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Kinase Inhibitor
Combination Therapy with LGX818 and MEK162 for Melanoma (COLUMBUS Trial)
Phase 3
Waitlist Available
Research Sponsored by Pfizer
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from randomization until disease progression or death, whichever occurred first (up to 29 months for part 1, excluding part 1: lgx818 300 mg group; up to 35 months for part 2 and part 1 lgx 300 mg group)
Awards & highlights
COLUMBUS Trial Summary
This trial is studying the combination of LGX818 and MEK162 compared to LGX818 or vemurafenib alone to see if it is more effective in treating patients with melanoma that has spread or cannot be removed by surgery.
Who is the study for?
This trial is for adults with advanced melanoma that can't be removed by surgery or has spread, and who have specific BRAF V600 mutations. They should not have had previous chemotherapy or more than one immunotherapy, and must not have certain eye diseases, untreated brain lesions, heart problems, uncontrolled hypertension, HIV/Hepatitis B/C infections or other conditions affecting study participation.Check my eligibility
What is being tested?
The study compares the effectiveness of two drug combinations against a single drug in treating melanoma. Patients are randomly assigned to receive either LGX818 plus MEK162 (Combo arm), LGX818 alone (LGX818 arm), or vemurafenib alone (vemurafenib arm). The goal is to see which treatment works best for controlling melanoma.See study design
What are the potential side effects?
Possible side effects include skin reactions, vision changes due to retinal issues, liver function abnormalities leading to yellowing of the skin/eyes (jaundice), muscle pain with elevated creatine kinase levels indicating muscle damage, heart complications like irregular heartbeat and digestive disturbances.
COLUMBUS Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from randomization until disease progression or death, whichever occurred first (up to 29 months for part 1, excluding part 1: lgx818 300 mg group; up to 35 months for part 2 and part 1 lgx 300 mg group)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from randomization until disease progression or death, whichever occurred first (up to 29 months for part 1, excluding part 1: lgx818 300 mg group; up to 35 months for part 2 and part 1 lgx 300 mg group)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Part 1: Progression Free Survival (PFS) by Blinded Independent Review Committee (BIRC) in Combo 450 Group as Compared to LGX818 Group
Part 1: Progression Free Survival (PFS) by Blinded Independent Review Committee (BIRC) in Combo 450 Group as Compared to Vemurafenib Group
Secondary outcome measures
Part 1 and Part 2: Change From Baseline in Emotional Functioning Scale Score of the EORTC QLQ-C30 at Day 1 of Cycle 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 23, 25 and End of Treatment Visit
Part 1 and Part 2: Change From Baseline in EuroQoL-5 Dimension-5 Level (EQ-5D-5L) Index Score at Day 1 of Cycle 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 23, 25 and End of Treatment Visit
Part 1 and Part 2: Change From Baseline in Global Health Status Score of EORTC QLQ-C30 at Day 1 of Cycle 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 23, 25 and End of Treatment Visit
+32 moreSide effects data
From 2023 Phase 2 trial • 158 Patients • NCT0215906623%
Hypoalbuminaemia
23%
Oedema peripheral
23%
Anaemia
15%
Gamma-glutamyltransferase increased
15%
Urinary tract infection
15%
Nausea
15%
Diarrhoea
15%
Blood creatine increased
15%
Visual field defect
15%
Blood creatine phosphokinase increased
15%
Blood creatinine increased
8%
Femur fracture
8%
Cancer pain
8%
Cardiac arrest
8%
Gastrointestinal haemorrhage
8%
Blood alkaline phosphatase increased
8%
Intestinal perforation
8%
Pyrexia
8%
Aphasia
8%
Vomiting
8%
Pain in extremity
8%
Rash maculo-papular
8%
Cardiac failure
8%
Colitis
8%
Fatigue
8%
Alanine aminotransferase increased
8%
Constipation
8%
Hypertension
100%
80%
60%
40%
20%
0%
Study treatment Arm
Part II: Encorafenib + Binimetinib + Capmatinib
Part I: Encorafenib + Binimetinib (Naive)
Part I: Encorafenib + Binimetinib (Non-naive)
Part II: Encorafenib + Binimetinib + Ribociclib
Part II: Encorafenib + Binimetinib + Infigratinib
Part II: Encorafenib + Binimetinib + Buparlisib
COLUMBUS Trial Design
4Treatment groups
Experimental Treatment
Active Control
Group I: LGX818 450 mg + MEK162Experimental Treatment2 Interventions
LGX818 450 mg QD + MEK162 45 mg BID
Group II: LGX818 300 mg + MEK162Experimental Treatment2 Interventions
LGX818 300 mg QD + MEK162 45 mg BID
Group III: LGX818Experimental Treatment1 Intervention
LGX818 300 mg QD
Group IV: VemurafenibActive Control1 Intervention
Vemurafenib 960 mg BID
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
LGX818
2012
Completed Phase 2
~630
MEK162
2013
Completed Phase 3
~1520
Find a Location
Who is running the clinical trial?
