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Lattice-Based Radiotherapy and Chemoimmunotherapy for Oropharyngeal Squamous Cell Carcinoma

NCT07428148 · Status: NOT_YET_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2026-02-23

No results posted yet for this study

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.

Conditions

  • Oropharyngeal Squamous Cell Carcinoma

Interventions

DRUG

Induction Chemo-Immunotherapy

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

RADIATION

Lattice Radiotherapy

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.

Sponsors & Collaborators

Principal Investigators

  • Kenneth Hu, MD · NYU Langone Health

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-05-31
Primary Completion
2031-05-31
Completion
2033-05-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07428148 on ClinicalTrials.gov