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

Melanoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04666272
• Other study ID #: CDRB436FCN01
• Status: Recruiting
• Start date: December 31, 2020
• Est. completion date: July 31, 2029

Study information

• Verified date: April 2024
• Source: Novartis
• Contact: Novartis Pharmaceuticals
• Phone: +41613241111
• Email: novartis.email[@]novartis.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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)

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: July 31, 2029
• Est. primary completion date: July 31, 2029
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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.

Related Conditions & MeSH terms

• Melanoma

Intervention

Drug:
• dabrafenib
There is no treatment allocation. Patients administered dabrafenib alone by prescription that have started before inclusion of the patient into the study could be enrolled.
• trametinib
There is no treatment allocation. Patients administered trametinib alone by prescription that have started before inclusion of the patient into the study could be enrolled.

Locations

Country	Name	City	State
China	Novartis Investigative Site	Beijing
China	Novartis Investigative Site	Changchun	Jilin
China	Novartis Investigative Site	Changsha	Hunan
China	Novartis Investigative Site	Fuzhou	Fujian
China	Novartis Investigative Site	Hangzhou	Zhejiang
China	Novartis Investigative Site	Kunming	Yunnan
China	Novartis Investigative Site	Nanjing	Jiangsu
China	Novartis Investigative Site	Wuhan
China	Novartis Investigative Site	Zhengzhou	Henan

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Relapse-free survival (RFS)	Relapse-free survival (RFS), defined as the time from start of treatment to disease recurrence or death due to any cause.	Up to 36 months
Secondary	Overall survival (OS)	Overall survival (OS) defined as the time from start of treatment to death due to any cause	Up to 36 months
Secondary	Safety of dabrafenib in combination with trametinib	Adverse events (AEs) and serious adverse events (SAEs) will be measured	Up to 36 months