Lattice-Based Radiotherapy and Chemoimmunotherapy for Oropharyngeal Squamous Cell Carcinoma

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

Sponsor
NYU Langone Health
Study ID
NCT07428148
Phase
PHASE1/PHASE2
Status
Not Yet Recruiting

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Conditions

  • Oropharyngeal Squamous Cell Carcinoma

Eligibility Criteria

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

Interventions

  • Induction Chemo-Immunotherapy — DRUG
    All participants will receive three 21-day cycles of carboplatin, paclitaxel, and pembrolizumab as induction therapy.
  • Lattice Radiotherapy — RADIATION
    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.

Study Details

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.

Key Dates

Start date
May 31, 2026
Status verified
Feb 2026
Primary completion
May 31, 2031
Completion
May 31, 2033

Study Design

Enrollment
60 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: (Cohort P) Phase I: 8 Gy Dose
    Individuals in the primary tumor only (P) cohort enrolled in Phase 1 who receive the 8 Gray (Gy) dose.
  • Experimental: (Cohort PN) Phase I: 8 Gy Dose
    Individuals in the primary + node (NP) cohort enrolled in Phase 1 who receive the 8 Gy dose.
  • Experimental: (Cohort P) Phase I: 16 Gy Dose
    Individuals in the primary tumor only (P) cohort enrolled in Phase 1 who receive the 16 Gy dose.
  • Experimental: (Cohort PN) Phase I: 16 Gy Dose
    Individuals in the primary + node (NP) cohort enrolled in Phase 1 who receive the 16 Gy dose.
  • Experimental: (Cohort P) Phase I: 24 Gy Dose
    Individuals in the primary tumor only (P) cohort enrolled in Phase 1 who receive the 24 Gy dose.
  • Experimental: (Cohort PN) Phase I: 24 Gy Dose
    Individuals in the primary + node (NP) cohort enrolled in Phase 1 who receive the 24 Gy dose.
  • Experimental: (Cohort P) Phase II: OBD
    Individuals in Cohort P who receive the optimal biological dose (OBD) for Cohort P as determined by BOIN12 in Phase I.
  • Experimental: (Cohort PN) Phase II: OBD
    Individuals in Cohort PN who receive the optimal biological dose (OBD) for Cohort PN as determined by BOIN12 in Phase I.

Primary Outcome Measure

Dose-limiting-toxicity (DLT) rate [ Time Frame: Up to Day 21 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
NYU Langone HealthNew YorkNew York10016-

Find similar trials in New York, NY

By research site
NYU Langone Health· New York, NY

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