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NCT02967692TerminatedPhase 3

A Study of the Anti-PD1 Antibody PDR001, in Combination With Dabrafenib and Trametinib in Advanced Melanoma

COMBI-i · Run by Novartis Pharmaceuticals

A Randomized, Double-blind, Placebo-controlled, Phase III Study Comparing the Combination of PDR001, Dabrafenib and Trametinib Versus Placebo, Dabrafenib and Trametinib in Previously Untreated Patients With Unresectable or Metastatic BRAF V600 Mutant Melanoma

Source: ClinicalTrials.gov · Last updated 18 Sept 2025

Reason given: Sponsor decision

Brief summary (registry, in English)

The purpose of this study was to evaluate safety and efficacy of the combination of an anti-PD-1 antibody (PDR001), a BRAF inhibitor (dabrafenib) and a MEK inhibitor (trametinib) in patients with BRAF V600 mutant, unresectable and metastatic melanoma.

Status (registry)
Terminated
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
568 (actual)
First submitted
16 Nov 2016
Start date
17 Feb 2017
Primary completion date
11 Aug 2020
Lead sponsor
Novartis Pharmaceuticals
Diseases
Melanoma
NCT number
NCT02967692
EudraCT number
2016-002794-35

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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
  • 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

Other illness

  • Any history of CNS metastases
  • Active autoimmune disease, and/or history of autoimmune disease(s) that required treatment
    • Parts 2 \& 3: Biomarker cohort \& double-blind, randomized, placebo-controlled part
  • Active autoimmune disease, and/or history of autoimmune disease(s) that required treatment
    • Other protocol-defined Inclusion/Exclusion may apply.

Other

  • Part 1: Safety run-in
  • Subjects with uveal or mucosal melanoma
  • Subjects with uveal or mucosal melanoma
  • Clinically active cerebral melanoma metastasis.

