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Drug combo slashes melanoma return risk in High-Risk patients

NCT ID NCT01682083

Disease control Sponsor: Novartis Pharmaceuticals Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested whether taking two targeted drugs (dabrafenib and trametinib) for 12 months after melanoma surgery could keep the cancer from returning. It included 870 adults with high-risk stage III melanoma that had a specific BRAF V600 mutation. Results showed the drug combination significantly delayed or prevented recurrence compared to placebo.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

870 people

The number who actually took part.

Started

Jan 2013

Finished

Jul 2023

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Key Inclusion Criteria: * At least 18 years of age * Completely resected histologically confirmed high-risk (Stage IIIa \[lymph node metastasis \> 1 mm\], IIIb or IIIc) cutaneous melanoma determined to be V600E/K mutation positive using the bioMerieux (bMX) THxID BRAF Assay by a central laboratory. Patients presenting with initial resectable lymph node recurrence after a diagnosis of Stage I or II melanoma were eligible * Must be surgically rendered free of disease (defined as the date of the most recent surgery) no more than 12 weeks before randomization * Recovered from definitive surgery (e.g., no uncontrolled wound infections or indwelling drains) * ECOG Performance Status of 0-1 * Had adequate hematologic, hepatic, renal and cardiac function. Key Exclusion Criteria: * Known mucosal or ocular melanoma or the presence of unresectable in-transit metastases * Evidence of distant metastatic disease on Screening evaluation * Prior anti-cancer treatment (chemotherapy, immunotherapy, biologic therapy, vaccine therapy, or investigational treatment) including radiotherapy for melanoma. Prior surgery for melanoma was allowed * History of another malignancy including melanoma or a concurrent malignancy. Patients who previously had Stage III melanoma or any malignancy with confirmed activating RAS mutation at any time were not eligible. Exceptions to this include: * Patients with a history of any malignancy that had been disease-free for at least 5 years were eligible except those with confirmed activating RAS mutations * Patients with a history of completely resected non-melanoma skin cancer (e.g., basal cell carcinoma, squamous cell carcinoma) were eligible irrespective of the time since the resection * Patients with successfully treated in situ carcinoma were eligible * Patients presenting with multiple primary melanomas were eligible only if the lesions were concurrent. Patients who had concurrent multiple primary melanomas that were "distant" were eligible provided each lesion was considered local disease or resectable regional disease.

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Conditions

The condition(s) this trial relates to.

