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NCT03073525 · ClinicalTrials.gov registry record · Phase 2
A Trial of Atezolizumab and Vigil in Patients With Advanced Gynecological Cancers
A Phase 2 study, sponsored by Gradalis.
- Completed
- Registry status
- Phase 2
- Development phase
- 25
- Enrollment target
NCT03073525: Completed Phase 2 study, sponsored by Gradalis.
NCT03073525 is a Phase 2 study that has completed, run by Gradalis. The registered enrollment target is 25 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (81% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03073525, a Phase 2 study, has completed, sponsored by Gradalis.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 25 participants
- Enrollment target
Study Summary
The clinical trial was a companion study to protocol CL-PTL-119 (A Randomized, Double-Blind, Placebo-Controlled Phase 2 Trial of Vigil Engineered Autologous Tumor Cell Immunotherapy in Subjects with Stage IIIb-IV Ovarian Cancer in Clinical Complete Response following Surgery and Primary Chemotherapy (VITAL) NCT02346747). Participants who had investigational product (Vigil) successfully made but were not eligible to enroll onto the VITAL study or previously randomized to placebo were given the opportunity to participate in this protocol. The main goal of this clinical trial was to determine the safety of combining Vigil therapy with atezolizumab.
Primary Outcome
The safety evaluation included Adverse Events (AEs), Adverse Events of Special Interest (AESIs), Serious Adverse Events (SAEs) and changes from baseline in laboratory evaluations, vital signs, electrocardiograms and physical examinations. AEs were graded according to the National Cancer Institute (NCI) CTCAE v4.03 and coded using the Medical Dictionary for Regulatory Activities. Laboratory abnormalities were graded according to the NCI CTCAE v4.03, if applicable.
Interventions
- DRUG Atezolizumab
- BIOLOGICAL Vigil
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 25 participants |
| Start Date | 2017-05-31 |
| Est. Completion | 2022-05-18 |
| Phase | Phase 2 |
What the finished NCT03073525 record still lists
NCT03073525 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 25 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (81% lower).
The record links to 0 conditions, and to 2 interventions - of which Atezolizumab is the first listed.
NCT03073525 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03073525 about?
NCT03073525 is a clinical study titled "A Trial of Atezolizumab and Vigil in Patients With Advanced Gynecological Cancers". The clinical trial was a companion study to protocol CL-PTL-119 (A Randomized, Double-Blind, Placebo-Controlled Phase 2 Trial of Vigil Engineered Autologous Tumor Cell Immunotherapy in Subjects with Stage IIIb-IV Ovarian Cancer in Clinical Complete Response following Surgery and Primary Chemotherapy...
What is the current status of trial NCT03073525?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 25 participants. The study started on 2017-05-31. Estimated completion is 2022-05-18.
What interventions are being tested in trial NCT03073525?
The interventions under investigation include: Atezolizumab (DRUG), Vigil (BIOLOGICAL).
Who is sponsoring clinical trial NCT03073525?
This trial is sponsored by Gradalis, which has 13 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03073525's enrollment target sits among peer trials
25 1719th of 2000 higher than 245 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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