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Triple therapy for melanoma: hope or hype?

NCT ID NCT02967692

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
The trial has finished. Results may not be published yet.
Stopped early This study
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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 26, 2026

Summary

This phase 3 study tested whether adding an immunotherapy drug (spartalizumab) to two targeted therapy drugs (dabrafenib and trametinib) works better than the targeted drugs alone for people with advanced BRAF V600 mutant melanoma. The trial enrolled 568 participants but was terminated early. The goal was to see if the combination could delay cancer progression and improve survival.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Spartalizumab (an immunotherapy drug) combined with dabrafenib and trametinib (targeted therapy drugs)
What this could lead to
If successful, this combination could improve control of advanced melanoma by boosting the immune system while blocking cancer growth.
What could go wrong
The trial was terminated early, so results are limited. Adding immunotherapy to targeted therapy may increase side effects without clear benefit.

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

568 people

The number who actually took part.

Started

Feb 2017

Finished

Aug 2024

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 to 100 years

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.

Inclusion criteria Part 1: Safety run-in * Histologically confirmed, unresectable or metastatic melanoma with BRAF V600 mutation * Aspartate transaminase (AST) \< 2.5× ULN and Alanine transaminase (ALT) \< 2.5× ULN * Measurable disease according to RECIST 1.1 * ECOG performance status ≤ 1 Part 2: Biomarker cohort * Histologically confirmed, unresectable or metastatic melanoma with BRAF V600 mutation * At least two cutaneous or subcutaneous or nodal lesions for tumor sample collection * Measurable disease according to RECIST 1.1 * ECOG performance status ≤ 2 Part 3: Double-blind, randomized, placebo-controlled part * Histologically confirmed, unresectable or metastatic melanoma with BRAF V600 mutation * ECOG performance status ≤ 2 * Measurable disease according to RECIST 1.1 Exclusion Criteria: Part 1: Safety run-in * Subjects with uveal or mucosal melanoma * Any history of CNS metastases * Prior systemic anti-cancer treatment for unresectable or metastatic melanoma * Neoadjuvant and/or adjuvant therapy for melanoma completed less than 6 months prior to enrollmen * Radiation therapy within 4 weeks prior to start of study treatment * Active autoimmune disease, and/or history of autoimmune disease(s) that required treatment Parts 2 \& 3: Biomarker cohort \& double-blind, randomized, placebo-controlled part * Subjects with uveal or mucosal melanoma * Prior systemic anti-cancer treatment for unresectable or metastatic melanoma * Neoadjuvant and/or adjuvant therapy for melanoma completed less than 6 months prior to enrollment * Radiation therapy within 4 weeks prior to start of study treatment * Clinically active cerebral melanoma metastasis. * Active autoimmune disease, and/or history of autoimmune disease(s) that required treatment Other protocol-defined Inclusion/Exclusion may apply.

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Conditions

The condition(s) this trial relates to.

melanoma metastatic melanoma skin neoplasm

As listed by the trial registrant

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

Melanoma

Contacts and locations

Locations

  • California Cancer Associates for Research and Excellence

    Encinitas, California, 92024, United States

  • California Pacific Medical Center

    San Francisco, California, 94115, United States

  • Johns Hopkins U

    Lutherville, Maryland, 21093, United States

  • Kyoto University Hospital

    Sakyo Ku, Kyoto, 606 8507, Japan

  • Kyushu University Hospital

    Fukuoka, Fukuoka, 812-8582, Japan

  • NYU Laura and Isaac Perlmutter Cancer Center

    New York, New York, 10016, United States

  • National Cancer Hospital

    Chuo Ku, Tokyo, 104 0045, Japan

  • Nebraska Cancer Specialists

    Omaha, Nebraska, 68130, United States

  • Novartis Investigative Site

    CABA, Buenos Aires, C1125ABD, Argentina

  • Novartis Investigative Site

    CABA, Buenos Aires, C1426ANZ, Argentina

  • Novartis Investigative Site

    Rosario, Santa Fe Province, S2000KZE, Argentina

  • Novartis Investigative Site

    Caba, C1431FWO, Argentina

  • Novartis Investigative Site

    Gateshead, New South Wales, 2290, Australia

  • Novartis Investigative Site

    North Sydney, New South Wales, 2060, Australia

  • Novartis Investigative Site

    Greenslopes, Queensland, 4120, Australia

  • Novartis Investigative Site

    Melbourne, Victoria, 3004, Australia

  • Novartis Investigative Site

    Nedlands, Western Australia, 6009, Australia

  • Novartis Investigative Site

    Innsbruck, Tyrol, 6020, Austria

  • Novartis Investigative Site

    Graz, 8036, Austria

  • Novartis Investigative Site

    Linz, 4020, Austria

  • Novartis Investigative Site

    Salzburg, A-5020, Austria

  • Novartis Investigative Site

    Sankt Pölten, 3100, Austria

  • Novartis Investigative Site

    Brussels, 1090, Belgium

  • Novartis Investigative Site

    Brussels, 1200, Belgium

  • Novartis Investigative Site

    Curitiba, Paraná, 80530 010, Brazil

  • Novartis Investigative Site

    Porto Alegre, Rio Grande do Sul, 90035-003, Brazil

  • Novartis Investigative Site

    São Paulo, São Paulo, 01246 000, Brazil

  • Novartis Investigative Site

    Rio de Janeiro, 20560-120, Brazil

  • Novartis Investigative Site

    Plovdiv, 4004, Bulgaria

  • Novartis Investigative Site

    Sofia, 1303, Bulgaria

  • Novartis Investigative Site

    Vancouver, British Columbia, V5Z 4E6, Canada

  • Novartis Investigative Site

    Toronto, Ontario, M4N 3M5, Canada

  • Novartis Investigative Site

    Montreal, Quebec, H3T 1E2, Canada

  • Novartis Investigative Site

    Montreal, Quebec, H4A 3J1, Canada

  • Novartis Investigative Site

    Sherbrooke, Quebec, J1H 5N4, Canada

  • Novartis Investigative Site

    Temuco, Araucania, 4810469, Chile

  • Novartis Investigative Site

    Santiago, 7500921, Chile

  • Novartis Investigative Site

    Santiago, 8420383, Chile

  • Novartis Investigative Site

    Brno, Czech Republic, 656 53, Czechia

  • Novartis Investigative Site

    Zlín, Czech Republic, 762 75, Czechia

  • Novartis Investigative Site

    Hradec Králové, CZE, 500 05, Czechia

  • Novartis Investigative Site

    Ostrava, Poruba, 708 52, Czechia

  • Novartis Investigative Site

    Olomouc, 779 00, Czechia

  • Novartis Investigative Site

    Prague, 100 34, Czechia

  • Novartis Investigative Site

    Prague, 12808, Czechia

  • Novartis Investigative Site

    Aarhus N, 8200, Denmark

  • Novartis Investigative Site

    Limoges, Haute Vienne, 87000, France

  • Novartis Investigative Site

    Amiens, 80054, France

  • Novartis Investigative Site

    Besançon, 25030, France

  • Novartis Investigative Site

    Bobigny, 93009, France

  • Novartis Investigative Site

    Bordeaux, 33075, France

  • Novartis Investigative Site

    Boulogne-Billancourt, 92104, France

  • Novartis Investigative Site

    Caen, 14033, France

  • Novartis Investigative Site

    Clermont-Ferrand, 63003, France

  • Novartis Investigative Site

    Dijon, 21034, France

  • Novartis Investigative Site

