Clinical trial · Observational
Real-world Evaluation of the Impact of Baseline Metastases on Clinical Outcomes Among BRAF Positive Metastatic Melanoma Patients
NCT05984615CI-TRIAL-00068706completedClinicalTrials.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 was a retrospective real-world evidence cohort study.
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 |
|---|---|---|---|
| BRAF Positive Metastatic Melanoma | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (2)
- label
- Immunotherapy (IO) Cohort
- label
- Targeted Therapy (TT) Cohort
Primary outcomes (7)
- measure
- Mean age
- timeFrame
- Baseline
- measure
- Number of male patients
- timeFrame
- Baseline
- measure
- Race
- timeFrame
- Baseline
- measure
- Mean Charlson comorbidity index (CCI) score
- timeFrame
- Baseline
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion criteria: * Diagnosis of melanoma (The International Classification of Diseases, 9th Revision \[ICD-9\] 172.x \& 10th revision \[ICD-10\] C43 or D03x). * Pathologic stage IV at initial diagnosis on or after 01 January 2011. * First-line treatment with IO monotherapy or combination therapy (nivolumab, pembrolizumab, ipilimumab + nivolumab) or TT combination therapy (dabrafenib + trametinib, vemurafenib+cobimetinib, encorafenib+binimetinib) on or after 01 January 2014. * Evidence of a BRAF test. * Evidence of a BRAF-positive result prior to or up to 30 days after first-line (1L) therapy initiation. * At least 18 years of age at the time of initiation of 1L treatment. Exclusion criteria: * Documented receipt of a clinical trial treatment for cancer at any time on or after 01 January 2014. * Diagnosis of a second primary cancer or secondary cancer following initiation of 1L metastatic melanoma (MM) treatment.
References
Publications (0)
Data not yet available
No reference posted for this study.