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Not yet taking people in United StatesPhase 2

Circulating Tumor DNA-Informed Adjuvant Therapy for Intermediate-Risk Head and Neck Cancer

Key facts

Who runs it
Kevin Contrera
Where
Pittsburgh, United StatesSee the site
Trial code
Status
Not yet recruiting
Phase
Phase 2
People taking part
140 people, planned
Starts
15 Nov 2026
Expected to end
15 Nov 2030
Type of study
Interventional, 4 groups
Treatments tested
  • Cisplatin or carboplatin
  • Intensity-modulated radiation therapy (IMRT) or Intensity-modulated proton therapy (IMPT)
  • Pembrolizumab
  • LymphDetect assay
  • Surgery +/- neoadjuvant pembrolizumab
Record updated
12 November 2026

Who can take part

Age
18 years and older
Sex
Women and men
Healthy volunteers
Cannot take part

The registry criteria, word for word

Show all 16 criteriaShow less

Who can take part

  • Must have histologically or cytologically confirmed newly diagnosed mucosal HNSCC (i.e., oral cavity, oropharynx, hypopharynx, or larynx); o Patients with intermediate-risk disease (stage cT2N0 with adverse pathologic features OR stage cT3-4Nany OR stage cTanyN1-3a) will be preferentially enrolled
  • Must have received no prior therapies for current malignancy, except for neoadjuvant pembrolizumab
  • Must be able to undergo curative-intent surgical resection with neck dissection and placement of a drain
  • Patient is considered a candidate for adjuvant chemotherapy (cisplatin) and radiation based on the clinical judgment of the treating investigator. This decision should be made based upon the patient's pre-operative assessment performed as part of the standard of care
  • Age ≥18 years
  • Performance status ECOG 0-2
  • Sexually active, fertile subjects and their partners must agree to use highly effective methods of contraception prior to study entry, during the course of the study, and for 30 days after the last dose of chemotherapy and/or radiation (whichever is later). In addition, men must agree not to donate sperm and women must agree not to donate eggs (ova, oocyte) for the purpose of reproduction during these same periods
  • Female subjects of childbearing potential must not be pregnant or breastfeeding at screening. Female subjects are considered to be of childbearing potential unless one of the following criteria is met:; o Permanent sterilization (hysterectomy, bilateral salpingectomy, or bilateral oophorectomy) or documented postmenopausal status (defined as 12 months of amenorrhea in a woman > 45 years of age in the absence of other biological or physiological causes). Note: Documentation may include review of medical records, medical examination, or medical history interview by study site staff
  • Must have the ability to understand and the willingness to sign a written informed consent document

Who cannot take part

  • Prior or recurrent HNSCC
  • HPV-related oropharyngeal cancer
  • Nasopharyngeal cancer
  • Sinonasal cancer
  • Other active malignancy, other than nonmetastatic skin, prostate, or thyroid malignancy
  • Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator
  • Distant metastasis

Where in United States

  • UPMC Hillman Cancer CenterPittsburgh, United StatesContact: Jennifer Ruth, RN, BSNNo longer taking part

About the trial

What the trial wants to find out

This study is being done to determine whether an assay called LymphDetect™ Head and Neck is a useful tool to help guide treatment decisions for patients with head and neck cancer. The LymphDetect™ assay works to detect a certain kind of DNA that is released by tumors called circulating tumor DNA or ctDNA for short. In this study, the presence of ctDNA will be assessed in fluid collected from the surgical drain that will be placed during curative-intent surgical procedure performed as a part of patient standard care. Treatment after surgery is determined by a patient's disease risk category (low-risk, intermediate-risk, or high-risk). Having intermediate-risk with detection of ctDNA in the surgical drain fluid (SDF+) may mean that a patient is at greater risk of their cancer coming back. To reduce this risk, treatment will be more intensive than if ctDNA in the surgical drain fluid (SDF-) was not found.

The 4 groups in the trial

  • Low-RiskTreatment being tested

    Treatment: LymphDetect assay and Surgery +/- neoadjuvant pembrolizumab

  • Intermediate Risk - Surgical Drain Fluid (negative)Treatment being tested

    IMRT or IMPT to 60 Gy in 30 fractions (2Gy/FX) ± Pembrolizumab - 200 mg q3w - Restart post-surgery (can begin prior to or at the same time as radiation therapy) and continue for up to 17 cycles (including neoadjuvant cycles). \[IMRT / IMPT Schedule to be determined by radiation oncologist, should be completed within 42 days of start date\]

    Treatment: Intensity-modulated radiation therapy (IMRT) or Intensity-modulated proton therapy (IMPT), Pembrolizumab, LymphDetect assay, and Surgery +/- neoadjuvant pembrolizumab

  • Intermediate Risk - Surgical Drain Fluid (positive)Treatment being tested

    IMRT or IMPT to 60 Gy in 30 fractions (2Gy/FX) with concurrent cisplatin 40 mg/m\^2 weekly for 6 doses or 3-weekly 100mg/m2 dose for 3 doses ± Pembrolizumab - 200 mg q3w - Restart post-surgery (can begin prior to or at the same time as radiation therapy) and continue for up to 17 cycles (including neoadjuvant cycles). \[Cisplatin: 40 mg/m\^2 weekly (6 total doses) - Day 1, 8, 15, 22, 29, and 36 of radiation therapy or Cisplatin: 100 mg/m\^2 q3w (3 total doses) - Day 1, 22, and 43 of radiation therapy (last dose of cisplatin may be after the last dose of radiation)\] (If Cisplatin is not tolerated, Carboplatin AUC 2 weekly for 6 doses may be given.)

    Treatment: Cisplatin or carboplatin, Intensity-modulated radiation therapy (IMRT) or Intensity-modulated proton therapy (IMPT), Pembrolizumab, LymphDetect assay, and Surgery +/- neoadjuvant pembrolizumab

  • High RiskTreatment being tested

    IMRT or IMPT to 60 Gy in 30 fractions (2Gy/FX) with concurrent cisplatin 40 mg/m\^2 weekly for 6 doses or 3-weekly 100mg/m2 dose for 3 doses ± Pembrolizumab - 200 mg q3w - Restart post-surgery (can begin prior to or at the same time as radiation therapy) and continue for up to 17 cycles (including neoadjuvant cycles). \[Cisplatin: 40 mg/m\^2 weekly (6 total doses) - Day 1, 8, 15, 22, 29, and 36 of radiation therapy or Cisplatin: 100 mg/m\^2 q3w (3 total doses) - Day 1, 22, and 43 of radiation therapy (last dose of cisplatin may be after the last dose of radiation)\] (If Cisplatin is not tolerated, Carboplatin AUC 2 weekly for 6 doses may be given.)

    Treatment: Cisplatin or carboplatin, Intensity-modulated radiation therapy (IMRT) or Intensity-modulated proton therapy (IMPT), Pembrolizumab, LymphDetect assay, and Surgery +/- neoadjuvant pembrolizumab

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Phase II Trial of Drain Fluid Circulating Tumor DNA-Informed Adjuvant Therapy for Intermediate-Risk Head and Neck Cancer
Record updated
12 November 2026