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Oropharyngeal Squamous Cell CarcinomaPhase 1/2NCT07428148

Lattice-Based Radiotherapy and Chemoimmunotherapy for Oropharyngeal Squamous Cell Carcinoma

A Phase 1/2 study testing Induction Chemo-Immunotherapy and Lattice Radiotherapy in people with Oropharyngeal Squamous Cell Carcinoma, run by NYU Langone Health at 1 site in United States.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

This single-arm Phase I/II trial evaluates induction chemoimmunotherapy combined with lattice radiotherapy (LRT) in patients with non-low risk oropharyngeal squamous cell carcinoma and primary tumor ≥3 cm or primary tumor and pathologic lymph node ≥3 cm in longest dimension. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Oropharyngeal Squamous Cell Carcinoma
What is being tested?
Induction Chemo-Immunotherapy and Lattice Radiotherapy
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteUnited States
Study dates
May 2026to May 2033
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Pathologically (histologically or cytologically) proven diagnosis of squamous cell carcinoma of the oropharynx, which includes the sites tonsil, base of tongue, soft palate, or posterior oropharyngeal wall. Histologic variants will be included (papillary squamous cell carcinoma and basaloid squamous cell carcinoma). Cytologic diagnosis from a cervical lymph node is sufficient in the presence of clinical evidence of a primary tumor in the oropharynx.
  • Clinical stage T1-T4, N1-N3, M0
  • If tissue is positive for p16 by immunohistochemical staining (>70% staining), patient must have >10 pk-year smoking history
  • Zubrod Performance Status of 0-1
  • Primary tumor ≥ 3 cm OR at least one lymph node ≥ 3 cm OR primary tumor and lymph node ≥ 3 cm
  • One of the following combinations of imaging is required within 8 weeks of registration: CT scan of the neck (with contrast) and a whole body PET/CT; or, an MRI of the neck (with contrast) and a whole body PET/CT. Note: A CT scan of the neck and/or a PET/CT performed for the purposes of radiation planning may serve as both staging and planning tools.
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  • Patients must provide their personal smoking history prior to registration. Patients with HPV positive oropharyngeal carcinoma must have a cumulative personal smoking history that exceeds 10 pack-years. Number of pack-years = [Frequency of smoking (number of cigarettes per day) x duration of cigarette smoking (years)] / 20. Note: Twenty cigarettes is considered equivalent to one pack. Cigar and pipe tobacco consumption is not included in calculating lifetime pack-years.
  • Negative serum pregnancy test within 14 days prior to registration for women of childbearing potential. Female subjects of childbearing potential and male subjects with female partners of childbearing potential must be willing to avoid pregnancy. Female subjects of childbearing potential who are undergoing RT or who are partners to male subjects in the study should avoid sexual activity or use a highly effective method of birth control during sexual intercourse. Acceptable, highly effective methods of birth control include: intrauterine device (IUD)/intrauterine hormone releasing system (IUS), bilateral tube occlusion, vasectomized partner, combined (estrogen and progesterone containing) or progesterone-only hormonal contraceptives (oral, intravaginal, transdermal, injectable).
  • Males who are sexually active with WOCBP must agree to follow instructions for method(s) of contraception (abstinence/protection) for the duration of treatment/study participation.
  • The patient must provide study-specific informed consent prior to study entry.
  • Adequate renal function within 2 weeks 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 Cockcorft-Gault formula.
  • Adequate hematologic function within 2 weeks prior to registration, defined as follows: Absolute neutrophil count (ANC) ≥ 1,500 cells/mm3; Platelets ≥ 100,000 cells/mm3; and Hemoglobin ≥ 8.0 g/dl. Note: the use of transfusion or other intervention to achieve Hgb ≥ 8.0 g/dl is acceptable
  • Patients who are HIV positive but who have no prior AIDS-defining illness and have CD4 cells of at least 350/mm3 are eligible. HIV-positive patients must not have multi-drug resistant HIV infection or other concurrent AIDS-defining conditions. Patients must not be sero-positive for Hepatitis B (Hepatitis B surface antigen positive or anti-hepatitis B core antigen positive) or sero-positive for Hepatitis C (anti-Hepatitis C antibody positive). However, patients who are immune to hepatitis B (anti-Hepatitis B surface antibody positive) are eligible (e.g. patients immunized against hepatitis B).
  • The patient must provide study-specific informed consent prior to study entry.

