ML29255 Neoadjuvant Vemurafenib and Cobimetinib Melanoma

Withdrawn before enrolling · Phase 2

Conditions studied: Stage IIIB-C Melanoma

In brief

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

Key facts

Study ID

NCT03005639

Run by

Inova Health Care Services

People needed

0

Starts

2017-06-01

Expected to finish

2018-02-24

Last updated by the study team

2018-05-09

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• Had prior radiotherapy at lymph node basin
• Prior treatment with BRAF inhibitor or MEK inhibitor
• Active infection
• Pregnant, lactating or breast feeding women
• Concomitant malignancies or previous malignancies within the last 5 years, with the exception of adequately treated basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix.
• History of malabsorption or other condition that would interfere with absorption of vemurafenib or cobimetinib
• Any underlying medical or psychiatric condition, which in the opinion of the Investigator will make the administration of vemurafenib and cobimetinib hazardous
• Unwillingness or inability to comply with study and follow-up procedures.
• The following foods/supplements are prohibited at least 7 days prior to initiation of and during study treatment:
• St. John's wort or hyperforin (potent cytochrome P450 CYP3A4 enzyme inducer)
• Grapefruit juice (potent cytochrome P450 CYP3A4 enzyme inhibitor)

Where it is running

• Inova Schar Cancer Institute — Fairfax, Virginia, United States

Full record on ClinicalTrials.gov

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