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

View Eligibility Criteria

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.

Study is for people with:

Melanoma

Phase:

Phase 3

Estimated Enrollment:

569

Study ID:

NCT02967692

Recruitment Status:

Active, not recruiting

Sponsor:

Novartis Pharmaceuticals

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There are 178 Locations for this study

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California Cancer Associates for Research and Excellence SC-2
Encinitas California, 92024, United States
UC Irvine Medical Center SC
Orange California, 92868, United States
California Pacific Medical Center
San Francisco California, 94115, United States
Stanford Cancer Center SC-2
Stanford California, 94305, United States
University of Kansas Cancer Center SC
Westwood Kansas, 66205, United States
Johns Hopkins U SC
Lutherville Maryland, 21093, United States
Nebraska Cancer Specialists
Omaha Nebraska, 68130, United States
NYU Laura and Isaac Perlmutter Cancer Center SC
New York New York, 10016, United States
University of Pittsburgh Medical Center SC
Pittsburgh Pennsylvania, 15213, United States
University of Tennessee Medical Center SC
Knoxville Tennessee, 37920, United States
University of TX MD Anderson Cancer Center SC-2
Houston Texas, 77030, United States
Utah Cancer Specialists SC-2
Salt Lake City Utah, 84106, United States
Novartis Investigative Site
Caba Buenos Aires, C1125, Argentina
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Caba Buenos Aires, C1426, Argentina
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Rosario Santa Fe, S2000, Argentina
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Buenos Aires , C1431, Argentina
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Gateshead New South Wales, 2290, Australia
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North Sydney New South Wales, 2060, Australia
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Greenslopes Queensland, 4120, Australia
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Prahran Victoria, 3181, Australia
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Nedlands Western Australia, 6009, Australia
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Innsbruck Tyrol, 6020, Austria
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Graz , 8036, Austria
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Linz , 4020, Austria
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Salzburg , A-502, Austria
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St Poelten , 3100, Austria
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Jette Brussel, 1090, Belgium
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Bruxelles , 1200, Belgium
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Curitiba PR, 80530, Brazil
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Porto Alegre RS, 90035, Brazil
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Sao Paulo SP, 01246, Brazil
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Rio de Janeiro , 20560, Brazil
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Plovdiv , 4004, Bulgaria
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Sofia , 1303, Bulgaria
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Vancouver British Columbia, V5Z 4, Canada
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Toronto Ontario, M4N 3, Canada
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Montreal Quebec, H3T 1, Canada
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Montreal Quebec, H4A 3, Canada
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Sherbrooke Quebec, J1H 5, Canada
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Temuco Araucania, 48104, Chile
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Santiago , 75009, Chile
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Santiago , 84203, Chile
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Zlin Czech Republic, 762 7, Czechia
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Hradec Kralove CZE, 500 0, Czechia
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Olomouc CZE, 775 2, Czechia
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Ostrava Poruba, 708 5, Czechia
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Brno , 65653, Czechia
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Praha 10 , 100 3, Czechia
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Praha , 12808, Czechia
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Aarhus , 8000 , Denmark
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Le Mans Cedex 09, 72037, France
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Limoges cedex Haute Vienne, 87000, France
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Amiens , 80054, France
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Besancon Cedex , 25030, France
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Bobigny Cedex , 93009, France
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Bordeaux Cedex , 33075, France
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Boulogne Billancourt , 92104, France
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CAEN Cedex , 14033, France
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Clermont Ferrand , 63003, France
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Dijon , 21000, France
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Grenoble , 38043, France
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Lille Cedex , 59037, France
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Lorient Cedex , 56322, France
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Lyon Cedex , 69373, France
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Marseille Cedex 05 , 13885, France
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Mulhouse cedex , 68070, France
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Nice Cedex , 06202, France
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Paris Cedex 10 , 75475, France
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Pierre Benite Cedex , 69495, France
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Poitiers , 86021, France
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Reims , 51092, France
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Rouen Cedex , 76031, France
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Strasbourg Cedex , 67091, France
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Toulouse Cedex 9 , 31059, France
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Vandoeuvre-les-Nancy cedex , 54519, France
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Villejuif Cedex , 94800, France
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Mannheim Baden-Wuerttemberg, 68305, Germany
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Regensburg Bavaria, 93053, Germany
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Berlin , 13353, Germany
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Berlin , 13578, Germany
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Bonn , 53105, Germany
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Chemnitz , 09117, Germany
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Dresden , 01307, Germany
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Duesseldorf , 40225, Germany
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Erfurt , 99089, Germany
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Essen , 45147, Germany
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Freiburg , 79106, Germany
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Gera , 07548, Germany
