Varun Monga, MBBS
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.
Primary Objectives: Safety Lead-in: I. To assess the safety and tolerability of VO in combination with pembrolizumab. Phase 2: 1. To assess the efficacy of VO in combination with pembrolizumab as determined by objective response rate (ORR). 2. To assess the safety and tolerability of VO in combination with pembrolizumab. Secondary Objectives: 1. To assess the duration of response (DOR). 2. To assess the complete response rate (CRR), clinical benefit rate (CBR), progression free survival, and 1-year and 2-year overall survival (OS). 3. To further assess the efficacy of VO in combination w…
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.…
Given intratumorally
Given IV
Arctuva estimate
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