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NCT02231775 · ClinicalTrials.gov registry record · Phase 2
Dabrafenib and Trametinib Before and After Surgery in Treating Patients With Stage IIIB-C Melanoma With BRAF V600 Mutation
A Phase 2 study of Stage IIIC Cutaneous Melanoma AJCC v7 and Stage IIIB Cutaneous Melanoma AJCC v7, sponsored by M.D. Anderson Cancer Center.
- Active
- Registry status
- Phase 2
- Development phase
- 58
- Enrollment target
- 1
- Study location
NCT02231775: Active Phase 2 study of Stage IIIC Cutaneous Melanoma AJCC v7 and Stage IIIB Cutaneous Melanoma AJCC v7, sponsored by M.D. Anderson Cancer Center.
NCT02231775 is a Phase 2 study of Stage IIIC Cutaneous Melanoma AJCC v7 and Stage IIIB Cutaneous Melanoma AJCC v7 that is active but no longer recruiting, run by M.D. Anderson Cancer Center. The registered enrollment target is 58 participants, below the 204-participant average among 12 other Stage IIIC Cutaneous Melanoma AJCC v7 trials with a reported enrollment target (72% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02231775, a Phase 2 study of Stage IIIC Cutaneous Melanoma AJCC v7 and Stage IIIB Cutaneous Melanoma AJCC v7, is active but no longer recruiting, sponsored by M.D. Anderson Cancer Center.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 58 participants
- Enrollment target
- 1
- Study location
Study Summary
This is a single arm phase II trial focused on how dabrafenib and trametinib before and after surgery works in treating patients with stage IIIB-C melanoma that has a specific mutation in the BRAF gene. Dabrafenib and trametinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving dabrafenib and trametinib before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving dabrafenib and trametinib after surgery may kill any remaining tumor cells.
Primary Outcome
RFS will be compared between patients with a pathologic complete response (pCR) and patients without a pCR using a two-sided log-rank test.
Conditions Studied
Interventions
- OTHER Laboratory Biomarker Analysis
- PROCEDURE Therapeutic Conventional Surgery
- DRUG Trametinib
- DRUG Dabrafenib
Study Locations (1)
Texas
- M D Anderson Cancer Center - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 58 participants |
| Start Date | 2014-10-22 |
| Est. Completion | 2027-04-01 |
| Phase | Phase 2 |
What the registry record for NCT02231775 still lists
NCT02231775 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 58 participants, a relatively small participant target, below the 204-participant average among 12 other Stage IIIC Cutaneous Melanoma AJCC v7 trials with a reported enrollment target (72% lower).
The record links to 2 conditions, with Stage IIIC Cutaneous Melanoma AJCC v7 appearing as the primary indexed condition, and to 4 interventions - of which Laboratory Biomarker Analysis is the first listed.
NCT02231775 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT02231775 about?
NCT02231775 is a clinical study titled "Dabrafenib and Trametinib Before and After Surgery in Treating Patients With Stage IIIB-C Melanoma With BRAF V600 Mutation". This is a single arm phase II trial focused on how dabrafenib and trametinib before and after surgery works in treating patients with stage IIIB-C melanoma that has a specific mutation in the BRAF gene. Dabrafenib and trametinib may stop the growth of tumor cells by blocking some of the enzymes need...
What is the current status of trial NCT02231775?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 58 participants. The study started on 2014-10-22. Estimated completion is 2027-04-01.
What conditions does trial NCT02231775 study?
This clinical trial studies the following conditions: Stage IIIC Cutaneous Melanoma AJCC v7, Stage IIIB Cutaneous Melanoma AJCC v7.
What interventions are being tested in trial NCT02231775?
The interventions under investigation include: Laboratory Biomarker Analysis (OTHER), Therapeutic Conventional Surgery (PROCEDURE), Trametinib (DRUG), Dabrafenib (DRUG).
Who is sponsoring clinical trial NCT02231775?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02231775 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Stage IIIC Cutaneous Melanoma AJCC v7
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 NCT02231775's enrollment target sits among peer trials
58 6th of 12 higher than 7 of 12 other Stage IIIC Cutaneous Melanoma AJCC v7 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Stage IIIC Cutaneous Melanoma AJCC v7 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
-
Nivolumab With Trametinib and Dabrafenib, or Encorafenib and Binimetinib in Treating Patients With BRAF Mutated Metastatic or Unresectable Stage III-IV Melanoma
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-
Ipilimumab With or Without High-Dose Recombinant Interferon Alfa-2b in Treating Patients With Stage III-IV Melanoma That Cannot Be Removed by Surgery
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-
Ipilimumab With or Without Sargramostim in Treating Patients With Stage III or Stage IV Melanoma That Cannot Be Removed by Surgery
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Talimogene Laherparepvec and Pembrolizumab in Treating Patients With Stage III-IV Melanoma
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Tumor-Infiltrating Lymphocytes After Combination Chemotherapy in Treating Patients With Metastatic Melanoma
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Ipilimumab With or Without Bevacizumab in Treating Patients With Stage III-IV Melanoma That Cannot Be Removed by Surgery
COMPLETED · Phase 2
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