18 and older, any sex, with Metastatic or Unresectable Cutaneous Melanoma. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Progression-Free Survival (PFS) by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1Primary· 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)
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 resp
Group
Value
95% CI
Binimetinib (MEK162)
2.83
2.76 – 3.55
Dacarbazine
1.51
1.48 – 1.71
Overall Survival (OS)Secondary· 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)
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.
Group
Value
95% CI
Binimetinib (MEK162)
10.97
8.94 – 13.60
Dacarbazine
10.09
7.03 – 16.46
Overall Response Rate (ORR)Secondary· 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)
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 befo
Confirmed ORR
Group
Value
95% CI
Binimetinib (MEK162)
15.2
11.2 – 20.1
Dacarbazine
6.8
3.1 – 12.5
Confirmed + Unconfirmed: ORR
Group
Value
95% CI
Binimetinib (MEK162)
22.7
17.8 – 28.2
Dacarbazine
9.8
5.3 – 16.1
Time to Response (TTR)Secondary· 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)
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 progre
Group
Value
95% CI
Binimetinib (MEK162)
1.45
1.45 – 1.48
Dacarbazine
2.79
1.22 – 3.38
Duration of Objective Response (DOR)Secondary· 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)
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, s
Group
Value
95% CI
Binimetinib (MEK162)
6.87
4.21 – 11.07
Dacarbazine
NA
4.14 – NA
Disease Control Rate (DCR)Secondary· 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)
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 d
Group
Value
95% CI
Binimetinib (MEK162)
58.4
52.2 – 64.3
Dacarbazine
24.8
17.7 – 33.0
Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)Secondary· From baseline up to 219.4 weeks for binimetinib arm; From baseline up to 123.9 weeks for dacarbazine arm
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.
AEs
Group
Value
95% CI
Binimetinib (MEK162)
269
Dacarbazine
104
SAEs
Group
Value
95% CI
Binimetinib (MEK162)
95
Dacarbazine
26
Number of Participants With Clinically Notable Hematology Shifts Based on National Cancer Institute Common Terminology Criteria (NCI-CTCAE) Grade, Version 4.03Secondary· From baseline up to 77 weeks in binimetinib arm; From baseline up to 61 weeks for dacarbazine arm
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 in
Activated partial thromboplastin time prolonged
Group
Value
95% CI
Binimetinib (MEK162)
7
Dacarbazine
2
Hemoglobin decreased
Group
Value
95% CI
Binimetinib (MEK162)
17
Dacarbazine
13
Prothrombin international normalized ratio increased
Group
Value
95% CI
Binimetinib (MEK162)
9
Dacarbazine
0
Lymphocytes increased
Group
Value
95% CI
Binimetinib (MEK162)
20
Dacarbazine
0
Lymphocytes decreased
Group
Value
95% CI
Binimetinib (MEK162)
35
Dacarbazine
19
Neutrophils decreased
Group
Value
95% CI
Binimetinib (MEK162)
8
Dacarbazine
21
Platelets decreased
Group
Value
95% CI
Binimetinib (MEK162)
3
Dacarbazine
17
Leukocytes increased
Group
Value
95% CI
Binimetinib (MEK162)
0
Dacarbazine
0
Number of Participants With Clinically Notable Clinical Chemistry/Biochemistry Shifts Based on NCI-CTCAE Grade, Version 4.03Secondary· From baseline up to 77 weeks in binimetinib arm; From baseline up to 61 weeks for dacarbazine arm
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
Albumin decreased
Group
Value
95% CI
Binimetinib (MEK162)
27
Dacarbazine
5
Alkaline phosphatase
Group
Value
95% CI
Binimetinib (MEK162)
8
Dacarbazine
2
Alanine aminotransferase
Group
Value
95% CI
Binimetinib (MEK162)
14
Dacarbazine
4
Aspartate aminotransferase
Group
Value
95% CI
