Clinical trial · Observational
Treatment Patterns and Outcomes of Targeted Therapy and Immunotherapy Among BRAF-Positive Melanoma Patients Treated in the Adjuvant Setting and Among BRAF-Positive Metastatic Melanoma Patients With Low Tumor Burden
Real-World Treatment Patterns and Outcomes of Targeted Therapy and Immunotherapy Among BRAF-Positive Melanoma Patients Treated in the Adjuvant Setting and Among BRAF-Positive Metastatic Melanoma Patients With Low Tumor Burden: An Observational Study
NCT05611229CI-TRIAL-00065392completedClinicalTrials.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 an observational study utilizing electronic health record (EHR)-derived data collected retrospectively during routine care of real-world patients with advanced melanoma from NOBLE (Novartis Braf+ meLanoma patients ObsErvational) dataset.
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 |
|---|---|---|---|
| Metastatic Melanoma | Melanoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (6)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Dabrafenib+Trametinib | Combination Product | — | UNRESOLVED |
| Encorafenib+Binimetinib | Combination Product | — | UNRESOLVED |
| Ipilimumab+Nivolumab | Combination Product | — | UNRESOLVED |
| Nivolumab | Drug | Nivolumab | ALIAS |
| Pembrolizumab | Drug | Pembrolizumab | ALIAS |
| Vemurafenib+Cobimetinib | Combination Product | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Population 1: BRAF+ melanoma patients treated with either TT or IO in the adjuvant setting
- description
- Included patients were aged more than or equal to 18 years, were required to have a diagnosis of melanoma (ICD-9 172.x \& ICD-10 C43.x or D03.x), pathologic stage III disease, evidence of resection, adjuvant treatment with IO (e.g., nivo or pembro) or TT (e.g., dab+tram) on or after January 1, 2014, and prior to August 30,2020 (data cut-off), and any evidence of a BRAF+ result.
- interventionNames
- Drug: Nivolumab
- Drug: Pembrolizumab
- Combination Product: Dabrafenib+Trametinib
- label
- Population 2: BRAF+ melanoma patients with LTB treated with TT or IO in the metastatic setting
- description
- Included patients were aged more than or equal to 18 years, and were required to have a diagnosis of melanoma (ICD-9 172.x \& ICD-10 C43 or D03x), a pathologic stage IV diagnosis, treatment with IO (e.g. ipi, nivo, pembro, ipi+nivo) or TT (dab+tram, vem+cobi, enco+bini) on or after January 1, 2014 and prior to May 31, 2020 (data cut-off), and evidence of a BRAF+ result after therapy initiation. Patients were required to be classified as LTB at the time of stage IV diagnosis. LTB was defined as having normal LDH and \<3 metastatic sites at the time of stage IV diagnosis.
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: Population 1(patients treated in the adjuvant setting) * Diagnosis of melanoma (ICD-9 172.x \& ICD-10 C43.x or D03.x) * Pathologic stage III on or after 2011 * Evidence of resection * Adjuvant treatment with IO (nivo, pembro) or TT (dab+tram) on or after 1/1/2014 and prior to 8/31/2020 * At least 6 months of follow-up time (until death, end of data cut-off, loss-of-follow-up, or progressed to stage IV diagnosis) from the initiation of therapy * Evidence of a BRAF+ result ≤30 days after therapy initiation in the adjuvant setting * At least 18 years of age at the time of initiation of treatment * No documented receipt of a clinical trial treatment for cancer at any time on or after January 1, 2014 Population 2 (patients with LTB treated in the metastatic setting) * Diagnosis of melanoma (ICD-9 172.x \& ICD-10 C43.x or D03.x) * Pathologic stage IV at initial diagnosis on or after 1/1/2011, or earlier stage disease accompanied by development of a first locoregional recurrence on or after 1/1/2011 * 1L treatment with IO (ipi, nivo, pembro, ipi+nivo) or TT (dab+tram, vemu+cobi, enco+bini) on or after 1/1/2014 and prior to 5/31/2020 * At least 6 months of follow-up time (until death, loss of follow-up, or end of data cut-off) from the initiation of therapy * Evidence of a BRAF+ result ≤30 days after 1L therapy initiation * LTB, defined as having \<3 involved organ sites and normal LDH test (less than upper limit of normal) at the time of receiving MM diagnosis * At least 18 years of age at the time of initiation of 1L treatment * No documented receipt of a clinical trial treatment for cancer at any time on or after 1/1/2014 Exclusion Criteria: None
References
Publications (0)
Data not yet available
No reference posted for this study.