PfizerLead Sponsor
4,567 Previous Clinical Trials
10,910,951 Total Patients Enrolled
51 Trials studying Melanoma
48,531 Patients Enrolled for Melanoma
Pfizer CT.gov Call CenterStudy DirectorPfizer
3,474 Previous Clinical Trials
8,092,119 Total Patients Enrolled
25 Trials studying Melanoma
2,505 Patients Enrolled for Melanoma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I haven't had extensive treatment for my advanced melanoma, except possibly one immunotherapy.I have been diagnosed with Gilbert's syndrome.I have heart problems or significant heart disease.My high blood pressure is not controlled even with medication.I am HIV positive or have active Hepatitis B/C.I have a muscle disorder that causes high CK levels.My melanoma is advanced and cannot be removed by surgery.My tumor has a BRAF V600E or V600K mutation.I have advanced melanoma and haven't been treated or have only had first-line immunotherapy.I have problems with my digestive system.There is a visible and measurable abnormality that can be seen in a picture or a scan.My heart, organs, and blood tests are all within normal ranges.I can perform daily activities without assistance.I am fully active or can carry out light work.My melanoma is in the eye (uveal) or in mucous membranes.I have untreated brain lesions.My cancer has spread to the lining of my brain and spinal cord.I have or had a condition affecting my retina, like CSR, RVO, or a degenerative disease.I have been treated with a BRAF or MEK inhibitor before.
Research Study Groups:
This trial has the following groups:- Group 1: LGX818 450 mg + MEK162
- Group 2: Vemurafenib
- Group 3: LGX818 300 mg + MEK162
- Group 4: LGX818
Awards:
This trial has 2 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Could you explain the possible adverse effects of LGX818?
"Based on our research, we believe that LGX818 is safe and it received a score of 3."
Answered by AI
From how many different places is this research being directed?
"To limit participant burden, this trial is enrolling at 58 sites which are primarily located in Rochester, Alexandria and Chicago. There may be a location near you, so please check the list of sites to find the one that is closest."
Answered by AI
What conditions does LGX818 commonly treat?
"While non-small cell lung carcinoma is the primary indication for LGX818, this drug can also help patients with metastatic melanoma, unresectable melanoma, and erdheim-chester disease."
Answered by AI
What are the most similar investigations to LGX818 that have already been completed?
"At the moment, there are 112 clinical trials involving LGX818 that are ongoing, with 7 of them being in Phase 3. Although many of the trials for LGX818 are taking place in Cambridge, England, there are 5230 total locations running clinical trials for LGX818."
Answered by AI
Can people with the qualifying medical condition join the trial at this time?
"As of right now, this study is not seeking any more patients. The listing for this clinical trial was originally posted on December 13th, 2013 and was last edited on October 7th, 2022. However, there are 779 other trials for melanoma and 112 for LGX818 that are currently looking for participants."
Answered by AI
How many men and women are participating in this clinical trial?
"This study is not recruiting at this moment. According to the posted information, the trial was first advertised on December 13th, 2013 and was last updated on October 7th, 2022. There are 779 other trials involving melanoma that are actively recruiting and 112 for LGX818."
Answered by AI
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