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Protein Kinase Inhibitor
Tazemetostat + Dabrafenib + Trametinib for Melanoma
Phase 1 & 2
Recruiting
Led By Tanner M Johanns
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patient must have a diagnosis of BRAF^V600E/K-mutated metastatic melanoma
Creatinine =< 1.5 mg/dL OR calculated creatinine clearance (Cockcroft-Gault formula) >= 50 mL/min
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 years
Awards & highlights
Study Summary
This trial is investigating whether a combination of tazemetostat, dabrafenib, and trametinib can effectively treat melanoma that has spread to other parts of the body and has a specific BRAF gene mutation.
Who is the study for?
Adults with BRAFV600 mutated metastatic melanoma that has worsened despite treatment can join this trial. They must have had prior anti-PD-1 therapy, be able to perform daily activities (ECOG <=2), and have organs functioning well. Pregnant women, those with certain psychiatric or medical conditions, or a history of specific cancers are excluded.Check my eligibility
What is being tested?
The trial is testing Tazemetostat combined with Dabrafenib and Trametinib to see if it's safe and effective for advanced melanoma after the usual treatments fail. It includes finding the right dose and understanding how these drugs might control tumor growth by blocking enzymes.See study design
What are the potential side effects?
Possible side effects include reactions related to immune system changes, liver issues, blood clots, heart problems like irregular heartbeat or heart failure, high blood pressure, eye problems such as retinal vein occlusion or detachment, skin reactions from drug sensitivity, gastrointestinal disturbances affecting absorption.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My melanoma is BRAF V600E/K mutation positive.
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My kidney function is normal or near normal.
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I can take care of myself but might not be able to do heavy physical work.
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My kidney function, measured by GFR, is normal or above 60.
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I am 18 years old or older.
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I am an adult.
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I can take pills and don't have major gut issues affecting drug absorption.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Median progression-free survival (PFS) (Phase II)
Recommended phase 2 dose (R2PD) (Phase I)
Secondary outcome measures
Incidence of adverse events
Overall response rates (complete response [CR], partial response [PR])
Overall survival
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Arm II (tazemetostat, dabrafenib, trametinib) phase I/phase IIExperimental Treatment8 Interventions
Patients receive tazemetostat orally PO BID, dabrafenib PO BID, and trametinib PO QD on days 1-28 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo tumor biopsy, CT scan, MRI, MUGA or ECHO throughout the study.
Group II: Arm I (tazemetostat) phase IIActive Control4 Interventions
Patients receive tazemetostat PO BID on days 1-28 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo tumor biopsy, CT scan and MRI throughout the study. At the time of progression, patients may crossover to Arm II after completion of radiation therapy.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Biopsy
2014
Completed Phase 4
~1090
Dabrafenib Mesylate
2014
Completed Phase 2
~10
Computed Tomography
2017
Completed Phase 2
~2720
Magnetic Resonance Imaging
2017
Completed Phase 3
~1190
Trametinib Dimethyl Sulfoxide
2014
Completed Phase 2
~10
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
13,665 Previous Clinical Trials
40,925,796 Total Patients Enrolled
557 Trials studying Melanoma
193,132 Patients Enrolled for Melanoma
Tanner M JohannsPrincipal InvestigatorYale University Cancer Center LAO
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My melanoma is BRAF V600E/K mutation positive.I have had interstitial lung disease or pneumonitis.I have brain melanoma that hasn't been treated or is getting worse, but no spinal issues.You have a history of certain heart problems like prolonged QT interval, recent heart attacks or procedures, severe heart failure, abnormal heart valves, uncontrolled arrhythmias, or certain high blood pressure that can't be controlled with medication.I do not have any unmanaged ongoing illnesses.My blood clotting tests are within normal limits.I don't have any major bleeding disorders but can be on certain blood thinners.I have a history of T-cell leukemia or lymphoma.My cancer progressed despite being on BRAF/MEK inhibitors.My cancer can be measured by tests.I have a tumor that can be biopsied.My cancer does not have a RAS mutation.I cannot use or have had issues with standard PD-1 immunotherapy.Your albumin level in the blood is at least 2.5 grams per deciliter.I am not pregnant or breastfeeding.I have had brain metastases treated and stable for 4 weeks, or have new stable brain metastases without symptoms.You have enough infection-fighting white blood cells in your body.Your AST and ALT levels in the blood are not more than 2.5 times the normal limit at the medical center where you are being treated.I have been treated with drugs that affect cell DNA or EZH2 before.I am not taking any medication that could interfere with the study.My kidney function is normal or near normal.I have had eye conditions like RVO or RPED.Your bilirubin levels in the blood are not higher than 1.5 times the normal limit, unless you have Gilbert's syndrome.I have another cancer type, but it won't affect this trial's treatment.I've had severe allergic reactions to specific cancer treatments or their ingredients.I am not HIV-positive or not on combination antiretroviral therapy.Your white blood cell count is at least 3,000 per microliter.I can understand and am willing to sign the consent form, or I have someone who can do it for me.I am currently receiving IV treatment for an infection.I can take care of myself but might not be able to do heavy physical work.I have had another cancer that was not treated to cure it.My tests show genetic changes linked to MDS and MPN.I have had hepatitis B or C, but it's now cleared.Your hemoglobin level is 9 grams per deciliter or higher.My kidney function, measured by GFR, is normal or above 60.I don't have ongoing major side effects from cancer treatment, except for hair loss.Your platelet count is at least 100,000 per microliter.I agree to have biopsies before and during treatment, or I have suitable tissue samples available.I am 18 years old or older.I haven't had any cancer treatments like chemotherapy or immunotherapy in the last 3 weeks.I have a history of blood cell cancer or related conditions.I am an adult.I can take pills and don't have major gut issues affecting drug absorption.I haven't had radiation therapy in the last 14 days, or if I did for pain relief, it was over 7 days ago without side effects.My diabetes is not under control.My cancer has an EZH2 alteration confirmed by a certified test.
Research Study Groups:
This trial has the following groups:- Group 1: Arm II (tazemetostat, dabrafenib, trametinib) phase I/phase II
- Group 2: Arm I (tazemetostat) phase II
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
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.
How many venues are being utilized for this clinical trial?
"Several medical centres are participating in this trial, including Northwestern University in Chicago, Illinois, Washington University School of Medicine in Saint Louis Missouri and the University of Pittsburgh Cancer Institute (UPCI) located in Pittsburgh Pennsylvania. Moreover there are other 4 sites also recruiting patients."
Answered by AI
Could you outline any previous experiments that have included Tazemetostat Hydrobromide?
"Tazemetostat Hydrobromide first received attention from academic researchers in 2012, with the University of Chicago Medical Center at its vanguard. Currently, there are 95 completed studies and 114 active research projects taking place around the world; many of which originate in Illinois' largest city."
Answered by AI
Is there a new intake of participants for this experiment?
"Affirmative. According to the information on clinicaltrials.gov, this research is presently looking for subjects, with plans initially posted on February 1st 2021 and most recently updated November 29th 2022. The trial requires 18 candidates from 7 distinct sites."
Answered by AI
What is the cap on the number of participants for this medical experiment?
"In order to execute this medical trial, 18 consenting participants that satisfy the prerequisites must be recruited. Potential patients can find sites such as Northwestern University in Chicago and Washington University School of Medicine in Saint Louis Missouri."
Answered by AI
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