ClinicalTrials.gg
Not yet recruitingNCT07932067Updated Nov 12, 2026

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

A Phase 2 interventional study of Cisplatin or carboplatin and Intensity-modulated radiation therapy (IMRT) or Intensity-modulated proton therapy (IMPT) in Head and Neck Cancer, sponsored by Kevin Contrera. Not yet recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-12.

Sponsored by Kevin Contrera · Phase 2, Interventional, and Treatment

Updated Nov 12, 2026Newly registeredGo to Updates ↓
Phase
Phase 2
Study type
Interventional
Enrollment
140
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 127 studies testing cisplatin in Head and Neck Neoplasms — 11 open to participants now, 18 under way, 1 of them phase 3. Cisplatin · Head and Neck Neoplasms.

Planned enrollment
20th of 119
140 · median 42
Started
2026
with 2 others
Phase 2
74 of 127
11 open now
Primary completion
2028-11
later than 14 of 17 live
Registered
127th of 127
by date

Among the 127 studies testing cisplatin in Head and Neck Neoplasms, this one is the 20th largest by planned enrollment of the 119 interventional ones that give a count, is one of 3 that started in 2026, is one of 74 in phase 2, reaches primary completion later than 14 of the 17 other live ones, and was the 127th registered.

Head and Neck Neoplasms

2,713 studies on the registry are indexed under Head and Neck Neoplasms; 596 are open to participants now.

Browse Head and Neck Neoplasms studies →

Open to participants now

11 of the 127 studies testing cisplatin in Head and Neck Neoplasms are open now, in 2 countries. Recruiting first, the newest first:

5 more — sign in →

By country, each count listing its studies:

All 11 open studies →

About cisplatin

Cisplatin: first FDA approval 1978 (PLATINOL-AQ). What it is approved for, and how studies give it, is on its page →

Who these studies take

Of the 453 Head and Neck Neoplasms studies recruiting now, 345 (76%) set no upper age limit and 51 (11%) stop at 75 or younger; 21 take children under 18; 27 take healthy volunteers.

This study: 18 Years and older · all sexes · no healthy volunteers.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 127 studies testing cisplatin in Head and Neck Neoplasms, or all of them as a file.
02

Study summary

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.

Read the detailed description

Patients who are Surgical Drain Fluid (SDF) positive have a more than eight-fold higher risk of Head and Neck Squamous Cell Carcinoma disease recurrence. Whether these pathologically intermediate-risk patients benefit from the addition of concurrent cisplatin to adjuvant radiotherapy is unknown. Various prognostic biomarkers have been proposed to identify patients at high risk of recurrence. Tissue-based biomarkers may be less prognostic after successful tumor extirpation. Several plasma-based ctDNA assays measuring treatment response in HPV- HNSCC are under investigation. However, data is limited on the role of such assays for the detection of molecular residual disease (MRD) after surgery, particularly for risk-informed adjuvant treatment decision making. Tumor-informed ctDNA from postoperative SDF, taken 24 hours after surgery, has been shown to be a promising biomarker for individualizing recurrence risk. The LymphDetect™ Head \& Neck system, will be used to measure circulating tumor DNA (ctDNA) in surgical drain fluid, the most proximal biofluid to a recently resected tumor, to assess cancer recurrence risk at the source of potential spread - before it can travel to other parts of the body. There is a critical need to improve recurrence risk estimates for patients with HPV- HNSCC to inform the extent of adjuvant management, improve oncologic outcomes, and limit unnecessary treatment morbidity and mortality.

03

Conditions studied

  • Head and Neck Cancer

Keywords

  • tumor-informed plasma-based ctDNA assay
  • circulating Tumor DNA (ctDNA)
  • molecular residual disease (MRD)
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Must have 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.

  2. Must have received no prior therapies for current , except for pembrolizumab.
  3. Must be able to undergo curative-intent surgical resection with neck dissection and placement of a drain.
  4. 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.
  5. Age ≥18 years.
  6. Performance status 0-2
  7. Sexually active, fertile subjects and their partners must agree to use highly effective methods of 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.
  8. Female subjects of 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 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.

