Melanoma Clinical Trial
A Study of the Anti-PD1 Antibody PDR001, in Combination With Dabrafenib and Trametinib in Advanced Melanoma
Summary
To evaluate the safety and efficacy of the combination of an anti-PD-1 antibody (Spartalizumab (PDR001)), a BRAF inhibitor (dabrafenib) and a MEK inhibitor (trametinib) in unresectable or metastatic BRAF V600 mutant melanoma
Eligibility Criteria
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
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
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
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
Prior loco-regional treatment for unresectable or metastatic melanoma in the last 6 month
Prior neoadjuvant and/or adjuvant therapy for melanoma completed less than 6 months
Radiation therapy within 4 weeks prior to start of study treatment
Active, known, suspected or a documented history of autoimmune disease
Parts 2 & 3: Biomarker cohort & double-blind, randomized, placebo-controlled part
Subjects with uveal or mucosal melanoma
Clinically active cerebral melanoma metastasis
Prior systemic anti-cancer treatment for unresectable or metastatic melanoma
Prior loco-regional treatment for unresectable or metastatic melanoma in the last 6 month
Prior neoadjuvant and/or adjuvant therapy for melanoma completed less than 6 months
Radiation therapy within 4 weeks prior to start of study treatment
Active, known, suspected or a documented history of autoimmune disease
Other protocol-defined Inclusion/Exclusion may apply.
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There are 178 Locations for this study
Encinitas California, 92024, United States
Orange California, 92868, United States
San Francisco California, 94115, United States
Stanford California, 94305, United States
Westwood Kansas, 66205, United States
Lutherville Maryland, 21093, United States
Omaha Nebraska, 68130, United States
New York New York, 10016, United States
Pittsburgh Pennsylvania, 15213, United States
Knoxville Tennessee, 37920, United States
Houston Texas, 77030, United States
Salt Lake City Utah, 84106, United States
Caba Buenos Aires, C1125, Argentina
Caba Buenos Aires, C1426, Argentina
Rosario Santa Fe, S2000, Argentina
Buenos Aires , C1431, Argentina
Gateshead New South Wales, 2290, Australia
North Sydney New South Wales, 2060, Australia
Greenslopes Queensland, 4120, Australia
Prahran Victoria, 3181, Australia
Nedlands Western Australia, 6009, Australia
Innsbruck Tyrol, 6020, Austria
Graz , 8036, Austria
Linz , 4020, Austria
Salzburg , A-502, Austria
St Poelten , 3100, Austria
Jette Brussel, 1090, Belgium
Bruxelles , 1200, Belgium
Curitiba PR, 80530, Brazil
Porto Alegre RS, 90035, Brazil
Sao Paulo SP, 01246, Brazil
Rio de Janeiro , 20560, Brazil
Plovdiv , 4004, Bulgaria
Sofia , 1303, Bulgaria
Vancouver British Columbia, V5Z 4, Canada
Toronto Ontario, M4N 3, Canada
Montreal Quebec, H3T 1, Canada
Montreal Quebec, H4A 3, Canada
Sherbrooke Quebec, J1H 5, Canada
Temuco Araucania, 48104, Chile
Santiago , 75009, Chile
Santiago , 84203, Chile
Zlin Czech Republic, 762 7, Czechia
Hradec Kralove CZE, 500 0, Czechia
Olomouc CZE, 779 0, Czechia
Ostrava Poruba, 708 5, Czechia
Brno , 65653, Czechia
Praha 10 , 100 3, Czechia
Praha , 12808, Czechia
Aarhus , 8000 , Denmark
Le Mans Cedex 09, 72037, France
Limoges cedex Haute Vienne, 87000, France
Amiens , 80054, France
Besancon Cedex , 25030, France
Bobigny Cedex , 93009, France
Bordeaux Cedex , 33075, France
Boulogne Billancourt , 92104, France
CAEN Cedex , 14033, France
