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NCT03206073 · ClinicalTrials.gov registry record · Phase 1
A Phase I/II Study of Pexa-Vec Oncolytic Virus in Combination With Immune Checkpoint Inhibition in Refractory Colorectal Cancer
A Phase 1 study, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 1
- Development phase
- 34
- Enrollment target
NCT03206073: Completed Phase 1 study, sponsored by National Cancer Institute (NCI).
NCT03206073 is a Phase 1 study that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 34 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03206073, a Phase 1 study, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 34 participants
- Enrollment target
Study Summary
Background: * Immune-based approaches in colorectal cancer have unfortunately with the notable exception of immune checkpoint inhibition in microsatellite instable (MSI-hi) disease been largely unsuccessful. The reasons for this are unclear but no doubt relate to the fact that in advanced disease colorectal cancer appears to be less immunogenic, as evidenced by the lack of infiltrating lymphocytes with advancing T stage * Pexa-Vec (JX-594) is a thymidine kinase gene-inactivated oncolytic vaccinia virus engineered for the expression of transgenes encoding human granulocyte- macrophage colony-stimulating factor (GM-CSF) and beta-galactosidase. Apart from the direct oncolytic activity, oncolytic viruses such as Pexa-Vec have been shown to mediate tumor cell death via the induction of innate and adaptive immune responses * Tremelimumab is a fully human monoclonal antibody that binds to cytotoxic T-lymphocyte-associated protein 4 (CTLA-4) expressed on the surface of activated T lymphocytes and causes inhibition of B7-CTLA-4-mediated downregulation of T-cell activation. Durvalumab is a human monoclonal antibody directed against programmed death-ligand 1 (PD-L1). * The aim of the study is to evaluate whether the anti-tumor immunity induced by Pexa-Vec oncolytic viral therapy can be enhanced by immune checkpoint inhibition. Objective: -To determine the safety, tolerability and feasibility of Pexa-Vec oncolytic virus in combination with immune checkpoint inhibition in patients with refractory metastatic colorectal cancer. Eligibility: * Histologically confirmed metastatic colorectal cancer. * Patients must have progressed on, been intolerant of or refused prior oxaliplatin- and irinotecan-containing, fluorouracil-based, chemotherapeutic regimen and have disease that is not amenable to potentially curative resection. Patients who have a known Kirsten rat sarcoma viral oncogene homolog (KRAS) wild type tumor must have progressed, been intolerant of or refused cetuximab or
Interventions
- DRUG Durvalumab
- DRUG Tremelimumab
- BIOLOGICAL Pexa-Vec
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 34 participants |
| Start Date | 2017-12-07 |
| Est. Completion | 2022-06-30 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03206073
The ClinicalTrials.gov registry entry for NCT03206073 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 34 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Cancer Institute (NCI), which has 3,257 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Durvalumab is the first listed.
NCT03206073 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03206073 about?
NCT03206073 is a clinical study titled "A Phase I/II Study of Pexa-Vec Oncolytic Virus in Combination With Immune Checkpoint Inhibition in Refractory Colorectal Cancer". Background: * Immune-based approaches in colorectal cancer have unfortunately with the notable exception of immune checkpoint inhibition in microsatellite instable (MSI-hi) disease been largely unsuccessful. The reasons for this are unclear but no doubt relate to the fact that in advanced disease c...
What is the current status of trial NCT03206073?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 34 participants. The study started on 2017-12-07. Estimated completion is 2022-06-30.
What interventions are being tested in trial NCT03206073?
The interventions under investigation include: Durvalumab (DRUG), Tremelimumab (DRUG), Pexa-Vec (BIOLOGICAL).
Who is sponsoring clinical trial NCT03206073?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
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