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NCT00857545 · ClinicalTrials.gov registry record · Phase 2

OPT-821 With or Without Vaccine Therapy in Treating Patients With Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Peritoneal Cancer in Second or Third Complete Remission

A Phase 2 study, sponsored by Gynecologic Oncology Group.

Completed
Registry status
Phase 2
Development phase
171
Enrollment target

NCT00857545 is a Phase 2 study that has completed, run by Gynecologic Oncology Group. The registered enrollment target is 171 participants.

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The verdict

NCT00857545, a Phase 2 study, has completed, sponsored by Gynecologic Oncology Group.

COMPLETED
Registry status
Phase 2
Development phase
171 participants
Enrollment target

Study Summary

This randomized phase II trial studies OPT-821 and vaccine therapy to see how well they work compared with OPT-821 alone in treating patients with ovarian epithelial cancer, fallopian tube cancer, or peritoneal cancer that has decreased or disappeared, but the cancer may still be in the body. Biological therapies, such as OPT-821, may stimulate the immune system in different ways and stop tumor cells from growing. Vaccines may help the body build an effective immune response to kill tumor cells. It is not yet known whether OPT-821 is more effective with or without vaccine therapy in treating patients with ovarian epithelial cancer, fallopian tube cancer, or peritoneal cancer.

Interventions

  • OTHER Laboratory Biomarker Analysis
  • BIOLOGICAL Polyvalent Antigen-KLH Conjugate Vaccine
  • BIOLOGICAL Saponin-based Immunoadjuvant OBI-821

Trial Details

FieldValue
Enrollment Target 171 participants
Start Date 2010-07
Phase Phase 2

Sponsor

Gynecologic Oncology Group

154 total trials

What the Registry Record Tells You About NCT00857545

The ClinicalTrials.gov registry entry for NCT00857545 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 171 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Gynecologic Oncology Group, which has 154 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 3 interventions - of which Laboratory Biomarker Analysis is the first listed.

NCT00857545 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT00857545 about?

NCT00857545 is a clinical study titled "OPT-821 With or Without Vaccine Therapy in Treating Patients With Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Peritoneal Cancer in Second or Third Complete Remission". This randomized phase II trial studies OPT-821 and vaccine therapy to see how well they work compared with OPT-821 alone in treating patients with ovarian epithelial cancer, fallopian tube cancer, or peritoneal cancer that has decreased or disappeared, but the cancer may still be in the body. Biolog...

What is the current status of trial NCT00857545?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 171 participants. The study started on 2010-07.

What interventions are being tested in trial NCT00857545?

The interventions under investigation include: Laboratory Biomarker Analysis (OTHER), Polyvalent Antigen-KLH Conjugate Vaccine (BIOLOGICAL), Saponin-based Immunoadjuvant OBI-821 (BIOLOGICAL).

Who is sponsoring clinical trial NCT00857545?

This trial is sponsored by Gynecologic Oncology Group, which has 154 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.