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Study Comparing the Efficacy of MEK162 Versus Dacarbazine in Unresectable or Metastatic NRAS Mutation-positive Melanoma

Primary Purpose

Metastatic or Unresectable Cutaneous Melanoma

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

MEK162

Dacarbazine

About this trial

This is an interventional treatment trial for Metastatic or Unresectable Cutaneous Melanoma focused on measuring Melanoma, Cutaneous melanoma, Skin disease, Skin cancer, Skin Neoplasms, Neoplasm Metastasis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Diagnosis of locally advanced, unresectable or metastatic cutaneous or melanoma of unknown primary AJCC Stage IIIC or IV (uveal and mucosal melanoma are excluded)
Presence of NRAS Q61 mutation in tumor tissue prior to randomization as determined by a Novartis designated central laboratory
Naïve untreated patients or patients who have progressed on or after any number of prior lines of immunotherapy for unresectable locally advanced or metastatic melanoma
Evidence of at least one measurable lesion as detected by radiological or photographic methods
Adequate bone marrow, organ function, cardiac and laboratory parameters
Normal functioning of daily living activities

Exclusion Criteria:

Any untreated CNS metastases
Uveal or mucosal melanoma
History of or current evidence of retinal vein occlusion (RVO) or risk factors of RVO
Patients with washout period < 6 weeks from the last dose of ipilimumab or other immunotherapy.
Previous systemic chemotherapy for unresectable locally advanced or metastatic melanoma.
History of Gilbert's syndrome
Prior therapy with a MEK- inhibitor
Impaired cardiovascular function or clinically significant cardiovascular diseases
Uncontrolled arterial hypertension despite medical treatment
HIV positive or active Hepatitis A or B
Impairment of gastrointestinal function
Patients who have undergone major surgery or radiotherapy ≤ 3 weeks prior to starting study drug or who have not recovered from side effects of such procedure;
Patients with neuromuscular disorders that are associated with elevated CK.
Pregnant or nursing (lactating) women
Medical, psychiatric, cognitive or other conditions that may compromise the patient's ability to understand the patient information, give informed consent, comply with the study protocol or complete the study

Other protocol-defined inclusion/exclusion criteria may apply

Sites / Locations

Highlands Oncology Group
Highlands Oncology Group
Florida Cancer Specialists
Florida Cancer Specialists
Florida Cancer Specialists
Florida Cancer Specialists
Florida Cancer Specialists
Florida Cancer Specialists
Florida Cancer Specialists
Florida Cancer Specialists
Florida Cancer Specialists
Florida Cancer Specialists
Florida Cancer Specialists
Florida Cancer Specialists
Florida Cancer Specialists
Florida Cancer Specialists
Florida Cancer Specialists
Florida Cancer Specialists
Florida Cancer Specialists
Florida Cancer Specialists
Florida Cancer Specialists
Florida Cancer Specialists
Florida Cancer Specialists
Florida Cancer Specialists
Florida Cancer Specialists
Florida Cancer Specialists
Florida Cancer Specialists
Florida Cancer Specialists
Florida Cancer Specialists
Florida Cancer Specialists
Florida Cancer Specialists
Florida Cancer Specialists
Oncology Specialists, SC
Oncology Specialists, SC
Goshen Center For Cancer Care
Eastern Maine Medical Center
Harry and Jeannette Weinberg Cancer Institute @Franklin Square
Massachusetts General Hospital
Brigham and Women's Hospital
Dana Farber Cancer Institute
Kresge Eye Institute
Barbara Ann Karmanos Cancer Institute
Kresge Eye Institute
Karmanos Cancer Institute of Farmington Hills
Nebraska Methodist Hospital
Hackensack University Medical Center
John Theurer Cancer Center at Hackensack University Medical Center
Cooper University Hospital
The Ohio State University James Cancer Hospital
The Ohio State University Martha Morehouse Medical Plaza
OHSU Knight Cancer Institute
Kaiser Permanente Northwest Region Oncology/Hematology
OHSU Center for Health and Healing
OHSU
Oregon Health and Science University
Cancer Center Associates - Medical Oncology
St. Luke's Cancer Center - Allentown Campus
St. Luke's Hospital - Allentown Campus
Cancer Center Associates - Medical Oncology
St. Luke's University Hospital - Bethlehem Campus
St. Luke's Cancer Center - Anderson Campus
Penn State Milton S. Hershey Medical Center
Hospital of the University of Pennsylvania, Perelman Center for Advanced Medicine
Thomas Jefferson Medical Oncology
Thomas Jefferson University
St. Luke's Hospital - Quakertown Campus
Sarah Cannon Research Institute
Texas Oncology-Austin Central
Elliot J. Ginchansky, MD, PA
Dennis B. Kay
Parkland Memorial Hospital
UT Southwestern University Hospital- St. Paul
Texas Oncology-Baylor Charles A. Sammons Cancer Center
UT Southwestern Medical Center at Dallas
UT Southwestern University Hospital - Zale Lipshy
US Oncology
US Oncology
Sanatorio de La Providencia
Centro de Investigación Clínica ? Clínica Viedma
Centro Oncologico de Rosario
Fundacion CIDEA
Chris O'Brien Lifehouse Hospital
Lake Macquarie Private Hospital
Melanoma Institute Australia
Princess Alexandra Hospital
Royal Adelaide Hospital
LKH-Universitätsklinikum Klinikum Graz
Universitätsklinikum Innsbruck
Salzburger Landeskliniken
Allgemeines Krankenhaus der Stadt Wien
Sint-Augustinuskliniek
UZ Gasthuisberg
CHU Sart Tilman
Hospital de Clinicas de Passo Fundo
Hospital Moinhos de Vento
Hospital Moinhos de Vento
INCA Instituto Nacional de Cancer
Hospital São José
Alberta Health Services - Cross Cancer Institute
London Regional Cancer Program
Sunnybrook Research Institute Centre
Princess Margaret Cancer Centre
McGill University Health Center / Royal Victoria Hospital
CHU de Quebec - L'Hotel-Dieu de Quebec
Mou/Mmci - Ppds
Fakultni nemocnice Ostrava
Fakultni nemocnice Kralovske Vinohrady
Vseobecna Fakultni Nemocnice V Praze
CHU Angers
CHRU de Lille - Hôpital Huriet
Centre Léon Bérard Centre Régional de Lutte Contre Le Cancer Rhône Alpes
Hôpital Saint-André
Centre Hospitalier Universitaire Ambroise Pare
Centre Hospitalier Le Mans
Hopitaux de La Timone
Groupe Hospitalier Archet I Et II
Hôpital Saint Louis
Service de PneumologieCHU Lyon Sud
Hôpital Robert Debré
Centre Hospitalier Universitaire Hopitaux de Rouen
Universitaetsklinikum Freiburg
Klinikum Mannheim Universitätsklinikum gGmbH
LMU Klinikum der Universität München
University Clinic Regensburg - PPDS
Universitätsklinikum Würzburg
Institut für Diagnostische und Interventionelle Radiologie Frankfurt
Universitätsklinikum Frankfurt
Elben Klinken Stade Buxtehude
Johannes Wesling Klinikum Minden
Klinikum Dorothea Christiane Erxleben Quedlinburg GmbH
Universitatsklinikum Leipzig
Charite Campus Mitte
Helios Klinikum Erfurt
Universitätsklinikum Carl Gustav Carus an der TU Dresden
Universitätsklinikum Essen
SRH Wald-Klinikum Gera GmbH
Medizinische Hochschule Hannover (Hannover Medical School)
University Clinic Heidelberg - PPDS
Universitatsklinikum Schleswig-Holstein
Uniklinik Köln
Universitatsklinikum Schleswig-Holstein
Fachklinik Hornheide
Klinikum Nuernberg Nord
Universitätsklinikum Tübingen
Universit*ätsklinikum Ulm
Laiko General Hospital of Athens
Magyar Honvédség Egészségügyi Központ
Orszagos Onkologiai Intezet
Somogy Megyei Kaposi Mór Oktató Kórház
Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz-Rendelointezet
Rambam Medical Center - PPDS
Hadassah Medical Center - PPDS
Sheba Medical Center - PPDS
AOU dell'Università degli Studi della Campania Luigi Vanvitelli
Istituto Dermopatico dell'Immacolata IRCCS
ASST degli Spedali Civili di Brescia - Spedali Civili di Brescia
Istituto Nazionale per lo studio e la cura dei tumori Fondazione Giovanni Pascale
Istituto Oncologico Veneto - I.R.C.C.S.
IRCCS Giovanni Paolo II Istituto Oncologico
ASST Papa Giovanni XXIII - Azienda Ospedaliera Papa Giovanni XXIII
IRCCS Az. Osp. Universitaria San Martino- IST
Ospedale San Raffaele S.r.l. - PPDS
Fondazione IRCCS 'Istituto Nazionale dei Tumori' di Milano
Istituto Nazionale Tumori Regina Elena
Azienza Ospedaliera Universitaria Senese
A.O.U. Città della Salute e della Scienza di Torino - Presidio S. Lazzaro
Shinshu University Hospital
National Cancer Center Hospital
Kansai Medical University Hospital
Asan Medical Center - PPDS
Samsung Medical Center - PPDS
Seoul National University Hospital
Severance Hospital Yonsei University Health System - PPDS
Radboud University Nijmegen Medical Centre
Het Nederlands Kanker Instituut Antoni Van Leeuwenhoek Ziekenhuis
Leids Universitair Medisch Centrum
Isala Klinieken
Centrum Medyczne MAVIT Sp. z o.o.
Lux Med
Centrum Onkologii Instytut im. Marii Sklodowskiej-Curie
Instituto Português de Oncologia de Lisboa Francisco Gentil, E.P.E.
Hospital Garcia de Orta*E.P.E.
Centro Hospitalar Lisboa Norte, E.P.E. - Hospital de Santa Maria
Instituto Portugues de Oncologia Do Porto Francisco Gentil Epe - PPDS
Russian Oncology Research Center n a N N Blokhin
Ryazan Regional Clinical Oncology Dispensary
Scientific Research Institute of Oncology n.a. N.N. Petrov
Narodny onkologicky ustav
University of The Free State
Sandton Oncology Medical Group
Sandton Oncology Medical Research
Steve Biko Academic Hospital
Mary Potter Oncology Centre
ICO l'Hospitalet - Hospital Duran i Reynals
Hospital Regional Universitario de Malaga Hospital General
Clinica Universidad Navarra
Hospital Universitario Vall d'Hebrón - PPDS
Hospital Clinic de Barcelona
ICO l'Hospitalet - Hospital Duran i Reynals
Complejo Hospitalario Universitario Insular - Materno Infantil
Hospital Universitario A Coruña
Hospital General Universitario Gregorio Maranon
MD Anderson Cancer Center
Hospital Universitario Fundacion Jimenez Diaz
Hospital Universitario HM Sanchinarro - CIOCC
Hospital Universitario Virgen Macarena
Hospital Virgen de La Salud
Fundacion Instituto Valenciano de Oncologia
Consorcio Hospital General Universitario de Valencia
Skanes Universitetssjukhus Lund
Skanes Universitetssjukhus Lund
Universitätsspital Zürich
Hôpitaux Universitaires de Genève
Centre Hospitalier Universitaire Vaudois
Ege University Medical Faculty
Adana Ba?kent Hastanesi K??la Yerle?kesi
Hacettepe University Medical Faculty
Baskent University Medical Faculty Ankara Hospital
Istanbul University Cerrahpasa Medical Faculty Hospital
Bristol Haematology and Oncology Centre
Royal Cornwall Hospital
The Royal Sussex County Hospital
Broomfield Hospital
Singleton Hospital - PPDS
Royal Preston Hospital
Royal Marsden Hospital - Surrey
Queen Elizabeth Hospital
St James s Institute of Clinical Oncology
Clatterbridge Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