    Grenoble, 38043, France

  • Novartis Investigative Site

    Le Mans, 72000, France

  • Novartis Investigative Site

    Lille, 59037, France

  • Novartis Investigative Site

    Lorient, 56322, France

  • Novartis Investigative Site

    Lyon, 69373, France

  • Novartis Investigative Site

    Marseille, 13885, France

  • Novartis Investigative Site

    Mulhouse, 68070, France

  • Novartis Investigative Site

    Nice, 06202, France

  • Novartis Investigative Site

    Paris, 75475, France

  • Novartis Investigative Site

    Pierre-Bénite, 69495, France

  • Novartis Investigative Site

    Poitiers, 86021, France

  • Novartis Investigative Site

    Reims, 51092, France

  • Novartis Investigative Site

    Rouen, 76031, France

  • Novartis Investigative Site

    Strasbourg, 67091, France

  • Novartis Investigative Site

    Toulouse, 31059, France

  • Novartis Investigative Site

    Vandœuvre-lès-Nancy, 54519, France

  • Novartis Investigative Site

    Villejuif, 94800, France

  • Novartis Investigative Site

    Mannheim, Baden-Wurttemberg, 68305, Germany

  • Novartis Investigative Site

    Regensburg, Bavaria, 93053, Germany

  • Novartis Investigative Site

    Leipzig, Saxony, 04103, Germany

  • Novartis Investigative Site

    Halle, Saxony-Anhalt, 06120, Germany

  • Novartis Investigative Site

    Berlin, 13353, Germany

  • Novartis Investigative Site

    Berlin, 13578, Germany

  • Novartis Investigative Site

    Bonn, 53105, Germany

  • Novartis Investigative Site

    Chemnitz, 09117, Germany

  • Novartis Investigative Site

    Dresden, 01307, Germany

  • Novartis Investigative Site

    Düsseldorf, 40225, Germany

  • Novartis Investigative Site

    Erfurt, 99089, Germany

  • Novartis Investigative Site

    Essen, 45147, Germany

  • Novartis Investigative Site

    Freiburg im Breisgau, 79106, Germany

  • Novartis Investigative Site

    Gera, 07548, Germany

  • Novartis Investigative Site

    Hamburg, 20246, Germany

  • Novartis Investigative Site

    Hanover, 30625, Germany

  • Novartis Investigative Site

    Heidelberg, 69120, Germany

  • Novartis Investigative Site

    Homburg, 66421, Germany

  • Novartis Investigative Site

    Kiel, 24105, Germany

  • Novartis Investigative Site

    Mainz, 55131, Germany

  • Novartis Investigative Site

    Marburg, 35039, Germany

  • Novartis Investigative Site

    Minden, 32429, Germany

  • Novartis Investigative Site

    München, 81377, Germany

  • Novartis Investigative Site

    Münster, 48157, Germany

  • Novartis Investigative Site

    Stade, 21682, Germany

  • Novartis Investigative Site

    Tübingen, 72076, Germany

  • Novartis Investigative Site

    Athens, 115 27, Greece

  • Novartis Investigative Site

    Athens, 18547, Greece

  • Novartis Investigative Site

    Budapest, H 1122, Hungary

  • Novartis Investigative Site

    Debrecen, 4032, Hungary

  • Novartis Investigative Site

    Szeged, H 6725, Hungary

  • Novartis Investigative Site

    Haifa, 3109601, Israel

  • Novartis Investigative Site

    Jerusalem, 9112001, Israel

  • Novartis Investigative Site

    Ramat Gan, 5265601, Israel

  • Novartis Investigative Site

    Bari, BA, 70124, Italy

  • Novartis Investigative Site

    Bergamo, BG, 24127, Italy

  • Novartis Investigative Site

    Bologna, BO, 40138, Italy

  • Novartis Investigative Site

    Brescia, BS, 25123, Italy

  • Novartis Investigative Site

    Meldola, FC, 47014, Italy

  • Novartis Investigative Site

    Genova, GE, 16132, Italy

  • Novartis Investigative Site

    Monza, MB, 20900, Italy

  • Novartis Investigative Site

    Milan, MI, 20133, Italy

  • Novartis Investigative Site

    Milan, MI, 20141, Italy

  • Novartis Investigative Site

    Modena, MO, 41124, Italy

  • Novartis Investigative Site

    Padova, PD, 35100, Italy

  • Novartis Investigative Site

    Roma, RM, 00167, Italy

  • Novartis Investigative Site

    Siena, SI, 53100, Italy

  • Novartis Investigative Site

    Candiolo, TO, 10060, Italy

  • Novartis Investigative Site

    Torino, TO, 10126, Italy

  • Novartis Investigative Site

