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NCT03162562 · ClinicalTrials.gov registry record · Phase 1
The Safety and Antitumor Activity of the Combination of Oregovomab and Hiltonol in Recurrent Advanced Ovarian Cancer
A Phase 1 study, sponsored by CanariaBio.
- Terminated
- Registry status
- Phase 1
- Development phase
- 10
- Enrollment target
NCT03162562: Clinical Trial Phase 1 study, sponsored by CanariaBio.
NCT03162562 is a Phase 1 study that was terminated before completion, run by CanariaBio. The registered enrollment target is 10 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (83% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03162562, a Phase 1 study, was terminated before completion, sponsored by CanariaBio.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 10 participants
- Enrollment target
Study Summary
This is a Phase Ib study to look at the combination of an antibody immunization vaccine strategy using oregovomab and an investigational stage immune booster (poly ICLC / Hiltonol), both of which have previously been used in combination with other cancer treatments and demonstrated to be active in advanced cancer, but which have not previously been used together. This study will assess the approach as to whether these two drugs can safely add to the response seen with either drug alone, both of which have doses that are based on prior studies. Subjects with stable disease for whom a 12 week break from therapy for their persistent and progressive advanced ovarian cancer is appropriate, who have signed informed consent and for whom baseline clinical information is completed, will receive 4 cycles of oregovomab/Hiltonol immunization every three weeks (weeks 0, 3, 6, and 9). Blood will be obtained for to look for a CA125 specific T cell response at 12 weeks before initiating any additional therapy according to the best clinical judgment of the investigator. At week 16 the subjects will receive a final dose of the combination of oregovomab/Hiltonol and at week 17 will have an additional blood draw for analysis of T-cell response.
Primary Outcome
The primary outcome is to establish the preliminary safety regarding the combination of the anti-CA-125 monoclonal antibody oregovomab and the TLR3 agonist immune adjuvant poly ICLC (Hiltonol ®) as a strategy to induce CA125 specific anti-tumor immunity in heavily pretreated subjects with progressive ovarian cancer.
Interventions
- DRUG Poly ICLC
- BIOLOGICAL Oregovomab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2017-05-30 |
| Est. Completion | 2020-11-05 |
| Phase | Phase 1 |
Why NCT03162562 stopped before completion
NCT03162562 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 10 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (83% lower).
The record links to 0 conditions, and to 2 interventions - of which Poly ICLC is the first listed.
NCT03162562 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03162562 about?
NCT03162562 is a clinical study titled "The Safety and Antitumor Activity of the Combination of Oregovomab and Hiltonol in Recurrent Advanced Ovarian Cancer". This is a Phase Ib study to look at the combination of an antibody immunization vaccine strategy using oregovomab and an investigational stage immune booster (poly ICLC / Hiltonol), both of which have previously been used in combination with other cancer treatments and demonstrated to be active in a...
What is the current status of trial NCT03162562?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 10 participants. The study started on 2017-05-30. Estimated completion is 2020-11-05.
What interventions are being tested in trial NCT03162562?
The interventions under investigation include: Poly ICLC (DRUG), Oregovomab (BIOLOGICAL).
Who is sponsoring clinical trial NCT03162562?
This trial is sponsored by CanariaBio, which has 3 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03162562's enrollment target sits among peer trials
10 1913th of 2000 higher than 46 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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