NCT03972046

Neoadjuvant Use of Talimogene Laherparepvec and BRAF/MEK Inhibitor for Advanced Nodal BRAF Mutant Melanoma

Neoadjuvant Use of Talimogene Laherparepvec and BRAF/MEK Inhibitor for Advanced Nodal BRAF Mutant Melanoma: A Pilot Study

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: TriHealth Inc. · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study will investigate whether the use of talimogene laherparepvec (T-VEC) in combination with BRAF/MEK inhibitor will result in durable regional and distant recurrence free survival in the neoadjuvant setting for treatment of advanced nodal BRAF mutant melanoma.

Detailed description

This is a prospective, non-randomized, open-label, single-center interventional study looking at the response rate when using talimogene laherparepvec (T-VEC) in combination with BRAF/MEK inhibitor in neoadjuvant setting for treatment of advanced nodal BRAF mutant melanoma. For this pilot study, a sample size of 20 participants, over 18 years of age will be included.

Conditions

• Melanoma (Skin)
• Melanoma Stage IIIb-IVM1a
• Metastasis Skin
• Tumor Skin
• BRAF Gene Mutation

Interventions

Type	Name	Description
DRUG	Talimogene laherparepvec (T-Vec)	Talimogene laherparepvec (T-Vec) up to 4mL subcutaneous injection
DRUG	Dabrafenib (BRAF Inhibitor)	Dabrafenib (BRAF Inhibitor) 150 mg by mouth twice a day
DRUG	Trametinib (MEK Inhibitor)	Trametinib (MEK Inhibitor) 2 mg by mouth once a day

Timeline

• Start date: 2019-06-24
• Primary completion: 2020-02-03
• Completion: 2020-02-03
• First posted: 2019-06-03
• Last updated: 2020-10-19

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study