A Phase 2, Multicenter, Randomized, Open-label Trial Assessing the Efficacy and Safety of Talimogene Laherparepvec Neoadjuvant Treatment Plus Surgery Versus Surgery Alone for Resectable, Stage IIIB to IVM1a Melanoma
Sponsor: |
Amgen |
Enrolling: |
Male and Female Patients |
IRB Number: |
AAAP3756 |
U.S. Govt. ID: |
NCT02211131 |
Contact: |
Adele Muthukumar: 212-305-0455 / am4418@columbia.edu |
This is a phase II research study for individuals with resectable, stage IIIB to IVM1a Melanoma. The research drug being studied is talimogene laherparepvec. Talimogene laherparepvec is still experimental and has not been approved by the Food and Drug Administration (FDA) for use in people with melanoma. The purpose of this study is to find out more about the study drug when given before surgery in people with advanced melanoma who are eligible for complete surgical removal (excision) of their melanoma. The study will see if talimogene laherparepvec followed by surgery to remove (excise) a melanoma tumor can decrease the likelihood of recurrence of the tumor (replace or return of the rumor) after the surgery in people with advanced melanoma. The study will also see if talimogene laherparepvec followed by surgery to remove (excise) the melanoma tumor is safe for people with advanced melanoma to take.
This study is closed
Investigator
Richard Carvajal, MD
Do you have a confirmed diagnosis of stage IIIB, IIIC or IVM1a melanoma? |
Yes |
No |
Are you to undergo surgery to remove the tumor? |
Yes |
No |