  9. Must have the ability to understand and the willingness to sign a written document.

Exclusion criteria

Exclusion Criteria:

  1. HPV-related oropharyngeal cancer
  2. Nasopharyngeal cancer
  3. Sinonasal cancer
  4. Prior or recurrent HNSCC
  5. Distant
  6. Other active , other than nonmetastatic skin, prostate, or thyroid malignancy
  7. 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.
Terms in these criteria, in plain language(9)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Histologically or cytologically confirmed

The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).

Your pathology report is the document that shows this.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

Adjuvant and neoadjuvant

Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.

ECOG performance status

A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.

0
Fully active, no restrictions.
1
Limited in strenuous activity, but walking and able to do light work, such as housework or office work.
2
Walking and able to look after yourself, but unable to work; up and about more than half of waking hours.
3
Able to look after yourself only in part; in bed or a chair more than half of waking hours.
4
Unable to look after yourself at all; in bed or a chair all day.

Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Postmenopausal

Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Metastases

Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
140 participants (estimated)

Study arms

  • Experimental
    Low-Risk

    Diagnostic Test: LymphDetect assay · Procedure: Surgery +/- neoadjuvant pembrolizumab

  • Experimental
    Intermediate Risk - Surgical Drain Fluid (negative)

    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). \[IMRT / IMPT Schedule to be determined by radiation oncologist, should be completed within 42 days of start date\]

    Radiation: Intensity-modulated radiation therapy (IMRT) or Intensity-modulated proton therapy (IMPT) · Drug: Pembrolizumab · Diagnostic Test: LymphDetect assay · Procedure: Surgery +/- neoadjuvant pembrolizumab

  • Experimental
    Intermediate Risk - Surgical Drain Fluid (positive)

    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.)

    Drug: Cisplatin or carboplatin · Radiation: Intensity-modulated radiation therapy (IMRT) or Intensity-modulated proton therapy (IMPT) · Drug: Pembrolizumab · Diagnostic Test: LymphDetect assay · Procedure: Surgery +/- neoadjuvant pembrolizumab

  • Experimental
    High Risk

    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.)

    Drug: Cisplatin or carboplatin · Radiation: Intensity-modulated radiation therapy (IMRT) or Intensity-modulated proton therapy (IMPT) · Drug: Pembrolizumab · Diagnostic Test: LymphDetect assay · Procedure: Surgery +/- neoadjuvant pembrolizumab

Interventions

  • DrugCisplatin or carboplatin

    Drug pages: Cisplatin · Carboplatin

    An alkylating agent that contains platinum, which binds to DNA in cancer cells, causing cross-links that prevent DNA replication and repair, leading to cell death, particularly in rapidly dividing cancer cells.

    Also known as: Platinol®

  • RadiationIntensity-modulated radiation therapy (IMRT) or Intensity-modulated proton therapy (IMPT)

    Advanced type of radiation therapy that uses powerful energy beams to kill cancer cells. The energy can come from X-rays, protons or other sources, in which the beams of radiation are carefully customized.

  • Humanized monoclonal antibody and a PD-1 inhibitor used in cancer immunotherapy that differs from chemotherapy as it does not directly kill cancer cells but stimulates the immune system, particularly T-cells, to recognize and attack cancer cells more effectively.

    Also known as: Keytruda®

  • Diagnostic testLymphDetect assay

    A tumor-informed ctDNA assay that uses Surgical Drain Fluid (SDF) collected 24 hours after the end of surgery to direct therapeutic intervention.

  • ProcedureSurgery +/- neoadjuvant pembrolizumab

    Performed within 28 days after baseline assessment to remove Head and Neck Cancer tumor(s).

06

What researchers measure

Primary outcomes

  1. 2-year Locoregional Control (LRC): SDF+ intermediate risk

    Proportion of patients without locoregional recurrence (growth or recurrence of the primary tumor or other nearby structures within the same anatomical region or nearby regional lymph nodes) at 2 years from the initiation of study treatment in patients who are SDF+ intermediate risk.

