Neoadjuvant and Adjuvant Dabrafenib and Trametinib in Patients With Clinical Stage III Melanoma (Combi-Neo)
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|ClinicalTrials.gov Identifier: NCT02231775|
Recruitment Status : Recruiting
First Posted : September 4, 2014
Last Update Posted : July 31, 2018
The goal of this clinical research study is to compare receiving the combination of dabrafenib and trametinib before surgery to having surgery alone in patients with melanoma. The safety of the study drug combination will also be studied.
This is an investigational study. Dabrafenib and trametinib are both FDA approved and commercially available for the treatment of melanoma that is unable to be removed or has spread in patients with V600E/K mutations. The use of the drugs in this study is investigational.
Up to 78 participants will be enrolled in this study. All will take part at MD Anderson.
|Condition or disease||Intervention/treatment||Phase|
|Melanoma||Drug: Dabrafenib Drug: Trametinib Procedure: Surgery||Phase 2|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||78 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Neoadjuvant and Adjuvant Dabrafenib and Trametinib in Patients With Clinical Stage III Melanoma (Combi-Neo)|
|Actual Study Start Date :||October 2014|
|Estimated Primary Completion Date :||October 2019|
|Estimated Study Completion Date :||October 2020|
Experimental: Dabrafenib + Trametinib + Surgery
Starting Dose of Dabrafenib: 150 mg by mouth twice a day. Starting Dose of Trametinib: 2 mg by mouth once daily.
At Week 8 after starting Dabrafenib and Trametinib, participant has MRI and/or CT scans of brain to check status of disease. Participant also has CT scans of the chest, abdomen, and pelvis. If scans show disease has not spread or grown, surgery is scheduled. Participant continues taking study drugs until day of surgery. Study drugs continued after surgical recovery for up to an additional 44 weeks.
Starting Dose: 150 mg by mouth twice a day.
Starting Dose: 2 mg by mouth once daily.
Other Name: GSK1120212
Participant has MRI and/or CT scans of brain to check status of disease after taking study drugs for 8 weeks. Participant also has CT scans of the chest, abdomen, and pelvis. If scans show disease has not spread or grown, surgical resection of gross disease is scheduled.
- Relapse-Free Survival (RFS) Between Participants Who Develop a Pathologic Complete Response (pCR) or do Not Achieve a pCR Following Dabrafenib and Trametinib Neoadjuvant Combination Therapy in Participants with Locally Advanced BRAF V600 Mutated Melanoma [ Time Frame: 2 years ]
RFS compared between patients with a pCR and patients without a pCR using a two-sided log-rank test. RFS calculated starting from the time of surgery.
Disease response recorded as complete response (CR), partial response (PR), stable disease (SD), or progressive disease (PD) according to RECIST 1.1 criteria.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02231775
|Contact: Jennifer Wargo, MD||713-745-1553|
|United States, Texas|
|University of Texas MD Anderson Cancer Center||Recruiting|
|Houston, Texas, United States, 77030|
|Contact: MD Anderson Health Information Specialist 877-632-6789|
|Study Chair:||Jennifer Wargo, MD||M.D. Anderson Cancer Center|