RECRUITING

Nilotinib Plus Dabrafenib/Trametinib in Metastatic Melanoma

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Conditions

Metastatic MelanomaBRAF Gene Mutationdose escalationnilotinibdabrafenibtrametinibpharmacokineticsCYP3A4

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This is a phase 1 dose-escalation study of nilotinib in combination with fixed-dose dabrafenib and trametinib regimen for patients with metastatic or unresectable melanoma carrying a BRAF V600 mutation and have relapsed on a BRAF/MEK inhibitor therapy. The goal is to assess the toxicity and tolerability and determine the maximum tolerated dose (MTD)/recommended phase 2 dose (RP2D) of the combination of nilotinib with dabrafenib and trametinib or with encorafenib and binimetinib. Additionally, this study will assess pharmacokinetic parameters of dabrafenib and nilotinib when used in combination.

Official Title

A Phase 1 Study of Nilotinib in Combination With Dabrafenib and Trametinib in BRAF V600 Mutant Metastatic Melanoma After Progression on BRAF/MEK Inhibition

Quick Facts

Study Start:2022-06-01
Study Completion:2027-03-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04903119

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Patients must have histologically confirmed metastatic or unresectable melanoma
  2. * Patients must have a BRAF V600 mutation
  3. * Patients must have failed or have stable disease on any BRAFi/MEKi regimen to qualify for the trial
  4. * Age ≥18 years
  5. * ECOG performance status ≤ 1
  6. * Patients must have adequate organ and marrow function
  7. * Patients with known human immunodeficiency virus (HIV) on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible
  8. * HBV viral load must be undetectable on suppressive therapy, if indicated.
  9. * Patients must have an undetectable HCV viral load.
  10. * Patients with treated brain metastases are eligible if follow-up brain imaging 4 weeks or longer after central nervous system (CNS)-directed therapy shows no evidence of progression.
  11. * Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial.
  12. * Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment
  13. * women of childbearing potential and men must agree to use adequate contraception
  14. * Ability to understand and the willingness to sign a written informed consent document.
  1. * Patients with chronic hypokalemia or chronic hypomagnesemia
  2. * Patients with long QT syndrome or baseline QTc (Fridericia) \>470 msec in males and \>480 msec in females
  3. * Patients who are receiving any other investigational therapies that could affect the primary or secondary outcomes of this study
  4. * Untreated brain metastases
  5. * History of allergic reactions attributed to compounds of similar chemical or biologic composition to nilotinib, dabrafenib, and trametinib.
  6. * Patients receiving any medications or substances that are strong CYP3A or CYP2C8 inhibitors or substances that are strong CYP3A inducers
  7. * Use of Proton pump inhibitors concurrent with nilotinib
  8. * Use of drugs or substances known to prolong QT interval is prohibited with Nilotinib
  9. * Patients with uncontrolled intercurrent illness.
  10. * Patients with psychiatric illness/social situations that would limit compliance with study requirements.
  11. * Pregnant or lactating women
  12. * Other prior malignancy active within 2 years, except for localized prostate cancer, cervical carcinoma in situ, non-melanoma carcinoma of the skin, stage 1 differentiated thyroid cancer or ductal carcinoma in situ of the breast that has/have undergone curative surgery or radiation

Contacts and Locations

Study Contact

Yvonne Taul, RN
CONTACT
859-323-7628
Yvonne.Taul@uky.edu

Principal Investigator

Ruta Arays, MD
PRINCIPAL_INVESTIGATOR
University of Kentucky

Study Locations (Sites)

Markey Cancer Center
Lexington, Kentucky, 40536
United States
St. Luke's University Health Network
Easton, Pennsylvania, 18045
United States
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, 37232
United States

Collaborators and Investigators

Sponsor: Ruta Arays

  • Ruta Arays, MD, PRINCIPAL_INVESTIGATOR, University of Kentucky

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-06-01
Study Completion Date2027-03-31

Study Record Updates

Study Start Date2022-06-01
Study Completion Date2027-03-31

Terms related to this study

Keywords Provided by Researchers

  • dose escalation
  • nilotinib
  • dabrafenib
  • trametinib
  • pharmacokinetics
  • CYP3A4

Additional Relevant MeSH Terms

  • Metastatic Melanoma
  • BRAF Gene Mutation