Metastatic MelanomaPhase 1NCT04903119
Nilotinib Plus Dabrafenib/Trametinib or Encorafenib/Binimetinib in Metastatic Melanoma
A Phase 1 study testing Nilotinib 100mg, Nilotinib 200mg and Nilotinib 300mg in people with Metastatic Melanoma and BRAF Gene Mutation, run by Rina Plattner at 4 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Melanoma, BRAF Gene Mutation
- What is being tested?
- Nilotinib 100mg, Nilotinib 200mg and Nilotinib 300mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 4 sitesUnited States
- Study dates
- 1 Jun 2022to 1 Jun 2030
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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
- 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. Any CLIA-certified mutation testing is acceptable to document mutation status.
- 3.1.3 Patients must have stable disease on dabrafenib and trametinib or on encorafenib and binimetinib for a duration of greater than or equal to 3 months OR have failed any BRAFi/MEKi regimen to qualify for the trial, including the dabrafenib/trametinib combination and/or the encorafenib/ binimetinib combination.
- 3.1.4 Patient may have had prior immunotherapy for metastatic disease or prior cellular therapy (although NOT mandatory). NOTE: Other prior therapies are not allowed, with the exception of radiation.
- 3.1.5 Age ≥18 years.
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- 3.1.6 ECOG performance status ≤ 1. See Appendix A.
- 3.1.7 Patients must have adequate organ and marrow function as defined below: absolute neutrophil count ≥1,500/mcL platelets ≥100,000/mcL total bilirubin ≤ institutional upper limit of normal (ULN) AST(SGOT)/ALT(SGPT) ≤3 × institutional ULN creatinine ≤ institutional ULN OR glomerular filtration rate (GFR) ≥60 mL/min/1.73 m2 unless data exists supporting safe use at lower kidney function values, no lower than 30 mL/min/1.73 m2 (see Appendix B)
- 3.1.8 Patients with known human immunodeficiency virus (HIV) on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial.
- 3.1.9 For patients with known history of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated.
- 3.1.10 Patients with a known history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with known HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load.
- 3.1.11 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.
- 3.1.12 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.
- 3.1.13 Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class 2B or better.
- 3.1.14 Measurable (target) disease by Response Evaluation Criteria In Solid Tumors (RECIST 1.1) criteria. Target lesions selected for tumor measurements should be those where additional (e.g., palliative) treatments are not indicated or anticipated.
- 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 the study with stable disease, it is possible they have no evidence of disease and/or do not have disease that meet RECIST 1.1 criteria if they have had clinical and radiographical response to treatment. This will be noted and monitored on subsequent surveillance imaging as per guidelines.
- 3.1.15 The effects of nilotinib, encorafenib, dabrafenib, binimetinib and trametinib on the developing human fetus are unknown, women of childbearing potential and men must agree to use adequate contraception (non-hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 4 months after completion of nilotinib, dabrafenib, and trametinib administration.
- 3.1.16 Patients must have the ability to understand and the willingness to sign a written informed consent document.
Who cannot join
- 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 or endocrinopathies on stable replacement therapy).
- 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.
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- 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. Because the lists of these agents are constantly changing, it is important to regularly consult a frequently-updated medical reference. As part of the enrollment/informed consent procedures, the patient will be counseled on the risk of interactions with other agents, and what to do if new medications need to be prescribed or if the patient is considering a new over-the-counter medicine or herbal product.
- 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 regularly consult a frequently-updated medical reference. As part of the enrollment/informed consent procedures, the patient will be counseled on the risk of interactions with other agents, and what to do if new medications need to be prescribed or if the patient is considering a new over-the-counter medicine or herbal product.
- 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.
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States4 sites, 4 recruiting
- Recruiting
St. Luke's University Health Network
Easton, Pennsylvania, 18045
Amy Grossman, 484-658-1788, amy.grossman@sluhn.org
- Not yet recruiting
University of Iowa
Iowa City, Iowa, 52242
Mohammed Milhem, MD, 319-356-2324, mohammed-milhem@uiowa.edu
Mohammed Milhem, MD
- Recruiting
Markey Cancer Center
Lexington, Kentucky, 40536
Heather Pavlik, RN, 859-323-7628, heather.schroer@uky.edu
- Recruiting
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, 37232
Douglas B Johnson, 800-811-8480, CTIP@VUMC.ORG
About this study
Official title: A Phase 1 Study of Nilotinib in Combination With Dabrafenib and Trametinib or Encorafenib/Binimetinib in BRAF V600 Mutant Metastatic Melanoma After Progression on BRAF/MEK Inhibition
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.
