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MelanomaPhase 3NCT01245062

GSK1120212 vs Chemotherapy in Advanced or Metastatic BRAF V600E/K Mutation-positive Melanoma

A Phase 3 study testing GSK1120212 and Chemotherapy in people with Melanoma, run by GlaxoSmithKline at 112 sites in 19 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is a two-arm, open-label, randomized Phase III study comparing single agent GSK1120212 to chemotherapy (either dacarbazine or paclitaxel) in subjects with Stage IIIc or Stage IV malignant cutaneous melanoma. All subjects must have a BRAF mutation-positive tumour sample. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Melanoma
What is being tested?
GSK1120212 and Chemotherapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
322 participants
Where
112 sitesin 19 countries
Study dates
22 Nov 2010to 16 Dec 2016
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • ≥18 years of age
  • Stage III unresectable (Stage IIIc) or metastatic (Stage IV) cutaneous melanoma which is also determined to be BRAF V600E/K mutation-positive by the central laboratory
  • Received no prior treatment or up to one prior regimen of chemotherapy for advanced or metastatic melanoma. Prior treatment with immunotherapy (with the exception of prior ipilimumab, which is only allowed if given in the adjuvant setting), cytokine therapy, biological or vaccine regimen is permitted. Prior use of sorafenib is allowed
  • Measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST 1.1)
  • Women of childbearing potential and men with reproductive potential must agree to use effective contraception during the study. Additionally women of childbearing potential must have a negative serum pregnancy test within 14 days prior to randomization
  • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1
  • Adequate screening organ function

Who cannot join

  • Any prior use of BRAF inhibitors or MEK inhibitors.
  • Subjects who have received dacarbazine or paclitaxel prior to randomization will not be eligible to receive the same chemotherapy as study medication (i.e. a subject who received prior dacarbazine cannot receive dacarbazine on this trial and would thus receive paclitaxel if randomized to the control arm)
  • History of another malignancy. Exception: Subjects who have been disease-free for 3 years, or subjects with a history of completely resected non-melanoma skin cancer or successfully treated in situ carcinoma are eligible. Subjects with second malignancies that are indolent or definitively treated may be enrolled. Consult GSK Medical Monitor if unsure whether second malignancies meet requirements specified above
  • Known Human Immunodeficiency Virus (HIV), Hepatitis B Virus (HBV), or Hepatitis C Virus (HCV) infection (with the exception of chronic or cleared HBV and HCV infection which will be allowed)
  • Brain metastases with the following exceptions that are ALL confirmed by the GSK Medical Monitor:
  • All known lesions must be previously treated with surgery or stereotactic radiosurgery, and Brain lesion(s), if still present, must be confirmed stable (i.e. no increase in lesion size) for ≥90 days prior to randomization (must be documented with two consecutive MRI or CT scans using contrast), and asymptomatic with no corticosteroids requirement for ≥ 30 days prior to randomization, and no enzyme-inducing anticonvulsants for ≥ 30 days prior to randomization
Show all 17Show fewer
  • History or evidence of cardiovascular risk including any of the following:
  • QTcB ≥ 480 msec.
  • History or evidence of current clinically significant uncontrolled arrhythmias. Exception: Subjects with controlled atrial fibrillation for >30 days prior to randomization are eligible
  • History of acute coronary syndromes (including myocardial infarction and unstable angina), coronary angioplasty, or stenting within 6 months prior to randomization.
  • History or evidence of current ≥ Class II congestive heart failure as defined by New York Heart Association
  • History of interstitial lung disease or pneumonitis
  • History or current evidence / risk of retinal vein occlusion (RVO) or central serous retinopathy (CSR):
  • History of RVO or CSR, or predisposing factors to RVO or CSR (e.g. uncontrolled glaucoma or ocular hypertension, uncontrolled hypertension, uncontrolled diabetes mellitus, or history of hyperviscosity or hypercoagulability syndromes).
  • Visible retinal pathology as assessed by ophthalmic exam that is considered a risk factor for RVO or CSR such as:
  • Evidence of new optic disc cupping.
  • Intraocular pressure > 21 mm Hg as measured by tonography

Trial locations and contacts

112 sites in 19 countries.