MEK162

Dacarbazine

Arm Description

Outcomes

Primary Outcome Measures

Progression-Free Survival (PFS) by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1

PFS: time from randomization to first documented PD or death due to any cause, whichever occurred first. RECIST 1.1, PD: >=20% increase in sum of diameter of target lesions (TLs) taking as reference the smallest sum on study (including baseline sum), sum must also be an absolute increase of >=5 mm; unequivocal progression of existing non-TLs; appearance of >=1 lesion. Complete response (CR): disappearance of all lesions; any pathological lymph nodes (TLs) or non-pathological (non-TLs) must have reduction in short axis to <10 mm; normalization of tumor marker level for non-TLs. Partial response (PR): >=30% decrease in sum of diameter of all TLs, referring baseline sum of diameters. Stable disease (SD): neither sufficient shrinkage to qualify for PR nor increase in lesions qualified for PD referring smallest sum diameter. With no event at time of analysis cut-off or at start of any new anti-neoplastic therapy, PFS censored at date of last adequate tumor assessment of CR, PR or SD.

Secondary Outcome Measures

Overall Survival (OS)

Overall survival was defined as the time from the date of randomization to the date of death due to any cause. If a participant was not known to have died, overall survival was censored at the date of last known date participant alive.

Overall Response Rate (ORR)

ORR: percentage of participants with best overall response (BOR) of CR or PR. BOR: best response recorded from start of treatment until CR or PR. RECIST V1.1, a) CR: disappearance of all lesions; any pathological lymph nodes (TLs) or non-pathological (non-TLs) must have reduction in short axis to <10 mm; normalization of tumor marker level for non-TLs; b) PR: >=30% decrease in sum of diameter of all TLs, taking as reference baseline sum of diameters. ORR is reported for confirmed and unconfirmed responses. Confirmed CR or PR = at least 2 determinations of CR or PR at least 4 weeks apart before PD. PD: >=20% increase in sum of diameter of all measured target lesions, taking as reference smallest sum of diameter of all TLs recorded at or after baseline, sum must also be absolute increase of >=5 mm. Unequivocal progression of existing non TLs. Appearance of at least 1 new lesion.

Time to Response (TTR)

TTR: time between date of randomization until first documented response of CR or PR. RECIST V1.1, a) CR: disappearance of all lesions; any pathological lymph nodes (TLs) or non-pathological (non-TLs) must have reduction in short axis to <10 mm; normalization of tumor marker level for non-TLs; b) PR: >=30% decrease in sum of diameter (dia) of all TLs, referring baseline sum of dia; c) PD: >=20% increase in sum of diameter of all measured TLs taking as reference smallest sum of diameter of all TLs recorded at or after baseline, sum must also be absolute increase of >=5 mm. Unequivocal progression of existing non-TLs. Appearance of >=1 new lesion. Participants who did not achieve PR or CR censored at last adequate tumor assessment date when they did not have PFS event (time from date of randomization to date of first documented PD or death due to any cause, whichever occur first) or at maximum follow-up when they had PFS event.

Duration of Objective Response (DOR)

DOR: time from date of first documented response (CR or PR) to first documented progression or death due to underlying cancer. RECIST V1.1, a) CR: disappearance of all lesions; any pathological lymph nodes (TLs) or non-pathological (non-TLs) must have reduction in short axis to <10 mm; normalization of tumor marker level for non-TLs; b) PR: >=30% decrease in sum of diameter (dia) of all TLs, referring baseline sum of dia; c) PD: >=20% increase in sum of diameter of all measured target lesions taking as reference smallest sum of diameter of all target lesions recorded at or after baseline, sum must also be absolute increase of >=5 mm. Unequivocal progression of existing non-target lesions. Appearance of at least 1 new lesion. If a participant with a CR or PR had no PD or death due to underlying cancer, participants was censored at date of last adequate tumor assessment.

Disease Control Rate (DCR)

DCR was calculated as the percentage of participants with a BOR of CR, PR, SD RECIST V1.1, a) CR: disappearance of all lesions; any pathological lymph nodes (TLs) or non-pathological (non-TLs) must have reduction in short axis to <10 mm; normalization of tumor marker level for non-TLs; b) PR: >=30% decrease in sum of diameter of all target lesions, taking as reference the baseline sum of diameters; c) SD: neither sufficient shrinkage to qualify for PR or CR nor an increase in lesions which would qualify for PD taking as reference the smallest sum diameters; d) PD: >=20% increase in sum of diameter of all measured target lesions, taking as reference the smallest sum of diameter of all target lesions recorded at or after baseline, sum must also be absolute increase of >=5 mm. Unequivocal progression of existing non-target lesions. Appearance of at least 1 new lesion.

Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)

An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship with the study treatment. SAE was defined as one of the following: was fatal or life-threatening; resulted in persistent or significant disability/incapacity; constituted a congenital anomaly/birth defect; was medically significant; required inpatient hospitalization or prolongation of existing hospitalization. Treatment-emergent AE was defined as an AE with onset date occurring during the on-treatment period. AEs included all SAEs and non-SAEs.

Number of Participants With Clinically Notable Hematology Shifts Based on National Cancer Institute Common Terminology Criteria (NCI-CTCAE) Grade, Version 4.03

Clinically notable shifts are defined as worsening by at least 2 grades or to >= grade 3. Severity was graded as Grade 1: asymptomatic or mild symptoms, clinical or diagnostic observations only, intervention not indicated; Grade 2: moderate, minimal, local or noninvasive intervention indicated, limiting age-appropriate instrumental activities of daily life (ADL); Grade 3: severe or medically significant but not immediately life-threatening, hospitalization or prolongation of existing hospitalization indicated, disabling, limiting self-care ADL; Grade 4: life-threatening consequence, urgent intervention indicated; Grade 5: death related to AE.

