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Lattice Radiotherapy and Chemo-Immunotherapy for Oral Cavity Squamous Cell Carcinoma

This study is looking at a new way to treat oral cavity squamous cell carcinoma (mouth cancer) using a combination of chemotherapy, immunotherapy, and a special type of radiation. The chemotherapy drugs are carboplatin, paclitaxel, and pembrolizumab, given in three cycles. The special radiation, called Lattice Radiotherapy (LRT), is given at the same time as the first chemotherapy cycle. The main goal of this study is to find the highest safe dose of this Lattice Radiotherapy when given with the other treatments before surgery. You may be able to join if you have non-metastatic (cancer that hasn't spread) oral cavity squamous cell carcinoma and are at least 18 years old. This study plans to enroll about 30 participants.

Study design
This is a single-arm study, meaning everyone receives the same treatment. It's a Phase 1B safety study that will enroll about 30 participants in total.
What's involved
You would receive three 21-day cycles of chemoimmunotherapy and Lattice Radiotherapy. Surgery would happen 6-8 weeks after the radiation treatment.
Compensation
Not stated in the trial record.
Follow-up
The main goal of the study is measured for up to 2 years after treatment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07335380

Lattice-Based Radiotherapy and Chemo-Immunotherapy for Oral Cavity Squamous Cell Carcinoma

Not Yet Recruiting
PHASE1Ages 18+InterventionalTreatment
NYU Langone Health
~30 participants
Updated 2026-01-29 on ClinicalTrials.gov
What's tested:ChemotherapyLattice Radiotherapy (LRT)

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Maximum tolerated dose (MTD) of pre-operative lattice radiotherapy delivered with chemoimmunotherapy
Measured over Up to Year 2

Conditions

Oral Cavity Squamous Cell Carcinoma

Explore related trials

Oral Cavity Squamous Cell Carcinoma

Where it's being run

1 sites across 1 states
New York1

Study leadership

  • Colin Hill, MD · PRINCIPAL_INVESTIGATOR · NYU Langone Health

Who to contact

Colin Hill, MD
[email protected]
212-731-5003
Email the study team

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Eligibility criteria

Inclusion

Non-metastatic, pathologically confirmed oral cavity squamous cell carcinoma, cT3-T4a cN0-N3 or cT1-T2 cN1-N3. Histologic variants will be included (papillary squamous cell carcinoma and basaloid squamous cell carcinoma, e.g.). Cytologic diagnosis from a cervical lymph node is sufficient in the presence of clinical evidence of a primary tumor in the oral cavity (oral tongue, floor of mouth, alveolar ridge, buccal or lip, i.e.)
Surgically resectable
Zubrod Performance Status of 0-1
(Phase I) Primary and lymph node ≥ 3 cm
(Phase II) Primary and lymph node ≥ 3 cm OR Primary ≥ 3 cm
Patients must provide their personal smoking history prior to registration.
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 women of childbearing potential 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
Adequate hematologic function within 2 weeks prior to registration
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).

Exclusion

Cancers considered to be primarily located in the oropharynx even if p16 negative
Carcinoma of the neck of unknown primary site origin (even if p16 negative)
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
Pregnancy; this exclusion is necessary because the treatment in this study may be significantly teratogenic
Prior allergic reaction to cisplatin

What this trial measures

  • Maximum tolerated dose (MTD) of pre-operative lattice radiotherapy delivered with chemoimmunotherapyUp to Year 2

    The BOIN (Bayesian Optimal Interval) algorithm will declare the MTD once a dose has an observed dose-limiting toxicity (DLT) rate compatible with the target toxicity level (θ = 0.20) and all higher doses are ruled out for excess risk.