ML29255 Neoadjuvant Vemurafenib and Cobimetinib Melanoma

NCT03005639 | Withdrawn Phase 2 DMC FDA Drug

• 1 other identifier: 16-2316
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Stage IIIB-C Melanoma

Outcome Measures

Primary Outcomes (1)

• Radiologic Complete Response Rate

  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.

  Day 56 (+/- 3 days)

Secondary Outcomes (1)

• Overall response rate, pathologic complete response rate

  Day 56 (+/- 3 days)

Study Arms (1)

Vemurafenib/Cobimetinib

EXPERIMENTAL

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

Interventions

Vemurafenib and Cobimetinib DRUG

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.

Also known as: Zelboraf for vemurafenib

Vemurafenib/Cobimetinib

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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)

Sponsors & Collaborators

• Inova Health Care Services: lead
• Genentech, Inc.: collaborator

Study Sites (1)

Inova Schar Cancer Institute

Fairfax, Virginia, 22031, United States

Location

MeSH Terms

Interventions

Vemurafenib; cobimetinib

Intervention Hierarchy (Ancestors)

Sulfonamides; Amides; Organic Chemicals; Sulfones; Sulfur Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Sekwon Jang, MD

  Inova Schar Cancer Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Masking Details: Open Label
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 2, 2016
• First Posted: December 29, 2016
• Study Start: June 1, 2017
• Primary Completion: February 24, 2018
• Study Completion: February 24, 2018
• Last Updated: May 9, 2018

Record last verified: 2018-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)