NCT03842943

Neoadjuvant Combination Immunotherapy for Stage III Melanoma

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 28 (estimated)
• Sponsor: University of Louisville · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Determine safety and efficacy of pre-operative combination immunotherapy with Talimogene Laherparepvec (T-VEC)/Pembrolizumab given prior to complete lymph node dissection in resectable stage 3 cutaneous melanoma with clinically apparent lymph node metastases.

Detailed description

This is a single arm Phase 2 study of pre-operative combination immunotherapy with pembrolizumab and T-VEC given for 6 months prior to complete lymph node dissection for stage 3 resectable cutaneous melanoma with clinically apparent lymph node metastases.

Conditions

• Cutaneous Melanoma

Interventions

Type	Name	Description
DRUG	Pembrolizumab	Preoperative infusions
DRUG	Talimogene Laherparepvec	Preoperative intralesional injection

Timeline

• Start date: 2019-07-03
• Primary completion: 2026-06-01
• Completion: 2028-06-01
• First posted: 2019-02-15
• Last updated: 2024-05-02

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study