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NCT06223568 · ClinicalTrials.gov registry record · Phase 2
Phase II Trial of Neoadjuvant Chemotherapy (NAC) Alone or in Combination With Immunotherapy Vaccine PRGN-2009 in Subjects With Newly Diagnosed HPV-Associated Oropharyngeal (Head and Neck) Cancer
A Phase 2 study of Squamous Cell Carcinoma of the Head and Neck and Oropharynx, sponsored by National Cancer Institute (NCI).
- Recruiting
- Registry status
- Phase 2
- Development phase
- 70
- Enrollment target
- 1
- Study location
NCT06223568: Recruiting Phase 2 study of Squamous Cell Carcinoma of the Head and Neck and Oropharynx, sponsored by National Cancer Institute (NCI).
NCT06223568 is a Phase 2 study of Squamous Cell Carcinoma of the Head and Neck and Oropharynx that is actively recruiting participants, run by National Cancer Institute (NCI). The registered enrollment target is 70 participants, below the 144-participant average among 29 other Squamous Cell Carcinoma of the Head and Neck trials with a reported enrollment target (51% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06223568, a Phase 2 study of Squamous Cell Carcinoma of the Head and Neck and Oropharynx, is actively recruiting participants, sponsored by National Cancer Institute (NCI).
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 70 participants
- Enrollment target
- 1
- Study location
Study Summary
Background: Throat cancer is a common tumor that can occur in people infected with the human papilloma virus (HPV). Most people with this cancer survive more than 5 years with standard chemotherapy drugs plus radiation. But radiation can cause serious adverse effects. Researchers believe that adding a vaccine (PRGN-2009) to this drug therapy may improve survival without the need for radiation. Objective: To test a study vaccine combined with standard chemotherapy in patients with HPV-associated throat cancers. Eligibility: People aged 18 years and older with newly diagnosed throat cancer associated with HPV. Design: Participants will be screened. They will have a physical exam and blood tests. They will have imaging scans and tests of their heart function and hearing. They will provide a sample of tissue from their tumor. A recent sample may be used; if none is available, a new sample will be taken. All participants will get two common drugs for treating cancer. These drugs are given through a tube attached to a needle inserted into a vein in the arm. Participants will receive these drugs on the first day of three 3-week cycles. Half of the participants will also get the vaccine. PRGN-2009 is injected under the skin in the arm. They will get these shots 4 times: 7 days before the start of the first cycle and on the 11th day of each cycle. Participants will have standard surgery to remove their tumors 3 to 6 weeks after completing the study treatment. They will have follow-up visits 3, 6, 12, and 24 months after their surgery. ...
Primary Outcome
The pCR rates will be determined on each arm and will be reported along with a 95% confidence interval. The two rates will be compared using a one-sided Fisher s exact test.
Conditions Studied
Interventions
- DRUG Docetaxel
- DRUG Cisplatin
- DRUG PRGN-2009
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 70 participants |
| Start Date | 2024-06-10 |
| Est. Completion | 2028-01-10 |
| Phase | Phase 2 |
What NCT06223568 shows while recruiting
NCT06223568 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 70 participants, a relatively small participant target, below the 144-participant average among 29 other Squamous Cell Carcinoma of the Head and Neck trials with a reported enrollment target (51% lower).
The record links to 5 conditions, with Squamous Cell Carcinoma of the Head and Neck appearing as the primary indexed condition, and to 3 interventions - of which Docetaxel is the first listed.
NCT06223568 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT06223568 about?
NCT06223568 is a clinical study titled "Phase II Trial of Neoadjuvant Chemotherapy (NAC) Alone or in Combination With Immunotherapy Vaccine PRGN-2009 in Subjects With Newly Diagnosed HPV-Associated Oropharyngeal (Head and Neck) Cancer". Background: Throat cancer is a common tumor that can occur in people infected with the human papilloma virus (HPV). Most people with this cancer survive more than 5 years with standard chemotherapy drugs plus radiation. But radiation can cause serious adverse effects. Researchers believe that addin...
What is the current status of trial NCT06223568?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 70 participants. The study started on 2024-06-10. Estimated completion is 2028-01-10.
What conditions does trial NCT06223568 study?
This clinical trial studies the following conditions: Squamous Cell Carcinoma of the Head and Neck, Oropharynx, Human Papillomavirus Viruses, Drug Therapy, Cancer Vaccine.
What interventions are being tested in trial NCT06223568?
The interventions under investigation include: Docetaxel (DRUG), Cisplatin (DRUG), PRGN-2009 (DRUG).
Who is sponsoring clinical trial NCT06223568?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06223568 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 NCT06223568's enrollment target sits among peer trials
70 13th of 29 higher than 17 of 29 other Squamous Cell Carcinoma of the Head and Neck trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Squamous Cell Carcinoma of the Head and Neck 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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