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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02967692
Recruitment Status : Recruiting
First Posted : November 18, 2016
Last Update Posted : August 27, 2019
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Brief 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

Condition or disease Intervention/treatment Phase
Melanoma Biological: Spartalizumab (PDR001) Other: Placebo Drug: Dabrafenib Drug: Trametinib Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 538 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : February 17, 2017
Estimated Primary Completion Date : September 9, 2019
Estimated Study Completion Date : July 11, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Melanoma

Arm Intervention/treatment
Experimental: Investigational treatment arm

Part 1: Safety run-in Up to 18 evaluable patients with previously untreated unresectable or metastatic BRAF V600 mutated melanoma will be enrolled and treated at different dose levels to determine the recommended Phase 3 regimen of PDR001 in combination with dabrafenib and trametinib.

Part 2: Biomarker cohort Approximately 20 patients with previously unresectable or metastatic BRAF V600 mutated melanoma will be enrolled to describe changes in the immune microenvironment and biomarker modulations

Part 3: Randomized double blind Approximately 500 patients with previously untreated unresectable and metastatic BRAF V600 mutated melanoma will be enrolled to compare the anti-tumor activity of PDR001 in combination with dabrafenib and trametinib versus placebo plus dabrafenib and trametinib.

Biological: Spartalizumab (PDR001)
Spartalizumab (PDR001) will be supplied in vial in liquid or lyophilized pharmaceutical form. Spartalizumab (PDR001) will be administered via intravenous infusion over 30 minutes (up to 2 hours) once every 4 or 8 weeks.

Drug: Dabrafenib
Dabrafenib will be provided by the sponsor to the investigative site or supplied locally as commercially available. Dabrafenib will be administered orally twice daily (150 mg BID) for Days 1-28 of a 28-day cycle.
Other Name: Tafinlar®

Drug: Trametinib
Trametinib will be provided by the sponsor to the investigative site or supplied locally as commercially available. Trametinib will be administered orally once daily (2 mg QD) for Days 1-28 of a 28-day cycle.
Other Name: Mekinist®

Placebo Comparator: Placebo comparator arm
Matching placebo in combination with dabrafenib and trametinib
Other: Placebo
Placebo will be a Dextrose 5% in water (D5W) infusion supplied by the site.
Other Name: Placebo control

Drug: Dabrafenib
Dabrafenib will be provided by the sponsor to the investigative site or supplied locally as commercially available. Dabrafenib will be administered orally twice daily (150 mg BID) for Days 1-28 of a 28-day cycle.
Other Name: Tafinlar®

Drug: Trametinib
Trametinib will be provided by the sponsor to the investigative site or supplied locally as commercially available. Trametinib will be administered orally once daily (2 mg QD) for Days 1-28 of a 28-day cycle.
Other Name: Mekinist®




Primary Outcome Measures :
  1. Safety Run-In (Part 1): Incidence of dose limiting toxicities (DLTs) [ Time Frame: 8 weeks ]
    Incidence of DLTs during the first 8 weeks of treatment with Spartalizumab (PDR001) in combination of dabrafenib and trametinib

  2. Biomarker cohort (Part 2): Immune microenvironment and biomarker modulation [ Time Frame: 2 years ]
    Changes in PD-L1 levels and CD8+ cells upon treatment with Spartalizumab (PDR001) in combination with dabrafenib and trametinib

  3. Randomized (Part 3): Progression-Free Survival (PFS), investigator assessed by RECIST 1.1 [ Time Frame: Up to disease progression or death due to any cause, whichever occurs first (5 years) ]
    Progression-free survival is defined as the time from the date of first dose to the date of the first documented radiological progression using RECIST 1.1 response criteria


Secondary Outcome Measures :
  1. Overall survival [ Time Frame: Up to death due to any cause (5 years) ]
    Overall survival is defined as the time from date of randomization to date of death due to any cause

  2. Overall response rate [ Time Frame: Up to disease progression or death due to any cause, whichever occurs first (5 years) ]
    ORR is defined as the proportion of subjects with confirmed best overall response of complete response (CR) or partial response (PR), as per investigator's assessment by RECIST 1.1

