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Talimogene laherparepvec before Surgery for the Treatment of High-Risk and Treatment-Naive Recurrent Melanoma


Active: Yes
Cancer Type: Melanoma NCT ID: NCT04427306
Trial Phases: Phase II Protocol IDs: CCSO034 (primary)
NCI-2020-04098
Eligibility: 18 Years and older, Male and Female Study Type: Treatment
Study Sponsor: University of California Davis Comprehensive Cancer Center
NCI Full Details: http://clinicaltrials.gov/show/NCT04427306

Summary

The phase II trial investigates a viral therapy called talimogene laherparepvec to see how well it works as a first step to shrink a tumor before the main treatment (surgical removal of the tumor) in patients with melanoma that has come back after a period of treatment (recurrent). Talimogene laherparepvec is a modified herpes virus designed to enhance the immune system to destroy melanoma cells. The information learned from this study may help researchers to improve currently poor outcomes associated with early intervention for melanoma care.

Objectives

PRIMARY OBJECTIVE:
I. Evaluate pathologic response of melanoma following intralesional talimogene laherparepvec (T-VEC) in the neoadjuvant setting prior to resection of a primary cutaneous melanoma and sentinel lymph node biopsy or in treatment naive local, in-transit, or dermal oligometastatic recurrence.

SECONDARY OBJECTIVES:
I. Determine the changes in the immune infiltrate in the primary tumor and in the draining sentinel lymph node.
II. Correlate immune phenotype with response rate, disease stage, sentinel node positivity.
III. Evaluate overall and recurrence-free survival.

CORRELATIVE AND EXPLORATORY OBJECTIVES:
I. Correlate molecular and inflammatory signature of primary tumors with response rate as well as changes in mutational burden in partial or non-responding tumors.
II. Determine changes in serum biomarkers associated with actionable targets as well as inflammatory signaling to evaluate feasibility and accuracy of serum protein analysis.
III. Determine changes in sentinel lymph node disease burden and subsequent rates of locoregional disease control, recurrence-free survival, melanoma specific survival and overall survival.
IV. Correlate molecular signature, immune phenotype and pattern of response in injected lesions to recurrence rate.

OUTLINE:
Patients receive T-VEC intratumorally (IT) over 30 minutes on days 1, 21, 35, and 49. Patients then undergo surgical resection of the tumor on day 56.

After completion of study treatment, patients are followed up at day 28 or 30, then every 3-6 months up to 24 months. If the patient discontinues treatment without disease progression, they are followed for 100 days.

Treatment Sites in Georgia

Winship Cancer Institute of Emory University
1365 Clifton Road NE
Building C
Atlanta, GA 30322
404-778-5180
winshipcancer.emory.edu

**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.