Number of Participants With Clinically Notable Clinical Chemistry/Biochemistry Shifts Based on NCI-CTCAE Grade, Version 4.03

Clinically notable shifts are defined as worsening by at least 2 grades or to >= grade 3. Severity was graded as Grade 1: asymptomatic or mild symptoms, clinical or diagnostic observations only, intervention not indicated; Grade 2: moderate, minimal, local or noninvasive intervention indicated, limiting age-appropriate instrumental ADL; Grade 3: severe or medically significant but not immediately life-threatening, hospitalization or prolongation of existing hospitalization indicated, disabling, limiting self-care ADL; Grade 4: life-threatening consequence, urgent intervention indicated; Grade 5: death related to AE.

Number of Participants With Clinically Notable Vital Signs

Abnormalities criteria included: low/high pulse rate (beats per minute [bpm]):<=50bpm with decrease from baseline >=15bpm/>=120bpm with increase from baseline >=15bpm; Low/high systolic blood pressure (millimeters of mercury [mmHg]): <=90mmHg with decrease from baseline >=20mmHg/>=160mmHg with increase from baseline >=20mmHg; Low/high diastolic blood pressure [mmHg]: <=50mmHg with decrease from baseline >=15mmHg/>=100mmHg with increase from baseline >=15mmHg; Low/high body weight (kilogram [kg]): >=20% decrease from baseline / >=10% increase from baseline; Low/high body temperature (degree Celsius [°C]): <=36°C / >= 37.5°C

Number of Participants With Notable Electrocardiogram (ECG) Values

Criteria for notable ECG values were as follow: QT interval (in millisecond [msec]) new (newly occurring post-baseline value) greater than (>) 450, 480, 500, increase from baseline >30, increase from baseline >60; corrected QT interval by Fredericia formula (QTcF) in msec new (newly occurring post-baseline value) > 450, 480, 500, increase from baseline >30, increase from baseline >60; corrected QT interval by Bazett's formula (QTcB) in msec new (newly occurring post-baseline value) > 450, 480, 500, increase from baseline >30, increase from baseline >60; heart rate in bpm new (newly occurring post-baseline value) <60 and >100.

Number of Participants With Adverse Events of Special Interest: Cardiac Events

An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship with the study treatment. Grade 1: asymptomatic or mild symptoms, clinical or diagnostic observations only, intervention not indicated; Grade 2: moderate, minimal, local or noninvasive intervention indicated, limiting age-appropriate instrumental activities of daily life (ADL); Grade 3: severe or medically significant but not immediately life-threatening, hospitalization or prolongation of existing hospitalization indicated, disabling, limiting self-care ADL; Grade 4: life-threatening consequence, urgent intervention indicated; Grade 5: death related to AE. Here, in this outcome measure data is reported for events falling in any of the grades.

Number of Participants With Clinically Significant Findings in Physical Examination

A complete physical examination included the examination of general appearance, skin, neck (including thyroid), eyes, ears, nose, throat, lungs, heart, abdomen, back, lymph nodes, extremities, vascular and neurological systems. If indicated based on medical history and/or symptoms, rectal, external genitalia, breast, and pelvic examinations were performed. Clinical significance in physical examination was reported as adverse events.

Number of Participants With Adverse Events of Special Interest: Ocular Events

An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship with the study treatment. Grade 1: Asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated; Grade 2: Moderate; minimal, local or noninvasive intervention indicated; limiting age appropriate instrumental ADL; Grade 3: Severe or medically significant but not immediately sight threatening; Hospitalization or prolongation of existing hospitalization indicated; disabling; limiting self-care ADL; Grade 4: Sight-threatening consequences; urgent intervention indicated; blindness (20/200 or worse) in the affected eye. Here, in this outcome measure data is reported for events falling in any of the grades.

Plasma Concentration of Binimetinib

Time to Definitive 10% Deterioration in Global Health Status Score of European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30)

The time to definitive 10% deterioration was defined as the time from the date of randomization to the date of event, which was defined as death due to any cause or at least 10% worsening of the corresponding scale score, relative to baseline, with no later improvement above this threshold observed during the course of the study or death due to any cause. If a participant had no event prior to analysis cut-off or start of another anticancer therapy, time to deterioration was censored at the date of the last adequate health related quality of life (HRQoL) evaluation. EORTC QLQ-C30: 5 functional scales (physical, role, cognitive, emotional, and social), a global health status scale, 3 symptom scales (nausea/vomiting, pain, fatigue) and 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea and financial difficulties). All scales and single-item measures range =0 to 100. High score for global health status = high quality of life.

Change From Baseline in Global Health Status Score of EORTC QLQ-C30 at Weeks 4, 7, 13, 19, 25, 34, 43, 52, 61, 70, End of Treatment, Safety Follow-up Visit, Post-Treatment Follow-up Visit 1, 2, 3, 4, 5 and 6

EORTC QLQ-C30: 5 functional scales (physical, role, cognitive, emotional, and social), a h global health status scale, 3 symptom scales (nausea/vomiting, pain, fatigue) and 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea and financial difficulties). All scales and single-item measures range =0 to 100. High score for global health status = high quality of life. Post-treatment tumor assessments follow up visits occurred at every 9 weeks if participants started new anticancer therapy.

Change From Baseline in EuroQoL-5 Dimensions- 5 Levels (EQ-5D-5L) Index Score at Weeks 4, 7, 13, 19, 25, 34, 43, 52, 61, 70, End of Treatment, Safety Follow-up Visit, Post-treatment Follow-up Visit 1, 2, 3, 4, 5 and 6

EQ-5D-5L, is a standardized measure of health utility that provides a single index value for one's health status. EQ-5D-5L contained 1 item for each of 5 dimensions: mobility, self-care, usual activities, pain/discomfort, anxiety/depression. Each dimension has 5 levels: 1= no problems, 2= slight problems, 3= moderate problems, 4= severe problems, and 5= extreme problems. Index score: participant responses to the 5 dimensions reflected a specific health state that corresponded to a population preference weight for that state on a continuous scale of 0 (death) to 1 (perfect health). Higher index scores = better health state. Post-treatment tumor assessments follow up visits occurred at every 9 weeks if participants started new anticancer therapy.

Time to Definitive 1 Point Deterioration in Eastern Cooperative Oncology Group (ECOG) Performance Status (PS)

ECOG PS was used to assess the physical health of participants, and ranged from 0 (most active) to 5 (dead). ECOG PS grades: 0= fully active, able to carry on all pre-disease performance without restriction, 1= restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work, 2= ambulatory and capable of all self-care but unable to carry out any work activities. Up and about more than 50% of waking hours, 3= capable of only limited self-care, confined to bed or chair more than 50% of waking hours, 4=completely disabled. cannot carry on any selfcare. Totally confined to bed or chair and 5= dead. Definitive deterioration is defined as on treatment death due to any cause or decrease in ECOG PS by at least one category from baseline score.

Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (PS)

ECOG PS was used to assess the physical health of participants, and ranged from 0 (most active) to 5 (dead). ECOG PS grades: 0= fully active, able to carry on all pre-disease performance without restriction, 1= restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work, 2= ambulatory and capable of all self-care but unable to carry out any work activities. Up and about more than 50% of waking hours, 3= capable of only limited self-care, 4=completely disabled. cannot carry on any selfcare. Totally confined to bed or chair confined to bed or chair more than 50% of waking hours and 5= dead. Post-treatment tumor assessments follow up visits occurred at every 9 weeks if participants started new anticancer therapy.

Number of Participants With Neuroblastoma RAS Viral (V-ras) Oncogene Homolog (NRAS) Mutation Status at Baseline

Number of participants with NRAS mutation status at baseline were reported.

