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AngiosarcomaPhase 2NCT06898970

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

A Phase 2 study testing Vusolimogene Oderparepvec (VO) and Pembrolizumab in people with Angiosarcoma and Angiosarcoma, Adult, run by Varun Monga, MBBS at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Angiosarcoma, Angiosarcoma, Adult
What is being tested?
Vusolimogene Oderparepvec (VO) and Pembrolizumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
18 participants
Where
1 siteUnited States
Study dates
9 Jan 2026to 31 Oct 2029
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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.
  • Age <=18 years on the day of signed informed consent.
  • Eastern Cooperative Oncology Group (ECOG) performance status <= 1 (Karnofsky ≥ 70%)
  • Adequate hematologic function including:
  • White blood cell count (WBC) >= 2.0 × 109/L
  • Absolute neutrophil count (ANC) >= 1.5 × 109/L
  • Platelet count >=100 × 109/L
  • Hemoglobin >= 9 g/dL or >= 5.6 mmol/L (without erythropoietin dependency and without packed red blood cell (pRBC) transfusion within 2 weeks of dosing)
  • Adequate hepatic function including:
  • Adequate renal function: Total bilirubin <= 1.5 × upper limit of normal (ULN) (except participants with Gilbert Syndrome who must have a total bilirubin of < 3.0 × ULN) or direct bilirubin <=ULN for a participant with total bilirubin level > 1.5 × ULN. If total bilirubin is > 1.5 × ULN but <= 3 × ULN, both aminotransferase (AST and ALT) levels must be <= 3 × ULN.
  • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) <= 3.0 × ULN (or <= 5.0 × ULN, if liver metastases) Note: If aminotransferase levels (AST and/or ALT) are > 3 × ULN but <= 5 × ULN, total bilirubin must be <= 1.5 × ULN.
  • Alkaline phosphatase (ALP) <= 2.5 × ULN (or <= 5.0 × ULN, if liver or bone metastases)
  • Blood creatinine <= 1.5 × ULN or measured or calculated (using Cockcroft) creatinine clearance >= 30 mL/minute for participants with creatinine levels > 1.5 × institutional ULN.
  • Adequate coagulation: Prothrombin time (PT) or international normalization ratio (INR) <=1.5 × ULN, and partial thromboplastin time (PTT) or activated partial thromboplastin time (aPTT) <= 1.5 × ULN. Note: For participants who are on chronic anticoagulant therapy these participants may be enrolled if the pretreatment INR < 2.5.
  • Adequate oxygen saturation: >=92% on room air.
  • Ability to understand and the willingness to sign a written informed consent document.
  • Participants with a history of treated brain metastasis and, at the time of screening, asymptomatic CNS metastases are eligible, provided they meet all the following:
  • Brain imaging at screening shows no evidence of interim progression for at least 4 weeks by repeat imaging, and clinically stable for at least 2 weeks
  • Have measurable disease outside the central nervous system (CNS)
  • Only supratentorial metastases allowed
  • No ongoing requirement for corticosteroids as therapy for CNS disease; anticonvulsants at a stable dose allowed
  • No stereotactic or whole brain radiation within 14 days prior to C1D1.
  • Individuals with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial.

Who cannot join

  • Prior treatment with an oncolytic therapy.
  • 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.
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  • 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.
  • Has received prior radiotherapy within two weeks of start of study treatment. Note: participants who are eligible must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis. A 1-week washout is permitted for palliative radiation (<=2 weeks of radiotherapy) to non-CNS disease.
  • History of interstitial lung disease.
  • History of documented allergic reactions or acute hypersensitivity attributed to VO and pembrolizumab or any of its excipients.
  • Has received a live vaccine within 30 days prior to the first dose of study drug. Examples of live vaccines include, but are not limited to: measles, mumps, rubella, varicella/zoster (chicken pox), yellow fever, rabies, Bacille Calmette-Guérin (BCG), and typhoid vaccine. Note: Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed, however, intranasal influenza vaccines (e.g., FluMist®) are live attenuated vaccines and are not allowed. Available Coronavirus disease of 2019 (COVID-19) vaccines do not contain live virus and are allowed.
  • Conditions requiring treatment with immunosuppressive doses (> 10 mg daily prednisone or equivalent) of systemic corticosteroids other than for corticosteroid replacement therapy within 14 days after enrollment. For the definition of replacement therapy.
  • Undergo major surgery ≤ 2 weeks prior to starting VO. Note: participants who undergo major surgery requiring general anesthesia such as exploratory laparotomy or thoracotomy and are eligible for the study must adequately recover prior to starting study treatment. Procedures such as central line placement, endoscopies and tooth extractions under local anesthesia do not meet criteria for major surgery.
  • Has a history of (non-infectious) pneumonitis that required corticosteroids or has current pneumonitis.
  • Has a history or current evidence of any condition, therapy, or laboratory abnormality that will be unfavorable for the administration of study drug or affect the explanation of drug toxicity or AEs, or interfere with the participant's participation for the full duration of the study, or is not in the best interest of the participant to participate, in the opinion of the treating Investigator.
  • Has known psychiatric, alcohol abuse, or substance abuse disorders that would interfere with cooperating with the requirements of the study.
  • Has serious uncontrolled medical disorders such as uncontrolled hypertension, bleeding diatheses, uncontrolled diabetes.
  • Has clinically significant cardiovascular disease within 12 months from first dose of study drug, including New York Heart Association Class III or IV congestive heart failure, unstable angina, myocardial infarction, cerebral vascular accident, history of myocarditis, or cardiac arrhythmia associated with hemodynamic instability.
  • Is a person deprived of their liberty by a judicial or administrative decision, or an adult person subject to a legal protection measure.
  • Has been treated with botanical preparations (e.g., herbal supplements or traditional Chinese medicines) intended for general health support or to treat the disease under study within 2 weeks prior to first dose and throughout the study.
  • Has an active, known, or suspected autoimmune disease. Note: participants with Type I diabetes mellitus, hypothyroidism only requiring hormone replacement, skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll.
  • Has a history of life-threatening toxicity related to prior immune therapy. Note: Toxicities that are unlikely to recur with standard countermeasures (e.g., hormone replacement after adrenal crisis) are allowed.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Lisa Tan contact

