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NCT02224781 · ClinicalTrials.gov registry record · Phase 3

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

A Phase 3 study of Metastatic Melanoma and Clinical Stage IV Cutaneous Melanoma AJCC v8, sponsored by National Cancer Institute (NCI).

Active
Registry status
Phase 3
Development phase
267
Enrollment target
20
Study locations

NCT02224781: Active Phase 3 study of Metastatic Melanoma and Clinical Stage IV Cutaneous Melanoma AJCC v8, sponsored by National Cancer Institute (NCI).

NCT02224781 is a Phase 3 study of Metastatic Melanoma and Clinical Stage IV Cutaneous Melanoma AJCC v8 that is active but no longer recruiting, run by National Cancer Institute (NCI). The registered enrollment target is 267 participants, above the 81-participant average among 91 other Metastatic Melanoma trials with a reported enrollment target (230% higher). The trial reports 20 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02224781, a Phase 3 study of Metastatic Melanoma and Clinical Stage IV Cutaneous Melanoma AJCC v8, is active but no longer recruiting, sponsored by National Cancer Institute (NCI).

ACTIVE NOT RECRUITING
Registry status
Phase 3
Development phase
267 participants
Enrollment target
20
Study locations

Study Summary

This phase III trial studies how well initial treatment with ipilimumab and nivolumab followed by dabrafenib and trametinib works and compares it to initial treatment with dabrafenib and trametinib followed by ipilimumab and nivolumab in treating patients with stage III-IV melanoma that contains a mutation known as BRAFV600 and cannot be removed by surgery (unresectable). Immunotherapy with monoclonal antibodies, such as ipilimumab and nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Dabrafenib and trametinib may block tumor growth by targeting the BRAFV600 gene. It is not yet known whether treating patients with ipilimumab and nivolumab followed by dabrafenib and trametinib is more effective than treatment with dabrafenib and trametinib followed by ipilimumab and nivolumab.

Interventions

  • PROCEDURE Biospecimen Collection
  • PROCEDURE Computed Tomography
  • PROCEDURE Echocardiography Test
  • BIOLOGICAL Ipilimumab
  • 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 Women's Cancer Care - Anchorage
  • Anchorage Oncology Centre - Anchorage
  • Katmai Oncology Group - Anchorage
  • Providence Alaska Medical Center - Anchorage
  • Fairbanks Memorial Hospital - Fairbanks

California

  • Kaiser Permanente-Anaheim - Anaheim
  • Mission Hope Medical Oncology - Arroyo Grande - Arroyo Grande
  • PCR Oncology - Arroyo Grande
  • Sutter Auburn Faith Hospital - Auburn
  • Sutter Cancer Centers Radiation Oncology Services-Auburn - Auburn

Arizona

  • CTCA at Western Regional Medical Center - Goodyear
  • Kingman Regional Medical Center - Kingman
  • Cancer Center at Saint Joseph's - Phoenix

Arkansas

  • CHI Saint Vincent Cancer Center Hot Springs - Hot Springs
  • University of Arkansas for Medical Sciences - Little Rock

Alabama

  • University of Alabama at Birmingham Cancer Center - Birmingham

Trial Details

FieldValue
Enrollment Target 267 participants
Start Date 2015-09-08
Est. Completion 2026-09-11
Phase Phase 3

Sponsor

National Cancer Institute (NCI)

3,257 total trials

What the Registry Record Tells You About NCT02224781

The ClinicalTrials.gov registry entry for NCT02224781 describes a study currently listed as active not recruiting, categorized as Phase 3. The registered enrollment target is 267 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 81-participant average among 91 other Metastatic Melanoma trials with a reported enrollment target (230% higher). The listed sponsor is National Cancer Institute (NCI), which has 3,257 total studies on file at ClinicalTrials.gov.

The record links to 5 conditions, with Metastatic Melanoma appearing as the primary indexed condition, and to 5 interventions - of which Biospecimen Collection is the first listed.

NCT02224781 reports 20 study locations spanning 5 distinct geographic areas - top geographies include Alaska, California, Arizona.

Frequently Asked Questions

What is clinical trial NCT02224781 about?

NCT02224781 is a clinical study titled "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". This phase III trial studies how well initial treatment with ipilimumab and nivolumab followed by dabrafenib and trametinib works and compares it to initial treatment with dabrafenib and trametinib followed by ipilimumab and nivolumab in treating patients with stage III-IV melanoma that contains a m...

What is the current status of trial NCT02224781?

This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 267 participants. The study started on 2015-09-08. Estimated completion is 2026-09-11.

What conditions does trial NCT02224781 study?

This clinical trial studies the following conditions: Metastatic Melanoma, Clinical Stage IV Cutaneous Melanoma AJCC v8, Unresectable Melanoma, Recurrent Melanoma, Clinical Stage III Cutaneous Melanoma AJCC v8.

What interventions are being tested in trial NCT02224781?

The interventions under investigation include: Biospecimen Collection (PROCEDURE), Computed Tomography (PROCEDURE), Echocardiography Test (PROCEDURE), Ipilimumab (BIOLOGICAL), Dabrafenib Mesylate (DRUG).

Who is sponsoring clinical trial NCT02224781?

This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT02224781 being conducted?

This trial has 20 study locations across Alabama, Alaska, Arizona, Arkansas, California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

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