112 sites in 19 countries

United States13 sites

  • GSK Investigational Site

    Athens, Georgia, 30607

  • GSK Investigational Site

    Boston, Massachusetts, 02114

  • GSK Investigational Site

    Chattanooga, Tennessee, 37404

  • GSK Investigational Site

    Columbia, South Carolina, 29210

  • GSK Investigational Site

    Columbus, Ohio, 43210

  • GSK Investigational Site

    Fort Myers, Florida, 33916

  • GSK Investigational Site

    Iowa City, Iowa, 52242

  • GSK Investigational Site

    Marietta, Georgia, 30060

  • GSK Investigational Site

    Memphis, Tennessee, 38120

  • GSK Investigational Site

    Metairie, Louisiana, 70006

  • GSK Investigational Site

    Morristown, New Jersey, 07962-1956

  • GSK Investigational Site

    Nashville, Tennessee, 37203

  • GSK Investigational Site

    Tucson, Arizona, 85724-5024

Other trials in United States

United Kingdom12 sites

  • GSK Investigational Site

    Aberdeen, AB25 2ZN

  • GSK Investigational Site

    Birmingham, B15 2TH

  • GSK Investigational Site

    Cambridge, Cambridgeshire, CB2 2QQ

  • GSK Investigational Site

    Chelmsford, CM1 7ET

  • GSK Investigational Site

    Leeds, LS9 7TF

  • GSK Investigational Site

    London, SW3 6JJ

  • GSK Investigational Site

    London, W1G 6AD

  • GSK Investigational Site

    Manchester, M20 4BX

  • GSK Investigational Site

    Northwood, Middlesex, HA6 2RN

  • GSK Investigational Site

    Oxford, OX3 7LJ

  • GSK Investigational Site

    Southampton, SO16 6YD

  • GSK Investigational Site

    Sutton, Surrey, SM2 5PT

Other trials in United Kingdom

Australia10 sites

  • GSK Investigational Site

    Garran, Australian Capital Territory, 2606

  • GSK Investigational Site

    Heidelberg, Victoria, 3084

  • GSK Investigational Site

    Kurralta Park, South Australia, 5037

  • GSK Investigational Site

    Melbourne, Victoria, 3004

  • GSK Investigational Site

    Port Macquarie, New South Wales, 2444

  • GSK Investigational Site

    South Brisbane, Queensland, 4101

  • GSK Investigational Site

    Townsville, Queensland, 4810

  • GSK Investigational Site

    Waratah, New South Wales, 2300

  • GSK Investigational Site

    Woodville, South Australia, 5011

  • GSK Investigational Site

    Woolloongabba, Queensland, 4102

Other trials in Australia

Canada10 sites

  • GSK Investigational Site

    Calgary, Alberta, T2N 4N2

  • GSK Investigational Site

    Halifax, Nova Scotia, B3H 2Y9

  • GSK Investigational Site

    Hamilton, Ontario, L8V 5C2

  • GSK Investigational Site

    London, Ontario, N6A 4L6

  • GSK Investigational Site

    Montreal, Quebec, H2L 4M1

  • GSK Investigational Site

    Montreal, Quebec, H2W 1S6

  • GSK Investigational Site

    Oshawa, Ontario, L1G 2B9

  • GSK Investigational Site

    Ottawa, Ontario, K1H 8L6

  • GSK Investigational Site

    Toronto, Ontario, M5G 2M9

  • GSK Investigational Site

    Vancouver, British Columbia, V5Z 4E6

Other trials in Canada

Germany10 sites

  • GSK Investigational Site

    Berlin, 10117

  • GSK Investigational Site

    Buxtehude, Lower Saxony, 21614

  • GSK Investigational Site

    Dresden, Saxony, 01307

  • GSK Investigational Site

    Essen, North Rhine-Westphalia, 45122

  • GSK Investigational Site

    Heidelberg, Baden-Wurttemberg, 69120

  • GSK Investigational Site

    Lübeck, Schleswig-Holstein, 23538

  • GSK Investigational Site

    Mannheim, Baden-Wurttemberg, 68167

  • GSK Investigational Site

    Munich, Bavaria, 80804

  • GSK Investigational Site

    Tübingen, Baden-Wurttemberg, 72076

  • GSK Investigational Site

    Würzburg, Bavaria, 97080

Other trials in Germany

France9 sites

