Using blood tests to determine treatment timing for HPV-related throat cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates the effectiveness of monitoring cell-free tumor DNA (ctDNA) levels in patients with HPV-associated oropharyngeal cancer (OPC) to assess cancer relapse risk. Participants will either have recently undergone surgery or be scheduled for it. The study has two arms: one aims to identify patients who can safely delay radiation therapy based on ctDNA levels, while the other seeks to determine if some patients can receive a shorter course of chemoradiation therapy. The approach utilizes advanced HPV ctDNA testing to guide treatment decisions.

Why it matters

Who can join: the full rules

Inclusion 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, 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 Criteria:

* 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.

Where it's running

• Baptist Alliance MCI (Data Collection Only)
  Miami, Florida, United States Recruiting
• Memorial Sloan Kettering Basking Ridge (Limited protocol activities)
  Basking Ridge, New Jersey, United States Recruiting
• Memorial Sloan Kettering Monmouth (Limited Protocol Activities)
  Middletown, New Jersey, United States Recruiting
• Memorial Sloan Kettering Bergen (Limited Protocol Activities)
  Montvale, New Jersey, United States Recruiting
• Memorial Sloan Kettering Suffolk-Commack (Limited Protocol Activities)
  Commack, New York, United States Recruiting
• Memorial Sloan Kettering Westchester (Limited Protocol Activites)
  East White Plains, New York, United States Recruiting

Study contacts

• Principal investigator: Acharf Shamseddine, MD — Memorial Sloan Kettering Cancer Center
• Study coordinator: Acharf Shamseddine, MD
• Email: shamseda@mskcc.org
• Phone: 631-623-4272

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Immunotherapy using E7 TCR-T cells for HPV-related cancers

  This study is testing a new immunotherapy using E7 TCR-T cells to see if it can help people with advanced HPV-related cancers like cervical and throat cancer feel better and improve their health.

  Recruiting at 3 sites Phase 2 Rutgers, The State University of New Jersey · Bethesda, Maryland and 2 other locations · NCT05686226

• E7 T-cell therapy for advanced HPV-related cancers

  This study is testing a new treatment using specially modified immune cells to see if it can help people with advanced cancers linked to HPV feel better and live longer.

  Recruiting at 2 sites Phase 1/2 Rutgers, The State University of New Jersey · New Brunswick, New Jersey and 1 other locations · NCT05639972

• Sacituzumab govitecan plus cetuximab for recurrent or metastatic head and neck squamous cell cancer

  This trial will test whether combining sacituzumab govitecan with cetuximab works and is safe for people whose head and neck squamous cell cancer has returned or spread after prior immunotherapy.

  Recruiting at 7 sites Phase 2 Memorial Sloan Kettering Cancer Center · Basking Ridge, New Jersey and 6 other locations · NCT07063212

• Combination treatment for recurrent or metastatic cervical cancer

  This study is testing if adding a new treatment called PRGN-2009 to pembrolizumab can help people with recurrent or metastatic cervical cancer who haven't responded to pembrolizumab alone.

  Recruiting at 3 sites Phase 2 Precigen, Inc · Little Rock, Arkansas and 2 other locations · NCT06157151

• New blood test to reduce radiation in HPV-related throat cancer treatment

  This study is testing a new blood test to see if it can help identify patients with HPV-related throat cancer who might not need radiation after surgery, aiming to reduce side effects while keeping survival rates high.

  Recruiting at 2 sites Phase 2 University of Maryland, Baltimore · Baltimore, Maryland and 4 other locations · NCT06088381

• Lowering radiation doses in chemotherapy for HPV-positive throat cancer

  This study is testing if giving lower doses of radiation along with regular chemotherapy can help people with HPV-positive throat cancer feel better and have fewer side effects after treatment.

  Recruiting Phase 2 University of Missouri-Columbia · Columbia, Missouri · NCT04444869

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.