  3. Duration of response [ Time Frame: Up to disease progression or death due to any cause, whichever occurs first (5 years) ]
    Duration of response is defined as the time from first documented response of CR or PR to date of first documented progression or death, according to RECIST 1.1 criteria

  4. Disease control rate [ Time Frame: Up to disease progression or death due to any cause, whichever occurs first (5 years) ]
    Disease control rate is defined as the proportion of patients with CR or PR or subjects with SD lasting for a duration of at least 24 weeks as per local review according to RECIST 1.1 criteria

  5. Global health status/quality of life score of the EORTC QLQ-C30 [ Time Frame: Up to 60 days post progression (5 years) ]
    Patient's health-related quality of life

  6. Global health status/quality of life score of the FACT-M subscale [ Time Frame: Up to 60 days post progression (5 years) ]
    Patient's health-related quality of life

  7. Global health status/quality of life score of the EQ-5D-5L [ Time Frame: Up to 60 days post progression (5 years) ]
    Patient's health-related quality of life

  8. Time to 10 point definitive deterioration in overall quality of life score from EORTC QLQ-C30 [ Time Frame: Up to 60 days post progression (5 years) ]
    Patient's health-related quality of life

  9. PFS by PD-L1 expression [ Time Frame: Up to disease progression or death due to any cause, whichever occurs first (5 years) ]

    PFS analysis will be performed by PD-L1 subgroup (positive, negative) where a positive status is defined as having ≥ 1% expression and a negative status is defined as having < 1% expression.

    Additionally PD-L1 subgroups will also be assessed using defined by a PD-L1 expression level cut-off of 10%, where a positive status is defined as having ≥ 10% expression and a negative status is defined as having < 10% expression.


  10. OS by PD-L1 expression [ Time Frame: Up to disease progression or death due to any cause, whichever occurs first (5 years) ]

    OS analysis will be performed by PD-L1 subgroup (positive, negative) where a positive status is defined as having ≥ 1% expression and a negative status is defined as having < 1% expression.

    Additionally PD-L1 subgroups will also be assessed using defined by a PD-L1 expression level cut-off of 10%, where a positive status is defined as having ≥ 10% expression and a negative status is defined as having < 10% expression.




Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02967692


Contacts
Layout table for location contacts
Contact: Novartis Pharmaceuticals 1-888-669-6682 novartis.email@novartis.com
Contact: Novartis Pharmaceuticals +41613241111 novartis.email@novartis.com