Who cannot join

  • Cancers considered to be from an oral cavity site (oral tongue, floor of mouth, alveolar ridge, buccal or lip), or the nasopharynx, hypopharynx, or larynx, even if p16 positive;
  • Carcinoma of the neck of unknown primary site origin (even if p16 positive)
  • Distant metastasis or adenopathy below the clavicles;
  • Gross total excision of both primary and nodal disease; this includes tonsillectomy, local excision of primary site, and nodal excision that removes all clinically and radiographically evident disease.
  • Simultaneous primary cancers or separate bilateral primary tumor sites;
  • Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 1095 days (3 years) (for example, carcinoma in situ of the breast, oral cavity, or cervix are all permissible);
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  • Prior systemic chemotherapy for the study cancer; note that prior chemotherapy for a different cancer is allowable;
  • Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields;
  • 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 intravenous antibiotics at the time of registration;
  • Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy within 30 days of registration;
  • Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects; note, however, that laboratory tests for liver function and coagulation parameters are not required for entry into this protocol other than those listed in 5.1.
  • Acquired immune deficiency syndrome (AIDS) based upon the current CDC definition with immune compromise greater than that noted in section 5.1; note, however, that HIV testing is not required for entry into this protocol. The need to exclude patients with AIDS from this protocol is necessary because the treatments involved in this protocol may be significantly immunosuppressive. Protocol-specific requirements may also exclude immune-compromised patients.
  • Pregnancy; this exclusion is necessary because the treatment in this study may be significantly teratogenic
  • Prior allergic reaction to cisplatin.
  • Exclusion Criteria for MRI: Normal MRI exclusion criteria will apply, including those on the following list. A standard MRI safety form will be used to identify potential conditions warranting exclusion.
  • Electrical implants such as cardiac pacemakers or perfusion pumps
  • Ferromagnetic implants such as aneurysm clips, surgical clips, prostheses, artificial heart, valves with steel parts, metal fragments, shrapnel, bullets, tattoos near the eye, or steel implants
  • Ferromagnetic objects such as jewelry or metal clips in clothing
  • Claustrophobia
  • History of seizures
  • Patients with GFR < 15 ml/min/1.73m2 or who are on dialysis will not have DCE-MRI scan. These patients will have conventional anatomical MRI without contrast and DW-MRI.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Kenneth Hu, MD contact

212-731-5003

kenneth.hu@nyulangone.org

Fraustina Hsu contact

cancertrials@nyulangone.org

United States1 site

  • NYU Langone Health

    New York, New York, 10016

Other trials in United States

About this study

Official title: Phase I/II Trial of Induction Lattice-Based Radiotherapy and Chemoimmunotherapy Preceding Response-Adapted Definitive Chemoradiation for Non-Low Risk Oropharyngeal Squamous Cell Carcinoma

This single-arm Phase I/II trial evaluates induction chemoimmunotherapy combined with lattice radiotherapy (LRT) in patients with non-low risk oropharyngeal squamous cell carcinoma and primary tumor ≥3 cm or primary tumor and pathologic lymph node ≥3 cm in longest dimension. BOIN12 adaptive dose-finding will guide dose across two anatomical cohorts-primary-tumor only (P) and primary + largest involved node (PN)-with a total target accrual of about 60 evaluable patients.

Dose-limiting toxicity is monitored separately in each cohort. If both tolerate the same dose, that unified optimal biological dose (OBD) advances to Phase II; if tolerability differs, the PN-specific OBD expands while the P cohort is analyzed descriptively.

After induction, imaging determines response: patients achieving ≥50% volumetric tumor shrinkage receive hypofractionated chemoradiation, whereas those with <50% shrinkage are treated with conventional fractionation, personalizing definitive therapy according to early safety and efficacy signals.

Being tested
Induction Chemo-Immunotherapy, Lattice Radiotherapy
Medical subject headings
Squamous Cell Carcinoma of Head and Neck

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Induction Chemo-ImmunotherapyDrug

    All participants will receive three 21-day cycles of carboplatin, paclitaxel, and pembrolizumab as induction therapy.

