Intratumoral Vusolimogene Oderparepvec (VO) in Combination With Pembrolizumab for Angiosarcoma

Part of paid clinical trials in San Francisco, California.

Sponsor
Varun Monga, MBBS
Study ID
NCT06898970
Phase
PHASE2
Status
Recruiting
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Conditions

  • Angiosarcoma
  • Angiosarcoma, Adult

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Vusolimogene Oderparepvec (VO) — BIOLOGICAL
    Given intratumorally
  • Pembrolizumab — DRUG
    Given IV

Study Details

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.

Key Dates

First listed
Mar 27, 2025
Start date
Jan 9, 2026
Status verified
Aug 2026
Primary completion
Oct 31, 2029
Completion
Oct 31, 2029

Study Design

Enrollment
18 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (Vusolimogene Oderparepvec (VO), Pembrolizumab)
    All participants receive a single dose of VO on Day -14. On Cycle 1 Day 1 (C1D1), participants receive second dose of VO, and subsequent doses occur every 3 weeks for 7 cycles in combination with 200 mg pembrolizumab every 3 weeks for 8 cycles starting C1D1. After 8 cycles of pembrolizumab, participants may have the pembrolizumab dose schedule altered to a single 400 mg dose every 6 weeks, and treatment with pembrolizumab may continue for up to 2 years after starting first dose on C1D1. Participants may receive up to eight additional doses of VO after progression for a total of 16 dosing days. Safety follow up visits occur 30 and 90 days after last dose of either treatment (whichever drug was taken last) or after the participant has taken 2 years of pembrolizumab as a part of this study.

Primary Outcome Measure

Percentage of participants with reported treatment-emergent adverse events (Safety Lead-In) [ Time Frame: Up to 1 year ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of California, San FranciscoSan FranciscoCalifornia94143
Lisa Tan
[email protected]
(415) 866-7866
[email protected]
877-827-3222
Varun Monga, MBBS (PRINCIPAL_INVESTIGATOR)

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