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A Study Comparing Trametinib and Dabrafenib Combination Therapy to Dabrafenib Monotherapy in Subjects With BRAF-mutant Melanoma

NCT ID: NCT01584648

Last Updated: 2021-02-17

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

423 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-05-04

Study Completion Date

2019-02-28

Brief Summary

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This was a two-arm, double-blinded, randomized, Phase III study comparing dabrafenib and trametinib combination therapy to dabrafenib administered with a placebo (dabrafenib monotherapy). Subjects with histologically confirmed cutaneous melanoma that is either Stage IIIC (unresectable) or Stage IV, and BRAF V600E/K mutation positive were screened for eligibility. Subjects who had prior systemic anti-cancer treatment in the advanced or metastatic setting were not eligible although prior systemic treatment in the adjuvant setting was allowed. Subjects were stratified according to the baseline lactate dehydrogenase level and BRAF genotype.

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Detailed Description

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Dabrafenib and trametinib was administered orally at their recommended monotherapy doses of 150 mg b.i.d and 2 mg q.d., respectively. Subjects in the combination therapy arm received both agents; subjects in the dabrafenib monotherapy arm received dabrafenib and placebo. Treatment was continued in both arms until disease progression, death, unacceptable toxicity, or withdrawal of consent.

After treatment discontinuation, subjects were followed for survival and disease progression as applicable to collect data for the secondary objective of overall survival (OS).

Crossover to the combination therapy arm was allowed for subjects still receiving study treatment on the dabrafenib monotherapy arm after the positive result for the final OS analysis.

Conditions

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Melanoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Dabrafenib + Trametinib

Dabrafenib and Trametinib combination

Group Type EXPERIMENTAL

Dabrafenib

Intervention Type DRUG

Dabrafenib 150 mg twice daily

Trametinib

Intervention Type DRUG

Trametinib 2 mg once daily

Dabrafenib + Placebo

Dabrafenib and Trametinib placebo

Group Type ACTIVE_COMPARATOR

Dabrafenib

Intervention Type DRUG

Dabrafenib 150 mg twice daily

Trametinib placebo

Intervention Type DRUG

Dabrafenib 150 mg twice daily and trametinib placebo

Interventions

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Dabrafenib

Dabrafenib 150 mg twice daily

Intervention Type DRUG

Trametinib

Trametinib 2 mg once daily

Intervention Type DRUG

Trametinib placebo

Dabrafenib 150 mg twice daily and trametinib placebo

Intervention Type DRUG

Other Intervention Names

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GSK2118436 GSK1120212 Placebo

Eligibility Criteria

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Inclusion Criteria

* Histologically confirmed cutaneous melanoma that is either Stage IIIC (unresectable) or Stage IV (metastatic), and determined to be BRAF V600E/K mutation-positive using the bioMerieux (bMx) investigational use only (IUO) THxID BRAF Assay (IDE: G120011). The assay will be conducted by a central reference laboratory. Subjects with ocular or mucosal melanoma are not eligible.
* The subject must have a radiologically measurable tumor
* The subject is able to carry out daily life activities without significant difficulty (ECOG performance status score of 0 or 1).
* Able to swallow and retain oral medication
* Sexually active subjects must use acceptable methods of contraception during the course of the study
* Adequate organ system function and blood counts

Exclusion Criteria

* Prior treatment with a BRAF or a MEK inhibitor
* Prior systemic anti-cancer treatment for Stage IIIC (unresectable) or Stage IV (metastatic) melanoma. Prior systemic treatment in the adjuvant setting is allowed. (Note: Ipilimumab treatment must end at least 8 weeks prior to randomization.)
* The subject has received major surgery or certain tyes of cancer therapy with 21 days of starting treatment
* Current use of prohibited medication listed in the protocol
* Left ventricular ejection fraction less than the lower limit of normal
* Uncontrolled blood pressurl
* History or current evidence of retinal vein occlusion or central serous retinopathy
* Brain metastases unless previously treated with surgery or stereotactic radiosurgery and the disease has been stable for at least 12 weeks
* The subject is pregnant or nursing
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

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Novartis Investigative Site

Scottsdale, Arizona, United States

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Tucson, Arizona, United States

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Los Angeles, California, United States

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Fort Myers, Florida, United States

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St. Petersburg, Florida, United States

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Tampa, Florida, United States

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West Palm Beach, Florida, United States

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Peoria, Illinois, United States

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Indianapolis, Indiana, United States

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Boston, Massachusetts, United States

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Boston, Massachusetts, United States

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New York, New York, United States

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Cincinnati, Ohio, United States

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Philadelphia, Pennsylvania, United States

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Columbia, South Carolina, United States

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Chattanooga, Tennessee, United States

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Nashville, Tennessee, United States

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Fort Worth, Texas, United States

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Richmond, Virginia, United States

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CABA, Buenos Aires, Argentina

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Capital Federal, Buenos Aires, Argentina

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Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina

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North Sydney, New South Wales, Australia

