Clinical trial · Observational
Treatment Patterns and Outcomes Study in Patients With Unresectable Stage III and Metastatic (Stage IV) Melanoma in the United States
NCT03199846CI-TRIAL-00031560completedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study will collect real-world data from advanced melanoma diagnosis through most recent visit and data sourced from patient medical records following a 2-part study design consisting of a random sample (Part 1) and an oversample (Part 2).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Melanoma | Melanoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Non-Interventional | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (6)
- label
- advanced melanoma patients
- description
- Part 1 will consist of a representative sample of advanced melanoma patients, irrespective of date of diagnosis of stage III unresectable and metastatic/stage IV, to address information objectives on treatment patterns, clinical outcomes, and resource use after the start of treatment post-launch of new drugs, ie, since 2011 for ipi and 2015 for ipi + nivo in advanced melanoma
- interventionNames
- Other: Non-Interventional
- label
- Ipi monotherapy
- description
- Part 2: patients must have been prescribed Ipi monotherapy during the index period between 01-Jan-2015 and 31-May-2016.
- interventionNames
- Other: Non-Interventional
- label
- Ipi + nivo combination therapy
- description
- Part 2: patients must have been prescribed Ipi + nivo combination therapy during the index period between 01-Jan-2015 and 31-May-2016.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Adults 18 years or older * Diagnosis of unresectable stage III and/or metastatic (stage IV) melanoma before 01-Nov-2015 * Initiating a new line of therapy during the index period between 01-Jan-2015 and 31-May-2016, irrespective of advanced melanoma diagnosis date * Medical history available for medical chart abstraction from date of diagnosis through most recent or current therapy (defined as end of data collection period) Exclusion Criteria: * Physicians unwilling or unable to follow study instructions * Patients who were previously enrolled in a cancer treatment-related clinical trial since the diagnosis of unresectable stage III and/or metastatic (stage IV) melanoma
References
Publications (0)
Data not yet available
No reference posted for this study.