  • GSK Investigational Site

    Boulogne-Billancourt, 92100

  • GSK Investigational Site

    Grenoble, 38043

  • GSK Investigational Site

    Montpellier, 34295

  • GSK Investigational Site

    Nantes, 44093

  • GSK Investigational Site

    Paris, 75475

  • GSK Investigational Site

    Pierre-Bénite, 69495

  • GSK Investigational Site

    Rennes, 35042

  • GSK Investigational Site

    Tours, 37044

  • GSK Investigational Site

    Villejuif, 94805

Other trials in France

Ukraine9 sites

  • GSK Investigational Site

    Dnipro, 49102

  • GSK Investigational Site

    Kharkiv, 61070

  • GSK Investigational Site

    Kyiv, 03022

  • GSK Investigational Site

    Kyiv, 03115

  • GSK Investigational Site

    Lviv, 79031

  • GSK Investigational Site

    Sumy, 40005

  • GSK Investigational Site

    Sympheropol, 95023

  • GSK Investigational Site

    Ternopil, 46023

  • GSK Investigational Site

    Uzhhorod, 88017

Other trials in Ukraine

Belgium8 sites

  • GSK Investigational Site

    Brussels, 1200

  • GSK Investigational Site

    Charleroi, 6000

  • GSK Investigational Site

    Ghent, 9000

  • GSK Investigational Site

    Jette, 1090

  • GSK Investigational Site

    Kortrijk, 8500

  • GSK Investigational Site

    Leuven, 3000

  • GSK Investigational Site

    Wilrijk, 2610

  • GSK Investigational Site

    Yvoir, 5530

Other trials in Belgium

Sweden5 sites

  • GSK Investigational Site

    Gothenburg, SE-413 45

  • GSK Investigational Site

    Linköping, SE-581 85

  • GSK Investigational Site

    Lund, SE-221 85

  • GSK Investigational Site

    Stockholm, SE-171 76

  • GSK Investigational Site

    Uppsala, SE-751 85

Other trials in Sweden

Czechia4 sites

  • GSK Investigational Site

    Hradec Králové, 500 05

  • GSK Investigational Site

    Ostrava, 708 52

  • GSK Investigational Site

    Prague, 128 08

  • GSK Investigational Site

    Zlín, 76275

Other trials in Czechia

Italy4 sites

  • GSK Investigational Site

    Milan, Lombardy, 20132

  • GSK Investigational Site

    Milan, Lombardy, 20133

  • GSK Investigational Site

    Milan, Lombardy, 20141

  • GSK Investigational Site

    Pisa, Tuscany, 56126

Other trials in Italy

Russia4 sites

  • GSK Investigational Site

    Chelyabinsk, 454087

  • GSK Investigational Site

    Magnitogorsk, 455001

  • GSK Investigational Site

    Moscow, 115478

  • GSK Investigational Site

    Saint Petersburg, 197758

Other trials in Russia

Greece3 sites

  • GSK Investigational Site

    Athens, 11527

  • GSK Investigational Site

    Athens, 185 47

  • GSK Investigational Site

    Thessaloniki, 564 29

Other trials in Greece

New Zealand3 sites

  • GSK Investigational Site

    Christchurch, 8011

  • GSK Investigational Site

    Dunedin, 9016

  • GSK Investigational Site

    Newtown, Wellington, 6002

Other trials in New Zealand

Poland3 sites

  • GSK Investigational Site

    Poznan, 61-866

  • GSK Investigational Site

    Warsaw, 02-781

  • GSK Investigational Site

    Warsaw, 04-125

Other trials in Poland

Austria2 sites

  • GSK Investigational Site

    Graz, 8036

  • GSK Investigational Site

    Vienna, 1090

Other trials in Austria

Argentina1 site

  • GSK Investigational Site

    Buenos Aires, C1121ABE

Other trials in Argentina

Norway1 site

  • GSK Investigational Site

    Oslo, 0310

Other trials in Norway

Switzerland1 site

  • GSK Investigational Site

    Zurich, 8091

Other trials in Switzerland

About this study

Official title: A Phase III Randomized, Open-label Study Comparing GSK1120212 to Chemotherapy in Subjects With Advanced or Metastatic BRAF V600E/K Mutation-positive Melanoma

