Completed

NCT Number: NCT06557291

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

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.

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Key information

Conditions

BRAF V600 Mutated-Stage III/IV Melanoma

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Novartis Pharmaceuticals

East Hanover, New Jersey, 07936, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

Relapse-free Survival-2 (RFS-2)

Time frame: 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 outcomes

Overall Survival (OS)

Time frame: 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)

Time frame: 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

Time frame: Up to 63 months
Mean Number of Times an AE Related to Dabrafenib and Trametinib Combination Therapy was Experienced

Time frame: Up to 63 months

Sponsors and collaborators

Lead sponsor

Novartis

Industry

Registry information

Official study title

Relapse-Free Survival With Adjuvant Dabrafenib/Trametinib Therapy After Relapse on Adjuvant Checkpoint Inhibitor Therapy and Subsequent Surgical Resection in Patients With BRAF V600-mutated Stage III/IV Melanoma

Important dates

Study start: 2022
Primary completion: 2023
Study completion: 2023
First posted: Aug 16, 2024
Registry last updated: Aug 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.