Using dabrafenib and trametinib to treat melanoma in Chinese patients after surgery

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

This study is testing if the combination of dabrafenib and trametinib can help Chinese patients with stage III melanoma after surgery to prevent the cancer from coming back.

Quick facts

• Study type: Observational
• Enrollment: 80 (estimated)
• Ages: 18 Years to 100 Years
• Sex: All
• Sponsor: Novartis (Industry-sponsored)
• Drugs / interventions: trametinib
• Locations: 9 sites (Fuzhou, Fujian and 8 other locations)
• Trial ID: NCT04666272 on ClinicalTrials.gov

What this trial studies

This observational study evaluates the effectiveness and safety of dabrafenib in combination with trametinib as an adjuvant treatment for Chinese patients with stage III BRAF V600 mutation-positive melanoma following complete surgical resection. It involves a treatment phase lasting 12 months, during which patients will receive the medications and be monitored for disease recurrence. Patients will be followed up every six months for up to 24 months after treatment ends to assess outcomes and any adverse effects.

Who should consider this trial

Good fit: Ideal candidates are Chinese patients aged 18 and older who have undergone complete resection of stage III BRAF V600 mutation-positive melanoma.

Not a fit: Patients with melanoma that is not BRAF V600 mutation-positive or those who have not undergone complete surgical resection may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could improve disease-free survival rates for patients with stage III BRAF V600 mutation-positive melanoma.

How similar studies have performed: Previous studies have shown positive outcomes with similar combinations of dabrafenib and trametinib in treating BRAF V600 mutation-positive melanoma, indicating a promising approach.

Eligibility criteria

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.

Where this trial is running

Fuzhou, Fujian and 8 other locations

• Novartis Investigative Site — Fuzhou, Fujian, China (Recruiting)
• Novartis Investigative Site — Zhengzhou, Henan, China (Recruiting)
• Novartis Investigative Site — Changsha, Hunan, China (Recruiting)
• Novartis Investigative Site — Nanjing, Jiangsu, China (Recruiting)
• Novartis Investigative Site — Changchun, Jilin, China (Recruiting)
• Novartis Investigative Site — Kunming, Yunnan, China (Recruiting)
• Novartis Investigative Site — Hangzhou, Zhejiang, China (Recruiting)
• Novartis Investigative Site — Beijing, China (Recruiting)
• Novartis Investigative Site — Wuhan, China (Recruiting)

Study contacts

• Study coordinator: Novartis Pharmaceuticals

Conditions Melanoma; BRAF V600 mutation-positive melanoma; cutaneous or mucosal melanoma; China; dabrafenib; trametinib