients with at least one diagnosis of malignant melanoma of skin anytime from the start of data collection until the start of study period.
- Patients with a procedure of first lymph node dissection or nodal basin ultrasound surveillance, per the National Comprehensive Cancer Network (NCCN) guidelines version 2.2020. The first lymph node dissection / nodal basin ultrasound surveillance signified that the patient was eligible to receive systemic treatment as adjuvant therapy.
- The first lymph node dissection or nodal basin ultrasound surveillance (index adjuvant date) must have had a diagnosis of malignant melanoma of skin within 6 months, to ensure that the dissection was related to melanoma.
- Patients with at least pharmacy or medical claim for the study drugs within 1 year on and after index date. The index date was the date of first prescription of study drug, IO (i.e., nivolumab, ipilimumab + nivolumab, pembrolizumab) or dabrafenib + trametinib.
- At least 18 years of age at the time of adjuvant treatment initiation.
Key exclusion criteria (3 listed)
- Patients with a diagnosis of non-melanoma primary malignancy during the 6 months pre-index period.
- Patients with chemotherapy or interferon alpha before index date.
- Patients with pregnancy any time during the study period.
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 |
|---|---|---|
| NivolumabPatients receiving nivolumab | Drug | Immunotherapy (IO) |
| Ipilimumab + nivolumabPatients receiving ipilimumab + nivolumab | Drug | Immunotherapy (IO) |
| PembrolizumabPatients receiving pembrolizumab | Drug | Immunotherapy (IO) |
| Dabrafenib + trametinibDabrafenib + trametinib | Drug | Targeted therapy (TT) |
Primary outcome
Number of patients on first systemic adjuvant therapy with adverse avents (AEs)
Time frame: Up to approximately 5 years
5 secondary outcomes
Number of patients with AEs following first systemic adjuvant therapy completion/discontinuation.
Time frame: Up to approximately 5 years
Healthcare resource utilization (HCRU) associated with AEs on first systemic adjuvant therapy
Time frame: Up to approximately 5 years
Healthcare costs associated with AEs on first systemic adjuvant therapy
Time frame: Up to approximately 5 years
HCRU associated with AEs following first systemic adjuvant therapy completion/discontinuation
Time frame: Up to approximately 5 years
Healthcare costs associated with AEs following first systemic adjuvant therapy completion/discontinuation
Time frame: Up to approximately 5 years
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 6 Feb 2023.
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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.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
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 Novartis Pharmaceuticals 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 8 inclusion and 3 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 6 Feb 2023. 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?
Number of patients on first systemic adjuvant therapy with adverse avents (AEs) (time frame: Up to approximately 5 years). 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 6 Feb 2023.