This is a two-arm, open-label, randomized Phase III study comparing single agent GSK1120212 to chemotherapy (either dacarbazine or paclitaxel) in subjects with Stage IIIc or Stage IV malignant cutaneous melanoma. All subjects must have a BRAF mutation-positive tumour sample. Subjects who have received up to one prior regimen of chemotherapy in the advanced or metastatic melanoma setting will be enrolled into the study. Subjects with any prior BRAF or MEK inhibitor use will be excluded. Approximately 297 subjects will be enrolled with 2:1 randomization (198 subjects into the GSK1120212 arm and 99 subjects into the chemotherapy arm). The primary endpoint for the statistical analysis will be a comparison of progression free survival for subjects receiving GSK1120212 compared to chemotherapy. Subjects who have progression on chemotherapy will be offered the option to receive GSK1120212.

Conditions
Melanoma
Being tested
GSK1120212, Chemotherapy
Keywords
MEK inhibitor, Cancer, Metastatic Melanoma, BRAF mutant metastatic melanoma, GSK1120212
Medical subject headings
Melanoma, Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • GSK1120212Drug

    MEK inhibitor

  • ChemotherapyDrug

    Investigator Choice of DTIC or paclitaxel

Study groups in NCT01245062
Study groupRoleWhat they receive
GSK1120212ExperimentalMEK inhibitor
Receives: Drug: GSK1120212
ChemotherapyActive comparatorInvestigator Choice of DTIC or paclitaxel
Receives: Drug: Chemotherapy
CrossoverExperimentalMEK inhibitor after documented progression on Chemotherapy Arm
Receives: Drug: GSK1120212

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression-free Survival in BRAF V600E Mutation-positive Participants Without a History of Brain Metastases as Assessed by the Investigator and Independent Review

    Progression-free survival (PFS) is defined as the time from randomization to the first documented occurrence of disease progression (PD) or death. PFS for investigator-assessed and blinded, independent, central review committee (BRIC)-assessed responses was summarized per Response Evaluation Criteria in Solid Tumors (RECIST), Version 1.1, which is a set of published rules defining when cancer participants improve (respond), stay the same (stabilize), or worsen (progress) during treatment. Disease progression is defined as at least a 20% increase in the sum of the diameters of target lesions with an absolute increase of at least 5 millimeters (mm) or the appearance of at least 1 new lesion, or the worsening of non-target lesions significant enough to require study treatment discontinuation. Primary Efficacy Population included all participants with BRAF V600E mutation-positive melanoma without a history of brain metastases.

    Measured: Day 1 until the earliest date of disease progression or death due to any cause (average of 20.3 months)

Secondary outcomes (16)

  1. Progression-free Survival in All Participants

    PFS is defined as the time from the date of randomization to the first documented occurrence of PD or death. Investigator-assessed and BRIC-assessed PFS were summarized per RECIST, Version 1.1. PD is defined as at least a 20% increase in the sum of the diameters of target lesions with an absolute increase of at least 5 mm or the appearance of one or more new lesions, or the worsening of non-target lesions significant enough to require study treatment discontinuation. Intend-To-Treat (ITT) Population included all randomized participants regardless of whether or not treatment was administered.

    Measured: Day 1 until the earliest date of disease progression or death due to any cause (average of 20.3 months)

  2. PFS in BRAF V600E Mutation-positive Participants Without a History of Brain Metastases and Without Prior Chemotherapy as Assessed by the Investigator

    PFS is defined as the time from the date of randomization to the first documented occurrence of PD or death. Investigator-assessed PFS was summarized per RECIST, Version 1.1. PD is defined as at least a 20% increase in the sum of the diameters of target lesions with an absolute increase of at least 5 mm or the appearance of one or more new lesions, or the worsening of non-target lesions significant enough to require study treatment discontinuation.

    Measured: Day 1 until the earliest date of disease progression or death due to any cause (average of 20.3 months)

  3. PFS in BRAF V600E Mutation-positive Participants Without a History of Brain Metastases and With Prior Chemotherapy as Assessed by the Investigator

    PFS is defined as the time from the date of randomization to the first documented occurrence of PD or death. Investigator-assessed PFS was summarized per RECIST, Version 1.1. PD is defined as at least a 20% increase in the sum of the diameters of target lesions with an absolute increase of at least 5 mm or the appearance of one or more new lesions, or the worsening of non-target lesions significant enough to require study treatment discontinuation.

