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New treatment option for HPV
Official title A Study on Using Cell-Free Tumor DNA (ctDNA) Testing to Decide When to StartRoutine Treatment in People With Human Papilloma Virus (HPV)- Associated Oropharynx Cancer (OPC)
ClinicalTrials.gov ID: NCT05307939
What this study is testing
What is Chemoradiation (Arm B)?
Chemoradiation (Arm B) is an investigational medicine, being studied as a potential treatment for hpv.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study will look at whether monitoring HPV ctDNA levels is an effective way to detect cancer relapse risk in people with HPV-OPC. All participants will have recently had surgery to treat their disease, or they will be scheduled to have this surgery.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Age ≥ 18
- ECOG 0-2
- HPV-16 squamous cell carcinoma of the oropharynx or HPV-16 head and neck squamous cell carcinoma of unknown primary . HPV status must be confirmed by...
- HPV ctDNA detectable by HPV digital PCR (Naveris assay) with a minimum of 50 copies/mL pre-operatively.
- Surgical resection of all gross disease with no gross disease visualized on post-operative imaging. o For patients with pT0 (unknown primary)...
You likely can't join if
- Metastatic disease
- Non-HPV16 genotype (i.e. HPV-18,-31, -33, -35)
- Patients who receive surgery at outside institution. Exceptions can be made for high-volume surgical centers at the discretion of the PI/co-PI
- Prior head and neck radiation
- Patients without pre-operative HPV ctDNA or pre-operative HPV ctDNA ≤ 50 copies/mL
- people with simultaneous primary cancers outside of the oropharynx o Note: Exceptions can be made for patients with simultaneous primaries outside of...
See the full eligibility criteria
- Age ≥ 18
- ECOG 0-2
- HPV-16 squamous cell carcinoma of the oropharynx or HPV-16 head and neck squamous cell carcinoma of unknown primary . HPV status must be confirmed by in-situ hybridization.
- HPV ctDNA detectable by HPV digital PCR (Naveris assay) with a minimum of 50 copies/mL pre-operatively.
- Surgical resection of all gross disease with no gross disease visualized on post-operative imaging. o For patients with pT0 (unknown primary) evaluation for the primary should include PET/CT, direct laryngoscopy...
- Two, undetectable (\<1 copy/mL) post-operative HPV ctDNA within 2-6 weeks following surgery (blood drawn at least one week apart preferred).
- A minimum of one of the following pathologic criteria: (Arm A)
- AJCC 7 Stage: pT0N1-N2b, pT1N1, pT2N1, or ≥pT3
- AJCC 7 ≥pN2
- Lymphovascular invasion
- Perineural invasion
- Close pathologic margin (≤ 3 mm)
- Signed informed consent form by the participant or their legally authorized representative (LAR).
- A minimum of one of the following pathologic criteria (Arm B):
- Microscopic positive margin
- Extracapsular extension
- Signed informed consent form by the participant or their legally authorized representative (LAR). Additional criteria for Arm B only:
- Adequate hematologic function within 30 days prior to registration, defined as follows:
- White Blood Count (WBC) ≥ 2 K/mcL
- Absolute neutrophil count (ANC) ≥ 1,000 cells/mm3
- Platelets ≥ 100,000 cells/mm3
- Hemoglobin ≥ 8.0 g/dl; Note: The use of transfusion or other intervention to achieve Hgb ≥ 8.0 g/dl is acceptable
- Adequate renal function within 30 days prior to registration, defined as follows:
- Serum creatinine \< 1.5 mg/dl or creatinine clearance (CC) ≥ 50 ml/min determined by 24-hour collection or estimated by Cockcroft-Gault formula:
- CCr male = [(140 - age) x (wt in kg)] divided by [(Serum Cr mg/dl) x (72)]
- CCr female = 0.85 x (CrCl male)
- Adequate hepatic function within 30 days prior to registration, defined as follows: \- Bilirubin \< 2 mg/dl o AST or ALT \< 3 x the upper limit of normal
- Negative serum pregnancy test within 14 days prior to registration for women of childbearing potential
- Metastatic disease
- Non-HPV16 genotype (i.e. HPV-18,-31, -33, -35)
- Patients who receive surgery at outside institution. Exceptions can be made for high-volume surgical centers at the discretion of the PI/co-PI
- Prior head and neck radiation
- Patients without pre-operative HPV ctDNA or pre-operative HPV ctDNA ≤ 50 copies/mL
- people with simultaneous primary cancers outside of the oropharynx o Note: Exceptions can be made for patients with simultaneous primaries outside of the oropharynx if determined by the PI/Co-PI, then the patient can...
- Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for 3 years or if cure rate from treatment at 5 years is 90% or greater o Note: Exceptions can be made for patients with prior invasive...
- Prior systemic chemotherapy for the study cancer o Note: prior chemotherapy for a different cancer is allowable
- Severe, active co-morbidity defined as follows:
- Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months
- Transmural myocardial infarction within the last 6 months
- Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration
- Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization within 30 days of registration
- Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects
- Lack of ability to understand and willingness to sign a written informed consent and complete questionnaires.
The study team makes the final eligibility decision.
Where it's taking place
- Miami, Florida, United States
- Basking Ridge, New Jersey, United States
- Middletown, New Jersey, United States
- Montvale, New Jersey, United States
- Commack, New York, United States
- East White Plains, New York, United States
- New York, New York, United States
- Rockville Centre, New York, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Miami, Florida, United States; Basking Ridge, New Jersey, United States; Middletown, New Jersey, United States; Montvale, New Jersey, United States; Commack, New York, United States; East White Plains, New York, United States and 2 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.