Who the study is looking for

  • 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

Age in the registry: 18 years to 100 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (165)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
-CABAArgentinaUnknown status
-RosarioArgentinaUnknown status
-GrazAustriaUnknown status
-InnsbruckAustriaUnknown status
-LinzAustriaUnknown status
-SalzburgAustriaUnknown status
-Sankt PöltenAustriaUnknown status
-GatesheadAustraliaUnknown status
-GreenslopesAustraliaUnknown status
-MelbourneAustraliaUnknown status
-NedlandsAustraliaUnknown status
-North SydneyAustraliaUnknown status
-BrusselsBelgiumUnknown status
-PlovdivBulgariaUnknown status
-SofiaBulgariaUnknown status
-CuritibaBrazilUnknown status
-Porto AlegreBrazilUnknown status
-Rio de JaneiroBrazilUnknown status
-São PauloBrazilUnknown status
-MontrealCanadaUnknown status
-SherbrookeCanadaUnknown status
-TorontoCanadaUnknown status
-VancouverCanadaUnknown status
-AarauSwitzerlandUnknown status
-ZurichSwitzerlandUnknown status
-SantiagoChileUnknown status
-TemucoChileUnknown status
-BrnoCzechiaUnknown status
-Hradec KrálovéCzechiaUnknown status
-OlomoucCzechiaUnknown status
-OstravaCzechiaUnknown status
-PragueCzechiaUnknown status
-ZlínCzechiaUnknown status
-BerlinGermanyUnknown status
-BonnGermanyUnknown status
-ChemnitzGermanyUnknown status
-DresdenGermanyUnknown status
-DüsseldorfGermanyUnknown status
-ErfurtGermanyUnknown status
-EssenGermanyUnknown status
-Freiburg im BreisgauGermanyUnknown status
-GeraGermanyUnknown status
-HalleGermanyUnknown status
-HamburgGermanyUnknown status
-HanoverGermanyUnknown status
-HeidelbergGermanyUnknown status
-HomburgGermanyUnknown status
-KielGermanyUnknown status
-LeipzigGermanyUnknown status
-MainzGermanyUnknown status
-MannheimGermanyUnknown status
-MarburgGermanyUnknown status
-MindenGermanyUnknown status
-MünchenGermanyUnknown status
-MünsterGermanyUnknown status
-RegensburgGermanyUnknown status
-StadeGermanyUnknown status
-TübingenGermanyUnknown status
-Aarhus NDenmarkUnknown status
-A CoruñaSpainUnknown status
-BadalonaSpainUnknown status
-BarcelonaSpainUnknown status
-Jerez de la FronteraSpainUnknown status
-Las Palmas de Gran CanariaSpainUnknown status
-MadridSpainUnknown status
-MálagaSpainUnknown status
-OviedoSpainUnknown status
-SevilleSpainUnknown status
-ValenciaSpainUnknown status
-AmiensFranceUnknown status
-BesançonFranceUnknown status
-BobignyFranceUnknown status
-BordeauxFranceUnknown status
-Boulogne-BillancourtFranceUnknown status
-CaenFranceUnknown status
-Clermont-FerrandFranceUnknown status
-DijonFranceUnknown status
-GrenobleFranceUnknown status
-Le MansFranceUnknown status
-LilleFranceUnknown status
-LimogesFranceUnknown status
-LorientFranceUnknown status
-LyonFranceUnknown status
-MarseilleFranceUnknown status
-MulhouseFranceUnknown status
-NiceFranceUnknown status
-ParisFranceUnknown status
-Pierre-BéniteFranceUnknown status
-PoitiersFranceUnknown status
-ReimsFranceUnknown status
-RouenFranceUnknown status
-StrasbourgFranceUnknown status
-ToulouseFranceUnknown status
-Vandœuvre-lès-NancyFranceUnknown status
-VillejuifFranceUnknown status
-GuildfordUnited KingdomUnknown status
-LeicesterUnited KingdomUnknown status
-LondonUnited KingdomUnknown status
-ManchesterUnited KingdomUnknown status
-MiddlesbroughUnited KingdomUnknown status
-PrestonUnited KingdomUnknown status
-Rickmansworth RoadUnited KingdomUnknown status
-SuttonUnited KingdomUnknown status
-TruroUnited KingdomUnknown status
-AthensGreeceUnknown status
-BudapestHungaryUnknown status
-DebrecenHungaryUnknown status
-SzegedHungaryUnknown status
-HaifaIsraelUnknown status
-JerusalemIsraelUnknown status
-Ramat GanIsraelUnknown status
-BariItalyUnknown status
-BergamoItalyUnknown status
-BolognaItalyUnknown status
-BresciaItalyUnknown status
-CandioloItalyUnknown status
-GenovaItalyUnknown status
-MeldolaItalyUnknown status
-MilanItalyUnknown status
-ModenaItalyUnknown status
-MonzaItalyUnknown status
-NaplesItalyUnknown status
-PadovaItalyUnknown status
-RomaItalyUnknown status
-SienaItalyUnknown status
-TorinoItalyUnknown status
-VeronaItalyUnknown status
Tokyo Metropolitan Komagome HospitalBunkyo KuJapanUnknown status
National Cancer HospitalChuo KuJapanUnknown status
Kyushu University HospitalFukuokaJapanUnknown status
Osaka International Cancer InstituteOsakaJapanUnknown status
Kyoto University HospitalSakyo-kuJapanUnknown status
-GuadalajaraMexicoUnknown status
-LeónMexicoUnknown status
-Mexico CityMexicoUnknown status
-AmersfroortNetherlandsUnknown status
-LeidenNetherlandsUnknown status
-OsloNorwayUnknown status
-GdanskPolandUnknown status
-WarsawPolandUnknown status
-LisbonPortugalUnknown status
-PortoPortugalUnknown status
-ChelyabinskRussiaUnknown status
-MoscowRussiaUnknown status
-Nizhny NovgorodRussiaUnknown status
-OmskRussiaUnknown status
-Saint PetersburgRussiaUnknown status
-SamaraRussiaUnknown status
-GothenburgSwedenUnknown status
-LundSwedenUnknown status
-StockholmSwedenUnknown status
-BangkokThailandUnknown status
-SongkhlaThailandUnknown status
California Cancer Associates for Research and ExcellenceEncinitasUnited StatesUnknown status
Univ of TX MD Anderson Cancer CntrHoustonUnited StatesUnknown status
University of Tennessee Medical CtrKnoxvilleUnited StatesUnknown status
Johns Hopkins ULuthervilleUnited StatesUnknown status
NYU Laura and Isaac Perlmutter Cancer CenterNew YorkUnited StatesUnknown status
Nebraska Cancer SpecialistsOmahaUnited StatesUnknown status
UC Irvine Medical CenterOrangeUnited StatesUnknown status
University of Pittsburgh Med CenterPittsburghUnited StatesUnknown status
Utah Cancer SpecialistsSalt Lake CityUnited StatesUnknown status
California Pacific Medical CenterSan FranciscoUnited StatesUnknown status
Stanford Cancer CenterStanfordUnited StatesUnknown status
University of Kansas Cancer CenterWestwoodUnited StatesUnknown status

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In 29 countries, 165 sites

France 26, Germany 25, Italy 16, United States 12, Spain 10, United Kingdom 9, Czechia 6, Russia 6, Australia 5, Austria 5, Japan 5, Brazil 4, Canada 4, Hungary 3, Israel 3, Mexico 3, Sweden 3, Argentina 2, Bulgaria 2, Chile 2, Netherlands 2, Poland 2, Portugal 2, Switzerland 2, Thailand 2, Belgium 1, Denmark 1, Greece 1, Norway 1

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This page is information, not medical advice. Discuss any trial with your doctor.