    Time frame: At 2 years

Secondary outcomes

  1. 2-year Locoregional Control (LRC): SDF- intermediate risk

    Proportion of patients without locoregional recurrence (growth or recurrence of the primary tumor or other nearby structures within the same anatomical region or nearby regional lymph nodes) at 2 years from the initiation of study treatment in patients who are SDF-intermediate risk.

    Time frame: At 2 years

  2. 2-year Locoregional Control (LRC)

    Proportion of all patients without disease recurrence (growth or recurrence of the primary tumor or other nearby structures within the same anatomical region or nearby regional lymph nodes) at 2 years from the initiation of study treatment.

    Time frame: At 2 years

  3. 2-year Event-free Survival (EFS): SDF+ intermediate risk

    Proportion of patients without disease recurrence (growth or recurrence of the primary tumor and nearby regional lymph nodes or other nearby structures within the same anatomical region), progression, or death from any cause in SDF+ intermediate risk patients at 2 years from the initiation of study treatment.

    Time frame: At 2 years

  4. 2-year Event-free Survival (EFS): SDF- intermediate risk

    Proportion of patients without disease recurrence (growth or recurrence of the primary tumor and nearby regional lymph nodes or other nearby structures within the same anatomical region), progression, or death from any cause in SDF- intermediate risk patients at 2 years from the initiation of study treatment.

    Time frame: At 2 year

  5. 2-year Event-free Survival (EFS)

    Proportion of all patients without disease recurrence (growth or recurrence of the primary tumor and nearby regional lymph nodes or other nearby structures within the same anatomical region), progression, or death from any cause at 2 years from the initiation of study treatment.

    Time frame: At 2 years

  6. 2-year Overall Survival (OS): SDF+ intermediate risk

    Proportion of SDF+ intermediate risk patients alive at 2 years from the initiation of study treatment.

    Time frame: At 2 years

  7. 2-year Overall Survival (OS): SDF- intermediate risk

    Proportion of SDF- intermediate risk patients alive at 2 years from the initiation of study treatment.

    Time frame: At 2 years

  8. 2-year Overall Survival (OS)

    Proportion of all patients alive at 2 years from the initiation of study treatment.

    Time frame: At 2 year

  9. Incidence of Grade ≥ 3 Treatment-related Adverse Events (AE)

    Number of (distinct) HNSCC patients with grade ≥ 3 Treatment-related Adverse Events (AE)s per CTCAE v5.0.

    Time frame: up to 30 days post-treatment

07

Study locations

1 site
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Nov 2026; primary completion for Nov 2028, 24 months later.

Of 215 non-industry phase 2 interventional studies under Head and Neck Neoplasms, half reached primary completion within 57 months of starting (the median), counting those still running; a quarter within 37 and three quarters within 84. This study's planned 24 months is below that.

Counting every sponsor, half of 259 studies reached it within 51 months; a quarter within 30 and three quarters within 76.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 27, 2026
First posted
Nov 12, 2026
StartEst.
Nov 15, 2026
Primary completionEst.
Nov 15, 2028
CompletionEst.
Nov 15, 2030
Last update
Nov 12, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Registered
First appeared on the registry. No changes since
Nov 12, 2026
Show all 1 update
  1. Nov 12, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07932067
Lead sponsor
Kevin Contrera
Collaborators
Droplet Biosciences, Inc.
Responsible party
Kevin Contrera (Assistant Professor, Department of Otolaryngology-Head & Neck Surgery, University of Pittsburgh) — Sponsor-investigator
First posted
Nov 12, 2026
Start date
Nov 15, 2026 (estimated)
Primary completion
Nov 15, 2028 (estimated)
Completion
Nov 15, 2030 (estimated)
Last update
Nov 12, 2026

Study contacts

Jennifer Ruth, RN, BSN
Contact
ruthj2@upmc.edu
412-623-8963
Mel J Mendez, RN, BSN
Contact
mendezmj@upmc.edu
878-261-6071
Kevin J Contrera, MD
principal investigator · UPMC Cancer Center Hillman

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

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Studies of the drugs tested here: Cisplatin · Carboplatin · Pembrolizumab

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