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Westmead, New South Wales, Australia

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Woolloongabba, Queensland, Australia

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Adelaide, South Australia, Australia

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Heidelberg, Victoria, Australia

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Nedlands, Western Australia, Australia

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Edmonton, Alberta, Canada

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Hamilton, Ontario, Canada

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London, Ontario, Canada

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Toronto, Ontario, Canada

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Montreal, Quebec, Canada

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Montreal, Quebec, Canada

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Bordeaux, , France

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Boulogne-Billancourt, , France

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Lyon, , France

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Marseille, , France

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Paris, , France

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Paris, , France

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Paris, , France

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Toulouse, , France

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Vandœuvre-lès-Nancy, , France

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Heidelberg, Baden-Wurttemberg, Germany

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Heilbronn, Baden-Wurttemberg, Germany

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Mannheim, Baden-Wurttemberg, Germany

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Tübingen, Baden-Wurttemberg, Germany

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Ulm, Baden-Wurttemberg, Germany

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Augsburg, Bavaria, Germany

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Erlangen, Bavaria, Germany

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Munich, Bavaria, Germany

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Munich, Bavaria, Germany

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Munich, Bavaria, Germany

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Nuremberg, Bavaria, Germany

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Regensburg, Bavaria, Germany

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Würzburg, Bavaria, Germany

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Darmstadt, Hesse, Germany

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Marburg, Hesse, Germany

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Buxtehude, Lower Saxony, Germany

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Hanover, Lower Saxony, Germany

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Bonn, North Rhine-Westphalia, Germany

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Cologne, North Rhine-Westphalia, Germany

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Essen, North Rhine-Westphalia, Germany

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Mainz, Rhineland-Palatinate, Germany

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Homburg, Saarland, Germany

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Dresden, Saxony, Germany

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Leipzig, Saxony, Germany

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Magdeburg, Saxony-Anhalt, Germany

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Kiel, Schleswig-Holstein, Germany

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Lübeck, Schleswig-Holstein, Germany

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Erfurt, Thuringia, Germany

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Gera, Thuringia, Germany

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Jena, Thuringia, Germany

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Berlin, , Germany

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Athens, , Greece

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N. Faliro, , Greece

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Thessaloniki, , Greece

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Rome, Lazio, Italy

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Rome, Lazio, Italy

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Genoa, Liguria, Italy

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Bergamo, Lombardy, Italy

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Milan, Lombardy, Italy

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Milan, Lombardy, Italy

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Candiolo (TO), Piedmont, Italy

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Padua, Veneto, Italy

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Amsterdam, , Netherlands

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Amsterdam, , Netherlands

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Zwolle, , Netherlands

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Kazan', , Russia

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Moscow, , Russia

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Saint Petersburg, , Russia

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Stavropol, , Russia

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Barcelona, , Spain

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Barcelona, , Spain

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Madrid, , Spain

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Madrid, , Spain

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Madrid, , Spain

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Pamplona, , Spain

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Valencia, , Spain

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Gothenburg, , Sweden

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Lund, , Sweden

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Stockholm, , Sweden

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Uppsala, , Sweden

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Dnipropetrovsk, , Ukraine

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Dnipropetrovsk, , Ukraine

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Donetsk, , Ukraine

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Khmelnytskyi, , Ukraine

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Kyiv, , Ukraine

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Lviv, , Ukraine

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Sumy, , Ukraine

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Northwood, Middlesex, United Kingdom

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Sutton, Surrey, United Kingdom

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Aberdeen, , United Kingdom

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Bebington, , United Kingdom

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Edgbaston, Birmingham, , United Kingdom

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Leeds, , United Kingdom

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London, , United Kingdom

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Newcastle upon Tyne, , United Kingdom

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Nottingham, , United Kingdom

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Oxford, , United Kingdom

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Preston, , United Kingdom

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Countries

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United States Argentina Australia Canada France Germany Greece Italy Netherlands Russia Spain Sweden Ukraine United Kingdom

References

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Schadendorf D, Robert C, Dummer R, Flaherty KT, Tawbi HA, Menzies AM, Banerjee H, Lau M, Long GV. Pyrexia in patients treated with dabrafenib plus trametinib across clinical trials in BRAF-mutant cancers. Eur J Cancer. 2021 Aug;153:234-241. doi: 10.1016/j.ejca.2021.05.005. Epub 2021 Jul 2.

Reference Type DERIVED
PMID: 34225229 (View on PubMed)

Syeda MM, Wiggins JM, Corless BC, Long GV, Flaherty KT, Schadendorf D, Nathan PD, Robert C, Ribas A, Davies MA, Grob JJ, Gasal E, Squires M, Marker M, Garrett J, Brase JC, Polsky D. Circulating tumour DNA in patients with advanced melanoma treated with dabrafenib or dabrafenib plus trametinib: a clinical validation study. Lancet Oncol. 2021 Mar;22(3):370-380. doi: 10.1016/S1470-2045(20)30726-9. Epub 2021 Feb 12.