    Measured: Day 1 until the earliest date of disease progression or death due to any cause (average of 20.3 months)

  4. Overall Survival in All Participants

    Overall survival was defined as the time from the date of randomization to the date of death due to any cause.

    Measured: Day 1 until death due to any cause (average of 20.3 months)

  5. Overall Survival in BRAF V600E Mutation-positive Participants Without a History of Brain Metastases

    Overall survival was defined as the time from the date of randomization to the date of death due to any cause. NA indicates data was not available.

    Measured: Day 1 until death due to any cause (average of 20.3 months)

  6. Number of BRAF V600E Mutation-positive Participants Without a History of Brain Metastases With Overall Response (OR) as Assessed by the Investigator and Independent Review

    OR is defined as the number of participants with evidence of complete response (CR; disappearance of all target lesions. Any pathological lymph node must be less than 10 mm in the short axis) or partial response (PR: at least a 30% decrease in the sum of the diameters of target lesions) evaluated by the Investigator and an independent review per RECIST, Version 1.1.

    Measured: Day 1 until the earliest date of disease progression or death due to any cause (average of 20.3 months)

  7. Number of Participants With OR as Assessed by the Investigator and Independent Review

    OR is defined as the number of participants with evidence of complete response (disappearance of all target lesions. Any pathological lymph node must be less than 10 mm in the short axis) or partial response (at least a 30% decrease in the sum of the diameters of target lesions) evaluated by the Investigator and an independent review per RECIST, Version 1.1.

    Measured: Day 1 until the earliest date of disease progression or death due to any cause (average of 20.3 months)

  8. Number of BRAF V600E Mutation-positive Participants Classified as Confirmed Responders (CR and PR) as Assessed by the Investigator

    OR is defined as the number of participants with evidence of complete response (disappearance of all extranodal lesions. Any pathological lymph node must be less than 10 mm in the short axis) or partial response (at least a 30% decrease in the sum of the diameters of target lesions) evaluated by the Investigator per RECIST, Version 1.1.

    Measured: Day 1 until the earliest date of disease progression or death due to any cause (average of 20.3 months)

  9. Number of BRAF V600K Mutation-positive Participants Classified as Confirmed Responders (CR and PR) as Assessed by the Investigator

    OR is defined as the number of participants with evidence of complete response (CR; disappearance of all extranodal lesions. Any pathological lymph node must be less than 10 mm in the short axis) or partial response (PR: at least a 30% decrease in the sum of the diameters of target lesions) evaluated by the Investigator per RECIST, Version 1.1.

    Measured: Day 1 until the earliest date of disease progression or death due to any cause (average of 20.3 months)

  10. Number of Participants With OR Following Cross-over to Trametinib

    OR is defined as the number of participants with evidence of CR (disappearance of all target lesions. Any pathological lymph node must be less than 10 millimeters in the short axis) or PR (at least a 30% decrease in the sum of the diameters of target lesions) evaluated by the Investigator in participants following cross-over to Trametinib. The evaluation was carried out by the Investigator per RECIST, Version 1.1. Cross-over Population included the subset of participants who were randomized to CT and who elected to cross-over to Trametinib following disease progression on CT. Only participants who received at least one dose of Trametinib were included in this population.

    Measured: Day 1 of cross-over therapy until the earliest date of disease progression or death due to any cause (average of 18.3 months)

  11. Duration of Response (DoR) for All BRAF V600E Mutation-positive Participants Without a Prior History of Brain Metastases Classified as Confirmed Responders (CR or PR) as Assessed by the Investigator Review

    DoR is defined as the time from the first documented evidence of CR (disappearance of all target lesions. Any pathological lymph node must be less than 10 mm in the short axis) or PR (at least a 30% decrease in the sum of the diameters of target lesions) until PD (at least a 20% increase in the sum of the diameters of target lesions with an absolute increase of at least 5 mm or the appearance of one or more new lesions, or the worsening of non-target lesions significant enough to require study treatment discontinuation) or death due to any cause. DoR for the investigator-assessed (INVA) response data were summarized per RECIST, Version 1.1. Only those participants with confirmed response (CR and PR) were analyzed. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles). NA indicates data was not available.