cutaneous melanoma melanoma neoplasm

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Melanoma

Contacts and locations

Locations

  • Novartis Investigative Site

    Birmingham, Alabama, 35243, United States

  • Novartis Investigative Site

    Tucson, Arizona, 85724, United States

  • Novartis Investigative Site

    San Francisco, California, 94115, United States

  • Novartis Investigative Site

    San Francisco, California, 94143, United States

  • Novartis Investigative Site

    Aurora, Colorado, 80045, United States

  • Novartis Investigative Site

    Lake Worth, Florida, 33461, United States

  • Novartis Investigative Site

    Orlando, Florida, 32806, United States

  • Novartis Investigative Site

    Tampa, Florida, 33612, United States

  • Novartis Investigative Site

    Atlanta, Georgia, 30322, United States

  • Novartis Investigative Site

    Atlanta, Georgia, 30341, United States

  • Novartis Investigative Site

    Lutherville-Timonium, Maryland, 21093, United States

  • Novartis Investigative Site

    Boston, Massachusetts, 02114, United States

  • Novartis Investigative Site

    Boston, Massachusetts, 02115, United States

  • Novartis Investigative Site

    Ann Arbor, Michigan, 48019, United States

  • Novartis Investigative Site

    Winston-Salem, North Carolina, 27157, United States

  • Novartis Investigative Site

    Columbus, Ohio, 43210, United States

  • Novartis Investigative Site

    Portland, Oregon, 97123, United States

  • Novartis Investigative Site

    Pittsburgh, Pennsylvania, 15232, United States

  • Novartis Investigative Site

    Nashville, Tennessee, 37203, United States

  • Novartis Investigative Site

    Dallas, Texas, 75390, United States

  • Novartis Investigative Site

    Capital Federal, Buenos Aires, C1426ANZ, Argentina

  • Novartis Investigative Site

    Buenos Aires, C1125ABD, Argentina

  • Novartis Investigative Site

    Gateshead, New South Wales, 2290, Australia

  • Novartis Investigative Site

    North Sydney, New South Wales, 2060, Australia

  • Novartis Investigative Site

    Tweed Heads, New South Wales, 2485, Australia

  • Novartis Investigative Site

    Westmead, New South Wales, 2145, Australia

  • Novartis Investigative Site

    Greenslopes, Queensland, 4120, Australia

  • Novartis Investigative Site

    Woolloongabba, Queensland, 4102, Australia

  • Novartis Investigative Site

    Adelaide, South Australia, 5000, Australia

  • Novartis Investigative Site

    Box Hill, Victoria, 3128, Australia

  • Novartis Investigative Site

    Heidelberg, Victoria, 3084, Australia

  • Novartis Investigative Site

    Melbourne, Victoria, 3004, Australia

  • Novartis Investigative Site

    Nedlands, Western Australia, 6009, Australia

  • Novartis Investigative Site

    Graz, 8036, Austria

  • Novartis Investigative Site

    Linz, A-4010, Austria

  • Novartis Investigative Site

    Salzburg, A-5020, Austria

  • Novartis Investigative Site

    Vienna, 1090, Austria

  • Novartis Investigative Site

    Wels, A-4600, Austria

  • Novartis Investigative Site

    Brussels, 1200, Belgium

  • Novartis Investigative Site

    Leuven, 3000, Belgium

  • Novartis Investigative Site

    Liège, 4000, Belgium

  • Novartis Investigative Site

    Wilrijk, 2610, Belgium

  • Novartis Investigative Site

    Curitiba, Paraná, 81520-060, Brazil

  • Novartis Investigative Site

    Ijuí, Rio Grande do Sul, 98700, Brazil

  • Novartis Investigative Site

    Edmonton, Alberta, T6G 1Z2, Canada

  • Novartis Investigative Site

    Hamilton, Ontario, L8V 5C2, Canada

  • Novartis Investigative Site

    Oshawa, Ontario, L1G 2B9, Canada

  • Novartis Investigative Site

    Ottawa, Ontario, K1H 8L6, Canada

  • Novartis Investigative Site

    Toronto, Ontario, M5G 2M9, Canada

  • Novartis Investigative Site

    Québec, Quebec, G1J 1Z4, Canada

  • Novartis Investigative Site

    Brno, 656 53, Czechia

  • Novartis Investigative Site

    Prague, 100 34, Czechia

  • Novartis Investigative Site

    Prague, 128 08, Czechia

  • Novartis Investigative Site

    Zlín, 76275, Czechia

  • Novartis Investigative Site

    Arhus C, 8000, Denmark

  • Novartis Investigative Site

    Herlev, 2730, Denmark

  • Novartis Investigative Site

    Odense, 5000 C, Denmark

  • Novartis Investigative Site

    Bordeaux, 33075, France

  • Novartis Investigative Site

    Boulogne-Billancourt, 92100, France

  • Novartis Investigative Site

    Brest, 29609, France

  • Novartis Investigative Site

    Dijon, 21079, France

  • Novartis Investigative Site

    Grenoble, 38043, France

  • Novartis Investigative Site

    Lille, 59037, France

  • Novartis Investigative Site

    Marseille, 13385, France

  • Novartis Investigative Site

    Montpellier, 34295, France

  • Novartis Investigative Site

    Nice, 06202, France

  • Novartis Investigative Site

    Paris, 75014, France

  • Novartis Investigative Site

    Paris, 75475, France

  • Novartis Investigative Site

    Pierre-Bénite, 69495, France

  • Novartis Investigative Site

    Reims, 51092, France

  • Novartis Investigative Site

    Rennes, 35042, France

  • Novartis Investigative Site

    Toulouse, 31059, France

  • Novartis Investigative Site

    Tours, 37044, France

  • Novartis Investigative Site

    Villejuif, 94805, France

  • Novartis Investigative Site

    Freiburg im Breisgau, Baden-Wurttemberg, 79104, Germany

  • Novartis Investigative Site

    Heilbronn, Baden-Wurttemberg, 74078, Germany

  • Novartis Investigative Site

    Mannheim, Baden-Wurttemberg, 68167, Germany

  • Novartis Investigative Site

    Tübingen, Baden-Wurttemberg, 72076, Germany

  • Novartis Investigative Site

    Ulm, Baden-Wurttemberg, 89081, Germany

  • Novartis Investigative Site

    Munich, Bavaria, 80337, Germany

  • Novartis Investigative Site

    Nuremberg, Bavaria, 90419, Germany

  • Novartis Investigative Site

    Regensburg, Bavaria, 93053, Germany

  • Novartis Investigative Site

    Würzburg, Bavaria, 97080, Germany

  • Novartis Investigative Site

    Darmstadt, Hesse, 64297, Germany

  • Novartis Investigative Site

    Marburg, Hesse, 35033, Germany

  • Novartis Investigative Site

    Wiesbaden, Hesse, 65199, Germany

  • Novartis Investigative Site

    Hanover, Lower Saxony, 30625, Germany

  • Novartis Investigative Site

    Schwerin, Mecklenburg-Vorpommern, 19049, Germany

  • Novartis Investigative Site

    Bochum, North Rhine-Westphalia, 44791, Germany

  • Novartis Investigative Site

    Cologne, North Rhine-Westphalia, 50937, Germany

  • Novartis Investigative Site

    Essen, North Rhine-Westphalia, 45147, Germany

  • Novartis Investigative Site

    Mainz, Rhineland-Palatinate, 55131, Germany

  • Novartis Investigative Site

    Magdeburg, Saxony-Anhalt, 39120, Germany

  • Novartis Investigative Site

    Kiel, Schleswig-Holstein, 24105, Germany

  • Novartis Investigative Site

    Lübeck, Schleswig-Holstein, 23538, Germany

  • Novartis Investigative Site

    Erfurt, Thuringia, 99089, Germany

  • Novartis Investigative Site

    Gera, Thuringia, 07548, Germany

  • Novartis Investigative Site

    Berlin, 10249, Germany

  • Novartis Investigative Site

    Athens, 11527, Greece

  • Novartis Investigative Site

    Thessaloniki, 54622, Greece

  • Novartis Investigative Site

    Thessaloniki, 56429, Greece

  • Novartis Investigative Site

    Ramat Gan, 52621, Israel

  • Novartis Investigative Site

    Rome, Lazio, 00167, Italy

  • Novartis Investigative Site

    Genoa, Liguria, 16132, Italy

  • Novartis Investigative Site

    Bergamo, Lombardy, 24127, Italy

  • Novartis Investigative Site

    Milan, Lombardy, 20133, Italy

  • Novartis Investigative Site

    Milan, Lombardy, 20141, Italy

  • Novartis Investigative Site

    Candiolo, Piedmont, 10060, Italy

  • Novartis Investigative Site

    Pisa, Tuscany, 56126, Italy

