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Lattice-Based Radiotherapy and Chemoimmunotherapy for Oropharyngeal Squamous Cell Carcinoma | Clinical Trials | Clareo Health

NOT_YET_RECRUITINGPHASE1/PHASE2

Lattice-Based Radiotherapy and Chemoimmunotherapy for Oropharyngeal Squamous Cell Carcinoma

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

NCT07428148•NYU Langone Health

View on ClinicalTrials.gov

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. 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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•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.
•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.
+5 more criteria

Exclusion Criteria

•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);
•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:
•1. Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months;
+13 more criteria

Locations (1)

NYU Langone Health

New York, New York, United States

Key Dates

Start Date

May 1, 2026

Primary Completion Date

May 1, 2031

Completion Date

May 1, 2033

Last Updated

February 23, 2026

Enrollment

ESTIMATED participants

Conditions

Oropharyngeal Squamous Cell Carcinoma

Interventions

Induction Chemo-Immunotherapy

DRUG

Lattice Radiotherapy

RADIATION

Contacts

Kenneth Hu, MD

CONTACT

212-731-5003 kenneth.hu@nyulangone.org

Fraustina Hsu

CONTACT

cancertrials@nyulangone.org

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 23, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Lattice-Based Radiotherapy and Chemoimmunotherapy for Oropharyngeal Squamous Cell Carcinoma

Inclusion Criteria

Exclusion Criteria

Testing Whether Cemiplimab (REGN2810) Plus CDX-1140 Given Prior to Surgery Are Better Than Cemiplimab (REGN2810) Alone in Patients With Stage III-IV Head and Neck Cancer

Radiation Therapy With or Without Cisplatin in Treating Patients With Stage III-IVA Squamous Cell Carcinoma of the Head and Neck Who Have Undergone Surgery

E7 T-cell Receptor (TCR) -T Cell Induction Therapy for Locoregionally Advanced HPV-associated Cancers

Shortened Course of Radiation Therapy After Trans-oral Robotic Surgery in Patients With HPV-Mediated Oropharyngeal Squamous Cell Carcinoma.

Lovastatin and Pembrolizumab for the Treatment of Patients With Recurrent or Metastatic Head and Neck Cancer, LAPP Trial

A Study to Evaluate Lenti-HPV-07 Immunotherapy Against HPV+ Cervical or Oropharyngeal Cancer