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Clinical Trial Finder

Search Results

Adjuvant Dabrafenib and Trametinib Treatment in Patients With Completely Resected High-risk Stage III Melanoma.

Study Purpose

Non-interventional (observational) cohort prospective real life study with primary and secondary data collection from patients on adjuvant treatment with dabrafenib + trametinib in patients with completely resected high-risk stage III (stage IIIA [lymph node > 1mm], IIIB, IIIC and IIID according to AJCC 8th edition) melanoma in Turkey.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Observational
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - Patients with complete surgical resection of histologically confirmed AJCC (8th edition) clinical stage III (stage IIIA [lymph node > 1mm],, IIIB, IIIC, IIID) melanoma, in whom a decision for adjuvant treatment with dabrafenib and trametinib has been made before entering the study; - V600E mutation-positive cutaneous melanoma; - ≥ 18 years of age; - Written informed consent signed.

Exclusion Criteria:

  • - Lack of basic demographic and staging data.
  • - Current active participation in an interventional clinical trial for treatment of melanoma.
  • - Pregnancy or breastfeeding women.
  • - Current primary diagnosis of a cancer other than melanoma, that requires systemic or other treatment.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04961619
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Novartis Pharmaceuticals
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Novartis Pharmaceuticals
Principal Investigator Affiliation Novartis Pharmaceuticals
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries Turkey
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Melanoma
Additional Details

The prospective registration of completely resected high-risk stage III melanoma patients treated with dabrafenib and trametinib in the adjuvant setting will be based on collaboration with centers of excellence on melanoma patients treatment. Pre-identified centers (up to 12) considered as the most advanced according to their knowledge and experience, will take part in the patients recruitment.

Arms & Interventions

Arms

: dabrafenib and trametinib

patients on adjuvant treatment with dabrafenib + trametinib

Interventions

Drug: - dabrafenib

There is no treatment allocation. Patients administered dabrafenib by prescription that have started before inclusion of the patient into the study will be enrolled.

Drug: - trametinib

There is no treatment allocation. Patients administered trametinib by prescription that have started before inclusion of the patient into the study will be enrolled.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Novartis Investigative Site, Bursa, Gorukle, Turkey

Status

Recruiting

Address

Novartis Investigative Site

Bursa, Gorukle, 16059

Site Contact

[email protected]

+41613241111

Novartis Investigative Site, Ankara, Turkey

Status

Recruiting

Address

Novartis Investigative Site

Ankara, , 06520

Site Contact

[email protected]

+41613241111

Novartis Investigative Site, Ankara, Turkey

Status

Recruiting

Address

Novartis Investigative Site

Ankara, , 06680

Site Contact

[email protected]

+41613241111

Novartis Investigative Site, Antalya, Turkey

Status

Recruiting

Address

Novartis Investigative Site

Antalya, , 07059

Site Contact

[email protected]

+41613241111

Novartis Investigative Site, Diyarbakir, Turkey

Status

Recruiting

Address

Novartis Investigative Site

Diyarbakir, , 21000

Site Contact

[email protected]

+41613241111

Novartis Investigative Site, Edirne, Turkey

Status

Recruiting

Address

Novartis Investigative Site

Edirne, , 22030

Site Contact

[email protected]

+41613241111

Novartis Investigative Site, Istanbul, Turkey

Status

Recruiting

Address

Novartis Investigative Site

Istanbul, , 34668

Site Contact

[email protected]

+41613241111

Novartis Investigative Site, Istanbul, Turkey

Status

Recruiting

Address

Novartis Investigative Site

Istanbul, ,

Site Contact

[email protected]

+41613241111

Novartis Investigative Site, Izmir, Turkey

Status

Recruiting

Address

Novartis Investigative Site

Izmir, , 35040

Site Contact

[email protected]

+41613241111

Novartis Investigative Site, Kecioren Ankara, Turkey

Status

Recruiting

Address

Novartis Investigative Site

Kecioren Ankara, , 06010

Site Contact

[email protected]

+41613241111

Resources

  • Patient and Caregiver Survey
  • Clinical Trial Endpoints
  • Research Resources
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The content provided on clinical trials is for informational purposes only and is not a substitute for medical consultation with your healthcare provider. We do not recommend or endorse any specific study and you are advised to discuss the information shown with your healthcare provider. While we believe the information presented on this website to be accurate at the time of writing, we do not guarantee that its contents are correct, complete, or applicable to any particular individual situation. We strongly encourage individuals to seek out appropriate medical advice and treatment from their physicians. We cannot guarantee the availability of any clinical trial listed and will not be responsible if you are considered ineligible to participate in a given clinical trial. We are also not liable for any injury arising as a result of participation.

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