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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.
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.
Primary Outcome
Overall Survival (OS) was defined as the time from randomization to death from any cause. Patients who have not died would be censored at the date of last known alive. 2-year OS rate was defined as a proportion of patients who are alive after two years of follow-up time among all cases who have died within 2 years or alive after 2-year follow-up time. Kaplan-Meier method was used to estimate 2-year OS.
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 267 participants |
| Start Date | 2015-09-08 |
| Est. Completion | 2026-09-11 |
| Phase | Phase 3 |
What the registry record for NCT02224781 still lists
NCT02224781 is an interventional study that assigns participants to a tested intervention. The registered 267 participants enrollment target is mid-sized for trials with a published cap, above the 81-participant average among 91 other Metastatic Melanoma trials with a reported enrollment target (230% higher).
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 names 20 study sites across 5 states, led by 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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Where NCT02224781's enrollment target sits among peer trials
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participants (enrollment target), bucketed by value
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