Read the detailed description
This is a phase 1 dose-escalation study of nilotinib in combination with a fixed-dose of dabrafenib and trametinib or with encorafenib and binimetinib. The first week, patients will be treated with dabrafenib (150mg, twice daily) and trametinib (2mg, once daily), or encorafenib (450 mg, daily) and binimetinib (45 mg twice daily). After 7 days, when both drugs have achieved steady-state levels and there is maximal induction of CYP3A4, nilotinib will be added, and all three drugs dosed concurrently for the rest of the study. Optional plasma pharmacokinetic (PKs) samples for dabrafenib and nilotinib will be obtained at baseline, weekly for the first four weeks, and at regular study visits for the duration of the trial. Tissue core biopsies and correlative plasma samples will be obtained at baseline, and 2 weeks after the start of nilotinib.
- Conditions
- Metastatic Melanoma, BRAF Gene Mutation
- Being tested
- Nilotinib 100mg, Nilotinib 200mg, Nilotinib 300mg, Nilotinib 400mg, Dabrafenib
- Keywords
- dose escalation, nilotinib, dabrafenib, trametinib, pharmacokinetics, CYP3A4, encorafenib, binimetinib
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nilotinib 100mgDrug
Patients will begin dabrafenib (150mg PO BID) and trametinib (2mg PO once daily) or encorafenib (450 mg PO) and binimetinib (45 mg PO BID) on day one and will continue for 28 days. After 7 days, nilotinib will be added at 100mg PO BID and will continue for 21 days. For each subsequent cycle, nilotinib will be given for 28 days.
Nilotinib 200mgDrug
Patients will begin dabrafenib (150mg PO BID) and trametinib (2mg PO once daily) or encorafenib (450 mg PO) and binimetinib (45 mg PO BID) on day one and will continue for 28 days. After 7 days, nilotinib will be added at 200mg PO BID and will continue for 21 days. For each subsequent cycle, nilotinib will be given for 28 days.
Nilotinib 300mgDrug
Patients will begin dabrafenib (150mg PO BID) and trametinib (2mg PO once daily) or encorafenib (450 mg PO) and binimetinib (45 mg PO BID) on day one and will continue for 28 days. After 7 days, nilotinib will be added at 300mg PO BID and will continue for 21 days. For each subsequent cycle, nilotinib will be given for 28 days.
Nilotinib 400mgDrug
Patients will begin dabrafenib (150mg PO BID) and trametinib (2mg PO once daily) or encorafenib (450 mg PO) and binimetinib (45 mg PO BID) on day one and will continue for 28 days. After 7 days, nilotinib will be added at 400mg PO BID and will continue for 21 days. For each subsequent cycle, nilotinib will be given for 28 days.
DabrafenibDrug
All patients will begin dabrafenib (150mg PO BID) on day one and will continue for 28 days.
TrametinibDrug
All patients will begin trametinib (2mg PO once daily) on day one and will continue for 28 days.
EncorafenibDrug
encorafenib will be administered orally 450mg once daily for 28 consecutive days
BinimetinibDrug
binimetinib will be administered orally 45mg twice daily for 28 consecutive days
| Study group | Role | What they receive |
|---|---|---|
| Level 1 | Experimental | Patients in this group will receive 100mg Nilotinib PO BID. Receives: Drug: Nilotinib 100mg; Drug: Dabrafenib; Drug: Trametinib; Drug: Encorafenib; Drug: Binimetinib |
| Level 2 | Experimental | Patients in this group will receive 200mg Nilotinib PO BID. Receives: Drug: Nilotinib 200mg; Drug: Dabrafenib; Drug: Trametinib; Drug: Encorafenib; Drug: Binimetinib |
| Level 3 | Experimental | Patients in this group will receive 300mg Nilotinib PO BID. Receives: Drug: Nilotinib 300mg; Drug: Dabrafenib; Drug: Trametinib; Drug: Encorafenib; Drug: Binimetinib |
| Level 4 | Experimental | Patients in this group will receive 400mg Nilotinib PO BID. Receives: Drug: Nilotinib 400mg; Drug: Dabrafenib; Drug: Trametinib; Drug: Encorafenib; Drug: Binimetinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Patients Experiencing Dose Limiting Toxicities
Percentage of patients who experienced dose-limiting toxicities associated with Nilotinib as defined by the study protocol.
