Relapse-Free Survival With Adjuvant Dabrafenib/Trametinib Therapy in Patients With BRAF V600-mutated Stage III/IV Melanoma

Completed

• Conditions: BRAF V600 Mutated-Stage III/IV Melanoma

• Registration Number: NCT06557291
• Lead Sponsor: Novartis

Brief Summary

This was a retrospective chart review study of all proto-oncogene B-Raf (BRAF) V600-mutated patients who received adjuvant checkpoint inhibitor (CPI) therapy, relapsed locoregionally or distantly, and were again resected to no evidence of disease (NED) and treated with adjuvant dabrafenib and trametinib (dab/tram) combination therapy.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-10-04
• Primary Completion: 2023-11-16
• Study Completion: 2023-11-16
• Status Verified: 2024-08
• Study First Submitted: 2024-08-13
• Study First Submitted QC: 2024-08-13
• Last Update Submitted: 2024-08-13
• Study First Posted: 2024-08-16
• Last Update Posted: 2024-08-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 38

Inclusion Criteria

• Any patient at least 18 years of age at the time of diagnosis of stage III/IV melanoma.
• Received surgical resection with no residual disease following initial stage III/IV melanoma diagnosis.
• Documented local or central assay-positive for tumor BRAF V600E/K mutation.
• Received adjuvant CPI alone or in combination with any other immune treatment as their first adjuvant therapy.
• Following adjuvant CPI, relapsed (locoregionally or distantly) on or off treatment and was again rendered free of disease after subsequent surgical resection.
• Received additional adjuvant dab/tram combination therapy after failing adjuvant CPI and being subsequently resected to NED.

Exclusion Criteria

• Previous administration of any BRAF- or mitogen-activated protein kinase (MEK)-targeted therapies.
• More than 120 days duration between surgery to render the patient NED after relapsing during or after adjuvant CPI therapy and initiation of dab/tram adjuvant therapy.
• Administration of any intervening antitumor medical and/or radiation therapy between failing adjuvant CPI and initiation of adjuvant dab/tram.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Relapse-free Survival-2 (RFS-2)	Up to 63 months	RFS-2 was defined as the time from the study index date until the date of the earliest clinician-documented disease progression, death, or start of a new line of anticancer treatment due to disease progression. Patients without a progression event as described above were censored at the last available follow-up, defined as last known clinic visit or last known contact with the patient (if occurred outside the clinic setting).; Index date was defined as the date that dab/tram combination therapy was initiated after being rendered disease-free for a second time following additional resection after prior relapse on initial CPI adjuvant therapy.

Secondary Outcome Measures

Name	Time	Method
Mean Number of Times an AE Related to Dabrafenib and Trametinib Combination Therapy was Experienced	Up to 63 months
Overall Survival (OS)	Up to 63 months	OS was defined as the time from the study index date until death due to any cause. Patients without a death event were censored at last available follow-up, defined as last known clinic visit or last known contact with the patient (if occurred outside the clinic setting).; Index date was defined as the date that dab/tram combination therapy was initiated after being rendered disease-free for a second time following additional resection after prior relapse on initial CPI adjuvant therapy.
Distant Metastases-free Survival (DMFS)	Up to 63 months	DMFS was defined as the time from the study index date until the first observation of disease progression with distant metastasis. Patients without a DMFS event as described above were censored at last available follow-up, defined as last known clinic visit or last known contact with the patient (if occurred outside the clinic setting).; Index date was defined as the date that dab/tram combination therapy was initiated after being rendered disease-free for a second time following additional resection after prior relapse on initial CPI adjuvant therapy.
Number of Patients with an Adverse Event (AE) Related to Dabrafenib and Trametinib Combination Therapy	Up to 63 months

Trial Locations

Locations (1)

Novartis Pharmaceuticals; 🇺🇸 East Hanover, New Jersey, United States