    Measured: Day 1 until the earliest date of disease progression or death due to any cause (average of 20.3 months)

  12. DoR for All BRAF V600E Mutation-positive Participants Without a Prior History of Brain Metastases Classified as Confirmed Responders (CR or PR) as Assessed by the Independent Review

    DoR is defined as the time from the first documented evidence of CR (disappearance of all target lesions. Any pathological lymph node must be less than 10 mm in the short axis) or PR (at least a 30% decrease in the sum of the diameters of target lesions) until PD (at least a 20% increase in the sum of the diameters of target lesions with an absolute increase of at least 5 mm or the appearance of one or more new lesions, or the worsening of non-target lesions significant enough to require study treatment discontinuation) or death due to any cause. DoR for the independently-assessed (INDA) response data were summarized per RECIST, Version 1.1. Only those participants with confirmed response (CR and PR) were analyzed. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles). NA indicates data was not available.

    Measured: Day 1 until the earliest date of disease progression or death due to any cause (average of 20.3 months)

  13. DoR for All Confirmed Responders (CR or PR) as Assessed by the Investigator Review

    DoR is defined as the time from the first documented evidence of CR (disappearance of all target lesions. Any pathological lymph node must be less than 10 mm in the short axis) or PR (at least a 30% decrease in the sum of the diameters of target lesions) until PD or death due to any cause. PD is defined as at least a 20% increase in the sum of the diameters of target lesions with an absolute increase of at least 5 mm or the appearance of one or more new lesions, or the worsening of non-target lesions significant enough to require study treatment discontinuation. DoR for the INVA response data was summarized per RECIST, Version 1.1. Only those participants with confirmed response (CR and PR) were analyzed. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles). NA indicates data was not available.

    Measured: Day 1 until the earliest date of disease progression or death due to any cause (average of 20.3 months)

  14. DoR for All Confirmed Responders (CR or PR) as Assessed by the Independent Review

    DoR is defined as the time from the first documented evidence of CR (disappearance of all target lesions. Any pathological lymph node must be less than 10 mm in the short axis) or PR (at least a 30% decrease in the sum of the diameters of target lesions) until PD or death due to any cause. PD is defined as at least a 20% increase in the sum of the diameters of target lesions with an absolute increase of at least 5 mm or the appearance of one or more new lesions, or the worsening of non-target lesions significant enough to require study treatment discontinuation. DoR for the INDA response data was summarized per RECIST, Version 1.1. Only those participants with confirmed response (CR and PR) were analyzed. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles). NA indicates data was not available.

    Measured: Day 1 until the earliest date of disease progression or death due to any cause (average of 20.3 months)

  15. DoR for All Responders (CR or PR) Following Cross-over to Trametinib as Assessed by the Investigator

    DoR is defined as the time from the first documented evidence of CR (disappearance of all extra nodal lesions. Any pathological lymph node must be less than 10 mm in the short axis) or PR (at least a 30% decrease in the sum of the diameters of target lesions) until PD or death due to any cause. PD is defined as at least a 20% increase in the sum of the diameters of target lesions with an absolute increase of at least 5 mm or the appearance of one or more new lesions, or the worsening of non-target lesions significant enough to require study treatment discontinuation. DoR data were summarized per RECIST, Version 1.1Only those participants with confirmed response (CR and PR) were analyzed. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles). NA indicates data was not available.

    Measured: Day 1 of cross-over therapy until the earliest date of disease progression or death due to any cause (average of 18.3 months)

  16. PFS Following Cross-over to Trametinib as Assessed by the Investigator

    PFS is defined as the time from the first dose of cross-over therapy to the first documented occurrence of PD or death. PFS was summarized per RECIST, Version 1.1. PD is defined as at least a 20% increase in the sum of the diameters of target lesions with an absolute increase of at least 5 mm or the appearance of one or more new lesions, or the worsening of non-target lesions significant enough to require study treatment discontinuation.

