Study on Vusolimogene Oderparepvec (VO) and Pembrolizumab for Treating Angiosarcoma

Inclusion Criteria

• Have a confirmed diagnosis of angiosarcoma that is advanced and cannot be surgically removed, or has spread to other parts of the body.
• Have previously received and not responded to at least one immunotherapy treatment within the last 6 months.
• Have at least one tumor that can be measured by scans and is at least 1 cm in size.
• Provide a recent tumor tissue sample for analysis.
• Have previously received standard chemotherapy treatments and the cancer has progressed.
• Have a life expectancy of at least 3 months.
• Women of childbearing potential must have a negative pregnancy test and agree to use effective birth control during the study and for a specified period after.
• Men must agree to use effective birth control and not donate sperm during the study and for a specified period after.
• Be 18 years or older.
• Be in good overall health with a performance status score of 0 or 1.
• Have adequate blood cell counts and organ function as determined by specific blood tests.
• Have adequate oxygen levels in the blood.
• Be able to understand and sign a consent form.
• Have treated and stable brain metastases, if present, with no ongoing need for steroids.

Exclusion Criteria

• Have received oncolytic therapy before.
• Are currently taking antiviral medications.
• Have active hepatitis B or C, or HIV infection.
• Have had a serious infection requiring IV antibiotics within 14 days before starting the study.
• Have active herpes infections or complications from herpes.
• Have received cancer treatment within 4 weeks before starting the study.
• Have not recovered from side effects of previous cancer treatments.
• Are participating in another clinical trial or have used an investigational device recently.
• Have received radiation therapy within 2 weeks before starting the study.
• Have a history of lung disease or severe allergic reactions to study drugs.
• Have received a live vaccine within 30 days before starting the study.
• Require high doses of steroids or have had major surgery recently.
• Have a history of pneumonitis or other serious medical conditions that could interfere with the study.
• Have uncontrolled medical conditions or significant heart disease.
• Are unable to comply with study requirements due to psychiatric or substance abuse disorders.
• Are taking herbal supplements or traditional medicines for health support or disease treatment.
• Have an autoimmune disease, except for certain stable conditions.
• Have had severe side effects from previous immune therapy.