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Locations
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United States, Arkansas
Highlands Oncology Group Withdrawn
Fayetteville, Arkansas, United States, 72703
United States, California
UC Irvine Medical Center SC Active, not recruiting
Orange, California, United States, 92868
California Cancer Associates for Research and Excellence SC-2 Active, not recruiting
San Diego, California, United States, 92024
California Pacific Medical Center Active, not recruiting
San Francisco, California, United States, 94115
UCSF Withdrawn
San Francisco, California, United States, 94115
Stanford Cancer Center SC-2 Active, not recruiting
Stanford, California, United States, 94305
United States, Colorado
University of Colorado Hospital SC-2 Completed
Aurora, Colorado, United States, 80045
United States, Florida
H Lee Moffitt Cancer Center and Research Institute SC Withdrawn
Tampa, Florida, United States, 33612
United States, Kansas
University of Kansas Cancer Center SC Active, not recruiting
Westwood, Kansas, United States, 66205
United States, Maryland
Johns Hopkins U SC Active, not recruiting
Lutherville, Maryland, United States, 21093
United States, Massachusetts
Massachusetts General Hospital SC-2 Completed
Boston, Massachusetts, United States, 02114
United States, Missouri
University of Missouri Withdrawn
Columbia, Missouri, United States, 65212
United States, Nebraska
Nebraska Cancer Specialists Completed
Omaha, Nebraska, United States, 68130
United States, New Jersey
Hackensack University Medical Center SC Withdrawn
Hackensack, New Jersey, United States, 07601
United States, New York
NYU Laura and Isaac Perlmutter Cancer Center SC Completed
New York, New York, United States, 10016
Icahn School of Medicine at Mount Sinai SC Recruiting
New York, New York, United States, 10029
Contact: Umar Farooq    212-824-7324    umar.farooq@mountsinai.org   
Principal Investigator: Philip Friedlander         
United States, Oregon
Oregon Health and Science University SC-1 Withdrawn
Portland, Oregon, United States, 97239
United States, Pennsylvania
University of Pittsburgh Medical Center SC Active, not recruiting
Pittsburgh, Pennsylvania, United States, 15213
United States, Tennessee
University of Tennessee Medical Center SC Active, not recruiting
Knoxville, Tennessee, United States, 37920
United States, Texas
University of Texas Southwestern Medical Center Withdrawn
Dallas, Texas, United States, 75390
University of TX MD Anderson Cancer Center SC-2 Active, not recruiting
Houston, Texas, United States, 77030
United States, Utah
Utah Cancer Specialists SC-2 Active, not recruiting
Salt Lake City, Utah, United States, 84106
Argentina
Novartis Investigative Site Completed
Caba, Buenos Aires, Argentina, C1118AAT
Novartis Investigative Site Active, not recruiting
Caba, Buenos Aires, Argentina, C1125ABD
Novartis Investigative Site Active, not recruiting
Caba, Buenos Aires, Argentina, C1426ANZ
Novartis Investigative Site Active, not recruiting
Rosario, Santa Fe, Argentina, S2000KZE
Novartis Investigative Site Completed
Buenos Aires, Argentina, C1431FWO
Australia, New South Wales
Novartis Investigative Site Active, not recruiting
Gateshead, New South Wales, Australia, 2290
Novartis Investigative Site Active, not recruiting
North Sydney, New South Wales, Australia, 2060
Australia, Queensland
Novartis Investigative Site Active, not recruiting
Greenslopes, Queensland, Australia, 4120
Australia, Victoria
Novartis Investigative Site Active, not recruiting
Prahran, Victoria, Australia, 3181
Australia, Western Australia
Novartis Investigative Site Active, not recruiting
Nedlands, Western Australia, Australia, 6009
Austria
Novartis Investigative Site Active, not recruiting
Innsbruck, Tyrol, Austria, 6020
Novartis Investigative Site Active, not recruiting
Graz, Austria, 8036
Novartis Investigative Site Active, not recruiting
Linz, Austria, 4020
Novartis Investigative Site Active, not recruiting