Reference Type DERIVED
PMID: 33587894 (View on PubMed)

Robert C, Grob JJ, Stroyakovskiy D, Karaszewska B, Hauschild A, Levchenko E, Chiarion Sileni V, Schachter J, Garbe C, Bondarenko I, Gogas H, Mandala M, Haanen JBAG, Lebbe C, Mackiewicz A, Rutkowski P, Nathan PD, Ribas A, Davies MA, Flaherty KT, Burgess P, Tan M, Gasal E, Voi M, Schadendorf D, Long GV. Five-Year Outcomes with Dabrafenib plus Trametinib in Metastatic Melanoma. N Engl J Med. 2019 Aug 15;381(7):626-636. doi: 10.1056/NEJMoa1904059. Epub 2019 Jun 4.

Reference Type DERIVED
PMID: 31166680 (View on PubMed)

Long GV, Grob JJ, Nathan P, Ribas A, Robert C, Schadendorf D, Lane SR, Mak C, Legenne P, Flaherty KT, Davies MA. Factors predictive of response, disease progression, and overall survival after dabrafenib and trametinib combination treatment: a pooled analysis of individual patient data from randomised trials. Lancet Oncol. 2016 Dec;17(12):1743-1754. doi: 10.1016/S1470-2045(16)30578-2. Epub 2016 Nov 16.

Reference Type DERIVED
PMID: 27864013 (View on PubMed)

Long GV, Stroyakovskiy D, Gogas H, Levchenko E, de Braud F, Larkin J, Garbe C, Jouary T, Hauschild A, Grob JJ, Chiarion-Sileni V, Lebbe C, Mandala M, Millward M, Arance A, Bondarenko I, Haanen JB, Hansson J, Utikal J, Ferraresi V, Kovalenko N, Mohr P, Probachai V, Schadendorf D, Nathan P, Robert C, Ribas A, DeMarini DJ, Irani JG, Swann S, Legos JJ, Jin F, Mookerjee B, Flaherty K. Dabrafenib and trametinib versus dabrafenib and placebo for Val600 BRAF-mutant melanoma: a multicentre, double-blind, phase 3 randomised controlled trial. Lancet. 2015 Aug 1;386(9992):444-51. doi: 10.1016/S0140-6736(15)60898-4. Epub 2015 May 31.

Reference Type DERIVED
PMID: 26037941 (View on PubMed)

Schadendorf D, Amonkar MM, Stroyakovskiy D, Levchenko E, Gogas H, de Braud F, Grob JJ, Bondarenko I, Garbe C, Lebbe C, Larkin J, Chiarion-Sileni V, Millward M, Arance A, Mandala M, Flaherty KT, Nathan P, Ribas A, Robert C, Casey M, DeMarini DJ, Irani JG, Aktan G, Long GV. Health-related quality of life impact in a randomised phase III study of the combination of dabrafenib and trametinib versus dabrafenib monotherapy in patients with BRAF V600 metastatic melanoma. Eur J Cancer. 2015 May;51(7):833-40. doi: 10.1016/j.ejca.2015.03.004. Epub 2015 Mar 17.

Reference Type DERIVED
PMID: 25794603 (View on PubMed)

Menzies AM, Ashworth MT, Swann S, Kefford RF, Flaherty K, Weber J, Infante JR, Kim KB, Gonzalez R, Hamid O, Schuchter L, Cebon J, Sosman JA, Little S, Sun P, Aktan G, Ouellet D, Jin F, Long GV, Daud A. Characteristics of pyrexia in BRAFV600E/K metastatic melanoma patients treated with combined dabrafenib and trametinib in a phase I/II clinical trial. Ann Oncol. 2015 Feb;26(2):415-21. doi: 10.1093/annonc/mdu529. Epub 2014 Nov 18.

Reference Type DERIVED
PMID: 25411413 (View on PubMed)

Long GV, Stroyakovskiy D, Gogas H, Levchenko E, de Braud F, Larkin J, Garbe C, Jouary T, Hauschild A, Grob JJ, Chiarion Sileni V, Lebbe C, Mandala M, Millward M, Arance A, Bondarenko I, Haanen JB, Hansson J, Utikal J, Ferraresi V, Kovalenko N, Mohr P, Probachai V, Schadendorf D, Nathan P, Robert C, Ribas A, DeMarini DJ, Irani JG, Casey M, Ouellet D, Martin AM, Le N, Patel K, Flaherty K. Combined BRAF and MEK inhibition versus BRAF inhibition alone in melanoma. N Engl J Med. 2014 Nov 13;371(20):1877-88. doi: 10.1056/NEJMoa1406037. Epub 2014 Sep 29.

Reference Type DERIVED
PMID: 25265492 (View on PubMed)

Other Identifiers

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2011-006087-49

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CDRB436B2301

Identifier Type: OTHER

Identifier Source: secondary_id

115306

Identifier Type: -

Identifier Source: org_study_id

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