(415) 866-7866

Lisa.Tan@ucsf.edu

United States1 site, 1 recruiting

  • University of California, San Francisco

    San Francisco, California, 94143

    Lisa Tan, (415) 866-7866, Lisa.Tan@ucsf.edu

    877-827-3222, cancertrials@ucsf.edu

    Recruiting

Other trials in United States

About this study

Official title: An Open-Label, Multicenter, Phase 2 Study With Safety Lead-In of Intratumoral Vusolimogene Oderparepvec (VO) in Combination With Pembrolizumab in Patients With Angiosarcoma

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.

Read the detailed description

Primary Objectives:

Safety Lead-in:

  1. 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 with pembrolizumab as determined by objective response rate (ORR) per modified Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1

OUTLINE:

Participants may continue study treatment for up to 2 years with pembrolizumab and 24 weeks with VO. Some participants may be eligible to receive treatment after progression. For participants who discontinued for reasons other than confirmed progressive disease (PD) or completed treatment, tumor response assessments will continue approximately every 12 weeks from the last tumor assessment for up to two years or until the start of subsequent anticancer treatment, confirmed disease progression, withdrawal of consent, loss to follow-up, death, whichever occurs first. Participants will also be followed-up every 6 months to assess for survival/disease/anti-cancer therapy status for up to 2 years

Being tested
Vusolimogene Oderparepvec (VO), Pembrolizumab
Keywords
Immunotherapy
Medical subject headings
Hemangiosarcoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Vusolimogene Oderparepvec (VO)Biological

    Also called RP1

    Given intratumorally

  • PembrolizumabDrug

    Also called Keytruda

    Given IV

Study groups in NCT06898970
Study groupRoleWhat they receive
Treatment (Vusolimogene Oderparepvec (VO), Pembrolizumab)ExperimentalAll 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.
Receives: Biological: Vusolimogene Oderparepvec (VO); Drug: Pembrolizumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of participants with reported treatment-emergent adverse events (Safety Lead-In)

    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.

    Measured: Up to 1 year

  2. Proportion of participants who experience an objective response (Phase 2 participants)

    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.

    Measured: Up to 1 year

  3. Percentage of participants with reported treatment-emergent adverse events

    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.

    Measured: Up to 1 year

Secondary outcomes (6)

  1. Median Duration of Response (DOR)

    The DOR is the time from the first day of documented response until disease progression. Objective response will be measured per RECIST v. 1.1 and is defined as complete response (CR), partial response (PR), or stable disease (SD) and confirmed by repeat imaging >=4 weeks after assessment for participants who completed at least 4 of the planned 8 intratumoral injections. The median time in months will be reported along with 25% confidence intervals.

    Measured: Up to 1 year

  2. Percentage of participants with documented Complete Response (CRR)

    The CRR is the percentage of participants with a demonstrated complete response as measured per RECIST v. 1.1 and confirmed by repeat imaging >=4 weeks after assessment for participants who completed at least 4 of the planned 8 intratumoral injections will be reported

    Measured: Up to 1 year

  3. Percentage of participants with documented Clinical Benefit (CBR)

    The percentage of participants with demonstrated Clinical Benefit as measured per modified RECIST v. 1.1 criteria and is defined as having a complete response (CR), partial response (PR), or stable disease (SD) and confirmed by repeat imaging >=4 weeks after assessment for participants who completed at least 4 of the planned 8 intratumoral injections for greater than 3 months (>=4 months)

    Measured: Up to 1 year

  4. Median Progression-Free Survival (PFS)

    The time that elapses between Day -14 and the earlier of the day of first documented disease progression or death from any cause for all evaluable patients. Disease progression is defined as progressive disease (PD) per modified RECIST 1.1,1 other documented clinical or radiographical progression per physician judgement, or death due to disease.

    Measured: Up to 2 years

  5. Median Overall Survival

    The OS is defined as the time that elapses in months between Day -14 and the date of death from any cause for all participants.

    Measured: Up to 2 years

  6. Percentage of participants who experience an objective response

    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 and will be collected up to 30 days after the last dose of either study treatment.

    Measured: Up to 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Mar 2025
  2. Study start9 Jan 2026
  3. Primary completion31 Oct 2029 (estimated)
  4. Study completion31 Oct 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
18 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06898970
Sponsor's protocol ID
25871
Other IDs
NCI-2025-02056
Status last verified
Aug 2026
First submitted
20 Mar 2025
Last updated
1 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: De-identified datasets may be shared with study collaborators during the course of the study through study closure.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Vusolimogene Oderparepvec (VO) and Pembrolizumab in people with Angiosarcoma and Angiosarcoma, Adult, run by Varun Monga, MBBS at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 30 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 1 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Lisa Tan ((415) 866-7866, Lisa.Tan@ucsf.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of participants with reported treatment-emergent adverse events (Safety Lead-In) (time frame: Up to 1 year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06898970.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2026.

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