Dabrafenib With Trametinib in the Adjuvant Treatment of High-risk BRAF V600 Mutation-positive Melanoma (COMBI-AD). (COMBI-AD)
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| ClinicalTrials.gov Identifier: NCT01682083 |
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Recruitment Status :
Completed
First Posted : September 10, 2012
Results First Posted : September 26, 2018
Last Update Posted : August 30, 2023
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Sponsor:
Novartis Pharmaceuticals
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
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| Study Type | Interventional |
|---|---|
| Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Treatment |
| Condition |
Melanoma |
| Interventions |
Drug: Dabrafenib Drug: Trametinib Drug: Placebos |
| Enrollment | 870 |
Participant Flow
| Recruitment Details | The study was conducted in 169 centers across 25 countries. Results reported have the data cut-off as of 30 June 2017. |
| Pre-assignment Details | Patients with completely resected, histologically confirmed, BRAF V600E/K mutation-positive, high-risk [Stage IIIA (lymph node metastasis >1 mm), IIIB, or IIIC] cutaneous melanoma. |
| Arm/Group Title | Dabrafenib and Trametinib Combination Therapy | Dabrafenib and Trametinib Placebos |
|---|---|---|
 Arm/Group Description |
Subjects received dabrafenib (150 mg twice daily) and trametinib (2 mg once daily) orally for 12 months. | Subjects received matching placebos orally for 12 months |
| Period Title: Overall Study | ||
| Started | 438 | 432 |
| Completed | 331 [1] | 277 [2] |
| Not Completed | 107 | 155 |
| Reason Not Completed | ||
| Lost to Follow-up | 11 | 18 |
| Withdrawal by Subject | 31 | 40 |
| Death | 60 | 93 |
| Physician Decision | 5 | 4 |
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[1]
Ongoing patients at the time of data cut-off. 3 patients were untreated
[2]
Ongoing patients at the time of data cut-off.
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Baseline Characteristics
| Arm/Group Title | Dabrafenib and Trametinib Combination Therapy | Dabrafenib and Trametinib Placebos | Total | |
|---|---|---|---|---|
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Arm/Group Description |
Subjects received dabrafenib (150 mg twice daily) and trametinib (2 mg once daily) orally for 12 months. | Subjects received matching placebos orally for 12 months | Total of all reporting groups | |
| Overall Number of Baseline Participants | 438 | 432 | 870 | |
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Baseline Analysis Population Description |
The Intent-to-Treat Population (ITT) consisted of all randomized patients whether or not randomized treatment was administered.
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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| Number Analyzed | 438 participants | 432 participants | 870 participants | |
| 50.4 (14.17) | 50.5 (13.14) | 50.4 (13.66) | ||
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Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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| Number Analyzed | 438 participants | 432 participants | 870 participants | |
| Female |
195 44.5%
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193 44.7%
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388 44.6%
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| Male |
243 55.5%
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239 55.3%
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482 55.4%
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Race/Ethnicity, Customized
Measure Type: Count of Participants Unit of measure: Participants |
Number Analyzed | 438 participants | 432 participants | 870 participants |
| White |
432 98.6%
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427 98.8%
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859 98.7%
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| Asian |
6 1.4%
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5 1.2%
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11 1.3%
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Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts
the PI's rights to discuss or publish trial results after the trial is completed.
The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (ie, data from all sites) in the clinical trial.
Results Point of Contact
| Name/Title: | Study Director |
| Organization: | Novartis Pharmaceuticals |
| Phone: | 862-778-8300 |
| EMail: | Novartis.email@novartis.com |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Novartis ( Novartis Pharmaceuticals ) |
| ClinicalTrials.gov Identifier: | NCT01682083 |
| Other Study ID Numbers: |
115532 2012-001266-15 ( EudraCT Number ) CDRB436F2301 ( Other Identifier: Novartis ) |
| First Submitted: | September 6, 2012 |
| First Posted: | September 10, 2012 |
| Results First Submitted: | May 29, 2018 |
| Results First Posted: | September 26, 2018 |
| Last Update Posted: | August 30, 2023 |