Intratumoral Vusolimogene Oderparepvec (VO) in Combination With Pembrolizumab for Angiosarcoma (NCT06898970) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Intratumoral Vusolimogene Oderparepvec (VO) in Combination With Pembrolizumab for Angiosarcoma
United States18 participantsStarted 2026-01-09
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. 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.
✓. 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.
✓. Participants must have received and progressed following first-line standard of care, including a taxane or anthracycline based chemotherapy regimen.
✓. 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.
✓. Life expectancy of at least 3 months, in the opinion of the treating investigator.
✓. Females of childbearing potential must have a negative beta-human chorionic gonadotropin (beta-hCG) test at screening within 7 days of Cycle 1 Day 1.
✓. Female participants of reproductive potential must agree to avoid becoming pregnant and adhere to a highly effective contraception method until 90 days after last dose of VO alone or 120 days after last dose of VO and pembrolizumab.
✓. Male participants of reproductive potential must agree to avoid impregnating a partner and adhere to a highly effective contraception method until 90 days after last dose of VO study agent and refrain from donating sperm during this period.
Exclusion criteria
What they're measuring
1
Percentage of participants with reported treatment-emergent adverse events (Safety Lead-In)
Timeframe: Up to 1 year
2
Proportion of participants who experience an objective response (Phase 2 participants)
Timeframe: Up to 1 year
3
Percentage of participants with reported treatment-emergent adverse events
✕. Currently receiving antiviral drug therapy (e.g. valacyclovir or acyclovir).
✕. Has acute or chronic active hepatitis B and C virus infection or known history of hepatitis B (defined as hepatitis B surface antigen \[HBsAg\] reactive) or known active hepatitis C virus (HCV) (defined as HCV RNA \[qualitative\]) or HIV infection.Note: No testing for Hepatitis B, Hepatitis C, or HIV is required unless mandated by local health authority or if clinically indicated.
✕. Had systemic infection requiring IV antibiotics or other serious infection within 14 days prior to dosing.
✕. Has active significant herpetic infections or prior complications of herpes simplex 1 (HSV-1) infection (e.g., herpetic keratitis or encephalitis).
✕. Systemic anticancer therapy within 4 weeks prior to enrollment or five half-lives, whichever is shorter, before the first administration of VO. Note: programmed cell death protein 1 (PD1)/programmed death-ligand 1 (PD-L1) directed therapy is allowed.
✕. Has not recovered from adverse events due to prior anti-cancer therapy to \<= grade 1 or baseline. Note: participants with toxicities after prior anticancer therapies that are not considered a likely safety risk such as Grade ≤ 2 neuropathy or alopecia, or immune mediated AEs that are unlikely to recur with standard countermeasures (e.g., hormone replacement after adrenal crisis, stable endocrine insufficiencies such as thyroid and adrenal insufficiency), are an exception to this criterion and may qualify for the study in discussion with the Principal Investigator.
✕. Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within four weeks prior to the first dose of study treatment. Note: participants who have entered the follow-up phase of an investigational study may participate as long as it has been four weeks since the last dose of the previous investigational agent.