ML29255 Neoadjuvant Vemurafenib and Cobimetinib Melanoma
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|ClinicalTrials.gov Identifier: NCT03005639|
Recruitment Status : Withdrawn (Sponsor has decided to close study.)
First Posted : December 29, 2016
Last Update Posted : May 9, 2018
Neoadjuvant Vemurafenib and Cobimetinib in BRAF V600 Mutant Stage IIIB-C Melanoma
• To evaluate the overall radiological complete response rate in patients with stage IIIB/C melanoma after 8 weeks of neoadjuvant vemurafenib and cobimetinib
|Condition or disease||Intervention/treatment||Phase|
|Stage IIIB-C Melanoma||Drug: Vemurafenib and Cobimetinib||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Masking Description:||Open Label|
|Official Title:||Neoadjuvant Vemurafenib and Cobimetinib in BRAF V600 Mutant Stage IIIB-C Melanoma|
|Actual Study Start Date :||June 1, 2017|
|Actual Primary Completion Date :||February 24, 2018|
|Actual Study Completion Date :||February 24, 2018|
Vemurafenib and cobimetinib as a combination has been approved by the United States Food and Drug Administration (FDA) for patients with more advanced melanoma. In this trial, vemurafenib and cobimetinib combination is considered to be experimental since safety of this combination prior to lymph node surgery has not been studied.
Drug: Vemurafenib and Cobimetinib
All participants will receive study treatment for up to 56 days (8 weeks). After completing treatment, they will undergo a lymph node removal surgery. After surgery, they will have follow-up visit 2-4 weeks after surgery.
Other Name: Zelboraf for vemurafenib
- Radiologic Complete Response Rate [ Time Frame: Day 56 (+/- 3 days) ]Radiologic complete response rate will be the primary endpoint. This will be assessed after completion of the 8-week treatment of vemurafenib and cobimetinib by CT measurements of tumor diameter pre-treatment and at day 56 (± 3 days) using RECIST 1.1. Complete response (CR) is defined by a reduction in the short-axis diameter of any pathologic lymph node to less than 10 mm, whereas partial response (PR) is defined as 30% or more decrease in the short axis. The analysis of response rate is based on the efficacy evaluable patients who has post-treatment CT scan at Day 43. Patients who discontinued study drug or withdraw from the study will be included only if they had post-treatment CT scan. We will calculate radiologic complete response rate with 95% confidence interval.
- Overall response rate, pathologic complete response rate [ Time Frame: Day 56 (+/- 3 days) ]Overall response rate is defined as the proportion of the patients in the analysis population who have a CR or PR. Pathologic complete response is defined as the absence of any residual invasive cancer on hematoxylin and eosin evaluation of all sampled lymph nodes +/- primary melanoma specimen following completion of neoadjuvant systemic therapy (ypT0ypN0 in the current AJCC staging system). The analysis of pathologic response is based on the efficacy evaluable patients who underwent therapeutic lymph node dissection. Patients who discontinued study drug or withdraw from the study will be included only if they underwent therapeutic lymph node dissection. We will calculate the pathological complete response rate with 95% confidence interval.
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): NCT03005639
|United States, Virginia|
|Inova Schar Cancer Institute|
|Fairfax, Virginia, United States, 22031|
|Principal Investigator:||Sekwon Jang, MD||Inova Schar Cancer Institute|