Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT02196181 · ClinicalTrials.gov registry record · Phase 2
Testing Two Different Treatment Schedules of Dabrafenib and Trametinib for Skin Cancer Which Has Spread
A Phase 2 study of Unresectable Melanoma and Stage IV Cutaneous Melanoma AJCC v6 and v7, sponsored by National Cancer Institute (NCI).
- Active
- Registry status
- Phase 2
- Development phase
- 280
- Enrollment target
- 20
- Study locations
NCT02196181: Active Phase 2 study of Unresectable Melanoma and Stage IV Cutaneous Melanoma AJCC v6 and v7, sponsored by National Cancer Institute (NCI).
NCT02196181 is a Phase 2 study of Unresectable Melanoma and Stage IV Cutaneous Melanoma AJCC v6 and v7 that is active but no longer recruiting, run by National Cancer Institute (NCI). The registered enrollment target is 280 participants, above the 130-participant average among 24 other Unresectable Melanoma trials with a reported enrollment target (115% higher). The trial reports 20 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02196181, a Phase 2 study of Unresectable Melanoma and Stage IV Cutaneous Melanoma AJCC v6 and v7, is active but no longer recruiting, sponsored by National Cancer Institute (NCI).
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 280 participants
- Enrollment target
- 20
- Study locations
Study Summary
This phase II trial compares the effect of dabrafenib and trametinib given continuously to given with a break in treatment (intermittent) in treating patients with stage III-IV melanoma that cannot be removed by surgery and contains a B-Raf proto-oncogene, serine/threonine kinase (BRAF) mutation. Dabrafenib and trametinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving dabrafenib and trametinib with intermittent dosing may be as effect as when given continuously in treating patients with stage III-IV melanoma with a BRAF mutation that cannot be removed by surgery.
Primary Outcome
Testing of the superiority of intermittent dosing of dabrafenib and trametinib compared to continuous dosing with these two same agents will be based on progression-free survival. Stratified Cox regression models stratified by stratification factors will be used for all analyses.
Conditions Studied
Interventions
- PROCEDURE Biospecimen Collection
- PROCEDURE Computed Tomography
- PROCEDURE Echocardiography Test
- PROCEDURE Multigated Acquisition Scan
- DRUG Dabrafenib Mesylate
Study Locations (20)
Alaska
- Anchorage Associates in Radiation Medicine - Anchorage
- Anchorage Radiation Therapy Center - Anchorage
- Alaska Breast Care and Surgery LLC - Anchorage
- Alaska Oncology and Hematology LLC - Anchorage
- Alaska Regional Hospital - Anchorage
- Alaska Women's Cancer Care - Anchorage
- Anchorage Oncology Centre - Anchorage
- Katmai Oncology Group - Anchorage
- Providence Alaska Medical Center - Anchorage
- Fairbanks Memorial Hospital - Fairbanks
Arkansas
- Mercy Hospital Fort Smith - Fort Smith
- CHI Saint Vincent Cancer Center Hot Springs - Hot Springs
- NEA Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro - Jonesboro
- John L McClellan Memorial Veterans Hospital - Little Rock
- University of Arkansas for Medical Sciences - Little Rock
- Highlands Oncology Group - Rogers - Rogers
Arizona
- Banner University Medical Center - Tucson - Tucson
- University of Arizona Cancer Center-North Campus - Tucson
- Onvida Health Yuma Medical Center - Yuma
Alabama
- University of Alabama at Birmingham Cancer Center - Birmingham
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 280 participants |
| Start Date | 2014-09-19 |
| Est. Completion | 2027-03-15 |
| Phase | Phase 2 |
What the registry record for NCT02196181 still lists
NCT02196181 is an interventional study that assigns participants to a tested intervention. The registered 280 participants enrollment target is mid-sized for trials with a published cap, above the 130-participant average among 24 other Unresectable Melanoma trials with a reported enrollment target (115% higher).
The record links to 3 conditions, with Unresectable Melanoma appearing as the primary indexed condition, and to 5 interventions - of which Biospecimen Collection is the first listed.
NCT02196181 names 20 study sites across 4 states, led by Alaska, Arkansas, Arizona.
Frequently Asked Questions
What is clinical trial NCT02196181 about?
NCT02196181 is a clinical study titled "Testing Two Different Treatment Schedules of Dabrafenib and Trametinib for Skin Cancer Which Has Spread". This phase II trial compares the effect of dabrafenib and trametinib given continuously to given with a break in treatment (intermittent) in treating patients with stage III-IV melanoma that cannot be removed by surgery and contains a B-Raf proto-oncogene, serine/threonine kinase (BRAF) mutation. Da...
What is the current status of trial NCT02196181?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 280 participants. The study started on 2014-09-19. Estimated completion is 2027-03-15.
What conditions does trial NCT02196181 study?
This clinical trial studies the following conditions: Unresectable Melanoma, Stage IV Cutaneous Melanoma AJCC v6 and v7, Stage III Cutaneous Melanoma AJCC v7.
What interventions are being tested in trial NCT02196181?
The interventions under investigation include: Biospecimen Collection (PROCEDURE), Computed Tomography (PROCEDURE), Echocardiography Test (PROCEDURE), Multigated Acquisition Scan (PROCEDURE), Dabrafenib Mesylate (DRUG).
Who is sponsoring clinical trial NCT02196181?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02196181 being conducted?
This trial has 20 study locations across Alabama, Alaska, Arizona, Arkansas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Unresectable Melanoma
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT02196181's enrollment target sits among peer trials
280 3rd of 24 higher than 22 of 24 other Unresectable Melanoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Unresectable Melanoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
A Trial of LNS8801 With or Without Pembrolizumab in Patients With Refractory Melanoma
RECRUITING · Phase 2
-
A Study of Lifileucel (Tumor-infiltrating Lymphocytes) in Adults With Advanced Melanoma
RECRUITING · Phase 2
-
Prebiotic Food-enriched Diet (PreFED) to Enhance the Microbiome and Response to First-line Immunotherapy in Unresectable Melanoma
RECRUITING · Phase 2
-
Interleukin-6 Receptor Inhibitor Sarilumab in Combination With Ipilimumab, Nivolumab and Relatlimab in Patients With Unresectable Stage III or Stage IV Melanoma
RECRUITING · Phase 2
-
Nivolumab With Trametinib and Dabrafenib, or Encorafenib and Binimetinib in Treating Patients With BRAF Mutated Metastatic or Unresectable Stage III-IV Melanoma
ACTIVE NOT RECRUITING · Phase 2
-
Diet and Immune Effects Trial: DIET- A Randomized Double Blinded Dietary Intervention Study in Patients With Metastatic Melanoma Receiving Immunotherapy
ACTIVE NOT RECRUITING · Phase 2
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT04084730 · 280 participants · Phase 2
Study of 3-Day Partial Breast Radiation Therapy in Women With Breast Cancer
- NCT04518657 · 280 participants · NA
Internet-Delivered Lifestyle Physical Activity Intervention for Cognitive Processing Speed in Multiple Sclerosis
- NCT04634916 · 280 participants · NA
Post-market Surveillance Study of the BD® WavelinQ™ EndoAVF System
- NCT04829617 · 280 participants · NA
Promoting Well-being and Health in Heart Failure
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI