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

Part of paid clinical trials in New York, New York.

Sponsor
NYU Langone Health
Study ID
NCT07335380
Phase
PHASE1
Status
Not Yet Recruiting

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Conditions

  • Oral Cavity Squamous Cell Carcinoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Chemotherapy — DRUG
    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 Details

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.

Key Dates

Start date
Apr 30, 2026
Status verified
Jan 2026
Primary completion
Mar 31, 2031
Completion
Mar 31, 2031

Study Design

Enrollment
30 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Part 1 - Dose-Escalation
    Treatment 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).
  • Experimental: Part 2 - Expansion
    All Part 2 subjects receive the MTD together with chemo-immunotherapy.

Primary Outcome Measure

Maximum tolerated dose (MTD) of pre-operative lattice radiotherapy delivered with chemoimmunotherapy [ Time Frame: Up to Year 2 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
NYU Langone HealthNew YorkNew York10016-

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NYU Langone Health· New York, NY

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