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NCT03712358 · ClinicalTrials.gov registry record · Phase 1
PVSRIPO for Patients With Unresectable Melanoma
A Phase 1 study, sponsored by Istari Oncology.
- Terminated
- Registry status
- Phase 1
- Development phase
- 12
- Enrollment target
NCT03712358 is a Phase 1 study that was terminated before completion, run by Istari Oncology. The registered enrollment target is 12 participants.
The verdict
NCT03712358, a Phase 1 study, was terminated before completion, sponsored by Istari Oncology.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 12 participants
- Enrollment target
Study Summary
This study is a Phase I study of oncolytic polio/rhinovirus recombinant (PVSRIPO) to primarily characterize the safety and tolerability of PVSRIPO in patients with AJCC Stage IIIB, IIIC, or IV melanoma in a modified 3+3 phase 1 trial design. Lesion biopsies and blood samples will be obtained pre- and post-injection throughout the study for routine histology/molecular genetic testing and immunologic analysis, respectively. Exploratory objectives include describing the response rates of PVSRIPO-injected versus non-injected lesion(s), the number of CD8 positive T cells present in the tumor biopsies before and after injection of PVSRIPO, and after PVSRIPO administration: the pathologic response in tumor biopsies, changes in the tumor microenvironment, and how systemic immune cell populations may change.
Interventions
- BIOLOGICAL PVSRIPO
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2018-11-26 |
| Est. Completion | 2021-03-23 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03712358
The ClinicalTrials.gov registry entry for NCT03712358 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 12 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Istari Oncology, which has 8 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which PVSRIPO is the first listed.
NCT03712358 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03712358 about?
NCT03712358 is a clinical study titled "PVSRIPO for Patients With Unresectable Melanoma". This study is a Phase I study of oncolytic polio/rhinovirus recombinant (PVSRIPO) to primarily characterize the safety and tolerability of PVSRIPO in patients with AJCC Stage IIIB, IIIC, or IV melanoma in a modified 3+3 phase 1 trial design. Lesion biopsies and blood samples will be obtained pre- an...
What is the current status of trial NCT03712358?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 12 participants. The study started on 2018-11-26. Estimated completion is 2021-03-23.
What interventions are being tested in trial NCT03712358?
The interventions under investigation include: PVSRIPO (BIOLOGICAL).
Who is sponsoring clinical trial NCT03712358?
This trial is sponsored by Istari Oncology, which has 8 total clinical trials registered on ClinicalTrials.gov.
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