NCT07428148

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

• Status: Not Yet Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: NYU Langone Health · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2026-05-01
• Primary completion: 2031-05-01
• Completion: 2033-05-01
• First posted: 2026-02-23
• Last updated: 2026-02-23

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study