Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Active Phase 2 study of Stage IIIA Cervical Cancer FIGO 2018 and Stage IIIB Cervical Cancer FIGO 2018, sponsored by M.D. Anderson Cancer Center.
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, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (83% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Measured from first vaccine injection up to 30 days following completion of chemoradiotherapy (chemoRT). Adverse events (AEs) will be assessed using the Common Terminology Criteria for Adverse Events (CTCAE), version 5.0. Any AE that occurs between the first day of PDS0101 injection and up to 30 days following completion of chemoRT (\~Day 80) will be considered as acute toxicity (AT).
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 22 participants |
| Start Date | 2020-10-14 |
| Est. Completion | 2027-03-08 |
| Phase | Phase 2 |
What the registry record for NCT04580771 still lists
NCT04580771 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 22 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (83% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
Similar trials for Stage IIIA Cervical Cancer FIGO 2018
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04580771's enrollment target sits among peer trials
22 1790th of 2000 higher than 207 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT02508038 · 22 participants · Phase 1
Alpha/Beta CD19+ Depleted Haploidentical Transplantation + Zometa for Pediatric Hematologic Malignancies and Solid Tumors
- NCT03099356 · 22 participants · Phase 2
Cyclophosphamide and Sirolimus for the Treatment of Metastatic, RAI-refractory, Differentiated Thyroid Cancer
- NCT03676647 · 22 participants
Diagnostic DNA Methylation Signature in Diagnosing Thyroid Cancer After Fine-Needle Aspiration in Patients With Thyroid Nodules
- NCT04569591 · 22 participants · NA
DDAVP for Pituitary Adenoma
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI