Register a trial

Please note the ANZCTR will be unattended from Friday 20 December 2024 for the holidays. The Registry will re-open on Tuesday 7 January 2025. Submissions and updates will not be processed during that time.

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01682083




Registration number
NCT01682083
Ethics application status
Date submitted
6/09/2012
Date registered
10/09/2012

Titles & IDs
Public title
Dabrafenib With Trametinib in the Adjuvant Treatment of High-risk BRAF V600 Mutation-positive Melanoma (COMBI-AD).
Scientific title
COMBI-AD: A Phase III Randomized Double Blind Study of Dabrafenib (GSK2118436) in COMBInation With Trametinib (GSK1120212) Versus Two Placebos in the ADjuvant Treatment of High-risk BRAF V600 Mutation-positive Melanoma After Surgical Resection
Secondary ID [1] 0 0
2012-001266-15
Secondary ID [2] 0 0
115532
Universal Trial Number (UTN)
Trial acronym
COMBI-AD
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Melanoma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Malignant melanoma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Dabrafenib
Treatment: Drugs - Trametinib
Treatment: Drugs - Placebos

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

Placebo comparator: Dabrafenib and trametinib placebos - Subjects received matching placebos orally for 12 months


Treatment: Drugs: Dabrafenib
Each capsule contained 50 mg or 75 mg of free base (present as the mesylate salt)

Treatment: Drugs: Trametinib
Each tablet contained 0.5 mg or 2.0 mg of trametinib parent (present as the DMSO solvate)

Treatment: Drugs: Placebos
The placebo capsules and tablets contained the same inactive ingredients and film coatings as the dabrafenib and trametinib study treatment
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Relapse-free Survival (RFS)
Timepoint [1] 0 0
Approximately 3.5 years
Secondary outcome [1] 0 0
Overall Survival
Timepoint [1] 0 0
approximately 3.5 years
Secondary outcome [2] 0 0
Distant Metastasis-free Survival
Timepoint [2] 0 0
approximately 3.5 years
Secondary outcome [3] 0 0
Freedom From Relapse
Timepoint [3] 0 0
approximately 3.5 years

Eligibility
Key inclusion criteria
Key

* Completely resected histologically confirmed high-risk [Stage IIIa (LN metastasis more than 1 mm), IIIb or IIIc cutaneous melanoma determined to be V600E/K mutation positive by a central laboratory. Patients presenting with initial resectable lymph node recurrence after a diagnosis of Stage I or II melanoma are eligible.
* Surgically rendered free of disease no more than 12 weeks before randomization.
* Recovered from definitive surgery (e.g. no uncontrolled wound infections or indwelling drains).
* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1.
* Adequate hematologic, hepatic, renal and cardiac function.

Key
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Known mucosal or ocular melanoma or the presence of unresectable in-transit metastases.
* Evidence of distant metastatic disease.
* Prior systemic anti-cancer treatment and radiotherapy for melanoma; prior surgery for melanoma is allowed.
* History of another malignancy or concurrent malignancy including prior malignant melanoma. Exceptions to this include: Patients who have been disease-free for 5 years or patients with a history completely resected non-melanoma skin cancer or successfully treated in situ carcinoma are eligible, for example cervical cancer in situ, atypical melanocytic hyperplasia or melanoma in situ, multiple primary melanomas, or other malignancies for which the patient has been disease free for > 5 years.
* History or current evidence of cardiovascular risk.
* History or current evidence of retinal vein occlusion (RVO) or central serous retinopathy (CSR)

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
8/01/2013
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
31/07/2023
Sample size
Target
Accrual to date
Final
870
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
Novartis Investigative Site - Gateshead
Recruitment hospital [2] 0 0
Novartis Investigative Site - North Sydney
Recruitment hospital [3] 0 0
Novartis Investigative Site - Tweed Heads
Recruitment hospital [4] 0 0
Novartis Investigative Site - Westmead
Recruitment hospital [5] 0 0
Novartis Investigative Site - Greenslopes
Recruitment hospital [6] 0 0
Novartis Investigative Site - Milton
Recruitment hospital [7] 0 0
Novartis Investigative Site - Woolloongabba
Recruitment hospital [8] 0 0
Novartis Investigative Site - Adelaide
Recruitment hospital [9] 0 0
Novartis Investigative Site - Box Hill
Recruitment hospital [10] 0 0
Novartis Investigative Site - Heidelberg
Recruitment hospital [11] 0 0
Novartis Investigative Site - Melbourne
Recruitment hospital [12] 0 0
Novartis Investigative Site - Nedlands
Recruitment postcode(s) [1] 0 0
2290 - Gateshead
Recruitment postcode(s) [2] 0 0
2060 - North Sydney
Recruitment postcode(s) [3] 0 0
2485 - Tweed Heads
Recruitment postcode(s) [4] 0 0
2145 - Westmead
Recruitment postcode(s) [5] 0 0
4120 - Greenslopes
Recruitment postcode(s) [6] 0 0
4064 - Milton
Recruitment postcode(s) [7] 0 0
4102 - Woolloongabba
Recruitment postcode(s) [8] 0 0
5000 - Adelaide
Recruitment postcode(s) [9] 0 0
3128 - Box Hill
Recruitment postcode(s) [10] 0 0
3084 - Heidelberg
Recruitment postcode(s) [11] 0 0
3004 - Melbourne
Recruitment postcode(s) [12] 0 0
6009 - Nedlands
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
California
Country [4] 0 0
United States of America
State/province [4] 0 0
Colorado
Country [5] 0 0
United States of America
State/province [5] 0 0
Connecticut
Country [6] 0 0
United States of America
State/province [6] 0 0
Florida
Country [7] 0 0
United States of America
State/province [7] 0 0
Georgia
Country [8] 0 0
United States of America
State/province [8] 0 0
Indiana
Country [9] 0 0
United States of America
State/province [9] 0 0
Maryland
Country [10] 0 0
United States of America
State/province [10] 0 0
Massachusetts
Country [11] 0 0
United States of America
State/province [11] 0 0
Michigan
Country [12] 0 0
United States of America
State/province [12] 0 0
New Jersey
Country [13] 0 0
United States of America
State/province [13] 0 0
North Carolina
Country [14] 0 0
United States of America
State/province [14] 0 0
Ohio
Country [15] 0 0
United States of America
State/province [15] 0 0
Oregon
Country [16] 0 0
United States of America
State/province [16] 0 0
Pennsylvania
Country [17] 0 0
United States of America
State/province [17] 0 0
Tennessee
Country [18] 0 0
United States of America
State/province [18] 0 0
Texas
Country [19] 0 0
United States of America
State/province [19] 0 0
Utah
Country [20] 0 0
United States of America
State/province [20] 0 0
Washington
Country [21] 0 0
Argentina
State/province [21] 0 0
Buenos Aires
Country [22] 0 0
Argentina
State/province [22] 0 0
Río Negro
Country [23] 0 0
Argentina
State/province [23] 0 0
Santa Fe
Country [24] 0 0
Argentina
State/province [24] 0 0
Ciudad Autonoma de Buenos Aires
Country [25] 0 0
Austria
State/province [25] 0 0
Graz
Country [26] 0 0
Austria
State/province [26] 0 0
Innsbruck
Country [27] 0 0
Austria
State/province [27] 0 0
Linz
Country [28] 0 0
Austria
State/province [28] 0 0
Salzburg
Country [29] 0 0
Austria
State/province [29] 0 0
Wels
Country [30] 0 0
Austria
State/province [30] 0 0
