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Lattice-Based Radiotherapy and Chemoimmunotherapy for Oropharyngeal Squamous Cell Carcinoma

ConditionOropharyngeal Squamous Cell Carcinoma
Trial statusNot yet recruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorNYU Langone Health

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Pathologically (histologically or cytologically) proven diagnosis of squamous cell carcinoma of the oropharynx, which includes the sites tonsil, base of tongue, soft palate, or posterior oropharyngeal wall. Histologic variants will be included (papillary squamous cell carcinoma and basaloid squamous cell carcinoma). Cytologic diagnosis from a cervical lymph node is sufficient in the presence of clinical evidence of a primary tumor in the oropharynx.

Clinical stage T1-T4, N1-N3, M0

If tissue is positive for p16 by immunohistochemical staining (>70% staining), patient must have >10 pk-year smoking history

Zubrod Performance Status of 0-1

Disqualifiers

Cancers considered to be from an oral cavity site (oral tongue, floor of mouth, alveolar ridge, buccal or lip), or the nasopharynx, hypopharynx, or larynx, even if p16 positive;

Carcinoma of the neck of unknown primary site origin (even if p16 positive)

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

60 Participants
are divided into 8 treatment groups

8

Treatment groups

See each treatment group below.

Group A: (Cohort P) Phase I: 8 Gy DoseExperimental treatment 2 interventions
Group B: (Cohort PN) Phase I: 8 Gy DoseExperimental treatment 2 interventions
Group C: (Cohort P) Phase I: 16 Gy DoseExperimental treatment 2 interventions
Group D: (Cohort PN) Phase I: 16 Gy DoseExperimental treatment 2 interventions
Group E: (Cohort P) Phase I: 24 Gy DoseExperimental treatment 2 interventions
Group F: (Cohort PN) Phase I: 24 Gy DoseExperimental treatment 2 interventions
Group G: (Cohort P) Phase II: OBDExperimental treatment 2 interventions
Group H: (Cohort PN) Phase II: OBDExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Dose-limiting-toxicity (DLT) rate

Phase I only - measured as the percentage of participants with DLTs during the initial treatment window.

Time frame
Up to Day 21
2

Proportion of patients with ≥ 50 % volumetric tumor shrinkage after induction therapy

Phase II only - proportion of patients who achieve at least 50 % volumetric tumor shrinkage after induction therapy.

Time frame
Up to Month 24

Secondary outcomes

1

Progression-Free Survival (PFS)

Time from initiation of treatment to progression of disease (i.e. disease worsening or spreading).

Time frame
Up to Month 24
2

Overall Survival (OS)

Time from initiation of treatment to death due to any cause.

Time frame
Up to Month 24
3

Distant Metastasis-Free Survival

Time from treatment initiation to the first diagnosis of distant cancer spread or death.

Time frame
Up to Month 24
4

Proportion of Patients with Change in CPS ≥20

Proportion of patients with a change in PD-L1 Combined Positive Score (CPS) of 20 or greater.

Time frame
Up to Month 24

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

NYU Langone Health

Lead sponsor

Source ClinicalTrials.gov

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