Binimetinib (MEK162)
20
Dacarbazine
1
Bilirubin
Group
Value
95% CI
Binimetinib (MEK162)
1
Dacarbazine
1
Corrected Calcium increased
Group
Value
95% CI
Binimetinib (MEK162)
2
Dacarbazine
4
Corrected Calcium decreased
Group
Value
95% CI
Binimetinib (MEK162)
2
Dacarbazine
0
Creatinine
Group
Value
95% CI
Binimetinib (MEK162)
9
Dacarbazine
2
Number of Participants With Clinically Notable Vital SignsSecondary· From baseline up to 77 weeks in binimetinib arm; From baseline up to 61 weeks for dacarbazine arm
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 t
Sitting Pulse Rate - High
Group
Value
95% CI
Binimetinib (MEK162)
4
Dacarbazine
1
Sitting Pulse Rate - Low
Group
Value
95% CI
Binimetinib (MEK162)
3
Dacarbazine
1
Sitting systolic blood pressure - High
Group
Value
95% CI
Binimetinib (MEK162)
43
Dacarbazine
8
Sitting systolic blood pressure -Low
Group
Value
95% CI
Binimetinib (MEK162)
2
Dacarbazine
4
Sitting diastolic blood pressure - High
Group
Value
95% CI
Binimetinib (MEK162)
28
Dacarbazine
4
Sitting diastolic blood pressure - Low
Group
Value
95% CI
Binimetinib (MEK162)
2
Dacarbazine
1
Weight - High
Group
Value
95% CI
Binimetinib (MEK162)
16
Dacarbazine
1
Weight - Low
Group
Value
95% CI
Binimetinib (MEK162)
0
Dacarbazine
0
Number of Participants With Notable Electrocardiogram (ECG) ValuesSecondary· From baseline up to 77 weeks in binimetinib arm; From baseline up to 61 weeks for dacarbazine arm
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
QT - New > 450 msec
Group
Value
95% CI
Binimetinib (MEK162)
32
Dacarbazine
8
QT - New > 480 msec
Group
Value
95% CI
Binimetinib (MEK162)
7
Dacarbazine
1
QT - New > 500 msec
Group
Value
95% CI
Binimetinib (MEK162)
5
Dacarbazine
0
QT - Increase from baseline > 30 msec
Group
Value
95% CI
Binimetinib (MEK162)
109
Dacarbazine
33
QT - Increase from baseline > 60 msec
Group
Value
95% CI
Binimetinib (MEK162)
28
Dacarbazine
5
QTcF - New > 450 msec
Group
Value
95% CI
Binimetinib (MEK162)
29
Dacarbazine
15
QTcF - New > 480 msec
Group
Value
95% CI
Binimetinib (MEK162)
10
Dacarbazine
1
QTcF - New > 500 msec
Group
Value
95% CI
Binimetinib (MEK162)
5
Dacarbazine
1
Number of Participants With Adverse Events of Special Interest: Cardiac EventsSecondary· From baseline up to 77 weeks in binimetinib arm; From baseline up to 61 weeks for dacarbazine arm
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;
Group
Value
95% CI
Binimetinib (MEK162)
35
Dacarbazine
2
Adverse events — posted to ClinicalTrials.gov
Time frame: From baseline up to 219.4 weeks for binimetinib arm; From baseline up to 123.9 weeks for dacarbazine arm.
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
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
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT03158103 — A Study of MEK162 (Binimetinib) in Combination With Pexidartinib in Patients With Advanced Gastrointestinal Stromal Tumo
· Phase 1
· completed
NCT02631447 — Sequential Combo Immuno and Target Therapy (SECOMBIT) Study
· Phase 2
· completed
NCT02285439 — Study of MEK162 for Children With Low-Grade Gliomas
· Phase 1, PHASE2
· completed
NCT02276027 — A Phase II, Open Label, Multiple Arm Study of AUY922, BYL719, INC280, LDK378 and MEK162 in Chinese Patients With Advance
· Phase 2
· completed
NCT02159066 — LGX818 and MEK162 in Combination With a Third Agent (BKM120, LEE011, BGJ398 or INC280) in Advanced BRAF Melanoma
· Phase 2
· completed
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
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Sponsor: as reported to ClinicalTrials.gov by Pfizer
Last refreshed: 22 March 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01763164.