Phase 3
N=552
Study of Dabrafenib+Trametinib in the Adjuvant Treatment of Stage III BRAF V600+ Melanoma After Complete Resection to Evaluate the Impact on Pyrexia Related Outcomes
Malignant Melanoma
Bottom Line
View on ClinicalTrials.gov: NCT03551626 ↗Enrolled (actual)
552
Serious AEs
21.9%
Results posted
Mar 2024
Primary outcome: Primary: Composite Rate of Pyrexia Related Events — 7.6 Percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Dabrafenib (Drug); Trametinib (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Novartis Pharmaceuticals
- Primary completion
- Oct 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Composite Rate of Pyrexia Related Events |
7.6 | — |
| SECONDARY Relapse Free Survival (RFS) Rate |
91.7; 57.5 | — |
| SECONDARY Overall Survival (OS) Rate |
99.1; 92.6 | — |
| SECONDARY Percentage of Participants Who Required Management of Pyrexia |
24; 210; 13; 29; 339 | — |
| SECONDARY Percentage of Participants Who Permanently Discontinued Treatment Due to Any Adverse Event (AE) |
87 | — |
| SECONDARY Change From Baseline in Subject-reported Quality of Life (QoL) Assessed by Functional Assessment Cancer Therapy - Melanoma Subscale Score (FACT-M MS) |
-2.46; -2.42; -2.26; -2.34; -2.03; -2.19 | — |
Summary
The main purpose of this study was to evaluate the impact on pyrexia-related outcomes of an adapted pyrexia adverse event (AE)-management algorithm, as well as safety, efficacy and health-related outcomes.
Eligibility Criteria
Key Inclusion Criteria
- Completely resected histologically confirmed cutaneous melanoma stage IIIA (LN metastasis >1 mm), IIIB, IIIC, IIID [AJCC (ed 8)] no more than 12 weeks, from last surgery, before Day 1
- Subjects presenting with initial resectable lymph node recurrence after a diagnosis of Stage I or II melanoma were eligible.
- Subjects who had previously had Stage III melanoma at any time were not eligible.
- Recovered from definitive surgery (e.g. no uncontrolled wound infections or indwelling drains).
- V600E/K mutation positive using a validated local test
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1
Key Exclusion Criteria
- Uveal or mucosal melanoma
- Evidence of metastatic disease including unresectable in-transit metastasis
- Received any prior adjuvant or neoadjuvant treatment, including but not limited to chemotherapy, checkpoint inhibitors, targeted therapy [e.g., BRAF and/or MEK inhibitors], biologic therapy, vaccine therapy, investigational treatment, or radiotherapy for melanoma
- Malignant disease, other than that being treated in this study. Exceptions to this exclusion include the following: malignancies that were treated curatively and had not recurred within 2 years prior to study treatment; completely resected basal cell and squamous cell skin cancers and any completely resected carcinoma in situ
- History or current evidence of cardiovascular risk
- A history or current evidence/risk of retinal vein occlusion (RVO) or central serous retinopathy
Data sourced from ClinicalTrials.gov (NCT03551626). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.