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New treatment option for Metastatic Melanoma
Official title Nilotinib Plus Dabrafenib/Trametinib or Encorafenib/Binimetinib in Metastatic Melanoma
ClinicalTrials.gov ID: NCT04903119
What this study is testing
What is Nilotinib 100mg?
Nilotinib 100mg is an investigational medicine, given as an once-weekly, being studied as a potential treatment for metastatic melanoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 3.1.1 Patients must have histologically confirmed metastatic or unresectable melanoma. Radiological evaluation should occur within 28 days prior to...
- Measurable disease per RECIST 1.1 requirements: defined as longest diameter to be recorded for non-nodal lesions \> 10mm and short axis for nodal...
You likely can't join if
- 3.2.1 Patients with chronic hypokalemia or chronic hypomagnesemia. Patients can be eligible with a repeat screening, if results show repletion.
- 3.2.2 Patients with long QT syndrome or baseline QTc (Fridericia) \>470 msec in males and \>480 msec in females (ULN for each respectively).
- 3.2.3 Patients who have not recovered from adverse events due to prior anti-cancer therapy (i.e., have residual toxicities \> Grade 1 or greater than...
- 3.2.4 Patients who are receiving any other investigational therapies that could affect the primary or secondary outcomes of this study.
- 3.2.5 Untreated brain metastases are not allowed.
- 3.2.6 History of allergic reactions attributed to compounds of similar chemical or biologic composition to nilotinib, dabrafenib, encorafenib...
See the full eligibility criteria
- 3.1.1 Patients must have histologically confirmed metastatic or unresectable melanoma. Radiological evaluation should occur within 28 days prior to enrollment initiation. 3.1.2 Patients must have a BRAF V600 mutation...
- Measurable disease per RECIST 1.1 requirements: defined as longest diameter to be recorded for non-nodal lesions \> 10mm and short axis for nodal lesions \>15 mm using conventional techniques For patients enrolling onto...
- 3.2.1 Patients with chronic hypokalemia or chronic hypomagnesemia. Patients can be eligible with a repeat screening, if results show repletion.
- 3.2.2 Patients with long QT syndrome or baseline QTc (Fridericia) \>470 msec in males and \>480 msec in females (ULN for each respectively).
- 3.2.3 Patients who have not recovered from adverse events due to prior anti-cancer therapy (i.e., have residual toxicities \> Grade 1 or greater than baseline) with the exception of alopecia, grade 2 fatigue, vitiligo...
- 3.2.4 Patients who are receiving any other investigational therapies that could affect the primary or secondary outcomes of this study.
- 3.2.5 Untreated brain metastases are not allowed.
- 3.2.6 History of allergic reactions attributed to compounds of similar chemical or biologic composition to nilotinib, dabrafenib, encorafenib, binimetinib and trametinib.
- 3.2.7 Patients receiving any medications or substances that are strong CYP3A inhibitors are ineligible for this trial. Patients receiving any medications or substances that are strong CYP3A inducers are ineligible...
- 3.2.8 Patients receiving any medications or substances that are strong CYP2C8 inhibitors are ineligible for the dabrafenib+ trametinib. Because the lists of these agents are constantly changing, it is important to...
- 3.2.9 Use of proton pump inhibitors concurrent with nilotinib is prohibited. Use of short-acting antacids or H2 blockers as an alternative to proton pump inhibitors is allowable.
- 3.2.10 Use of drugs or substances known to prolong QT interval is prohibited with Nilotinib
- 3.2.11 Patients with uncontrolled intercurrent illness.
- 3.2.12 Patients with psychiatric illness/social situations that would limit compliance with study requirements.
- 3.2.13 Pregnant or lactating women
- 3.3 There are no exclusions for trial participation based on gender nor race.
The study team makes the final eligibility decision.
Where it's taking place
- Iowa City, Iowa, United States
- Lexington, Kentucky, United States
- Easton, Pennsylvania, United States
- Nashville, Tennessee, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Iowa City, Iowa, United States; Lexington, Kentucky, United States; Easton, Pennsylvania, United States; Nashville, Tennessee, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.