Full Information

NCT ID

NCT01763164

First Posted

January 4, 2013

Last Updated

March 18, 2021

Sponsor

Pfizer

1. Study Identification

Unique Protocol Identification Number

NCT01763164

Brief Title

Study Comparing the Efficacy of MEK162 Versus Dacarbazine in Unresectable or Metastatic NRAS Mutation-positive Melanoma

Official Title

The NEMO Trial (NRAS Melanoma and MEK Inhibitor):A Randomized Phase III, Open Label, Multicenter, Two-arm Study Comparing the Efficacy of MEK162 Versus Dacarbazine in Patients With Advanced Unresectable or Metastatic NRAS Mutation-positive Melanoma

Study Type

Interventional

2. Study Status

Record Verification Date

March 2021

Overall Recruitment Status

Completed

Study Start Date

July 12, 2013 (Actual)

Primary Completion Date

December 1, 2015 (Actual)

Study Completion Date

June 4, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Pfizer

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

Two-arm, randomized, prospective, open-label, multi-center, phase III study to compare the efficacy and safety of MEK162 (45 mg BID) versus dacarbazine (1000 mg/m2 IV every 3 weeks) in patients with advanced (Stage IIIC) unresectable or metastatic (Stage IV) NRAS Q61 mutation-positive cutaneous or unknown primary melanoma. The mutation analysis will be performed at a central laboratory. Only those patients with Q61 mutation per central laboratory and meet all eligibility criteria will be randomized. A total of 393 patients will be randomized 2:1 to receive either MEK162 or dacarbazine. Patients will be stratified according to AJCC stage (IIIC, IVM1a, and IVM1b versus IVM1c), ECOG Performance status (0 versus 1) and any prior number of lines of immunotherapy (immunotherapies versus none). This study will use an Interactive Response Technology (IRT). The primary end point of the study is progression-free survival. Key secondary end point is overall survival

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Metastatic or Unresectable Cutaneous Melanoma

Keywords

Melanoma, Cutaneous melanoma, Skin disease, Skin cancer, Skin Neoplasms, Neoplasm Metastasis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

402 (Actual)

8. Arms, Groups, and Interventions

Arm Title

MEK162

Arm Type

Experimental

Arm Title

Dacarbazine

Arm Type

Active Comparator

Intervention Type

Drug

Intervention Name(s)

MEK162

Intervention Description

MEK162 will be administered as a fixed dose of 45 mg (3 x 15 mg tablets) BID, with a glass of water and taken with or without food.

Intervention Type

Drug

Intervention Name(s)

Dacarbazine

Intervention Description

Patients randomized to dacarbazine will receive an IV infusion of dacarbazine 1000 mg/m2 over the course of 1 hour on day 1 and then every three weeks.

Primary Outcome Measure Information:

Title

Progression-Free Survival (PFS) by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1

Description

Time Frame

From the date of randomization to the date of the first documented PD or death, whichever occurred first (maximum up to 77 weeks for binimetinib arm; maximum up to 61 weeks for dacarbazine arm)

Secondary Outcome Measure Information:

Title

Overall Survival (OS)

Description

Time Frame

From the date of randomization to the date of death (maximum up to 107 weeks for binimetinib arm; maximum up to 88 weeks for dacarbazine arm)

Title

Overall Response Rate (ORR)

Description

Time Frame

From date of randomization until first documented response of CR or PR (maximum up to 77 weeks for binimetinib arm; maximum up to 61 weeks for dacarbazine arm)

Title

Time to Response (TTR)

Description

Time Frame

From date of randomization until first documented response of CR or PR (maximum up to 77 weeks for binimetinib arm; maximum up to 61 weeks for dacarbazine arm)

Title

Duration of Objective Response (DOR)

Description

Time Frame

From the date of first documented response (CR or PR) to the first documented progression or death (maximum up to 77 weeks for binimetinib arm; maximum up to 61 weeks for dacarbazine arm)

Title

Disease Control Rate (DCR)

Description

Time Frame

From date of randomization until first documented response of CR, PR, SD or non-CR/non-PD (maximum up to 77 weeks for binimetinib arm; maximum up to 61 weeks for dacarbazine arm)

Title

Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)

Description

Time Frame

From baseline up to 219.4 weeks for binimetinib arm; From baseline up to 123.9 weeks for dacarbazine arm

Title

Number of Participants With Clinically Notable Hematology Shifts Based on National Cancer Institute Common Terminology Criteria (NCI-CTCAE) Grade, Version 4.03

Description

Time Frame

From baseline up to 77 weeks in binimetinib arm; From baseline up to 61 weeks for dacarbazine arm

Title

Number of Participants With Clinically Notable Clinical Chemistry/Biochemistry Shifts Based on NCI-CTCAE Grade, Version 4.03

Description

Clinically notable shifts are defined as worsening by at least 2 grades or to >= grade 3. Severity was graded as Grade 1: asymptomatic or mild symptoms, clinical or diagnostic observations only, intervention not indicated; Grade 2: moderate, minimal, local or noninvasive intervention indicated, limiting age-appropriate instrumental ADL; Grade 3: severe or medically significant but not immediately life-threatening, hospitalization or prolongation of existing hospitalization indicated, disabling, limiting self-care ADL; Grade 4: life-threatening consequence, urgent intervention indicated; Grade 5: death related to AE.

Time Frame

From baseline up to 77 weeks in binimetinib arm; From baseline up to 61 weeks for dacarbazine arm

Title

Number of Participants With Clinically Notable Vital Signs

Description

Time Frame

From baseline up to 77 weeks in binimetinib arm; From baseline up to 61 weeks for dacarbazine arm

Title

Number of Participants With Notable Electrocardiogram (ECG) Values

Description

Time Frame

From baseline up to 77 weeks in binimetinib arm; From baseline up to 61 weeks for dacarbazine arm

Title

Number of Participants With Adverse Events of Special Interest: Cardiac Events

Description

Time Frame

From baseline up to 77 weeks in binimetinib arm; From baseline up to 61 weeks for dacarbazine arm

Title

Number of Participants With Clinically Significant Findings in Physical Examination

Description

Time Frame

From baseline up to 77 weeks in binimetinib arm; From baseline up to 61 weeks for dacarbazine arm

Title

Number of Participants With Adverse Events of Special Interest: Ocular Events

Description

Time Frame

From baseline up to 77 weeks in binimetinib arm; From baseline up to 61 weeks for dacarbazine arm

Title

Plasma Concentration of Binimetinib

Time Frame

Day 1 of Week 1: Pre-dose, 1, 1.5, 2, 10 hours post-dose; Day 1 of Weeks 4, 7: Pre-dose, 1.5 hours post-dose; Day 1 of Weeks 10, 13: Pre-dose

Title

Time to Definitive 10% Deterioration in Global Health Status Score of European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30)

Description

Time Frame

From baseline up to 77 weeks in binimetinib arm; From baseline up to 61 weeks for dacarbazine arm

Title

Description

Time Frame

Both arms: Baseline, Day 1 Treatment Week (TW) 4,7,13,19,25,34,43,52; Post-treatment follow-up Visit (FUV) 1 to 6; Binimetinib: Day 1 TW61,70; End of treatment (EOT= TW73); Safety FUV=30 days post TW73; Dacarbazine: EOT=TW 57;Safety FUV=30 days post TW57

Title

Description

Time Frame

Title

Time to Definitive 1 Point Deterioration in Eastern Cooperative Oncology Group (ECOG) Performance Status (PS)

Description

Time Frame

From baseline up to 73 weeks 3 days for binimetinib arm; From baseline up to 57 weeks 3 days for dacarbazine arm

Title

Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (PS)

Description

ECOG PS was used to assess the physical health of participants, and ranged from 0 (most active) to 5 (dead). ECOG PS grades: 0= fully active, able to carry on all pre-disease performance without restriction, 1= restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work, 2= ambulatory and capable of all self-care but unable to carry out any work activities. Up and about more than 50% of waking hours, 3= capable of only limited self-care, 4=completely disabled. cannot carry on any selfcare. Totally confined to bed or chair confined to bed or chair more than 50% of waking hours and 5= dead. Post-treatment tumor assessments follow up visits occurred at every 9 weeks if participants started new anticancer therapy.

Time Frame

For both arms: Baseline, Weeks 4, 7, 10, 13, 16, 19, 22, 25, 28, 31, 34, 37, 40, 43, 46, 49, 52, 55 and 30-day Follow-up For binimetinib only: Weeks 58, 61, 64, 67, 70, 73

Title

Number of Participants With Neuroblastoma RAS Viral (V-ras) Oncogene Homolog (NRAS) Mutation Status at Baseline

Description

Number of participants with NRAS mutation status at baseline were reported.

