Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT04432597 · ClinicalTrials.gov registry record · Phase 1
HPV Vaccine PRGN-2009 Alone or in Combination With Anti-PDL1/TGF-Beta Trap (M7824) in Subjects With HPV Associated Cancers
A Phase 1 study of Cervical Cancer and Oropharyngeal Cancer, sponsored by National Cancer Institute (NCI).
- Active
- Registry status
- Phase 1
- Development phase
- 39
- Enrollment target
- 1
- Study location
NCT04432597 is a Phase 1 study of Cervical Cancer and Oropharyngeal Cancer that is active but no longer recruiting, run by National Cancer Institute (NCI). The registered enrollment target is 39 participants, below the 570-participant average among 144 other Cervical Cancer trials with a reported enrollment target (93% lower). The trial reports 1 study location across 1 state.
The verdict
NCT04432597, a Phase 1 study of Cervical Cancer and Oropharyngeal Cancer, is active but no longer recruiting, sponsored by National Cancer Institute (NCI).
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 39 participants
- Enrollment target
- 1
- Study location
Study Summary
Background: For some cancers associated with human papillomavirus (HPV), standard treatments are not helpful. Researchers want to see if a vaccine for HPV combined with a drug called M7824 (MSB0011359C) has a better effect on these cancers than when they work alone. Objective: To find a safe dose of HPV vaccine alone or combined with M7824. Also, to test if either HPV vaccine alone or combined with M7824 causes a better immune response. Eligibility: People ages 18 and older with locally advanced or metastatic HPV associated cancer (Phase I) or stage II or III p16-positive oropharyngeal cancer (Phase II) Design: Participants will be screened with: Medical history Physical exam Blood, urine, and heart tests Possible photos of skin lesions Computed tomography (CT), magnetic resonance imaging (MRI), or nuclear bone scan: Participants will lie in a machine that takes pictures of the body. For the CT scan, they may have a contrast agent injected into a vein. Participants may have up to 2 tumor biopsies. For participants in Phase II, this may be performed with a thin tube placed through the nose into the airway. Participants will receive the HPV vaccine alone or with M7824. For participants on the Phase II, they will receive two doses of HPV vaccine under the skin either alone or with M7824 as an infusion spaced two weeks apart. This will be done prior to their planned chemoradiation or surgery. For participants on the Phase I, they will get the HPV vaccine injected under the skin 2 to 3 times in the first month. Then they will have a booster every 4 weeks. They will receive M7824 as an infusion into a vein every 2 weeks. Treatment will last up to 1 year. After they stop treatment, participants will have a visit within 4 weeks. They will then be contacted for long-term follow-up every year, for the rest of their lives. ...
Conditions Studied
Interventions
- PROCEDURE Biopsy
- DIAGNOSTIC_TEST EKG
- BIOLOGICAL PRGN-2009
- BIOLOGICAL M7824
- DIAGNOSTIC_TEST CT Scan
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 39 participants |
| Start Date | 2020-08-11 |
| Est. Completion | 2026-03-31 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04432597
The ClinicalTrials.gov registry entry for NCT04432597 describes a study currently listed as active not recruiting, categorized as Phase 1. The registered enrollment target is 39 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 570-participant average among 144 other Cervical Cancer trials with a reported enrollment target (93% lower). The listed sponsor is National Cancer Institute (NCI), which has 3,257 total studies on file at ClinicalTrials.gov.
The record links to 5 conditions, with Cervical Cancer appearing as the primary indexed condition, and to 5 interventions - of which Biopsy is the first listed.
NCT04432597 reports 1 study location spanning 1 distinct geographic area - top geographies include Maryland.
Frequently Asked Questions
What is clinical trial NCT04432597 about?
NCT04432597 is a clinical study titled "HPV Vaccine PRGN-2009 Alone or in Combination With Anti-PDL1/TGF-Beta Trap (M7824) in Subjects With HPV Associated Cancers". Background: For some cancers associated with human papillomavirus (HPV), standard treatments are not helpful. Researchers want to see if a vaccine for HPV combined with a drug called M7824 (MSB0011359C) has a better effect on these cancers than when they work alone. Objective: To find a safe dose...
What is the current status of trial NCT04432597?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 39 participants. The study started on 2020-08-11. Estimated completion is 2026-03-31.
What conditions does trial NCT04432597 study?
This clinical trial studies the following conditions: Cervical Cancer, Oropharyngeal Cancer, Anal Cancer, HPV Positive Cancer, Vulvar, Vaginal, Penile, Rectal Cancer.
What interventions are being tested in trial NCT04432597?
The interventions under investigation include: Biopsy (PROCEDURE), EKG (DIAGNOSTIC_TEST), PRGN-2009 (BIOLOGICAL), M7824 (BIOLOGICAL), CT Scan (DIAGNOSTIC_TEST).
Who is sponsoring clinical trial NCT04432597?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04432597 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Cervical Cancer
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.
-
KK-LC-1 TCR-T Cell Therapy for Gastric, Breast, Cervical, and Lung Cancer
RECRUITING · Phase 1
-
A Study of MT-4561 in Patients With Various Advanced Solid Tumors
RECRUITING · Phase 1
-
A Beta-only IL-2 ImmunoTherapY Study
RECRUITING · Phase 1
-
Open Label Study to Evaluate BL-M07D1 in HER2 Expressing Malignant Solid Tumors
RECRUITING · Phase 1
-
177Lu-BetaBart in Patients With Relapsed/Refractory, Locally Advanced Inoperable, or Metastatic Solid Tumors
RECRUITING · Phase 1
-
A Study of LY4052031 in Participants With Advanced or Metastatic Urothelial Cancer or Other Solid Tumors
RECRUITING · Phase 1
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
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.