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Oral Cavity Squamous Cell CarcinomaPhase 1NCT07335380

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

A Phase 1 study testing Chemotherapy and Lattice Radiotherapy (LRT) in people with Oral Cavity 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

Single-arm, two-part, phase IB safety study that uses a Bayesian Optimal Interval (BOIN-12) dose-escalation scheme. Part 1 (Dose Finding) - Sentinel start at 9 Gy × 3 followed by fixed 3-patient BOIN cohorts exploring 8 Gy × 3 → 9 Gy × 3 → 10 Gy × 3. Target DLT rate θ = 0.20; ≈ 7-15 participants. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Oral Cavity Squamous Cell Carcinoma
What is being tested?
Chemotherapy and Lattice Radiotherapy (LRT)
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteUnited States
Study dates
Apr 2026to Mar 2031
Phase
Phase 1
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

  • 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.
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  • 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).

Who cannot join

  • 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);
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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
  • 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

Trial locations and contacts

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

Colin Hill, MD contact

212-731-5003

Colin.Hill@Nyulangone.org

United States1 site

  • NYU Langone Health

    New York, New York, 10016

Other trials in United States

About this study

Official title: Phase IB Trial of Preoperative Lattice-Based Hypofractionated Radiotherapy and Chemo-Immunotherapy for Oral Cavity Squamous Cell Carcinoma

Single-arm, two-part, phase IB safety study that uses a Bayesian Optimal Interval (BOIN-12) dose-escalation scheme.

Part 1 (Dose Finding) - Sentinel start at 9 Gy × 3 followed by fixed 3-patient BOIN cohorts exploring 8 Gy × 3 → 9 Gy × 3 → 10 Gy × 3. Target DLT rate θ = 0.20; ≈ 7-15 participants.

Part 2 (Expansion) - Additional enrolment at the selected maximum tolerated dose (MTD) until ≈ 30 evaluable subjects (Parts 1 + 2 combined). Patients receive peaks to the primary tumor alone (Group A) or to the primary + involved nodes (Group B) at the investigators' discretion (non-random).

Surgery occurs 6-8 weeks after RT; adjuvant therapy is pathology-driven.

Being tested
Chemotherapy, Lattice Radiotherapy (LRT)
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.

  • ChemotherapyDrug

    Patients receive standard induction chemoimmunotherapy (carboplatin, paclitaxel, and pembrolizumab) in three 21-day cycles, beginning on Day 1.

  • Lattice Radiotherapy (LRT)Radiation

    LRT is administered concurrently with the first cycle of chemoimmunotherapy according to the dose-finding rules

Study groups in NCT07335380
Study groupRoleWhat they receive
Part 1 - Dose-EscalationExperimentalTreatment starts at dose level 2 (9 Gy × 3 lattice fractions). A single "sentinel" patient is treated first; if no dose-limiting toxicity (DLT) occurs, the trial continues in fixed three-patient cohorts. The Bayesian Optimal Interval (BOIN) algorithm, set to a target DLT rate of 20%, governs escalation or de-escalation among the three prespecified dose levels (8, 9 and 10 Gy × 3). The principal objective of Part 1 is to identify the maximum tolerated dose (MTD).
Receives: Drug: Chemotherapy; Radiation: Lattice Radiotherapy (LRT)
Part 2 - ExpansionExperimentalAll Part 2 subjects receive the MTD together with chemo-immunotherapy.
Receives: Drug: Chemotherapy; Radiation: Lattice Radiotherapy (LRT)

What is being measured

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

  1. Maximum tolerated dose (MTD) of pre-operative lattice radiotherapy delivered with chemoimmunotherapy

    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.

    Measured: Up to Year 2

Secondary outcomes (6)

  1. Percentage of participants with complete pathologic response (pCR)

    Measured: Up to Year 2

  2. Percentage of participants with major response

    Defined as ≤ 10 % viable tumor.

    Measured: Up to Year 2

  3. Percentage of participants with macroscopic residual disease

    Defined as > 10 % viable tumor.

    Measured: Up to Year 2

  4. Progression-free survival (PFS)

    Time from Day 1 of protocol therapy to locoregional or distant progression or death, estimated with Kaplan-Meier methods.

    Measured: Up to Year 2

  5. Overall survival (OS)

    Time from Day 1 of therapy to death from any cause, analyzed with Kaplan-Meier curves

    Measured: Up to Year 2

  6. Distant-metastasis-free survival (DMFS)

    Time to first distant failure or death.

    Measured: Up to Year 2

Timeline

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

  1. First posted13 Jan 2026
  2. Study startApr 2026 (estimated)
  3. Primary completionMar 2031 (estimated)
  4. Study completionMar 2031 (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
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Factorial
Masking
None (open label)
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07335380
Sponsor's protocol ID
25-00185
Status last verified
Jan 2026
First submitted
5 Jan 2026
Last updated
29 Jan 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: The de-identified participant data from the final research dataset will be shared upon reasonable request beginning 9 to 36 months after publication or as required by a condition of awards or supporting agreements, provided the requesting investigator executes a data use agreement with NYU Langone Health. This instance of data sharing will also require separate IRB review as well as review from NYU Langone's Data Sharing Strategy Board (DSSB). Requests should be directed to: colin.hill@nyulangone.org. The protocol and statistical analysis plan will be posted on Clinicaltrials.gov only as required by federal regulation or supporting awards and agreements.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Chemotherapy and Lattice Radiotherapy (LRT) in people with Oral Cavity 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 12 inclusion and 17 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 29 Jan 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 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.

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 Colin Hill, MD (212-731-5003, Colin.Hill@Nyulangone.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Maximum tolerated dose (MTD) of pre-operative lattice radiotherapy delivered with chemoimmunotherapy (time frame: Up to Year 2). 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 NCT07335380.

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 29 Jan 2026.

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