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

NCT04580771 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2026-04-15

No results posted yet for this 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.

Conditions

  • Locally Advanced Cervical Squamous Cell Carcinoma, Not Otherwise Specified
  • Stage IB3 Cervical Cancer FIGO 2018
  • Stage II Cervical Cancer FIGO 2018
  • Stage IIA Cervical Cancer FIGO 2018
  • Stage IIA1 Cervical Cancer FIGO 2018
  • Stage IIA2 Cervical Cancer FIGO 2018
  • Stage IIB Cervical Cancer FIGO 2018
  • Stage III Cervical Cancer FIGO 2018
  • Stage IIIA Cervical Cancer FIGO 2018
  • Stage IIIB Cervical Cancer FIGO 2018
  • Stage IIIC Cervical Cancer FIGO 2018
  • Stage IIIC1 Cervical Cancer FIGO 2018
  • Stage IIIC2 Cervical Cancer FIGO 2018
  • Stage IVA Cervical Cancer FIGO 2018

Interventions

DRUG

Cisplatin

Given IV

BIOLOGICAL

Liposomal HPV-16 E6/E7 Multipeptide Vaccine PDS0101

Given SC

RADIATION

Radiation Therapy

Undergo radiation therapy

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • M.D. Anderson Cancer Center

    lead OTHER

Principal Investigators

  • Ann H Klopp · M.D. Anderson Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-10-14
Primary Completion
2027-03-08
Completion
2027-03-08
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04580771 on ClinicalTrials.gov