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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

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ClinicalTrials.gov Identifier: NCT04666272
Recruitment Status : Recruiting
First Posted : December 14, 2020
Last Update Posted : March 18, 2022
Sponsor:
Information provided by (Responsible Party):
Novartis ( 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.

Condition or disease Intervention/treatment
Melanoma Drug: dabrafenib Drug: trametinib

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)

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Study Type : Observational
Estimated Enrollment : 150 participants
Observational Model: Cohort
Time Perspective: Prospective
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
Actual Study Start Date : December 31, 2020
Estimated Primary Completion Date : December 31, 2026
Estimated Study Completion Date : December 31, 2026

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Melanoma
MedlinePlus related topics: Melanoma

Group/Cohort Intervention/treatment
dabrafenib in combination with trametinib as adjuvant treatment
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.
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.

Drug: 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.




Primary Outcome Measures :
  1. Relapse-free survival (RFS) [ Time Frame: 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 :
  1. Overall survival (OS) [ Time Frame: Up to 36 months ]
    Overall survival (OS) defined as the time from start of treatment to death due to any cause

  2. Safety of dabrafenib in combination with trametinib [ Time Frame: Up to 36 months ]
    Adverse events (AEs) and serious adverse events (SAEs) will be measured



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
This study will include Chinese patients with stage III BRAF V600 mutation positive melanoma treated with dabrafenib in combination with trametinib in a commercial setting.
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04666272


Contacts
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Contact: Novartis Pharmaceuticals +41613241111 novartis.email@novartis.com
Contact: Novartis Pharmaceuticals

Locations
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China, Henan
Novartis Investigative Site Recruiting
Zhengzhou, Henan, China, 410100
China, Hunan
Novartis Investigative Site Recruiting
Changsha, Hunan, China, 410013
China, Jiangsu
Novartis Investigative Site Recruiting
Nanjing, Jiangsu, China, 210008
China, Jilin
Novartis Investigative Site Recruiting
Changchun, Jilin, China, 130022
China, Zhejiang
Novartis Investigative Site Recruiting
Hangzhou, Zhejiang, China, 310022
China
Novartis Investigative Site Recruiting
Beijing, China, 100036
Novartis Investigative Site Recruiting
Wuhan, China, 430022
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
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Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
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Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT04666272    
Other Study ID Numbers: CDRB436FCN01
First Posted: December 14, 2020    Key Record Dates
Last Update Posted: March 18, 2022
Last Verified: March 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Novartis ( Novartis Pharmaceuticals ):
BRAF V600 mutation-positive melanoma
cutaneous or mucosal melanoma
China
dabrafenib
trametinib
Additional relevant MeSH terms:
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Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas
Trametinib
Dabrafenib
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action