    Measured: Day 1 of cross-over therapy until the earliest date of disease progression or death due to any cause (average of 18.3 months)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Nov 2010 (estimated)
  2. Study start22 Nov 2010
  3. Primary completion26 Oct 2011
  4. Study completion16 Dec 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
322 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01245062
Sponsor's protocol ID
114267
Status last verified
Jan 2018
First submitted
18 Nov 2010
Last updated
5 Apr 2018
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • KT Flaherty, C Robert, P Hersey, P Nathan, C Garbe, M Milhem, L Demidov, J Hassel, P Rutkowski, P Mohr, R Dummer, U Trefzer, JMG Larkin, J Utikal, B Dreno, M Nyakas, MR Middleton, JC Becker, M Casey, LJ Sherman, FS Wu, D Ouellet, AM Martin, K Patel, & D S. MEK inhibition improves survival in Melanoma with activating BRAF Mutations. [N Engl J Med]. 2012;367:107-14.

  • Flaherty KT, Robert C, Hersey P, Nathan P, Garbe C, Milhem M, Demidov LV, Hassel JC, Rutkowski P, Mohr P, Dummer R, Trefzer U, Larkin JM, Utikal J, Dreno B, Nyakas M, Middleton MR, Becker JC, Casey M, Sherman LJ, Wu FS, Ouellet D, Martin AM, Patel K, Schadendorf D; METRIC Study Group. Improved survival with MEK inhibition in BRAF-mutated melanoma. N Engl J Med. 2012 Jul 12;367(2):107-14. doi: 10.1056/NEJMoa1203421. Epub 2012 Jun 4.

    PubMed 22663011

  • Robert C, Flaherty K, Nathan P, Hersey P, Garbe C, Milhem M, Demidov L, Mohr P, Hassel JC, Rutkowski P, Dummer R, Utikal J, Kiecker F, Larkin J, D'Amelio A Jr, Mookerjee B, Schadendorf D. Five-year outcomes from a phase 3 METRIC study in patients with BRAF V600 E/K-mutant advanced or metastatic melanoma. Eur J Cancer. 2019 Mar;109:61-69. doi: 10.1016/j.ejca.2018.12.015. Epub 2019 Jan 25.

    PubMed 30690294

  • Latimer NR, Bell H, Abrams KR, Amonkar MM, Casey M. Adjusting for treatment switching in the METRIC study shows further improved overall survival with trametinib compared with chemotherapy. Cancer Med. 2016 May;5(5):806-15. doi: 10.1002/cam4.643. Epub 2016 Jan 27.

    PubMed 27172483

  • Santiago-Walker A, Gagnon R, Mazumdar J, Casey M, Long GV, Schadendorf D, Flaherty K, Kefford R, Hauschild A, Hwu P, Haney P, O'Hagan A, Carver J, Goodman V, Legos J, Martin AM. Correlation of BRAF Mutation Status in Circulating-Free DNA and Tumor and Association with Clinical Outcome across Four BRAFi and MEKi Clinical Trials. Clin Cancer Res. 2016 Feb 1;22(3):567-74. doi: 10.1158/1078-0432.CCR-15-0321. Epub 2015 Oct 7.

    PubMed 26446943

  • Schadendorf D, Amonkar MM, Milhem M, Grotzinger K, Demidov LV, Rutkowski P, Garbe C, Dummer R, Hassel JC, Wolter P, Mohr P, Trefzer U, Lefeuvre-Plesse C, Rutten A, Steven N, Ullenhag G, Sherman L, Wu FS, Patel K, Casey M, Robert C. Functional and symptom impact of trametinib versus chemotherapy in BRAF V600E advanced or metastatic melanoma: quality-of-life analyses of the METRIC study. Ann Oncol. 2014 Mar;25(3):700-706. doi: 10.1093/annonc/mdt580. Epub 2014 Feb 6.

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Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing GSK1120212 and Chemotherapy in people with Melanoma, run by GlaxoSmithKline at 112 sites in 19 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 112 sites in United States, United Kingdom, Australia, Canada, Germany and 14 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 15 Mar 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-free Survival in BRAF V600E Mutation-positive Participants Without a History of Brain Metastases as Assessed by the Investigator and Independent Review (time frame: Day 1 until the earliest date of disease progression or death due to any cause (average of 20.3 months)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01245062, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Apr 2018.

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