  • Novartis Investigative Site

    Padova, Veneto, 35128, Italy

  • Novartis Investigative Site

    Shizuoka, 411-8777, Japan

  • Novartis Investigative Site

    Tokyo, 104-0045, Japan

  • Novartis Investigative Site

    Amsterdam, 1066 CX, Netherlands

  • Novartis Investigative Site

    Amsterdam, 1081 HV, Netherlands

  • Novartis Investigative Site

    Groningen, 9713 GZ, Netherlands

  • Novartis Investigative Site

    Leeuwarden, 8934 AD, Netherlands

  • Novartis Investigative Site

    Maastricht, 6229 HX, Netherlands

  • Novartis Investigative Site

    Nijmegen, 6525 GA, Netherlands

  • Novartis Investigative Site

    Rotterdam, 3015 GD, Netherlands

  • Novartis Investigative Site

    Auckland, 0622, New Zealand

  • Novartis Investigative Site

    Ålesund, 6026, Norway

  • Novartis Investigative Site

    Oslo, 0310, Norway

  • Novartis Investigative Site

    Gdansk, 80-215, Poland

  • Novartis Investigative Site

    Konin, 62-500, Poland

  • Novartis Investigative Site

    Poznan, 60-693, Poland

  • Novartis Investigative Site

    Warsaw, 02-781, Poland

  • Novartis Investigative Site

    Chelyabinsk, 454087, Russia

  • Novartis Investigative Site

    Moscow, 115478, Russia

  • Novartis Investigative Site

    Moscow, 143423, Russia

  • Novartis Investigative Site

    Ryazan, 390011, Russia

  • Novartis Investigative Site

    Saint Petersburg, 191014, Russia

  • Novartis Investigative Site

    Saint Petersburg, 197758, Russia

  • Novartis Investigative Site

    Saint Petersburg, 198255, Russia

  • Novartis Investigative Site

    Volgograd, 400138, Russia

  • Novartis Investigative Site

    Badalona, 08916, Spain

  • Novartis Investigative Site

    Barcelona, 08035, Spain

  • Novartis Investigative Site

    Barcelona, 08036, Spain

  • Novartis Investigative Site

    Donostia / San Sebastian, 20014, Spain

  • Novartis Investigative Site

    Las Palmas de Gran Canaria, 35016, Spain

  • Novartis Investigative Site

    Madrid, 28034, Spain

  • Novartis Investigative Site

    Madrid, 28041, Spain

  • Novartis Investigative Site

    Madrid, 28046, Spain

  • Novartis Investigative Site

    Palma de Mallorca, 07198, Spain

  • Novartis Investigative Site

    Pamplona, 31008, Spain

  • Novartis Investigative Site

    Santander, 39008, Spain

  • Novartis Investigative Site

    Valencia, 46014, Spain

  • Novartis Investigative Site

    Gothenburg, SE-413 45, Sweden

  • Novartis Investigative Site

    Lund, SE-221 85, Sweden

  • Novartis Investigative Site

    Stockholm, SE-171 76, Sweden

  • Novartis Investigative Site

    Uppsala, SE-751 85, Sweden

  • Novartis Investigative Site

    Basel, 4031, Switzerland

  • Novartis Investigative Site

    Chur, 7000, Switzerland

  • Novartis Investigative Site

    Zurich, 8091, Switzerland

  • Novartis Investigative Site

    Taipei, 10002, Taiwan

  • Novartis Investigative Site

    Taoyuan, 33305, Taiwan

  • Novartis Investigative Site

    Northwood, Middlesex, HA6 2RN, United Kingdom

  • Novartis Investigative Site

    Exeter, EX2 5DW, United Kingdom

  • Novartis Investigative Site

    Glasgow, G12 0YN, United Kingdom

  • Novartis Investigative Site

    Guildford, GU2 7XX, United Kingdom

  • Novartis Investigative Site

    Leeds, LS9 7TF, United Kingdom

  • Novartis Investigative Site

    London, NW3 2QG, United Kingdom

  • Novartis Investigative Site

    London, SW3 6JJ, United Kingdom

  • Novartis Investigative Site

    London, W1G 6AD, United Kingdom

  • Novartis Investigative Site

    Manchester, M20 4BX, United Kingdom

  • Novartis Investigative Site

    Newcastle upon Tyne, NE7 7DN, United Kingdom

  • Novartis Investigative Site

    Norwich, NR4 7UY, United Kingdom

  • Novartis Investigative Site

    Preston, PR2 9HT, United Kingdom

  • Novartis Investigative Site

    Southampton, SO16 6YD, United Kingdom

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