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Halle Saale , 06120, Germany
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Hamburg , 20246, Germany
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Hannover , 30625, Germany
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Heidelberg , 69120, Germany
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Homburg , 66421, Germany
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Kiel , 24105, Germany
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Leipzig , 04103, Germany
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Mainz , 55131, Germany
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Marburg , 35039, Germany
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Minden , 32429, Germany
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Muenchen , 81377, Germany
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Muenster , 48157, Germany
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Stade , 21682, Germany
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Tübingen , 72076, Germany
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Athens , 115 2, Greece
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Athens , 18547, Greece
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Budapest , H 112, Hungary
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Debrecen , 4032, Hungary
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Szeged , H 672, Hungary
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Haifa , 31096, Israel
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Jerusalem , 91120, Israel
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Ramat Gan , 52621, Israel
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Bari BA, 70124, Italy
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Bergamo BG, 24127, Italy
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Bologna BO, 40138, Italy
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Brescia BS, 25123, Italy
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Meldola FC, 47014, Italy
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Genova GE, 16132, Italy
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Monza MB, 20900, Italy
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Milano MI, 20133, Italy
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Milano MI, 20141, Italy
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Modena MO, 41124, Italy
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Padova PD, 35100, Italy
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Roma RM, 00167, Italy
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Siena SI, 53100, Italy
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Candiolo TO, 10060, Italy
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Torino TO, 10126, Italy
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Verona VR, 37126, Italy
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Napoli , 80131, Italy
Kyushu University Hospital
Fukuoka city Fukuoka, 812-8, Japan
Kyoto University Hospital
Sakyo Ku Kyoto, 606 8, Japan
Osaka International Cancer Institute
Osaka-city Osaka, 541-8, Japan
Tokyo Metropolitan Komagome Hospital
Bunkyo ku Tokyo, 113-8, Japan
National Cancer Hospital
Chuo ku Tokyo, 104 0, Japan
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Mexico Distrito Federal, 14080, Mexico
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Leon Guanajuato, 37000, Mexico
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Guadalajara Jalisco Jalisco, , Mexico
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Breda , 4819 , Netherlands
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Leiden , 2300 , Netherlands
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Oslo , 0379, Norway
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Gdansk , 80 95, Poland
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Warszawa , 02 78, Poland
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Lisboa , 1099 , Portugal
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Porto , 4200-, Portugal
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Chelyabinsk , 45404, Russian Federation
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Moscow , 11547, Russian Federation
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Moscow , 14342, Russian Federation
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Nizhny Novgorod , 60313, Russian Federation
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Omsk , 64401, Russian Federation
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Samara , 44301, Russian Federation
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St Petersburg , 19702, Russian Federation
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St Petersburg , 19775, Russian Federation
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Malaga Andalucia, 29010, Spain
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Sevilla Andalucia, 41009, Spain
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Oviedo Asturias, 33011, Spain
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Jerez Cadiz, 11407, Spain
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Badalona Catalunya, 08916, Spain
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Barcelona Catalunya, 08036, Spain
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Valencia Comunidad Valenciana, 46014, Spain
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La Coruna Galicia, 15006, Spain
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Las Palmas De Gran Canarias Las Palmas De Gran Canaria, 35016, Spain
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Madrid , 28009, Spain
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Madrid , 28034, Spain
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Madrid , 28050, Spain
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Madrid , 28222, Spain
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Goteborg , SE-41, Sweden
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Lund , 221 8, Sweden
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Stockholm , SE 17, Sweden
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Aarau , 5001, Switzerland
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Zuerich , 8091, Switzerland
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Songkhla Hat Yai, 90110, Thailand
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Bangkok , 10330, Thailand
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Truro Cornwall, TR1 3, United Kingdom
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Surrey England, GU2 7, United Kingdom
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Northwood Middlesex, HA6 2, United Kingdom
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Sutton Surrey, SM2 5, United Kingdom
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Leicester , LE1 5, United Kingdom
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London , NW3 2, United Kingdom
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Manchester , M20 4, United Kingdom
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Middlesbrough , TS4 3, United Kingdom
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Preston , PR2 9, United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Melanoma

Phase:

Phase 3

Estimated Enrollment:

569

Study ID:

NCT02967692

Recruitment Status:

Active, not recruiting

Sponsor:


Novartis Pharmaceuticals

How clear is this clinincal trial information?

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