Clermont Ferrand , 63003, France
Dijon , 21000, France
Grenoble , 38043, France
Lille Cedex , 59037, France
Lorient Cedex , 56322, France
Lyon , 69373, France
Marseille Cedex 05 , 13885, France
Mulhouse cedex , 68070, France
Nice Cedex , 06202, France
Paris Cedex 10 , 75475, France
Pierre Benite , 69495, France
Poitiers , 86021, France
Reims , 51092, France
Rouen Cedex , 76031, France
Strasbourg Cedex , 67091, France
Toulouse , 31059, France
Vandoeuvre-les-Nancy cedex , 54519, France
Villejuif Cedex , 94800, France
Mannheim Baden-Wuerttemberg, 68305, Germany
Regensburg Bavaria, 93053, Germany
Berlin , 13353, Germany
Berlin , 13578, Germany
Bonn , 53105, Germany
Chemnitz , 09117, Germany
Dresden , 01307, Germany
Duesseldorf , 40225, Germany
Erfurt , 99089, Germany
Essen , 45147, Germany
Freiburg , 79106, Germany
Gera , 07548, Germany
Halle Saale , 06120, Germany
Hamburg , 20246, Germany
Hannover , 30625, Germany
Heidelberg , 69120, Germany
Homburg , 66421, Germany
Kiel , 24105, Germany
Leipzig , 04103, Germany
Mainz , 55131, Germany
Marburg , 35039, Germany
Minden , 32429, Germany
Muenchen , 81377, Germany
Muenster , 48157, Germany
Stade , 21682, Germany
Tübingen , 72076, Germany
Athens , 115 2, Greece
Athens , 18547, Greece
Budapest , H 112, Hungary
Debrecen , 4032, Hungary
Szeged , H 672, Hungary
Haifa , 31096, Israel
Jerusalem , 91120, Israel
Ramat Gan , 52621, Israel
Bari BA, 70124, Italy
Bergamo BG, 24127, Italy
Bologna BO, 40138, Italy
Brescia BS, 25123, Italy
Meldola FC, 47014, Italy
Genova GE, 16132, Italy
Monza MB, 20900, Italy
Milano MI, 20133, Italy
Milano MI, 20141, Italy
Modena MO, 41124, Italy
Padova PD, 35100, Italy
Roma RM, 00167, Italy
Siena SI, 53100, Italy
Candiolo TO, 10060, Italy
Torino TO, 10126, Italy
Verona VR, 37126, Italy
Napoli , 80131, Italy
Fukuoka city Fukuoka, 812-8, Japan
Sakyo Ku Kyoto, 606 8, Japan
Osaka-city Osaka, 541-8, Japan
Bunkyo ku Tokyo, 113-8, Japan
Chuo ku Tokyo, 104 0, Japan
Mexico Distrito Federal, 14080, Mexico
Leon Guanajuato, 37178, Mexico
Guadalajara Jalisco Jalisco, , Mexico
Breda , 4819 , Netherlands
Leiden , 2300 , Netherlands
Oslo , 0379, Norway
Gdansk , 80 95, Poland
Warszawa , 02 78, Poland
Lisboa , 1099 , Portugal
Porto , 4200-, Portugal
Chelyabinsk , 45404, Russian Federation
Moscow , 11547, Russian Federation
Moscow , 14342, Russian Federation
Nizhny Novgorod , 60313, Russian Federation
Omsk , 64401, Russian Federation
Samara , 44301, Russian Federation
St Petersburg , 19702, Russian Federation
St Petersburg , 19775, Russian Federation
Malaga Andalucia, 29010, Spain
Sevilla Andalucia, 41009, Spain
Oviedo Asturias, 33011, Spain
Jerez Cadiz, 11407, Spain
Badalona Catalunya, 08916, Spain
Barcelona Catalunya, 08036, Spain
Valencia Comunidad Valenciana, 46014, Spain
La Coruna Galicia, 15006, Spain
Las Palmas De Gran Canarias Las Palmas De Gran Canaria, 35016, Spain
Madrid , 28009, Spain
Madrid , 28034, Spain
Madrid , 28050, Spain
Madrid , 28222, Spain
Goteborg , SE-41, Sweden
Lund , 221 8, Sweden
Stockholm , SE 17, Sweden
Aarau , 5001, Switzerland
Zuerich , 8091, Switzerland
Songkhla Hat Yai, 90110, Thailand
Bangkok , 10330, Thailand
Truro Cornwall, TR1 3, United Kingdom
Surrey England, GU2 7, United Kingdom
Northwood Middlesex, HA6 2, United Kingdom
Sutton Surrey, SM2 5, United Kingdom
Leicester , LE1 5, United Kingdom
London , NW3 2, United Kingdom
Manchester , M20 4, United Kingdom
Middlesbrough , TS4 3, United Kingdom
Preston , PR2 9, United Kingdom
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