Intratumoral Vusolimogene Oderparepvec (VO) in Combination With Pembrolizumab for Angiosarcoma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorVarun Monga, MBBS
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Single group
Treatments tested in this trial
Vusolimogene Oderparepvec (VO)
Biological/VaccineGiven intratumorally
Pembrolizumab
DrugGiven IV
Treatment groups
18 Participants
are divided into 1 treatment groupGroup A: Treatment (Vusolimogene Oderparepvec (VO), Pembrolizumab)Experimental treatment 2 interventions
Trial outcomes
Primary outcomes
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.
Time frame
Up to 1 year2
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.
Time frame
Up to 1 year3
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.
Time frame
Up to 1 yearSecondary outcomes
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.
Time frame
Up to 1 year2
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
Time frame
Up to 1 year3
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)
Time frame
Up to 1 year4
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.
Time frame
Up to 2 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Varun Monga, MBBS
Lead sponsor
University of California, San Francisco
Sponsor institution
Replimune, Inc.
Collaborator
Source ClinicalTrials.gov