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NCT04580771 · ClinicalTrials.gov registry record · Phase 2

A Vaccine (PDS0101) and Chemoradiation for the Treatment of Stage IB3-IVA Cervical Cancer, the IMMUNOCERV Trial

A Phase 2 study of Stage IIIA Cervical Cancer FIGO 2018 and Stage IIIB Cervical Cancer FIGO 2018, sponsored by M.D. Anderson Cancer Center.

Active
Registry status
Phase 2
Development phase
22
Enrollment target
1
Study location

NCT04580771 is a Phase 2 study of Stage IIIA Cervical Cancer FIGO 2018 and Stage IIIB Cervical Cancer FIGO 2018 that is active but no longer recruiting, run by M.D. Anderson Cancer Center. The registered enrollment target is 22 participants. The trial reports 1 study location across 1 state.

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The verdict

NCT04580771, a Phase 2 study of Stage IIIA Cervical Cancer FIGO 2018 and Stage IIIB Cervical Cancer FIGO 2018, is active but no longer recruiting, sponsored by M.D. Anderson Cancer Center.

ACTIVE NOT RECRUITING
Registry status
Phase 2
Development phase
22 participants
Enrollment target
1
Study location

Study Summary

This phase IIA trial studies the effect of a vaccine (PDS0101) when given together with chemotherapy and radiation therapy (chemoradiation) in treating patients with stage IB3-IVA cervical cancer. Chemotherapy drugs, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. PDS0101 is a type of vaccine that is intended to help the immune system respond to human papillomavirus (HPV16)-infected cervical tumor cells. PDS0101 contains two active components: the first is called R-DOTAP (Versamune) and is included in the vaccine to boost the immune system's response against the HPV viral proteins and the second group of active components are selected small pieces of proteins (called peptides) taken from the HPV virus. Giving PDS0101 in combination with chemoradiation may work help to control cervical cancer.

Interventions

  • DRUG Cisplatin
  • RADIATION Radiation Therapy
  • BIOLOGICAL Liposomal HPV-16 E6/E7 Multipeptide Vaccine PDS0101

Study Locations (1)

Texas

  • M D Anderson Cancer Center - Houston

Trial Details

FieldValue
Enrollment Target 22 participants
Start Date 2020-10-14
Est. Completion 2027-03-08
Phase Phase 2

Sponsor

M.D. Anderson Cancer Center

2,692 total trials

What the Registry Record Tells You About NCT04580771

The ClinicalTrials.gov registry entry for NCT04580771 describes a study currently listed as active not recruiting, categorized as Phase 2. The registered enrollment target is 22 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is M.D. Anderson Cancer Center, which has 2,692 total studies on file at ClinicalTrials.gov.

The record links to 10 conditions, with Stage IIIA Cervical Cancer FIGO 2018 appearing as the primary indexed condition, and to 3 interventions - of which Cisplatin is the first listed.

NCT04580771 reports 1 study location spanning 1 distinct geographic area - top geographies include Texas.

Frequently Asked Questions

What is clinical trial NCT04580771 about?

NCT04580771 is a clinical study titled "A Vaccine (PDS0101) and Chemoradiation for the Treatment of Stage IB3-IVA Cervical Cancer, the IMMUNOCERV Trial". This phase IIA trial studies the effect of a vaccine (PDS0101) when given together with chemotherapy and radiation therapy (chemoradiation) in treating patients with stage IB3-IVA cervical cancer. Chemotherapy drugs, such as cisplatin, work in different ways to stop the growth of tumor cells, either...

What is the current status of trial NCT04580771?

This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 22 participants. The study started on 2020-10-14. Estimated completion is 2027-03-08.

What conditions does trial NCT04580771 study?

This clinical trial studies the following conditions: Stage IIIA Cervical Cancer FIGO 2018, Stage IIIB Cervical Cancer FIGO 2018, Stage IB3 Cervical Cancer FIGO 2018, Stage II Cervical Cancer FIGO 2018, Stage IIA Cervical Cancer FIGO 2018.

What interventions are being tested in trial NCT04580771?

The interventions under investigation include: Cisplatin (DRUG), Radiation Therapy (RADIATION), Liposomal HPV-16 E6/E7 Multipeptide Vaccine PDS0101 (BIOLOGICAL).

Who is sponsoring clinical trial NCT04580771?

This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04580771 being conducted?

This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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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.