    Verona, VR, 37134, Italy

  • Novartis Investigative Site

    Naples, 80131, Italy

  • Novartis Investigative Site

    León, Guanajuato, 37178, Mexico

  • Novartis Investigative Site

    Guadalajara, Jalisco, 44100, Mexico

  • Novartis Investigative Site

    Mexico City, Mexico City, 14080, Mexico

  • Novartis Investigative Site

    Leiden, South Holland, 2333, Netherlands

  • Novartis Investigative Site

    Amersfroort, 3818 ES, Netherlands

  • Novartis Investigative Site

    Oslo, 0310, Norway

  • Novartis Investigative Site

    Gdansk, 80 952, Poland

  • Novartis Investigative Site

    Warsaw, 02 781, Poland

  • Novartis Investigative Site

    Lisbon, 1099 023, Portugal

  • Novartis Investigative Site

    Porto, 4200-072, Portugal

  • Novartis Investigative Site

    Chelyabinsk, 454048, Russia

  • Novartis Investigative Site

    Moscow, 115478, Russia

  • Novartis Investigative Site

    Moscow, 143423, Russia

  • Novartis Investigative Site

    Nizhny Novgorod, 603137, Russia

  • Novartis Investigative Site

    Omsk, 644013, Russia

  • Novartis Investigative Site

    Saint Petersburg, 197758, Russia

  • Novartis Investigative Site

    Saint Petersburg, 198255, Russia

  • Novartis Investigative Site

    Samara, 443011, Russia

  • Novartis Investigative Site

    Málaga, Andalusia, 29010, Spain

  • Novartis Investigative Site

    Seville, Andalusia, 41009, Spain

  • Novartis Investigative Site

    Jerez de la Frontera, Cadiz, 11407, Spain

  • Novartis Investigative Site

    Badalona, Catalonia, 08916, Spain

  • Novartis Investigative Site

    Barcelona, Catalonia, 08036, Spain

  • Novartis Investigative Site

    A Coruña, Galicia, 15006, Spain

  • Novartis Investigative Site

    Oviedo, Principality of Asturias, 33011, Spain

  • Novartis Investigative Site

    Valencia, Valencia, 46014, Spain

  • Novartis Investigative Site

    Las Palmas de Gran Canaria, 35016, Spain

  • Novartis Investigative Site

    Madrid, 28009, Spain

  • Novartis Investigative Site

    Madrid, 28034, Spain

  • Novartis Investigative Site

    Madrid, 28050, Spain

  • Novartis Investigative Site

    Madrid, 28222, Spain

  • Novartis Investigative Site

    Gothenburg, SE-413 45, Sweden

  • Novartis Investigative Site

    Lund, 221 85, Sweden

  • Novartis Investigative Site

    Stockholm, SE 171 76, Sweden

  • Novartis Investigative Site

    Aarau, Canton of Aargau, 5001, Switzerland

  • Novartis Investigative Site

    Zurich, 8091, Switzerland

  • Novartis Investigative Site

    Songkhla, Hat Yai, 90110, Thailand

  • Novartis Investigative Site

    Bangkok, 10330, Thailand

  • Novartis Investigative Site

    Truro, Cornwall, TR1 3LJ, United Kingdom

  • Novartis Investigative Site

    Guildford, Surrey, GU2 7XX, United Kingdom

  • Novartis Investigative Site

    Sutton, Surrey, SM2 5PT, United Kingdom

  • Novartis Investigative Site

    Leicester, LE1 5WW, United Kingdom

  • Novartis Investigative Site

    London, NW3 2QG, United Kingdom

  • Novartis Investigative Site

    Manchester, M20 2BX, United Kingdom

  • Novartis Investigative Site

    Middlesbrough, TS4 3BW, United Kingdom

  • Novartis Investigative Site

    Preston, PR2 9HT, United Kingdom

  • Novartis Investigative Site

    Rickmansworth Road, WD187HT, United Kingdom

  • Osaka International Cancer Institute

    Osaka, Osaka, 541-8567, Japan

  • Stanford Cancer Center

    Stanford, California, 94305, United States

  • Tokyo Metropolitan Komagome Hospital

    Bunkyo Ku, Tokyo, 113-8677, Japan

  • UC Irvine Medical Center

    Orange, California, 92613-4091, United States

  • Univ of TX MD Anderson Cancer Cntr

    Houston, Texas, 77030, United States

  • University of Kansas Cancer Center

    Westwood, Kansas, 66205, United States

  • University of Pittsburgh Med Center

    Pittsburgh, Pennsylvania, 15213, United States

  • University of Tennessee Medical Ctr

    Knoxville, Tennessee, 37920, United States

  • Utah Cancer Specialists

    Salt Lake City, Utah, 84106, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.