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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: Active Phase 1 study of Cervical Cancer and Oropharyngeal Cancer, sponsored by National Cancer Institute (NCI).
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. According to ClinicalTrials.gov, the official US trial registry.
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. ...
Primary Outcome
Phase I: To determine the recommended phase II dose (RP2D) of PRGN-2009 Human Papillomavirus Vaccine (HPV) vaccine alone or in combination with M7824 (MSB0011359C). Recommended Phase 2 Dose, the dose of a drug or drug combination that was identified in a Phase 1 study (dose finding study) that was identified for continued study.
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 |
What the registry record for NCT04432597 still lists
NCT04432597 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 39 participants, a relatively small participant target, below the 570-participant average among 144 other Cervical Cancer trials with a reported enrollment target (93% lower).
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 a single indexed study location in 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
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Where NCT04432597's enrollment target sits among peer trials
39 113th of 144 higher than 32 of 144 other Cervical Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Cervical Cancer 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.
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