Measured: 28 days
Secondary outcomes (3)
Dose-Adjusted Steady State Concentration of Dabrafenib
The dose-adjusted steady state concentrations (Css) of dabrafenib will be calculated on day 8 (dabrafenib alone) compared to day 15 (dabrafenib + nilotinib).
Measured: 15 days
Change in Nilotinib Concentration
Plasma concentrations of Nilotinib will be measured on day 8 (pre-Nilotinib) and day 29.
Measured: 1 month
Duration of Response
Duration of overall response will be determined by the time measurement criteria are met for complete response (CR) or partial response (PR) - whichever is first recorded - until the first date that recurrent or progressive disease is objectively documented.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2021
- Study start1 Jun 2022
- Primary completion1 Jul 2028 (estimated)
- Study completion1 Jun 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic MelanomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rina Plattner
- Sponsor type
- University, hospital or other
- Collaborators
- Novartis, National Cancer Institute (NCI)
- Responsible party
- Sponsor-investigator, Rina Plattner, University of Kentucky
- Investigators
- Ruta Arays, MD, Principal investigator, University of KentuckyRina Plattner, PhD, Principal investigator, University of Kentucky
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04903119
- Sponsor's protocol ID
- MCC-20-MEL-11-PMC
- Other IDs
- 1R01CA258751-01A1
- Status last verified
- Feb 2026
- First submitted
- 26 Apr 2021
- Last updated
- 13 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Study of Nilotinib in Combination With Dabrafenib and Trametinib or Encorafenib/Binimetinib in BRAF V600 Mutant Metastatic Melanoma After Progression on BRAF/MEK Inhibition
- ClinicalTrials.gov ID
- NCT04903119
- Acronym / sponsor ID
- MCC-20-MEL-11-PMC
- Conditions
- Metastatic Melanoma, BRAF Gene Mutation
- Keywords
- dose escalation, nilotinib, dabrafenib, trametinib, pharmacokinetics, CYP3A4, encorafenib, binimetinib
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Rina PlattnerUniversity, hospital or other
- Collaborators
- Novartis, National Cancer Institute (NCI)
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 1 Jul 2028 (estimated)
- Study completion
- 1 Jun 2030 (estimated)
- First posted
- 26 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a phase 1 dose-escalation study of nilotinib in combination with a fixed-dose of dabrafenib and trametinib or with encorafenib and binimetinib. The first week, patients will be treated with dabrafenib (150mg, twice daily) and trametinib (2mg, once daily), or encorafenib (450 mg, daily) and binimetinib (45 mg twice daily). After 7 days, when both drugs have achieved steady-state levels and there is maximal induction of CYP3A4, nilotinib will be added, and all three drugs dosed concurrently for the rest of the study. Optional plasma pharmacokinetic (PKs) samples for dabrafenib and nilotinib will be obtained at baseline, weekly for the first four weeks, and at regular study visits for the duration of the trial. Tissue core biopsies and correlative plasma samples will be obtained at baseline, and 2 weeks after the start of nilotinib.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Level 1 | Experimental | Drug: Nilotinib 100mg, Drug: Dabrafenib, Drug: Trametinib, Drug: Encorafenib, Drug: BinimetinibPatients in this group will receive 100mg Nilotinib PO BID. |
| Level 2 | Experimental | Drug: Nilotinib 200mg, Drug: Dabrafenib, Drug: Trametinib, Drug: Encorafenib, Drug: BinimetinibPatients in this group will receive 200mg Nilotinib PO BID. |
| Level 3 | Experimental | Drug: Nilotinib 300mg, Drug: Dabrafenib, Drug: Trametinib, Drug: Encorafenib, Drug: BinimetinibPatients in this group will receive 300mg Nilotinib PO BID. |
| Level 4 | Experimental | Drug: Nilotinib 400mg, Drug: Dabrafenib, Drug: Trametinib, Drug: Encorafenib, Drug: BinimetinibPatients in this group will receive 400mg Nilotinib PO BID. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- 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. Any CLIA-certified mutation testing is acceptable to document mutation status.
