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NCT03004183 · ClinicalTrials.gov registry record · Phase 2
SBRT and Oncolytic Virus Therapy Before Pembrolizumab for Metastatic TNBC and NSCLC
A Phase 2 study, sponsored by The Methodist Hospital Research Institute.
- Completed
- Registry status
- Phase 2
- Development phase
- 57
- Enrollment target
NCT03004183: Completed Phase 2 study, sponsored by The Methodist Hospital Research Institute.
NCT03004183 is a Phase 2 study that has completed, run by The Methodist Hospital Research Institute. The registered enrollment target is 57 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (57% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03004183, a Phase 2 study, has completed, sponsored by The Methodist Hospital Research Institute.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 57 participants
- Enrollment target
Study Summary
This is a Phase II trial to determine the efficacy and safety of stereotactic body radiation therapy (SBRT) and in situ oncolytic virus therapy used as a window of opportunity treatment before pembrolizumab in patients with metastatic triple negative breast cancer (TNBC) and metastatic non-small cell lung cancer (NSCLC). In situ oncolytic virus therapy will consist of adenovirus-mediated expression of herpes simplex virus thymidine kinase (ADV/HSV-tk) plus valacyclovir therapy.
Primary Outcome
The objective response rate (ORR) of ADV/HSV-tk plus (+) valacyclovir therapy in combination with SBRT used as a window of opportunity treatment before pembrolizumab in patients with metastatic TNBC and metastatic NSCLC. Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 will be used to assess treatment response. Modified immune-related response criteria (irRC; derived from RECIST 1.1) will also be documented.
Interventions
- DRUG Pembrolizumab
- RADIATION SBRT
- DRUG Valacyclovir
- BIOLOGICAL ADV/HSV-tk
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 57 participants |
| Start Date | 2017-07-01 |
| Est. Completion | 2024-01-09 |
| Phase | Phase 2 |
What the finished NCT03004183 record still lists
NCT03004183 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 57 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (57% lower).
The record links to 0 conditions, and to 4 interventions - of which Pembrolizumab is the first listed.
NCT03004183 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03004183 about?
NCT03004183 is a clinical study titled "SBRT and Oncolytic Virus Therapy Before Pembrolizumab for Metastatic TNBC and NSCLC". This is a Phase II trial to determine the efficacy and safety of stereotactic body radiation therapy (SBRT) and in situ oncolytic virus therapy used as a window of opportunity treatment before pembrolizumab in patients with metastatic triple negative breast cancer (TNBC) and metastatic non-small cel...
What is the current status of trial NCT03004183?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 57 participants. The study started on 2017-07-01. Estimated completion is 2024-01-09.
What interventions are being tested in trial NCT03004183?
The interventions under investigation include: Pembrolizumab (DRUG), SBRT (RADIATION), Valacyclovir (DRUG), ADV/HSV-tk (BIOLOGICAL).
Who is sponsoring clinical trial NCT03004183?
This trial is sponsored by The Methodist Hospital Research Institute, which has 126 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03004183's enrollment target sits among peer trials
57 1141st of 2000 higher than 855 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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