Intratumoral Vusolimogene Oderparepvec (VO) with Pembrolizumab for Angiosarcoma
This study is testing a new combination treatment for adults with angiosarcoma, a rare cancer of the blood vessels. You might be able to join if your angiosarcoma has spread or can't be removed with surgery, and has gotten worse after at least one previous immunotherapy treatment. The study is giving two medicines: Vusolimogene Oderparepvec (VO) directly into the tumor, and Pembrolizumab through an IV. Researchers want to see how safe this combination is and how well it shrinks tumors. This is the first time these two treatments are being used together for advanced angiosarcoma. The study is currently recruiting about 18 participants.
- Study design
- This is an open-label study, meaning both you and your doctors will know which treatments you are receiving. It is a multicenter study, involving several locations, and plans to enroll 18 participants.
- What's involved
- You may receive Pembrolizumab for up to 2 years and Vusolimogene Oderparepvec (VO) for 24 weeks. Tumor assessments will continue approximately every 12 weeks for up to two years after treatment ends or until your disease progresses.
- Compensation
- Not stated in the trial record.
- Follow-up
- After treatment, tumor response assessments will continue approximately every 12 weeks for up to two years or until disease progression, withdrawal, or death.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Intratumoral Vusolimogene Oderparepvec (VO) in Combination With Pembrolizumab for Angiosarcoma
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Varun Monga, MBBS · PRINCIPAL_INVESTIGATOR · University of California, San Francisco
Who to contact
This trial hasn't published a contact. View it on ClinicalTrials.gov
What this trial measures
- Percentage of participants with reported treatment-emergent adverse events (Safety Lead-In)Up to 1 year
Safety and tolerability will be reported as the percentage of the first 6 participants (the safety-lead in participants) who received at least one dose of study treatment with any reported treatment-emergent adverse events (TEAEs), \>= Grade 3 TEAEs, serious adverse events (SAEs), and TEAEs requiring discontinuation of VO. Adverse events will be classified using NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
- Proportion of participants who experience an objective response (Phase 2 participants)Up to 1 year
Objective response will be measured per RECIST v. 1.1 and is defined as complete response (CR) or partial response (PR) and confirmed by repeat imaging \>=4 weeks after assessment for participants who completed at least 4 of the planned 8 intratumoral injections.
- Percentage of participants with reported treatment-emergent adverse eventsUp to 1 year
The percentage of all participants who received at least one dose of study treatment with any treatment-emergent adverse events (TEAEs), ≥ Grade 3 TEAEs, serious adverse events (SAEs), and TEAEs requiring discontinuation of VO. Adverse events will be classified using NCI Common Terminology Criteria for Adverse Events (CTCAE) v. 5.0.