- 3.1.3 Patients must have stable disease on dabrafenib and trametinib or on encorafenib and binimetinib for a duration of greater than or equal to 3 months OR have failed any BRAFi/MEKi regimen to qualify for the trial, including the dabrafenib/trametinib combination and/or the encorafenib/ binimetinib combination.
- 3.1.4 Patient may have had prior immunotherapy for metastatic disease or prior cellular therapy (although NOT mandatory). NOTE: Other prior therapies are not allowed, with the exception of radiation.
Key exclusion criteria (14 listed)
- 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 or endocrinopathies on stable replacement therapy).
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nilotinib 100mgPatients will begin dabrafenib (150mg PO BID) and trametinib (2mg PO once daily) or encorafenib (450 mg PO) and binimetinib (45 mg PO BID) on day one and will continue for 28 days. After 7 days, nilotinib will be added at 100mg PO BID and will continue for 21 days. For each subsequent cycle, nilotinib will be given for 28 days. | Drug | Level 1 |
| Nilotinib 200mgPatients will begin dabrafenib (150mg PO BID) and trametinib (2mg PO once daily) or encorafenib (450 mg PO) and binimetinib (45 mg PO BID) on day one and will continue for 28 days. After 7 days, nilotinib will be added at 200mg PO BID and will continue for 21 days. For each subsequent cycle, nilotinib will be given for 28 days. | Drug | Level 2 |
| Nilotinib 300mgPatients will begin dabrafenib (150mg PO BID) and trametinib (2mg PO once daily) or encorafenib (450 mg PO) and binimetinib (45 mg PO BID) on day one and will continue for 28 days. After 7 days, nilotinib will be added at 300mg PO BID and will continue for 21 days. For each subsequent cycle, nilotinib will be given for 28 days. | Drug | Level 3 |
| Nilotinib 400mgPatients will begin dabrafenib (150mg PO BID) and trametinib (2mg PO once daily) or encorafenib (450 mg PO) and binimetinib (45 mg PO BID) on day one and will continue for 28 days. After 7 days, nilotinib will be added at 400mg PO BID and will continue for 21 days. For each subsequent cycle, nilotinib will be given for 28 days. | Drug | Level 4 |
| DabrafenibAll patients will begin dabrafenib (150mg PO BID) on day one and will continue for 28 days. | Drug | Level 1, Level 2, Level 3, Level 4 |
| TrametinibAll patients will begin trametinib (2mg PO once daily) on day one and will continue for 28 days. | Drug | Level 1, Level 2, Level 3, Level 4 |
| Encorafenibencorafenib will be administered orally 450mg once daily for 28 consecutive days | Drug | Level 1, Level 2, Level 3, Level 4 |
| Binimetinibbinimetinib will be administered orally 45mg twice daily for 28 consecutive days | Drug | Level 1, Level 2, Level 3, Level 4 |
Primary outcome
Percentage of Patients Experiencing Dose Limiting Toxicities
Time frame: 28 days
Percentage of patients who experienced dose-limiting toxicities associated with Nilotinib as defined by the study protocol.
3 secondary outcomes
Dose-Adjusted Steady State Concentration of Dabrafenib
Time frame: 15 days
Change in Nilotinib Concentration
Time frame: 1 month
Duration of Response
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ruta Arays, MD principal investigator
University of Kentucky
Rina Plattner, PhD principal investigator
University of Kentucky
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Nilotinib 100mg, Nilotinib 200mg and Nilotinib 300mg in people with Metastatic Melanoma and BRAF Gene Mutation, run by Rina Plattner at 4 sites in United States.
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 18 inclusion and 14 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: looking for participants now, as of the sponsor's last update on 13 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Heather Pavlik, RN (859-323-7628, heather.schroer@uky.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Patients Experiencing Dose Limiting Toxicities (time frame: 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Feb 2026.