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NCT01416038 · ClinicalTrials.gov registry record · Phase 1
Phase 1 Study of a Cancer Vaccine to Treat Patients With Advanced Stage Ovarian, Fallopian or Peritoneal Cancer
A Phase 1 study, sponsored by ImmunoVaccine Technologies, Inc. (IMV Inc.).
- Completed
- Registry status
- Phase 1
- Development phase
- 19
- Enrollment target
NCT01416038 is a Phase 1 study that has completed, run by ImmunoVaccine Technologies, Inc. (IMV Inc.). The registered enrollment target is 19 participants.
The verdict
NCT01416038, a Phase 1 study, has completed, sponsored by ImmunoVaccine Technologies, Inc. (IMV Inc.).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 19 participants
- Enrollment target
Study Summary
Immunotherapy is a novel way to treat cancer and does so by targeting the immune system to destroy tumor cells. Many different therapeutic vaccines have been evaluated in phase 1, 2, and even phase 3 trials. Much has been learned about the principles of applying immune-based therapies and specifically the types of patients that may be most likely to mount an effective immune response. When used alone, cancer vaccines may have their greatest impact earlier in the disease course or in situations with minimal residual disease. ImmunoVaccine Technologies Inc. (Immunovaccine) is an immuno-oncology company developing a novel adjuvanting technology platform termed DepoVax. DepoVax was created to enhance the speed, strength and duration of an immune response. The peptide antigens included in DPX-Survivac are designed to target Survivin, a protein which is over-expressed in many cancer types, including epithelial ovarian cancers. This study was designed be a phase 1-2 trial to determine the safety and immunogenicity profiles of DPX-Survivac, a therapeutic vaccine co-administered with a regimen of low dose oral cyclophosphamide. The dosing-finding phase 1 study of 15 subjects would move directly into a randomized phase 2 study. However, with the evolving field of immunotherapy Immunovaccine has begun to focus on combination therapies, combining DPX-Survivac treatment with checkpoint inhibitors and other immune modulators, such as in NCT02785250.
Interventions
- BIOLOGICAL DPX-Survivac
- DRUG low dose cyclophosphamide (oral)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 19 participants |
| Start Date | 2011-12 |
| Est. Completion | 2013-05 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01416038
The ClinicalTrials.gov registry entry for NCT01416038 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 19 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is ImmunoVaccine Technologies, Inc. (IMV Inc.), which has 6 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which DPX-Survivac is the first listed.
NCT01416038 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01416038 about?
NCT01416038 is a clinical study titled "Phase 1 Study of a Cancer Vaccine to Treat Patients With Advanced Stage Ovarian, Fallopian or Peritoneal Cancer". Immunotherapy is a novel way to treat cancer and does so by targeting the immune system to destroy tumor cells. Many different therapeutic vaccines have been evaluated in phase 1, 2, and even phase 3 trials. Much has been learned about the principles of applying immune-based therapies and specifical...
What is the current status of trial NCT01416038?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 19 participants. The study started on 2011-12. Estimated completion is 2013-05.
What interventions are being tested in trial NCT01416038?
The interventions under investigation include: DPX-Survivac (BIOLOGICAL), low dose cyclophosphamide (oral) (DRUG).
Who is sponsoring clinical trial NCT01416038?
This trial is sponsored by ImmunoVaccine Technologies, Inc. (IMV Inc.), which has 6 total clinical trials registered on ClinicalTrials.gov.
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