Salzburg, Austria, A-5020
Novartis Investigative Site Active, not recruiting
St. Poelten, Austria, 3100
Belgium
Novartis Investigative Site Active, not recruiting
Jette, Brussel, Belgium, 1090
Novartis Investigative Site Active, not recruiting
Bruxelles, Belgium, 1200
Novartis Investigative Site Terminated
Gent, Belgium, 9000
Brazil
Novartis Investigative Site Active, not recruiting
Curitiba, PR, Brazil, 80530 010
Novartis Investigative Site Active, not recruiting
Porto Alegre, RS, Brazil, 90035-003
Novartis Investigative Site Completed
Barretos, SP, Brazil, 14784 400
Novartis Investigative Site Active, not recruiting
Sao Paulo, SP, Brazil, 01246 000
Novartis Investigative Site Active, not recruiting
Rio de Janeiro, Brazil, 20560-120
Bulgaria
Novartis Investigative Site Completed
Pleven, Bulgaria, 5800
Novartis Investigative Site Active, not recruiting
Plovdiv, Bulgaria, 4004
Novartis Investigative Site Active, not recruiting
Sofia, Bulgaria, 1303
Canada, Alberta
Novartis Investigative Site Completed
Edmonton, Alberta, Canada, T6G 1Z2
Canada, British Columbia
Novartis Investigative Site Active, not recruiting
Vancouver, British Columbia, Canada, V5Z 4E6
Canada, Ontario
Novartis Investigative Site Completed
Kingston, Ontario, Canada, K7L 2V7
Novartis Investigative Site Completed
Toronto, Ontario, Canada, M4N 3M5
Canada, Quebec
Novartis Investigative Site Active, not recruiting
Montreal, Quebec, Canada, H3T 1E2
Novartis Investigative Site Active, not recruiting
Montreal, Quebec, Canada, H4A 3J1
Novartis Investigative Site Completed
Sherbrooke, Quebec, Canada, J1H 5N4
Chile
Novartis Investigative Site Active, not recruiting
Temuco, Araucania, Chile, 4810469
Novartis Investigative Site Active, not recruiting
Santiago, Chile, 7500921
Novartis Investigative Site Active, not recruiting
Santiago, Chile, 8420383
Czechia
Novartis Investigative Site Completed
Ostrava Poruba, Czech Republic, Czechia, 708 52
Novartis Investigative Site Active, not recruiting
Zlin, Czech Republic, Czechia, 76275
Novartis Investigative Site Active, not recruiting
Hradec Kralove, CZE, Czechia, 500 05
Novartis Investigative Site Active, not recruiting
Olomouc, CZE, Czechia, 775 20
Novartis Investigative Site Active, not recruiting
Brno, Czechia, 65653
Novartis Investigative Site Active, not recruiting
Praha 10, Czechia, 100 34
Novartis Investigative Site Active, not recruiting
Praha, Czechia, 12808
Denmark
Novartis Investigative Site Active, not recruiting
Aarhus, Denmark, 8000 C
Novartis Investigative Site Completed
Herlev, Denmark, DK 2730
Novartis Investigative Site Completed
Odense C, Denmark, DK 5000
France
Novartis Investigative Site Active, not recruiting
Le Mans, Cedex 09, France, 72037
Novartis Investigative Site Active, not recruiting
Limoges cedex, Haute Vienne, France, 87000
Novartis Investigative Site Active, not recruiting
Amiens Cedex 1, France, 80054
Novartis Investigative Site Active, not recruiting
Besancon Cedex, France, 25030
Novartis Investigative Site Active, not recruiting
Bobigny Cedex, France, 93009
Novartis Investigative Site Active, not recruiting
Bordeaux Cedex, France, 33075
Novartis Investigative Site Active, not recruiting
Boulogne Billancourt, France, 92104
Novartis Investigative Site Active, not recruiting
CAEN Cedex, France, 14033
Novartis Investigative Site Withdrawn
Chambray-lès-Tours, France, 37170
Novartis Investigative Site Active, not recruiting
Clermont Ferrand cedex 1, France, 63003
Novartis Investigative Site Active, not recruiting
Dijon, France, 21000
Novartis Investigative Site Active, not recruiting
Grenoble, France, 38043
Novartis Investigative Site Active, not recruiting
Lille Cedex, France, 59037
Novartis Investigative Site Active, not recruiting
Lorient Cedex, France, 56322
Novartis Investigative Site Active, not recruiting
Lyon Cedex, France, 69373
Novartis Investigative Site Active, not recruiting
Marseille Cedex 05, France, 13885
