Nilotinib Plus Dabrafenib/Trametinib in Metastatic Melanoma

Status Recruiting

Clinical 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. 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. Additionally, this study will assess pharmacokinetic parameters of dabrafenib and nilotinib when used in combination.

Clinical Trial Description

This is a phase 1 dose-escalation study of nilotinib in combination with a fixed-dose of dabrafenib and trametinib. The first week, patients will be treated with dabrafenib (150mg, twice daily) and trametinib (2mg, once 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. 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

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04903119
Study type	Interventional
Source	University of Kentucky
Contact	Yvonne Taul, RN
Phone	859-323-7628
Email	Yvonne.Taul@uky.edu
Status	Recruiting
Phase	Phase 1
Start date	June 1, 2022
Completion date	March 31, 2027

View Details

See also
Status	Clinical Trial	Phase
Active, not recruiting	`NCT02224781` - Dabrafenib and Trametinib Followed by Ipilimumab and Nivolumab or Ipilimumab and Nivolumab Followed by Dabrafenib and Trametinib in Treating Patients With Stage III-IV BRAFV600 Melanoma	Phase 3
Active, not recruiting	`NCT05470283` - Phase I, Open-Label, Study of Tumor Infiltrating Lymphocytes Engineered With Membrane Bound IL15 Plus Acetazolamide in Adult Patients With Metastatic Melanoma	Phase 1
Recruiting	`NCT05388877` - E6201 and Dabrafenib for the Treatment of Central Nervous System Metastases From BRAF V600 Mutated Metastatic Melanoma	Phase 1
Active, not recruiting	`NCT05103891` - Relative Bioavailability of Binimetinib 3 x 15 mg and 45 mg Formulations	Phase 1
Completed	`NCT00414765` - Aldesleukin in Participants With Metastatic Renal Cell Carcinoma or Metastatic Melanoma	Phase 4
Completed	`NCT02857270` - A Study of LY3214996 Administered Alone or in Combination With Other Agents in Participants With Advanced/Metastatic Cancer	Phase 1
Completed	`NCT01621490` - PH 1 Biomarker Study of Nivolumab and Ipilimumab and Nivolumab in Combination With Ipilimumab in Advanced Melanoma	Phase 1
Recruiting	`NCT05779423` - Cryoablation+Ipilimumab+Nivolumab in Melanoma	Phase 2
Active, not recruiting	`NCT04940299` - Tocilizumab, Ipilimumab, and Nivolumab for the Treatment of Advanced Melanoma, Non-Small Cell Lung Cancer, or Urothelial Carcinoma	Phase 2
Active, not recruiting	`NCT02278887` - Study Comparing TIL to Standard Ipilimumab in Patients With Metastatic Melanoma	Phase 3
Active, not recruiting	`NCT02360579` - Study of Lifileucel (LN-144), Autologous Tumor Infiltrating Lymphocytes, in the Treatment of Patients With Metastatic Melanoma	Phase 2
Terminated	`NCT02521870` - A Trial of Intratumoral Injections of SD-101 in Combination With Pembrolizumab in Patients With Metastatic Melanoma or Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma	Phase 1/Phase 2
Completed	`NCT02177110` - A Translational Systems Medicine Approach to Provide Predictive Capacity for Therapy Response in Advanced or Metastatic Malignant Melanoma
Withdrawn	`NCT01340729` - Open-Label Study of TPI 287 for Patients With Metastatic Melanoma	Phase 1/Phase 2
Withdrawn	`NCT01416844` - Study of Immune Responses in Patients With Metastatic Melanoma	Phase 2
Terminated	`NCT01468818` - Immunotherapy Using Tumor Infiltrating Lymphocytes for Patients With Metastatic Melanoma	Phase 2
Completed	`NCT00984464` - Study of REOLYSIN® in Combination With Paclitaxel and Carboplatin in Patients With Metastatic Melanoma	Phase 2
Completed	`NCT00631618` - Clinical Trial of Sutent to Treat Metastatic Melanoma	Phase 2
Terminated	`NCT00571116` - Disulfiram Plus Arsenic Trioxide In Patients With Metastatic Melanoma and at Least One Prior Systemic Therapy	Phase 1
Recruiting	`NCT00226473` - Standard Palliative Care Versus Standard Palliative Care Plus Polychemotherapy in Metastasized Malignant Melanoma	Phase 4