Wien
Country [31] 0 0
Belgium
State/province [31] 0 0
Brussels
Country [32] 0 0
Belgium
State/province [32] 0 0
Leuven
Country [33] 0 0
Belgium
State/province [33] 0 0
Liege
Country [34] 0 0
Belgium
State/province [34] 0 0
Wilrijk
Country [35] 0 0
Brazil
State/province [35] 0 0
Goiás
Country [36] 0 0
Brazil
State/province [36] 0 0
Paraná
Country [37] 0 0
Brazil
State/province [37] 0 0
Rio Grande Do Sul
Country [38] 0 0
Brazil
State/province [38] 0 0
Rio De Janeiro
Country [39] 0 0
Brazil
State/province [39] 0 0
São Paulo
Country [40] 0 0
Canada
State/province [40] 0 0
Alberta
Country [41] 0 0
Canada
State/province [41] 0 0
Ontario
Country [42] 0 0
Canada
State/province [42] 0 0
Quebec
Country [43] 0 0
Czechia
State/province [43] 0 0
Brno
Country [44] 0 0
Czechia
State/province [44] 0 0
Hradec Kralove
Country [45] 0 0
Czechia
State/province [45] 0 0
Olomouc
Country [46] 0 0
Czechia
State/province [46] 0 0
Praha 10
Country [47] 0 0
Czechia
State/province [47] 0 0
Praha 2
Country [48] 0 0
Czechia
State/province [48] 0 0
Zlin
Country [49] 0 0
Denmark
State/province [49] 0 0
Arhus C
Country [50] 0 0
Denmark
State/province [50] 0 0
Herlev
Country [51] 0 0
Denmark
State/province [51] 0 0
Odense
Country [52] 0 0
France
State/province [52] 0 0
Bordeaux
Country [53] 0 0
France
State/province [53] 0 0
Boulogne-Billancourt
Country [54] 0 0
France
State/province [54] 0 0
Brest cedex
Country [55] 0 0
France
State/province [55] 0 0
Dijon
Country [56] 0 0
France
State/province [56] 0 0
Grenoble
Country [57] 0 0
France
State/province [57] 0 0
Lille
Country [58] 0 0
France
State/province [58] 0 0
Marseille cedex 5
Country [59] 0 0
France
State/province [59] 0 0
Montpellier cedex 5
Country [60] 0 0
France
State/province [60] 0 0
Nice
Country [61] 0 0
France
State/province [61] 0 0
Paris Cedex 10
Country [62] 0 0
France
State/province [62] 0 0
Paris
Country [63] 0 0
France
State/province [63] 0 0
Pierre-Benite cedex
Country [64] 0 0
France
State/province [64] 0 0
Reims Cedex
Country [65] 0 0
France
State/province [65] 0 0
Rennes Cedex
Country [66] 0 0
France
State/province [66] 0 0
Toulouse cedex 9
Country [67] 0 0
France
State/province [67] 0 0
Tours Cedex 9
Country [68] 0 0
France
State/province [68] 0 0
Villejuif cedex
Country [69] 0 0
Germany
State/province [69] 0 0
Baden-Wuerttemberg
Country [70] 0 0
Germany
State/province [70] 0 0
Bayern
Country [71] 0 0
Germany
State/province [71] 0 0
Hessen
Country [72] 0 0
Germany
State/province [72] 0 0
Mecklenburg-Vorpommern
Country [73] 0 0
Germany
State/province [73] 0 0
Niedersachsen
Country [74] 0 0
Germany
State/province [74] 0 0
Nordrhein-Westfalen
Country [75] 0 0
Germany
State/province [75] 0 0
Rheinland-Pfalz
Country [76] 0 0
Germany
State/province [76] 0 0
Saarland
Country [77] 0 0
Germany
State/province [77] 0 0
Sachsen-Anhalt
Country [78] 0 0
Germany
State/province [78] 0 0
Schleswig-Holstein
Country [79] 0 0
Germany
State/province [79] 0 0
Thueringen
Country [80] 0 0
Germany
State/province [80] 0 0
Berlin
Country [81] 0 0
Greece
State/province [81] 0 0
Athens
Country [82] 0 0
Greece
State/province [82] 0 0
Thessaloniki
Country [83] 0 0
Israel
State/province [83] 0 0
Jerusalem
Country [84] 0 0
Israel
State/province [84] 0 0
Ramat Gan
Country [85] 0 0
Italy
State/province [85] 0 0
Lazio
Country [86] 0 0
Italy
State/province [86] 0 0
Liguria
Country [87] 0 0
Italy
State/province [87] 0 0
Lombardia
Country [88] 0 0
Italy
State/province [88] 0 0
Piemonte
Country [89] 0 0
Italy
State/province [89] 0 0
Toscana
Country [90] 0 0
Italy
State/province [90] 0 0
Veneto
