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

Recruiting

• Conditions: Melanoma
• Interventions: Drug: dabrafenib; Drug: trametinib

• Registration Number: NCT04666272
• Lead Sponsor: Novartis Pharmaceuticals

Brief 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.

Detailed Description

The study will consist of a treatment phase and follow-up phase. The treatment period is 12 months. Discontinuation of study treatment may occur earlier than 12 months for disease recurrence, death, unacceptable toxicity or withdrawal of consent. Patients will be followed for disease recurrence every 6 months and up to 24 months after the end of treatment (EOT)

Study Timeline

• Study First Submitted: 2020-12-07
• Study First Submitted QC: 2020-12-07
• Study First Posted: 2020-12-14
• Study Start: 2020-12-31
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-21
• Last Update Posted: 2024-06-24
• Primary Completion: 2029-07-31
• Study Completion: 2029-07-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

Patient(s) must meet all of the following criteria to be eligible for inclusion:

1. ≥18 years old of age at the time of informed consent and of Chinese descent

2. Signed written informed consent

3. Going to receive commercial dabrafenib and trametinib according to approved label

4. Completely resected histologically confirmed Stage III BRAF V600 mutation positive cutaneous or mucosal melanoma as defined by the following staging systems:

   • for stage III cutaneous melanoma: as per American Joint Committee on Cancer (AJCC) 8th edition for melanoma
   • for stage III mucosal melanoma of the head and neck origin: as per AJCC 8th edition for mucosal melanoma of the head and neck
   • for stage III mucosal melanoma of anal canal, rectum and genital track origin: as per Chinese guidelines on the diagnosis and treatment of melanoma 2019 edition

5. Must be surgically rendered free of disease (defined as the date of the most recent surgery) no more than 12 weeks before enrollment

6. Recovered from definitive surgery (e.g. no uncontrolled wound infections or indwelling drains)

7. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1

Exclusion Criteria

Patient will be excluded from this study if he/she meets any of the following criteria:

1. Known ocular melanoma
2. Patient received other systemic neo-adjuvant and/or adjuvant therapy for melanoma (including dabrafenib in combination with trametinib started before ICF signature)
3. Patient is not able to comply with the planned study procedures
4. Taken an investigational drug within 28 days prior to enrolment
5. 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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
dabrafenib in combination with trametinib as adjuvant treatment	dabrafenib	Patients will be treated according to the China package insert for dabrafenib and trametinib. The approved starting doses of dabrafenib (150 mg twice daily) and trametinib (2 mg once daily) will be used.
dabrafenib in combination with trametinib as adjuvant treatment	trametinib	Patients will be treated according to the China package insert for dabrafenib and trametinib. The approved starting doses of dabrafenib (150 mg twice daily) and trametinib (2 mg once daily) will be used.

Primary Outcome Measures

Name	Time	Method
Relapse-free survival (RFS)	Up to 36 months	Relapse-free survival (RFS), defined as the time from start of treatment to disease recurrence or death due to any cause.

Secondary Outcome Measures

Name	Time	Method
Overall survival (OS)	Up to 36 months	Overall survival (OS) defined as the time from start of treatment to death due to any cause
Safety of dabrafenib in combination with trametinib	Up to 36 months	Adverse events (AEs) and serious adverse events (SAEs) will be measured

Trial Locations

Locations (1)

Novartis Investigative Site; 🇨🇳 Wuhan, China