Adaptive BRAF-MEK Inhibitor Therapy for Advanced BRAF Mutant Melanoma
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|ClinicalTrials.gov Identifier: NCT03543969|
Recruitment Status : Recruiting
First Posted : June 1, 2018
Last Update Posted : September 6, 2019
This is a pilot study evaluating the feasibility of using adaptive intermittent dosing of vemurafenib and cobimetinib in BRAF mutant patients with elevated baseline lactate dehydrogenase (LDH).
The purpose of this study is to determine whether an intermittent adaptive dosing of vemurafenib and cobimetinib may be superior to standard, continuous dosing with these study drugs.
|Condition or disease||Intervention/treatment||Phase|
|Melanoma (Skin) Skin Cancer Skin Melanoma Skin Carcinoma||Drug: Vemurafenib Drug: Cobimetinib||Early Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Pilot Study of Adaptive BRAF-MEK Inhibitor Therapy for Advanced BRAF Mutant Melanoma|
|Actual Study Start Date :||May 23, 2018|
|Estimated Primary Completion Date :||September 2020|
|Estimated Study Completion Date :||September 2021|
Experimental: BRAF-MEK Inhibitor Therapy
Vemurafenib twice a day and cobimetinib daily, 3 weeks on / 2 weeks off / 3 weeks on, for an 8-week cycle.
After 8 week cycle, response to these study drugs will be analyzed based on several parameters to determine if participants will proceed in the study.
Participants will be invited for post-treatment follow-up visits for up to 5 years.
Vemurafenib will be dosed at 960 mg by mouth (PO) twice a day (BID).
Cobimetinib will be dosed at 60 mg daily.
- 8 Week Completion Rate [ Time Frame: At the end of the first 8 week treatment period ]Number of participants who reach 8 weeks with the prescribed on/off schedule without progression of disease. Progression as per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.
- Time to Treatment Failure [ Time Frame: Up to 5 years ]Time to treatment failure, defined as the time from the day of first dose of study drugs to the first day of treatment with another regimen or with the same regimen in a non-adaptive fashion.
- Objective Tumor Response Rate [ Time Frame: Up to 5 years ]Number of participants with tumor response. Response according to RECIST 1.1.
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): NCT03543969
|United States, Florida|
|H. Lee Moffitt Cancer Center and Research Institute||Recruiting|
|Tampa, Florida, United States, 33612|
|Contact: Leticia Tetteh 813-745-4617 email@example.com|
|Principal Investigator: Zeynep Eroglu, M.D.|
|Principal Investigator:||Zeynep Eroglu, M.D.||H. Lee Moffitt Cancer Center and Research Institute|