Pre-operative immunotherapy for stage III melanoma
Neoadjuvant Combination Immunotherapy for Stage III Melanoma
This study is testing a combination of two immunotherapy treatments to see if they can shrink tumors in patients with stage III melanoma before they have surgery.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 28 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Louisville Academic / other |
| Drugs / interventions | pembrolizumab, immunotherapy |
| Locations | 1 site (Louisville, Kentucky) |
| Trial ID | NCT03842943 on ClinicalTrials.gov |
What this trial studies
This Phase 2 clinical trial evaluates the safety and efficacy of a combination immunotherapy using Talimogene Laherparepvec (T-VEC) and Pembrolizumab administered for six months before complete lymph node dissection in patients with resectable stage III cutaneous melanoma. The study focuses on individuals with clinically apparent lymph node metastases and aims to determine how well this pre-operative treatment can improve outcomes. Participants will receive the immunotherapy to potentially shrink tumors before surgical intervention.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with pathologically confirmed resectable stage III cutaneous melanoma and clinically apparent lymph node metastases.
Not a fit: Patients with metastatic melanoma or those with primary mucosal or uveal melanoma will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could improve surgical outcomes and overall survival rates for patients with stage III melanoma.
How similar studies have performed: Other studies have shown promising results with similar immunotherapy approaches in melanoma, indicating potential for success in this trial.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 18 years of age, any race or sex, who have pathologically confirmed cutaneous melanoma * ECOG performance status of 0 or 1 * Adequate hematologic, hepatic, renal and coagulation function * Must have measurable disease and have an injectable target lymph node for intralesional therapy administration * Primary melanoma has been resected * Pathologically confirmed resectable stage III disease, clinically apparent. Resectability is at the discretion of the treating surgeon who is a melanoma specialist. * Stage III disease can be at time of diagnosis of primary melanoma or a recurrence after initial treatment of stage I-II disease. * BRAF mutant or wild type allowed (mutations status not necessary for enrollment) * Signed, written informed consent Exclusion Criteria: * Cannot have metastatic (AJCC M1) disease * No primary mucosal or uveal melanoma * No evidence of melanoma associated with immunodeficiency state or history or other malignancies (other than non-melanoma skin cancer) within the past 3 years * May not have been previously treated with T-VEC, any other oncolytic virus, pembrolizumab, or any other PD-1, PD-L1, or PD-L2 inhibitor * Must not have a history or evidence of symptomatic autoimmune pneumonitis, glomerulonephritis, vasculitis, or other symptomatic autoimmune disease, document history of autoimmune disease or syndrome requiring systemic treatment in the past two years (i.e. use of disease modifying agents, steroids, or immunosuppressive agents) except vitiligo or resolved childhood asthma/atopy, or evidence of clinically significant immunosuppression * Must not have active herpetic skin lesions or prior complications of herpetic infection and must not require intermittent or chronic treatment with an anti-herpetic drug (e.g. acyclovir) other than intermittent topical use
Where this trial is running
Louisville, Kentucky
- University of Louisville — Louisville, Kentucky, United States (Recruiting)
Study contacts
- Principal investigator: Michael Egger, MD — University of Louisville
- Study coordinator: Michael Egger, MD
- Email: michael.egger@louisville.edu
- Phone: 502-629-6950
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.