Novartis Investigative Site Completed
Mulhouse cedex, France, 68070
Novartis Investigative Site Active, not recruiting
Nice, France, 06202
Novartis Investigative Site Active, not recruiting
Paris Cedex 10, France, 75475
Novartis Investigative Site Active, not recruiting
Pierre Benite Cedex, France, 69495
Novartis Investigative Site Active, not recruiting
Poitiers, France, 86021
Novartis Investigative Site Active, not recruiting
Reims, France, 51092
Novartis Investigative Site Active, not recruiting
Rouen Cedex, France, 76031
Novartis Investigative Site Active, not recruiting
Strasbourg, France, 67091
Novartis Investigative Site Active, not recruiting
Toulouse Cedex 9, France, 31059
Novartis Investigative Site Completed
Vandoeuvre-les-Nancy cedex, France, 54519
Novartis Investigative Site Active, not recruiting
Villejuif Cedex, France, 94805
Germany
Novartis Investigative Site Completed
Mannheim, Baden-Wuerttemberg, Germany, 68305
Novartis Investigative Site Active, not recruiting
Regensburg, Bavaria, Germany, 93053
Novartis Investigative Site Completed
Berlin, Germany, 13353
Novartis Investigative Site Active, not recruiting
Berlin, Germany, 13578
Novartis Investigative Site Active, not recruiting
Bonn, Germany, 53105
Novartis Investigative Site Active, not recruiting
Chemnitz, Germany, 09117
Novartis Investigative Site Active, not recruiting
Dresden, Germany, 01307
Novartis Investigative Site Active, not recruiting
Duesseldorf, Germany, 40225
Novartis Investigative Site Active, not recruiting
Erfurt, Germany, 99089
Novartis Investigative Site Withdrawn
Erlangen, Germany, 91054
Novartis Investigative Site Active, not recruiting
Essen, Germany, 45147
Novartis Investigative Site Withdrawn
Frankfurt, Germany, 60590
Novartis Investigative Site Active, not recruiting
Freiburg, Germany, 79106
Novartis Investigative Site Completed
Gera, Germany, 07548
Novartis Investigative Site Active, not recruiting
Halle Saale, Germany, 06120
Novartis Investigative Site Active, not recruiting
Hamburg, Germany, 20246
Novartis Investigative Site Active, not recruiting
Hannover, Germany, 30625
Novartis Investigative Site Active, not recruiting
Heidelberg, Germany, 69120
Novartis Investigative Site Completed
Homburg, Germany, 66421
Novartis Investigative Site Active, not recruiting
Kiel, Germany, 24105
Novartis Investigative Site Active, not recruiting
Leipzig, Germany, 04103
Novartis Investigative Site Active, not recruiting
Mainz, Germany, 55131
Novartis Investigative Site Active, not recruiting
Marburg, Germany, 35039
Novartis Investigative Site Active, not recruiting
Minden, Germany, 32429
Novartis Investigative Site Active, not recruiting
Muenchen, Germany, 81377
Novartis Investigative Site Active, not recruiting
Muenster, Germany, 48157
Novartis Investigative Site Active, not recruiting
Stade, Germany, 21682
Novartis Investigative Site Active, not recruiting
Tübingen, Germany, 72076
Novartis Investigative Site Completed
Wuerzburg, Germany, 97080
Greece
Novartis Investigative Site Active, not recruiting
Athens, Greece, 115 27
Novartis Investigative Site Active, not recruiting
Athens, Greece, 18547
Novartis Investigative Site Completed
Thessaloniki, Greece, 54622
Hungary
Novartis Investigative Site Terminated
Budapest, Hungary, 1134
Novartis Investigative Site Active, not recruiting
Budapest, Hungary, H 1122
Novartis Investigative Site Active, not recruiting
Debrecen, Hungary, 4032
Novartis Investigative Site Active, not recruiting
Szeged, Hungary, H-6725
Israel
Novartis Investigative Site Completed
Haifa, Israel, 3525408
Novartis Investigative Site Active, not recruiting
Jerusalem, Israel, 91120
Novartis Investigative Site Active, not recruiting
Ramat Gan, Israel, 5265601
Italy
Novartis Investigative Site Active, not recruiting
Bari, BA, Italy, 70124
Novartis Investigative Site Active, not recruiting
Bergamo, BG, Italy, 24127
Novartis Investigative Site Active, not recruiting
Brescia, BS, Italy, 25123
Novartis Investigative Site Active, not recruiting
Meldola, FC, Italy, 47014
Novartis Investigative Site Active, not recruiting
Genova, GE, Italy, 16132
Novartis Investigative Site Active, not recruiting
Monza, MB, Italy, 20900
Novartis Investigative Site Active, not recruiting
Milano, MI, Italy, 20133
Novartis Investigative Site Active, not recruiting
Milano, MI, Italy, 20141
Novartis Investigative Site Active, not recruiting
Modena, MO, Italy, 41124
Novartis Investigative Site Active, not recruiting
Padova, PD, Italy, 35100
Novartis Investigative Site Active, not recruiting
Roma, RM, Italy, 00167
Novartis Investigative Site Active, not recruiting
Siena, SI, Italy, 53100
Novartis Investigative Site Active, not recruiting
Candiolo, TO, Italy, 10060
Novartis Investigative Site Active, not recruiting
Torino, TO, Italy, 10126
Novartis Investigative Site Completed
Verona, VR, Italy, 37126
Novartis Investigative Site Active, not recruiting
Bologna, Italy, 40138
Novartis Investigative Site Active, not recruiting
Napoli, Italy, 80131
Japan
Kyushu University Hospital Recruiting
Higashi-ku, Fukuoka, Japan, 812-8582
Kyoto University Hospital Recruiting
Sakyo-ku, Kyoto, Japan, 606-8507
Osaka International Cancer Institute Recruiting
Chuo-ku, Osaka, Japan, 541-8567
Tokyo Metropolitan Komagome Hospital Recruiting
Bunkyo-ku, Tokyo, Japan, 113-8677
National Cancer Hospital Recruiting
Chuo-ku, Tokyo, Japan, 104-0045
Mexico
Novartis Investigative Site Completed
Mexico, Distrito Federal, Mexico, 14080
Novartis Investigative Site Active, not recruiting
Leon, Guanajuato, Mexico, 37000
Novartis Investigative Site Active, not recruiting
Guadalajara Jalisco, Jalisco, Mexico
Netherlands
Novartis Investigative Site Active, not recruiting
Breda, Netherlands, 4819 EV
Novartis Investigative Site Terminated
Groningen, Netherlands, 9713 GZ
Novartis Investigative Site Active, not recruiting
Leiden, Netherlands, 2300 RC
Norway
Novartis Investigative Site Active, not recruiting
Oslo, Norway, 0379
Poland
Novartis Investigative Site Active, not recruiting
Gdansk, Poland, 80 952
Novartis Investigative Site Completed
Lodz, Poland, 93 513
Novartis Investigative Site Completed
Poznan, Poland, 60-355
Novartis Investigative Site Active, not recruiting
Warszawa, Poland, 02 781
Portugal
Novartis Investigative Site Active, not recruiting
Lisboa, Portugal, 1099 023
Novartis Investigative Site Completed
Lisboa, Portugal, 1749-035
Novartis Investigative Site Completed
Porto, Portugal, 4200-072
Russian Federation
Novartis Investigative Site Active, not recruiting
Chelyabinsk, Russian Federation, 454048
Novartis Investigative Site Active, not recruiting
Moscow, Russian Federation, 115478
Novartis Investigative Site Completed
Moscow, Russian Federation, 115478
Novartis Investigative Site Active, not recruiting
Moscow, Russian Federation, 143423
Novartis Investigative Site Active, not recruiting
Nizhny Novgorod, Russian Federation, 603137
Novartis Investigative Site Active, not recruiting
Omsk, Russian Federation, 644013
Novartis Investigative Site Active, not recruiting
Samara, Russian Federation, 443011
Novartis Investigative Site Active, not recruiting
St Petersburg, Russian Federation, 197022
Novartis Investigative Site Active, not recruiting
St Petersburg, Russian Federation, 197758
Spain
Novartis Investigative Site Completed
Granada, Andalucia, Spain, 18014
Novartis Investigative Site Completed
Malaga, Andalucia, Spain, 29010
Novartis Investigative Site Active, not recruiting
Sevilla, Andalucia, Spain, 41009
Novartis Investigative Site Active, not recruiting
Oviedo, Asturias, Spain, 33006
Novartis Investigative Site Active, not recruiting
Jerez, Cadiz, Spain, 11407
Novartis Investigative Site Active, not recruiting
Badalona, Catalunya, Spain, 08916
Novartis Investigative Site Completed
Barcelona, Catalunya, Spain, 08035
Novartis Investigative Site Active, not recruiting
Barcelona, Catalunya, Spain, 08036
Novartis Investigative Site Completed
