Status:
RECRUITING
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)
Lead Sponsor:
Memorial Sloan Kettering Cancer Center
Conditions:
HPV
Oropharynx Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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 dis...
Eligibility Criteria
Inclusion
- 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, ipsilateral tonsillectomy, and targeted biopsy. This should be followed by a neck dissection.
- 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
Exclusion
- 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
- Subjects 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 proceed with protocol activities
- 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 malignancy if determined by the PI/Co-PI, then the patient can proceed with protocol activities
- 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.
Key Trial Info
Start Date :
March 24 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 24 2027
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT05307939
Start Date
March 24 2022
End Date
March 24 2027
Last Update
November 5 2025
Active Locations (8)
Enter a location and click search to find clinical trials sorted by distance.
1
Baptist Alliance MCI (Data Collection Only)
Miami, Florida, United States, 33143
2
Memorial Sloan Kettering Basking Ridge (Limited protocol activities)
Basking Ridge, New Jersey, United States, 07920
3
Memorial Sloan Kettering Monmouth (Limited Protocol Activities)
Middletown, New Jersey, United States, 07748
4
Memorial Sloan Kettering Bergen (Limited Protocol Activities)
Montvale, New Jersey, United States, 07645