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Arm 1 for Oropharynx

Q: Am I eligible to participate in this clinical research study?

To meet the study's eligibility criteria, participants must have oropharynx involvement and fall within the age range of 18 to 120. The trial aims to enroll a total of 70 individuals.

Q: Are participants aged 45 and above being actively sought for enrollment in this research study?

As indicated in the study's inclusion criteria, individuals who are at least 18 years old and up to 120 years old are eligible for participation.

Q: What are the potential risks associated with Arm 1 when administered to patients?

Based on the nature of this Phase 2 trial, Arm 1 received a safety rating of 2 from our team at Power. While there is some evidence supporting its safety, no data has been found yet to support its effectiveness.

Q: Are patients currently able to enroll in this ongoing clinical trial?

As indicated by the information available on clinicaltrials.gov, this particular study is not currently actively seeking participants. The trial was first posted on January 30th, 2024 and underwent its most recent update on January 24th, 2024. It's worth noting that despite this specific study being inactive in recruitment, there are presently 494 other studies actively searching for eligible patients.

Phase 2

Waitlist Available

Led By Clint T Allen, M.D.

Research Sponsored by National Cancer Institute (NCI)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

History of HPV-positive status determined by a standard-of-care HPV testing. All participants with high-risk HPV serotypes are eligible.

ECOG performance status <= 2.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3, 6, 12, 24 months after surgery per soc until recurrence.

Awards & highlights

Study Summary

This trial is testing a new vaccine (PRGN-2009) combined with standard chemotherapy drugs in patients with throat cancer caused by the human papilloma virus (HPV). The researchers want to

Who is the study for?

This trial is for adults over 18 with newly diagnosed HPV-related throat cancer. Participants must pass a physical exam, blood tests, imaging scans, heart function and hearing tests. They should also provide a tumor tissue sample.Check my eligibility

What is being tested?

The study is testing the effectiveness of adding a vaccine (PRGN-2009) to standard chemotherapy drugs (Docetaxel and Cisplatin) in treating HPV-associated throat cancers without radiation. Half will receive the vaccine; all will undergo surgery post-treatment.See study design

What are the potential side effects?

Possible side effects include those from chemotherapy like nausea, hair loss, fatigue, increased risk of infection and from the vaccine such as redness or pain at injection site, fever, and potential allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been tested positive for high-risk HPV.

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I can take care of myself but might not be able to do heavy physical work.

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My blood counts and kidney and liver functions are within normal ranges.

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I am 18 years old or older.

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I am scheduled for and have agreed to surgery to remove my cancer.

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I am willing to have a biopsy of my tumor for research.

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My throat cancer is in an early stage and can be removed by surgery.

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I have Hepatitis B or C, but my viral load is undetectable.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3, 6, 12, 24 months after surgery per soc until recurrence.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3, 6, 12, 24 months after surgery per soc until recurrence.

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3, 6, 12, 24 months after surgery per soc until recurrence. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Determine the rate of pCR with NAC (DC) alone or in combination with PRGN-2009 (DCP) in participants with newly diagnosed HPV-associated OPSCC

Secondary outcome measures

Determine 2-year recurrence-free survival (RFS) observed with DC and DCP

Determine the toxicity observed with DC and DCP

Trial Design

2Treatment groups

Experimental Treatment

Group I: Arm 2Experimental Treatment3 Interventions

DCP (docetaxel + cisplatin + PRGN-2009)

Group II: Arm 1Experimental Treatment2 Interventions

DC (docetaxel + cisplatin)

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Docetaxel

1995

Completed Phase 4

~5620

Cisplatin

2013

Completed Phase 3

~1940

0 / 8Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor

13,687 Previous Clinical Trials

40,930,301 Total Patients Enrolled

Clint T Allen, M.D.Principal InvestigatorNational Cancer Institute (NCI)

3 Previous Clinical Trials

4,070 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Am I eligible to participate in this clinical research study?

"To meet the study's eligibility criteria, participants must have oropharynx involvement and fall within the age range of 18 to 120. The trial aims to enroll a total of 70 individuals."

Answered by AI

Are participants aged 45 and above being actively sought for enrollment in this research study?

"As indicated in the study's inclusion criteria, individuals who are at least 18 years old and up to 120 years old are eligible for participation."

Answered by AI

What are the potential risks associated with Arm 1 when administered to patients?

"Based on the nature of this Phase 2 trial, Arm 1 received a safety rating of 2 from our team at Power. While there is some evidence supporting its safety, no data has been found yet to support its effectiveness."

Answered by AI

Are patients currently able to enroll in this ongoing clinical trial?

"As indicated by the information available on clinicaltrials.gov, this particular study is not currently actively seeking participants. The trial was first posted on January 30th, 2024 and underwent its most recent update on January 24th, 2024. It's worth noting that despite this specific study being inactive in recruitment, there are presently 494 other studies actively searching for eligible patients."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2024. "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". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06223568.

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