Valencia, Comunidad Valenciana, Spain, 46009
Novartis Investigative Site Active, not recruiting
Valencia, Comunidad Valenciana, Spain, 46014
Novartis Investigative Site Completed
Caceres, Extremadura, Spain, 10003
Novartis Investigative Site Active, not recruiting
La Coruna, Galicia, Spain, 15006
Novartis Investigative Site Completed
Palma De Mallorca, Islas Baleares, Spain, 07120
Novartis Investigative Site Active, not recruiting
Las Palmas De Gran Canarias, Las Palmas De Gran Canaria, Spain, 35016
Novartis Investigative Site Completed
El Palmar, Murcia, Spain, 30120
Novartis Investigative Site Completed
Pamplona, Navarra, Spain, 31008
Novartis Investigative Site Completed
San Sebastián, Pais Vasco, Spain, 20014
Novartis Investigative Site Active, not recruiting
Madrid, Spain, 28009
Novartis Investigative Site Completed
Madrid, Spain, 28034
Novartis Investigative Site Completed
Madrid, Spain, 28040
Novartis Investigative Site Completed
Madrid, Spain, 28041
Novartis Investigative Site Active, not recruiting
Madrid, Spain, 28050
Novartis Investigative Site Active, not recruiting
Madrid, Spain, 28222
Sweden
Novartis Investigative Site Active, not recruiting
Goteborg, Sweden, SE-413 45
Novartis Investigative Site Active, not recruiting
Lund, Sweden, 221 85
Novartis Investigative Site Active, not recruiting
Stockholm, Sweden, SE 171 76
Switzerland
Novartis Investigative Site Active, not recruiting
Aarau, Switzerland, 5001
Novartis Investigative Site Completed
Basel, Switzerland, 4031
Novartis Investigative Site Completed
Bern, Switzerland, 3010
Novartis Investigative Site Completed
Lausanne, Switzerland, 1011
Novartis Investigative Site Active, not recruiting
Zuerich, Switzerland, 8091
Thailand
Novartis Investigative Site Completed
Songkhla, Hat Yai, Thailand, 90110
Novartis Investigative Site Completed
Bangkok, Thailand, 10330
Novartis Investigative Site Completed
Bangkok, Thailand, 10400
Novartis Investigative Site Completed
Bangkok, Thailand, 10700
United Kingdom
Novartis Investigative Site Active, not recruiting
Truro, Cornwall, United Kingdom, TR1 3LJ
Novartis Investigative Site Active, not recruiting
Surrey, England, United Kingdom, GU2 7XX
Novartis Investigative Site Active, not recruiting
Northwood, Middlesex, United Kingdom, HA6 2RN
Novartis Investigative Site Active, not recruiting
Sutton, Surrey, United Kingdom, SM2 5PT
Novartis Investigative Site Active, not recruiting
Leicester, United Kingdom, LE1 5WW
Novartis Investigative Site Active, not recruiting
London, United Kingdom, NW3 2QG
Novartis Investigative Site Active, not recruiting
Manchester, United Kingdom, M20 9BX
Novartis Investigative Site Active, not recruiting
Middlesborough, United Kingdom, TS4 3BW
Novartis Investigative Site Active, not recruiting
Preston, United Kingdom, PR2 9HT
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
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Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals

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Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT02967692     History of Changes
Other Study ID Numbers: CPDR001F2301
2016-002794-35 ( EudraCT Number )
First Posted: November 18, 2016    Key Record Dates
Last Update Posted: August 27, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com


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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Novartis ( Novartis Pharmaceuticals ):
melanoma
unresectable BRAF V600 mutated melanoma
metastatic BRAF V600 mutated melanoma
Spartalizumab (PDR001)
dabrafenib
trametinib
immunotherapy
PD 1 inhibitor
anti PD1
PD-1
anti-PD-1
combination treatment
malignant skin cancer
skin cancer
BRAF V600
Additional relevant MeSH terms:
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Melanoma
Nevi and Melanomas
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Trametinib
Dabrafenib
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action