Time Frame

Baseline

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Diagnosis of locally advanced, unresectable or metastatic cutaneous or melanoma of unknown primary AJCC Stage IIIC or IV (uveal and mucosal melanoma are excluded) Presence of NRAS Q61 mutation in tumor tissue prior to randomization as determined by a Novartis designated central laboratory Naïve untreated patients or patients who have progressed on or after any number of prior lines of immunotherapy for unresectable locally advanced or metastatic melanoma Evidence of at least one measurable lesion as detected by radiological or photographic methods Adequate bone marrow, organ function, cardiac and laboratory parameters Normal functioning of daily living activities Exclusion Criteria: Any untreated CNS metastases Uveal or mucosal melanoma History of or current evidence of retinal vein occlusion (RVO) or risk factors of RVO Patients with washout period < 6 weeks from the last dose of ipilimumab or other immunotherapy. Previous systemic chemotherapy for unresectable locally advanced or metastatic melanoma. History of Gilbert's syndrome Prior therapy with a MEK- inhibitor Impaired cardiovascular function or clinically significant cardiovascular diseases Uncontrolled arterial hypertension despite medical treatment HIV positive or active Hepatitis A or B Impairment of gastrointestinal function Patients who have undergone major surgery or radiotherapy ≤ 3 weeks prior to starting study drug or who have not recovered from side effects of such procedure; Patients with neuromuscular disorders that are associated with elevated CK. Pregnant or nursing (lactating) women Medical, psychiatric, cognitive or other conditions that may compromise the patient's ability to understand the patient information, give informed consent, comply with the study protocol or complete the study Other protocol-defined inclusion/exclusion criteria may apply

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Pfizer CT.gov Call Center

Organizational Affiliation

Pfizer

Official's Role

Study Director

Facility Information:

Facility Name

Highlands Oncology Group

City

Fayetteville

State/Province

Arkansas

ZIP/Postal Code

72703

Country

United States

Facility Name

Highlands Oncology Group

City

Rogers

State/Province

Arkansas

ZIP/Postal Code

72758

Country

United States

Facility Name

Florida Cancer Specialists

City

Altamonte Springs

State/Province

Florida

ZIP/Postal Code

32701

Country

United States

Facility Name

Florida Cancer Specialists

City

Bonita Springs

State/Province

Florida

ZIP/Postal Code

34135

Country

United States

Facility Name

Florida Cancer Specialists

City

Bradenton

State/Province

Florida

ZIP/Postal Code

34209

Country

United States

Facility Name

Florida Cancer Specialists

City

Brandon

State/Province

Florida

ZIP/Postal Code

33511

Country

United States

Facility Name

Florida Cancer Specialists

City

Cape Coral

State/Province

Florida

ZIP/Postal Code

33914

Country

United States

Facility Name

Florida Cancer Specialists

City

Clearwater

State/Province

Florida

ZIP/Postal Code

33756

Country

United States

Facility Name

Florida Cancer Specialists

City

Clearwater

State/Province

Florida

ZIP/Postal Code

33761

Country

United States

Facility Name

Florida Cancer Specialists

City

Fort Myers

State/Province

Florida

ZIP/Postal Code

33905

Country

United States

Facility Name

Florida Cancer Specialists

City

Fort Myers

State/Province

Florida

ZIP/Postal Code

33908

Country

United States

Facility Name

Florida Cancer Specialists

City

Gainesville

State/Province

Florida

ZIP/Postal Code

32605

Country

United States

Facility Name

Florida Cancer Specialists

City

Hudson

State/Province

Florida

ZIP/Postal Code

34667

Country

United States

Facility Name

Florida Cancer Specialists

City

Inverness

State/Province

Florida

ZIP/Postal Code

34453

Country

United States

Facility Name

Florida Cancer Specialists

City

Largo

State/Province

Florida

ZIP/Postal Code

33770

Country

United States

Facility Name

Florida Cancer Specialists

City

Largo

State/Province

Florida

ZIP/Postal Code

33777

Country

United States

Facility Name

Florida Cancer Specialists

City

Naples

State/Province

Florida

ZIP/Postal Code

34102

Country

United States

Facility Name

Florida Cancer Specialists

City

Naples

State/Province

Florida

ZIP/Postal Code

34119

Country

United States

Facility Name

Florida Cancer Specialists

City

New Port Richey

State/Province

Florida

ZIP/Postal Code

34655

Country

United States

Facility Name

Florida Cancer Specialists

City

Orange City

State/Province

Florida

ZIP/Postal Code

32763

Country

United States

Facility Name

Florida Cancer Specialists

City

Orlando

State/Province

Florida

ZIP/Postal Code

32806

Country

United States

Facility Name

Florida Cancer Specialists

City

Port Charlotte

State/Province

Florida

ZIP/Postal Code

33980

Country

United States

Facility Name

Florida Cancer Specialists

City

Saint Petersburg

State/Province

Florida

ZIP/Postal Code

33705

Country

United States

Facility Name

Florida Cancer Specialists

City

Saint Petersburg

State/Province

Florida

ZIP/Postal Code

33707

Country

United States

Facility Name

Florida Cancer Specialists

City

Sarasota

State/Province

Florida

ZIP/Postal Code

34232

Country

United States

Facility Name

Florida Cancer Specialists

City

Sarasota

State/Province

Florida

ZIP/Postal Code

34236

Country

United States

Facility Name

Florida Cancer Specialists

City

Spring Hill

State/Province

Florida

ZIP/Postal Code

34608

Country

United States

Facility Name

Florida Cancer Specialists

City

Tampa

State/Province

Florida

ZIP/Postal Code

33607

Country

United States

Facility Name

Florida Cancer Specialists

City

Tampa

State/Province

Florida

ZIP/Postal Code

33613

Country

United States

Facility Name

Florida Cancer Specialists

City

Tavares

State/Province

Florida

ZIP/Postal Code

32778

Country

United States

Facility Name

Florida Cancer Specialists

City

Venice

State/Province

Florida

ZIP/Postal Code

34285

Country

United States

Facility Name

Florida Cancer Specialists

City

Venice

State/Province

Florida

ZIP/Postal Code

34292

Country

United States

Facility Name

Oncology Specialists, SC

City

Niles

State/Province

Illinois

ZIP/Postal Code

60714

Country

United States

Facility Name

Oncology Specialists, SC

City

Park Ridge

State/Province

Illinois

ZIP/Postal Code

60068

Country

United States

Facility Name

Goshen Center For Cancer Care

City

Goshen

State/Province

Indiana

ZIP/Postal Code

46526

Country

United States

Facility Name

Eastern Maine Medical Center

City

Bangor

State/Province

Maine

ZIP/Postal Code

04401

Country

United States

Facility Name

Harry and Jeannette Weinberg Cancer Institute @Franklin Square

City

Baltimore

State/Province

Maryland

ZIP/Postal Code

21237

Country

United States

Facility Name

Massachusetts General Hospital

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02114

Country

United States

Facility Name

Brigham and Women's Hospital

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02115

Country

United States

Facility Name

Dana Farber Cancer Institute

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02215

Country

United States

Facility Name

Kresge Eye Institute

City

Bingham Farms

State/Province

Michigan

ZIP/Postal Code

48025

Country

United States

Facility Name

Barbara Ann Karmanos Cancer Institute

City

Detroit

State/Province

Michigan

ZIP/Postal Code

48201

Country

United States

Facility Name

Kresge Eye Institute

City

Detroit

State/Province

Michigan

ZIP/Postal Code

48201

Country

United States

Facility Name

Karmanos Cancer Institute of Farmington Hills

City

Farmington Hills

State/Province

Michigan

ZIP/Postal Code

48334

Country

United States

Facility Name

Nebraska Methodist Hospital

City

Omaha

State/Province

Nebraska

ZIP/Postal Code

68114

Country

United States

Facility Name

Hackensack University Medical Center

City

Hackensack

State/Province

New Jersey

ZIP/Postal Code

07601

Country

United States

Facility Name

John Theurer Cancer Center at Hackensack University Medical Center

City

Hackensack

State/Province

New Jersey

ZIP/Postal Code

07601

Country

United States

Facility Name

Cooper University Hospital

City

Voorhees

State/Province

New Jersey

ZIP/Postal Code

08043

Country

United States

Facility Name

The Ohio State University James Cancer Hospital

City

Columbus

State/Province

Ohio

ZIP/Postal Code

43210

Country

United States

Facility Name

The Ohio State University Martha Morehouse Medical Plaza

City

Columbus

State/Province

Ohio

ZIP/Postal Code

43221

Country

United States

Facility Name

OHSU Knight Cancer Institute

City

Portland

State/Province

Oregon

ZIP/Postal Code

97201

Country

United States

Facility Name

Kaiser Permanente Northwest Region Oncology/Hematology

City

Portland

State/Province

Oregon

ZIP/Postal Code

97227

Country

United States

Facility Name

OHSU Center for Health and Healing

City

Portland

State/Province

Oregon

ZIP/Postal Code

97239

Country

United States

Facility Name

OHSU

City

Portland

State/Province

Oregon

ZIP/Postal Code

97239

Country

United States

Facility Name

Oregon Health and Science University

City

Portland

State/Province

Oregon

ZIP/Postal Code

97239

Country

United States

Facility Name

Cancer Center Associates - Medical Oncology

City

Allentown

State/Province

Pennsylvania

ZIP/Postal Code

18104

Country

United States

Facility Name

St. Luke's Cancer Center - Allentown Campus

City

Allentown

State/Province

Pennsylvania

ZIP/Postal Code

18104

Country

United States

Facility Name

St. Luke's Hospital - Allentown Campus

City

Allentown

State/Province

Pennsylvania

ZIP/Postal Code

18104

Country

United States

Facility Name

Cancer Center Associates - Medical Oncology

City

Bethlehem

State/Province

Pennsylvania

ZIP/Postal Code

18015

Country

United States

Facility Name

St. Luke's University Hospital - Bethlehem Campus

City

Bethlehem

State/Province

Pennsylvania

ZIP/Postal Code

18015

Country

United States

Facility Name

St. Luke's Cancer Center - Anderson Campus

City

Easton

State/Province

Pennsylvania

ZIP/Postal Code

18045

Country

United States

Facility Name

Penn State Milton S. Hershey Medical Center

City

Hershey

State/Province

Pennsylvania

ZIP/Postal Code

17033

Country

United States

Facility Name

Hospital of the University of Pennsylvania, Perelman Center for Advanced Medicine

