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Dabrafenib for Melanoma (COMBI-AD Trial)

Phase 3

Waitlist Available

Research Sponsored by Novartis Pharmaceuticals

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up approximately 3.5 years

Awards & highlights

COMBI-AD Trial Summary

This trial was testing whether a combination of two drugs was better than placebos at preventing melanoma from coming back in people who had surgery to remove the cancer.

COMBI-AD Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ approximately 3.5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~approximately 3.5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and approximately 3.5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Relapse-free Survival (RFS)

Secondary outcome measures

Distant Metastasis-free Survival

Freedom From Relapse

Overall Survival

COMBI-AD Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Dabrafenib and trametinibExperimental Treatment2 Interventions

Subjects received dabrafenib (150 mg twice daily) and trametinib (2 mg once daily) orally for 12 months.

Group II: Dabrafenib and trametinib placebosPlacebo Group1 Intervention

Subjects received matching placebos orally for 12 months

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Dabrafenib

FDA approved

Trametinib

FDA approved

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Novartis PharmaceuticalsLead Sponsor

2,855 Previous Clinical Trials

4,196,480 Total Patients Enrolled

51 Trials studying Melanoma

30,033 Patients Enrolled for Melanoma

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Could you please describe any adverse effects of Dabrafenib?

"Dabrafenib's safety is based on its efficacy data from Phase 3 trials, and it has thus been given a score of 3."

Answered by AI

Are there many different sites conducting this research in Canada?

"This study, which is currently looking for participants, has 34 sites. These locations include Pittsburgh, Ottawa and Oshawa as well as 31 other cities. If you are selected to participate, it would be advantageous to select a site close to your home to reduce travel burden."

Answered by AI

Are there any unfilled participant roles in this clinical trial at the moment?

"As of September 14th, 2022, this trial is no longer recruiting patients. It was initially posted on 8 January, 2013. If you are looking for similar studies, 781 trials for melanoma and 99 Dabrafenib studies are still enrolling participants."

Answered by AI

Could you please list other instances where Dabrafenib has been tested?

"Dabrafenib was first researched in 2012 by the University of Chicago Medical Center. Since then, there have been 327 completed clinical trials and 99 ongoing studies. A large proportion of these active trials are based in Pittsburgh and Ontario."

Answered by AI

How many people total are included in this research project?

"Currently, this study is not looking for new patients to participate. The original posting was on 1/8/2013 and the most recent update was on 9/14/2022. There are 781 other trials related to melanoma and 99 studies involving Dabrafenib that are currently admitting new participants."

Answered by AI

Recent research and studies

The Lancet OncologyJournal

Adjuvant Dabrafenib Plus Trametinib Versus Placebo in Patients with Resected, Brafv600-mutant, Stage III Melanoma (COMBI-AD): Exploratory Biomarker Analyses from a Randomised, Phase 3 Trial

Dummer, Reinhard, Jan C Brase, James Garrett, Catarina D Campbell, Eduard Gasal, Matthew Squires, Daniel Gusenleitner, et al.. 2020. “Adjuvant Dabrafenib Plus Trametinib Versus Placebo in Patients with Resected, Brafv600-mutant, Stage III Melanoma (COMBI-AD): Exploratory Biomarker Analyses from a Randomised, Phase 3 Trial”. The Lancet Oncology. Elsevier BV. doi:10.1016/s1470-2045(20)30062-0.

European Journal of CancerJournal

Pyrexia in Patients Treated with Dabrafenib Plus Trametinib Across Clinical Trials in Braf-mutant Cancers

Schadendorf, Dirk, Caroline Robert, Reinhard Dummer, Keith T. Flaherty, Hussein A. Tawbi, Alexander M. Menzies, Hiya Banerjee, Mike Lau, and Georgina V. Long. 2021. “Pyrexia in Patients Treated with Dabrafenib Plus Trametinib Across Clinical Trials in Braf-mutant Cancers”. European Journal of Cancer. Elsevier BV. doi:10.1016/j.ejca.2021.05.005.

The Lancet OncologyJournal

Patient-reported Outcomes in Patients with Resected, High-risk Melanoma with BRAFV600E or BRAFV600K Mutations Treated with Adjuvant Dabrafenib Plus Trametinib (COMBI-AD): A Randomised, Placebo-controlled, Phase 3 Trial

Schadendorf, Dirk, Axel Hauschild, Mario Santinami, Victoria Atkinson, Mario Mandalà, Vanna Chiarion-Sileni, James Larkin, et al.. 2019. “Patient-reported Outcomes in Patients with Resected, High-risk Melanoma with BRAFV600E or BRAFV600K Mutations Treated with Adjuvant Dabrafenib Plus Trametinib (COMBI-AD): A Randomised, Placebo-controlled, Phase 3 Trial”. The Lancet Oncology. Elsevier BV. doi:10.1016/s1470-2045(18)30940-9.

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