Intratumoral Vusolimogene Oderparepvec (VO) in Combination With Pembrolizumab for Angiosarcoma
Trial Parameters
Brief Summary
This is a multicenter, open-label study of Intratumoral Vusolimogene Oderparepvec (VO) to investigate safety and estimate when used in combination with pembrolizumab for treating participants with angiosarcoma. This is the first study evaluating this novel combination in participants with advanced angiosarcoma who have progressed after prior immunotherapy.
Eligibility Criteria
Inclusion Criteria: 1. Participants with biopsy proven cutaneous angiosarcoma that is locally advanced and unresectable or metastatic and has received and progressed on at least one prior immunotherapy based regimen within 6 months prior to screening. 2. At least one measurable tumor of ≥ 1 cm in longest diameter or ≥ 1.5 cm in shortest diameter (for lymph nodes) and injectable lesions which in aggregate comprise \>= 1 cm in longest diameter. 3. Participants must have received and progressed following first-line standard of care, including a taxane or anthracycline based chemotherapy regimen. 4. Measurable disease based upon Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. Lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions. 5. Life expectancy of at least 3 months, in the opinion of the treating investigator. 6. Females of childbearing potential must have a negative beta-human chorionic gonado