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19104

Country

United States

Facility Name

Thomas Jefferson Medical Oncology

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19107

Country

United States

Facility Name

Thomas Jefferson University

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19107

Country

United States

Facility Name

St. Luke's Hospital - Quakertown Campus

City

Quakertown

State/Province

Pennsylvania

ZIP/Postal Code

18951

Country

United States

Facility Name

Sarah Cannon Research Institute

City

Nashville

State/Province

Tennessee

ZIP/Postal Code

37203

Country

United States

Facility Name

Texas Oncology-Austin Central

City

Austin

State/Province

Texas

ZIP/Postal Code

78731

Country

United States

Facility Name

Elliot J. Ginchansky, MD, PA

City

Dallas

State/Province

Texas

ZIP/Postal Code

75230

Country

United States

Facility Name

Dennis B. Kay

City

Dallas

State/Province

Texas

ZIP/Postal Code

75231

Country

United States

Facility Name

Parkland Memorial Hospital

City

Dallas

State/Province

Texas

ZIP/Postal Code

75235

Country

United States

Facility Name

UT Southwestern University Hospital- St. Paul

City

Dallas

State/Province

Texas

ZIP/Postal Code

75235

Country

United States

Facility Name

Texas Oncology-Baylor Charles A. Sammons Cancer Center

City

Dallas

State/Province

Texas

ZIP/Postal Code

75246

Country

United States

Facility Name

UT Southwestern Medical Center at Dallas

City

Dallas

State/Province

Texas

ZIP/Postal Code

75390

Country

United States

Facility Name

UT Southwestern University Hospital - Zale Lipshy

City

Dallas

State/Province

Texas

ZIP/Postal Code

75390

Country

United States

Facility Name

US Oncology

City

Fort Worth

State/Province

Texas

ZIP/Postal Code

76177-3204

Country

United States

Facility Name

US Oncology

City

The Woodlands

State/Province

Texas

ZIP/Postal Code

77380

Country

United States

Facility Name

Sanatorio de La Providencia

City

Buenos Aires

State/Province

Ciudad Autónoma DE Buenosaires

ZIP/Postal Code

C1050AAK

Country

Argentina

Facility Name

Centro de Investigación Clínica ? Clínica Viedma

City

Viedma

State/Province

RÍO Negro

ZIP/Postal Code

08500

Country

Argentina

Facility Name

Centro Oncologico de Rosario

City

Rosario

State/Province

Santa FE

ZIP/Postal Code

S2000KZE

Country

Argentina

Facility Name

Fundacion CIDEA

City

Buenos Aires

ZIP/Postal Code

C1125ABE

Country

Argentina

Facility Name

Chris O'Brien Lifehouse Hospital

City

Camperdown

State/Province

New South Wales

ZIP/Postal Code

2050

Country

Australia

Facility Name

Lake Macquarie Private Hospital

City

Gateshead

State/Province

New South Wales

ZIP/Postal Code

02290

Country

Australia

Facility Name

Melanoma Institute Australia

City

North Sydney

State/Province

New South Wales

ZIP/Postal Code

2060

Country

Australia

Facility Name

Princess Alexandra Hospital

City

Woolloongabba

State/Province

Queensland

ZIP/Postal Code

4102

Country

Australia

Facility Name

Royal Adelaide Hospital

City

Adelaide

State/Province

South Australia

ZIP/Postal Code

05000

Country

Australia

Facility Name

LKH-Universitätsklinikum Klinikum Graz

City

Graz

State/Province

Steiermark

ZIP/Postal Code

08036

Country

Austria

Facility Name

Universitätsklinikum Innsbruck

City

Innsbruck

State/Province

Tirol

ZIP/Postal Code

06020

Country

Austria

Facility Name

Salzburger Landeskliniken

City

Salzburg

ZIP/Postal Code

05020

Country

Austria

Facility Name

Allgemeines Krankenhaus der Stadt Wien

City

Vienna

ZIP/Postal Code

01090

Country

Austria

Facility Name

Sint-Augustinuskliniek

City

Wilrijk

State/Province

Antwerpen

ZIP/Postal Code

2610

Country

Belgium

Facility Name

UZ Gasthuisberg

City

Leuven

ZIP/Postal Code

03000

Country

Belgium

Facility Name

CHU Sart Tilman

City

Liege

ZIP/Postal Code

04000

Country

Belgium

Facility Name

Hospital de Clinicas de Passo Fundo

City

Passo Fundo

State/Province

RIO Grande DO SUL

ZIP/Postal Code

99010-260

Country

Brazil

Facility Name

Hospital Moinhos de Vento

City

Porto Alegre

State/Province

RIO Grande DO SUL

ZIP/Postal Code

90035-903

Country

Brazil

Facility Name

Hospital Moinhos de Vento

City

Porto Alegre

State/Province

RIO Grande DO SUL

ZIP/Postal Code

90560-030

Country

Brazil

Facility Name

INCA Instituto Nacional de Cancer

City

Rio de Janeiro

ZIP/Postal Code

20220410

Country

Brazil

Facility Name

Hospital São José

City

Sao Paulo

ZIP/Postal Code

01321-001

Country

Brazil

Facility Name

Alberta Health Services - Cross Cancer Institute

City

Edmonton

State/Province

Alberta

ZIP/Postal Code

T6G 1Z2

Country

Canada

Facility Name

London Regional Cancer Program

City

London

State/Province

Ontario

ZIP/Postal Code

N6A 4L6

Country

Canada

Facility Name

Sunnybrook Research Institute Centre

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M4N 3M5

Country

Canada

Facility Name

Princess Margaret Cancer Centre

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M5G 2M9

Country

Canada

Facility Name

McGill University Health Center / Royal Victoria Hospital

City

Montreal

State/Province

Quebec

ZIP/Postal Code

H4A 3J1

Country

Canada

Facility Name

CHU de Quebec - L'Hotel-Dieu de Quebec

City

Quebec

ZIP/Postal Code

G1R 2J6

Country

Canada

Facility Name

Mou/Mmci - Ppds

City

Brno

State/Province

Jihomoravský KRAJ

ZIP/Postal Code

656 53

Country

Czechia

Facility Name

Fakultni nemocnice Ostrava

City

Ostrava

ZIP/Postal Code

708 52

Country

Czechia

Facility Name

Fakultni nemocnice Kralovske Vinohrady

City

Praha 10

ZIP/Postal Code

100 34

Country

Czechia

Facility Name

Vseobecna Fakultni Nemocnice V Praze

City

Praha 2

ZIP/Postal Code

128 08

Country

Czechia

Facility Name

CHU Angers

City

Angers

State/Province

Maine-et-loire

ZIP/Postal Code

49033

Country

France

Facility Name

CHRU de Lille - Hôpital Huriet

City

Lille

State/Province

Nord

ZIP/Postal Code

59037

Country

France

Facility Name

Centre Léon Bérard Centre Régional de Lutte Contre Le Cancer Rhône Alpes

City

Lyon

State/Province

Rhône

ZIP/Postal Code

69373

Country

France

Facility Name

Hôpital Saint-André

City

Bordeaux

ZIP/Postal Code

33000

Country

France

Facility Name

Centre Hospitalier Universitaire Ambroise Pare

City

Boulogne Billancourt

ZIP/Postal Code

92100

Country

France

Facility Name

Centre Hospitalier Le Mans

City

Le Mans

ZIP/Postal Code

72037

Country

France

Facility Name

Hopitaux de La Timone

City

Marseille

ZIP/Postal Code

13385

Country

France

Facility Name

Groupe Hospitalier Archet I Et II

City

Nice

ZIP/Postal Code

06202

Country

France

Facility Name

Hôpital Saint Louis

City

Paris

ZIP/Postal Code

75010

Country

France

Facility Name

Service de PneumologieCHU Lyon Sud

City

Pierre Benite

ZIP/Postal Code

69495

Country

France

Facility Name

Hôpital Robert Debré

City

Reims

ZIP/Postal Code

51092

Country

France

Facility Name

Centre Hospitalier Universitaire Hopitaux de Rouen

City

Rouen