  • Lattice RadiotherapyRadiation

    On Day 1 of the first cycle, each participant also begins lattice radiotherapy (LRT). Cohort P receives LRT to the primary tumor only; Cohort NP receives LRT to the primary tumor + involved lymph nodes ≥ 3 cm.

Study groups in NCT07428148
Study groupRoleWhat they receive
(Cohort P) Phase I: 8 Gy DoseExperimentalIndividuals in the primary tumor only (P) cohort enrolled in Phase 1 who receive the 8 Gray (Gy) dose.
Receives: Drug: Induction Chemo-Immunotherapy; Radiation: Lattice Radiotherapy
(Cohort PN) Phase I: 8 Gy DoseExperimentalIndividuals in the primary + node (NP) cohort enrolled in Phase 1 who receive the 8 Gy dose.
Receives: Drug: Induction Chemo-Immunotherapy; Radiation: Lattice Radiotherapy
(Cohort P) Phase I: 16 Gy DoseExperimentalIndividuals in the primary tumor only (P) cohort enrolled in Phase 1 who receive the 16 Gy dose.
Receives: Drug: Induction Chemo-Immunotherapy; Radiation: Lattice Radiotherapy
(Cohort PN) Phase I: 16 Gy DoseExperimentalIndividuals in the primary + node (NP) cohort enrolled in Phase 1 who receive the 16 Gy dose.
Receives: Drug: Induction Chemo-Immunotherapy; Radiation: Lattice Radiotherapy
(Cohort P) Phase I: 24 Gy DoseExperimentalIndividuals in the primary tumor only (P) cohort enrolled in Phase 1 who receive the 24 Gy dose.
Receives: Drug: Induction Chemo-Immunotherapy; Radiation: Lattice Radiotherapy
(Cohort PN) Phase I: 24 Gy DoseExperimentalIndividuals in the primary + node (NP) cohort enrolled in Phase 1 who receive the 24 Gy dose.
Receives: Drug: Induction Chemo-Immunotherapy; Radiation: Lattice Radiotherapy
(Cohort P) Phase II: OBDExperimentalIndividuals in Cohort P who receive the optimal biological dose (OBD) for Cohort P as determined by BOIN12 in Phase I.
Receives: Drug: Induction Chemo-Immunotherapy; Radiation: Lattice Radiotherapy
(Cohort PN) Phase II: OBDExperimentalIndividuals in Cohort PN who receive the optimal biological dose (OBD) for Cohort PN as determined by BOIN12 in Phase I.
Receives: Drug: Induction Chemo-Immunotherapy; Radiation: Lattice Radiotherapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Dose-limiting-toxicity (DLT) rate

    Phase I only - measured as the percentage of participants with DLTs during the initial treatment window.

    Measured: Up to Day 21

  2. Proportion of patients with ≥ 50 % volumetric tumor shrinkage after induction therapy

    Phase II only - proportion of patients who achieve at least 50 % volumetric tumor shrinkage after induction therapy.

    Measured: Up to Month 24

Secondary outcomes (4)

  1. Progression-Free Survival (PFS)

    Time from initiation of treatment to progression of disease (i.e. disease worsening or spreading).

    Measured: Up to Month 24

  2. Overall Survival (OS)

    Time from initiation of treatment to death due to any cause.

    Measured: Up to Month 24

  3. Distant Metastasis-Free Survival

    Time from treatment initiation to the first diagnosis of distant cancer spread or death.

    Measured: Up to Month 24

  4. Proportion of Patients with Change in CPS ≥20

    Proportion of patients with a change in PD-L1 Combined Positive Score (CPS) of 20 or greater.

    Measured: Up to Month 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Feb 2026
  2. Study startMay 2026 (estimated)
  3. Primary completionMay 2031 (estimated)
  4. Study completionMay 2033 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07428148
Sponsor's protocol ID
25-00211
Status last verified
Feb 2026
First submitted
17 Feb 2026
Last updated
23 Feb 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Induction Chemo-Immunotherapy and Lattice Radiotherapy in people with Oropharyngeal Squamous Cell Carcinoma, run by NYU Langone Health at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 23 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Kenneth Hu, MD (212-731-5003, kenneth.hu@nyulangone.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Dose-limiting-toxicity (DLT) rate (time frame: Up to Day 21). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07428148.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2026.

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