Country [91] 0 0
Japan
State/province [91] 0 0
Shizuoka
Country [92] 0 0
Japan
State/province [92] 0 0
Tokyo
Country [93] 0 0
Netherlands
State/province [93] 0 0
Amsterdam
Country [94] 0 0
Netherlands
State/province [94] 0 0
Groningen
Country [95] 0 0
Netherlands
State/province [95] 0 0
Leeuwarden
Country [96] 0 0
Netherlands
State/province [96] 0 0
Maastricht
Country [97] 0 0
Netherlands
State/province [97] 0 0
Nijmegen
Country [98] 0 0
Netherlands
State/province [98] 0 0
Rotterdam
Country [99] 0 0
New Zealand
State/province [99] 0 0
Auckland
Country [100] 0 0
Norway
State/province [100] 0 0
Alesund
Country [101] 0 0
Norway
State/province [101] 0 0
Oslo
Country [102] 0 0
Poland
State/province [102] 0 0
Gdansk
Country [103] 0 0
Poland
State/province [103] 0 0
Konin
Country [104] 0 0
Poland
State/province [104] 0 0
Poznan
Country [105] 0 0
Poland
State/province [105] 0 0
Warszawa
Country [106] 0 0
Russian Federation
State/province [106] 0 0
Chelyabinsk
Country [107] 0 0
Russian Federation
State/province [107] 0 0
Moscow
Country [108] 0 0
Russian Federation
State/province [108] 0 0
Ryazan
Country [109] 0 0
Russian Federation
State/province [109] 0 0
St. Petersburg
Country [110] 0 0
Russian Federation
State/province [110] 0 0
Volgograd
Country [111] 0 0
Spain
State/province [111] 0 0
Badalona
Country [112] 0 0
Spain
State/province [112] 0 0
Barcelona
Country [113] 0 0
Spain
State/province [113] 0 0
Cartagena
Country [114] 0 0
Spain
State/province [114] 0 0
Las Palmas De Gran Canaria
Country [115] 0 0
Spain
State/province [115] 0 0
Madrid
Country [116] 0 0
Spain
State/province [116] 0 0
Malaga
Country [117] 0 0
Spain
State/province [117] 0 0
Palma de Mallorca
Country [118] 0 0
Spain
State/province [118] 0 0
Pamplona
Country [119] 0 0
Spain
State/province [119] 0 0
San Sebastian
Country [120] 0 0
Spain
State/province [120] 0 0
Santander
Country [121] 0 0
Spain
State/province [121] 0 0
Sevilla
Country [122] 0 0
Spain
State/province [122] 0 0
Valencia
Country [123] 0 0
Sweden
State/province [123] 0 0
Goteborg
Country [124] 0 0
Sweden
State/province [124] 0 0
Lund
Country [125] 0 0
Sweden
State/province [125] 0 0
Stockholm
Country [126] 0 0
Sweden
State/province [126] 0 0
Uppsala
Country [127] 0 0
Switzerland
State/province [127] 0 0
Basel
Country [128] 0 0
Switzerland
State/province [128] 0 0
Chur
Country [129] 0 0
Switzerland
State/province [129] 0 0
Zurich
Country [130] 0 0
Taiwan
State/province [130] 0 0
Taichung
Country [131] 0 0
Taiwan
State/province [131] 0 0
Taipei
Country [132] 0 0
Taiwan
State/province [132] 0 0
Taoyuan
Country [133] 0 0
United Kingdom
State/province [133] 0 0
Middlesex
Country [134] 0 0
United Kingdom
State/province [134] 0 0
Exeter
Country [135] 0 0
United Kingdom
State/province [135] 0 0
Glasgow
Country [136] 0 0
United Kingdom
State/province [136] 0 0
Guildford
Country [137] 0 0
United Kingdom
State/province [137] 0 0
Leeds
Country [138] 0 0
United Kingdom
State/province [138] 0 0
London
Country [139] 0 0
United Kingdom
State/province [139] 0 0
Manchester
Country [140] 0 0
United Kingdom
State/province [140] 0 0
Newcastle upon Tyne
Country [141] 0 0
United Kingdom
State/province [141] 0 0
Norwich
Country [142] 0 0
United Kingdom
State/province [142] 0 0
Preston
Country [143] 0 0
United Kingdom
State/province [143] 0 0
Southampton

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Novartis Pharmaceuticals
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Novartis Pharmaceuticals
Address 0 0
Novartis Pharmaceuticals
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT01682083