ZIP/Postal Code

76031

Country

France

Facility Name

Universitaetsklinikum Freiburg

City

Freiburg im Breisgau

State/Province

Baden-württemberg

ZIP/Postal Code

79104

Country

Germany

Facility Name

Klinikum Mannheim Universitätsklinikum gGmbH

City

Mannheim

State/Province

Baden-württemberg

ZIP/Postal Code

68135

Country

Germany

Facility Name

LMU Klinikum der Universität München

City

München

State/Province

Bayern

ZIP/Postal Code

80337

Country

Germany

Facility Name

University Clinic Regensburg - PPDS

City

Regensburg

State/Province

Bayern

ZIP/Postal Code

93053

Country

Germany

Facility Name

Universitätsklinikum Würzburg

City

Würzburg

State/Province

Bayern

ZIP/Postal Code

97080

Country

Germany

Facility Name

Institut für Diagnostische und Interventionelle Radiologie Frankfurt

City

Frankfurt

State/Province

Hessen

ZIP/Postal Code

60590

Country

Germany

Facility Name

Universitätsklinikum Frankfurt

City

Frankfurt

State/Province

Hessen

ZIP/Postal Code

60590

Country

Germany

Facility Name

Elben Klinken Stade Buxtehude

City

Buxtehude

State/Province

Niedersachsen

ZIP/Postal Code

21614

Country

Germany

Facility Name

Johannes Wesling Klinikum Minden

City

Minden

State/Province

Nordrhein-westfalen

ZIP/Postal Code

32429

Country

Germany

Facility Name

Klinikum Dorothea Christiane Erxleben Quedlinburg GmbH

City

Quedlinburg

State/Province

Sachsen-anhalt

ZIP/Postal Code

06484

Country

Germany

Facility Name

Universitatsklinikum Leipzig

City

Leipzig

State/Province

Sachsen

ZIP/Postal Code

04103

Country

Germany

Facility Name

Charite Campus Mitte

City

Berlin

State/Province

Schleswig-holstein

ZIP/Postal Code

10117

Country

Germany

Facility Name

Helios Klinikum Erfurt

City

Erfurt

State/Province

Thüringen

ZIP/Postal Code

99089

Country

Germany

Facility Name

Universitätsklinikum Carl Gustav Carus an der TU Dresden

City

Dresden

ZIP/Postal Code

01307

Country

Germany

Facility Name

Universitätsklinikum Essen

City

Essen

ZIP/Postal Code

45147

Country

Germany

Facility Name

SRH Wald-Klinikum Gera GmbH

City

Gera

ZIP/Postal Code

07548

Country

Germany

Facility Name

Medizinische Hochschule Hannover (Hannover Medical School)

City

Hannover

ZIP/Postal Code

30625

Country

Germany

Facility Name

University Clinic Heidelberg - PPDS

City

Heidelberg

ZIP/Postal Code

69120

Country

Germany

Facility Name

Universitatsklinikum Schleswig-Holstein

City

Kiel

ZIP/Postal Code

24105

Country

Germany

Facility Name

Uniklinik Köln

City

Koeln

ZIP/Postal Code

50937

Country

Germany

Facility Name

Universitatsklinikum Schleswig-Holstein

City

Lübeck

ZIP/Postal Code

23538

Country

Germany

Facility Name

Fachklinik Hornheide

City

Münster

ZIP/Postal Code

48157

Country

Germany

Facility Name

Klinikum Nuernberg Nord

City

Nürnberg

ZIP/Postal Code

90419

Country

Germany

Facility Name

Universitätsklinikum Tübingen

City

Tübingen

ZIP/Postal Code

72076

Country

Germany

Facility Name

Universit*ätsklinikum Ulm

City

Ulm

ZIP/Postal Code

89081

Country

Germany

Facility Name

Laiko General Hospital of Athens

City

Athens

ZIP/Postal Code

115 27

Country

Greece

Facility Name

Magyar Honvédség Egészségügyi Központ

City

Budapest

ZIP/Postal Code

01062

Country

Hungary

Facility Name

Orszagos Onkologiai Intezet

City

Budapest

ZIP/Postal Code

H-1122

Country

Hungary

Facility Name

Somogy Megyei Kaposi Mór Oktató Kórház

City

Kaposvár

ZIP/Postal Code

07400

Country

Hungary

Facility Name

Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz-Rendelointezet

City

Szolnok

ZIP/Postal Code

05004

Country

Hungary

Facility Name

Rambam Medical Center - PPDS

City

Haifa

ZIP/Postal Code

3109601

Country

Israel

Facility Name

Hadassah Medical Center - PPDS

City

Jerusalem

ZIP/Postal Code

91120

Country

Israel

Facility Name

Sheba Medical Center - PPDS

City

Ramat Gan

ZIP/Postal Code

5262100

Country

Israel

Facility Name

AOU dell'Università degli Studi della Campania Luigi Vanvitelli

City

Napoli

State/Province

Campania

ZIP/Postal Code

80138

Country

Italy

Facility Name

Istituto Dermopatico dell'Immacolata IRCCS

City

Roma

State/Province

Lazio

ZIP/Postal Code

00167

Country

Italy

Facility Name

ASST degli Spedali Civili di Brescia - Spedali Civili di Brescia

City

Brescia

State/Province

Lombardia

ZIP/Postal Code

25123

Country

Italy

Facility Name

Istituto Nazionale per lo studio e la cura dei tumori Fondazione Giovanni Pascale

City

Napoli

State/Province

Naples

ZIP/Postal Code

80131

Country

Italy

Facility Name

Istituto Oncologico Veneto - I.R.C.C.S.

City

Padova

State/Province

Veneto

ZIP/Postal Code

35128

Country

Italy

Facility Name

IRCCS Giovanni Paolo II Istituto Oncologico

City

Bari

ZIP/Postal Code

70126

Country

Italy

Facility Name

ASST Papa Giovanni XXIII - Azienda Ospedaliera Papa Giovanni XXIII

City

Bergamo

ZIP/Postal Code

24129

Country

Italy

Facility Name

IRCCS Az. Osp. Universitaria San Martino- IST

City

Genova

ZIP/Postal Code

16132

Country

Italy

Facility Name

Ospedale San Raffaele S.r.l. - PPDS

City

Milano

ZIP/Postal Code

20132

Country

Italy

Facility Name

Fondazione IRCCS 'Istituto Nazionale dei Tumori' di Milano

City

Milano

ZIP/Postal Code

20133

Country

Italy

Facility Name

Istituto Nazionale Tumori Regina Elena

City

Roma

ZIP/Postal Code

00144

Country

Italy

Facility Name

Azienza Ospedaliera Universitaria Senese

City

Siena

ZIP/Postal Code

53100

Country

Italy

Facility Name

A.O.U. Città della Salute e della Scienza di Torino - Presidio S. Lazzaro

City

Torino

ZIP/Postal Code

10126

Country

Italy

Facility Name

Shinshu University Hospital

City

Matsumoto

State/Province

Nagano

ZIP/Postal Code

390-8621

Country

Japan

Facility Name

National Cancer Center Hospital

City

Chuo-ku

ZIP/Postal Code

1040045

Country

Japan

Facility Name

Kansai Medical University Hospital

City

Hirakata-city

ZIP/Postal Code

573-1191

Country

Japan

Facility Name

Asan Medical Center - PPDS

City

Seoul

ZIP/Postal Code

05505

Country

Korea, Republic of

Facility Name

Samsung Medical Center - PPDS

City

Seoul

ZIP/Postal Code

06351

Country

Korea, Republic of

Facility Name

Seoul National University Hospital

City

Seoul

ZIP/Postal Code

110-744

Country

Korea, Republic of

Facility Name

Severance Hospital Yonsei University Health System - PPDS

City

Seoul

ZIP/Postal Code

3722

Country

Korea, Republic of

Facility Name

Radboud University Nijmegen Medical Centre

City

Nijmegen

State/Province

Gelderland

ZIP/Postal Code

6525 GA

Country

Netherlands

Facility Name

Het Nederlands Kanker Instituut Antoni Van Leeuwenhoek Ziekenhuis

City

Amsterdam

State/Province

Noord-holland

ZIP/Postal Code

1066 CX

Country

Netherlands

Facility Name

Leids Universitair Medisch Centrum

City

Leiden

State/Province

Zuid-holland

ZIP/Postal Code

2333ZA

Country

Netherlands

Facility Name

Isala Klinieken

City

Zwolle

ZIP/Postal Code

8025 AB

Country

Netherlands

Facility Name

Centrum Medyczne MAVIT Sp. z o.o.

