Active — Not RecruitingNot Applicable

Effectiveness and Safety of Dabrafenib in Combination With Trametinib as Adjuvant Treatment for Chinese Patients With Stage III BRAF V600 Mutation-positive Melanoma After Complete Resection

China78 participantsStarted 2020-12-31

Plain-language summary

This is a prospective, open label, single-arm, multicenter, non-interventional study of dabrafenib in combination with trametinib as adjuvant treatment for Chinese patients with stage III BRAF V600 mutation positive melanoma after complete resection.

Who can participate

Age range18 Years – 100 Years

SexALL

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Inclusion criteria

✓. ≥18 years old of age at the time of informed consent and of Chinese descent
✓. Signed written informed consent
✓. Going to receive commercial dabrafenib and trametinib according to approved label
✓. Completely resected histologically confirmed Stage III BRAF V600 mutation positive cutaneous or mucosal melanoma as defined by the following staging systems:
✓. Must be surgically rendered free of disease (defined as the date of the most recent surgery) no more than 12 weeks before enrollment
✓. Recovered from definitive surgery (e.g. no uncontrolled wound infections or indwelling drains)
✓. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1

Exclusion criteria

✕. Known ocular melanoma
✕. Patient received other systemic neo-adjuvant and/or adjuvant therapy for melanoma (including dabrafenib in combination with trametinib started before ICF signature)
✕. Patient is not able to comply with the planned study procedures
✕. Taken an investigational drug within 28 days prior to enrolment
✕. History of another malignancy (including melanoma) or a concurrent malignancy, except malignancies that were treated curatively and have not recurred within 2 years prior to treatment.

What they're measuring

Relapse-free survival (RFS)

Timeframe: Up to 36 months

Trial details

NCT IDNCT04666272

SponsorNovartis Pharmaceuticals

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2028-02-04

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