City

Warszawa

State/Province

Mazowieckie

ZIP/Postal Code

01-673

Country

Poland

Facility Name

Lux Med

City

Warszawa

ZIP/Postal Code

02-676

Country

Poland

Facility Name

Centrum Onkologii Instytut im. Marii Sklodowskiej-Curie

City

Warszawa

ZIP/Postal Code

02-781

Country

Poland

Facility Name

Instituto Português de Oncologia de Lisboa Francisco Gentil, E.P.E.

City

Lisbon

State/Province

Lisboa

ZIP/Postal Code

1099-023

Country

Portugal

Facility Name

Hospital Garcia de Orta*E.P.E.

City

Almada

ZIP/Postal Code

2801-951

Country

Portugal

Facility Name

Centro Hospitalar Lisboa Norte, E.P.E. - Hospital de Santa Maria

City

Lisboa

ZIP/Postal Code

1649-035

Country

Portugal

Facility Name

Instituto Portugues de Oncologia Do Porto Francisco Gentil Epe - PPDS

City

Porto

ZIP/Postal Code

4200-072

Country

Portugal

Facility Name

Russian Oncology Research Center n a N N Blokhin

City

Moscow

ZIP/Postal Code

115478

Country

Russian Federation

Facility Name

Ryazan Regional Clinical Oncology Dispensary

City

Ryazan

ZIP/Postal Code

390011

Country

Russian Federation

Facility Name

Scientific Research Institute of Oncology n.a. N.N. Petrov

City

St. Petersburg

ZIP/Postal Code

197758

Country

Russian Federation

Facility Name

Narodny onkologicky ustav

City

Bratislava

ZIP/Postal Code

833 01

Country

Slovakia

Facility Name

University of The Free State

City

Bloemfontein

State/Province

FREE State

ZIP/Postal Code

09301

Country

South Africa

Facility Name

Sandton Oncology Medical Group

City

Johannesburg

State/Province

Gauteng

ZIP/Postal Code

02196

Country

South Africa

Facility Name

Sandton Oncology Medical Research

City

Johannesburg

State/Province

Gauteng

ZIP/Postal Code

02199

Country

South Africa

Facility Name

Steve Biko Academic Hospital

City

Pretoria

State/Province

Gauteng

ZIP/Postal Code

00002

Country

South Africa

Facility Name

Mary Potter Oncology Centre

City

Pretoria

State/Province

Gauteng

ZIP/Postal Code

00027

Country

South Africa

Facility Name

ICO l'Hospitalet - Hospital Duran i Reynals

City

L'Hospitalet de Llobregat

State/Province

Barcelona

ZIP/Postal Code

08907

Country

Spain

Facility Name

Hospital Regional Universitario de Malaga Hospital General

City

Malaga

State/Province

Málaga

ZIP/Postal Code

29010

Country

Spain

Facility Name

Clinica Universidad Navarra

City

Pamplona

State/Province

Navarra

ZIP/Postal Code

31008

Country

Spain

Facility Name

Hospital Universitario Vall d'Hebrón - PPDS

City

Barcelona

ZIP/Postal Code

08035

Country

Spain

Facility Name

Hospital Clinic de Barcelona

City

Barcelona

ZIP/Postal Code

08036

Country

Spain

Facility Name

ICO l'Hospitalet - Hospital Duran i Reynals

City

Barcelona

ZIP/Postal Code

08907

Country

Spain

Facility Name

Complejo Hospitalario Universitario Insular - Materno Infantil

City

Gran Canaria

ZIP/Postal Code

35001

Country

Spain

Facility Name

Hospital Universitario A Coruña

City

La Coruna

ZIP/Postal Code

15006

Country

Spain

Facility Name

Hospital General Universitario Gregorio Maranon

City

Madrid

ZIP/Postal Code

28009

Country

Spain

Facility Name

MD Anderson Cancer Center

City

Madrid

ZIP/Postal Code

28033

Country

Spain

Facility Name

Hospital Universitario Fundacion Jimenez Diaz

City

Madrid

ZIP/Postal Code

28040

Country

Spain

Facility Name

Hospital Universitario HM Sanchinarro - CIOCC

City

Madrid

ZIP/Postal Code

28050

Country

Spain

Facility Name

Hospital Universitario Virgen Macarena

City

Sevilla

ZIP/Postal Code

41009

Country

Spain

Facility Name

Hospital Virgen de La Salud

City

Toledo

ZIP/Postal Code

45004

Country

Spain

Facility Name

Fundacion Instituto Valenciano de Oncologia

City

Valencia

ZIP/Postal Code

46009

Country

Spain

Facility Name

Consorcio Hospital General Universitario de Valencia

City

Valencia

ZIP/Postal Code

46014

Country

Spain

Facility Name

Skanes Universitetssjukhus Lund

City

Lund

State/Province

Skane LAN

Country

Sweden

Facility Name

Skanes Universitetssjukhus Lund

City

Lund

ZIP/Postal Code

221 85

Country

Sweden

Facility Name

Universitätsspital Zürich

City

Zurich

State/Province

Zürich (DE)

ZIP/Postal Code

08091

Country

Switzerland

Facility Name

Hôpitaux Universitaires de Genève

City

Genève

ZIP/Postal Code

01211

Country

Switzerland

Facility Name

Centre Hospitalier Universitaire Vaudois

City

Lausanne

ZIP/Postal Code

01011

Country

Switzerland

Facility Name

Ege University Medical Faculty

City

Bornova

State/Province

Izmir

ZIP/Postal Code

35100

Country

Turkey

Facility Name

Adana Ba?kent Hastanesi K??la Yerle?kesi

City

Adana

ZIP/Postal Code

01230

Country

Turkey

Facility Name

Hacettepe University Medical Faculty

City

Ankara

ZIP/Postal Code

06100

Country

Turkey

Facility Name

Baskent University Medical Faculty Ankara Hospital

City

Ankara

ZIP/Postal Code

06490

Country

Turkey

Facility Name

Istanbul University Cerrahpasa Medical Faculty Hospital

City

Istanbul

ZIP/Postal Code

34098

Country

Turkey

Facility Name

Bristol Haematology and Oncology Centre

City

Bristol

State/Province

Bristol, CITY OF

ZIP/Postal Code

BS2 8ED

Country

United Kingdom

Facility Name

Royal Cornwall Hospital

City

Truro

State/Province

Cornwall

ZIP/Postal Code

TR1 3LJ

Country

United Kingdom

Facility Name

The Royal Sussex County Hospital

City

Brighton

State/Province

EAST Sussex

ZIP/Postal Code

BN2 5BE

Country

United Kingdom

Facility Name

Broomfield Hospital

City

Chelmsford

State/Province

Essex

ZIP/Postal Code

CM1 7ET

Country

United Kingdom

Facility Name

Singleton Hospital - PPDS

City

Swansea

State/Province

Glamorgan

ZIP/Postal Code

SA2 8QA

Country

United Kingdom

Facility Name

Royal Preston Hospital

City

Preston

State/Province

Lancashire

ZIP/Postal Code

PR2 9HT

Country

United Kingdom

Facility Name

Royal Marsden Hospital - Surrey

City

London

State/Province

London, CITY OF

ZIP/Postal Code

SW3 6JJ

Country

United Kingdom

Facility Name

Queen Elizabeth Hospital

City

Birmingham

ZIP/Postal Code

B15 2TH

Country

United Kingdom

Facility Name

St James s Institute of Clinical Oncology

City

Leeds

ZIP/Postal Code

LS9 7TF

Country

United Kingdom

Facility Name

Clatterbridge Hospital

City

Wirral

ZIP/Postal Code

CH63 4JY

Country

United Kingdom

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

IPD Sharing URL

https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests

Citations:

PubMed Identifier

28284557

Citation

Dummer R, Schadendorf D, Ascierto PA, Arance A, Dutriaux C, Di Giacomo AM, Rutkowski P, Del Vecchio M, Gutzmer R, Mandala M, Thomas L, Demidov L, Garbe C, Hogg D, Liszkay G, Queirolo P, Wasserman E, Ford J, Weill M, Sirulnik LA, Jehl V, Bozon V, Long GV, Flaherty K. Binimetinib versus dacarbazine in patients with advanced NRAS-mutant melanoma (NEMO): a multicentre, open-label, randomised, phase 3 trial. Lancet Oncol. 2017 Apr;18(4):435-445. doi: 10.1016/S1470-2045(17)30180-8. Epub 2017 Mar 9.

Results Reference

derived

Learn more about this trial

Study Comparing the Efficacy of MEK162 Versus Dacarbazine in Unresectable or Metastatic NRAS Mutation-positive Melanoma

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