MedTrace Logo

CD40 Agonist and PD-1 Inhibitor in HNSCC

NCT06159621 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 27

Last updated 2025-12-03

No results posted yet for this study

Summary

Prospective, open-label, phase 1 study of CD40 agonist (LVGN7409) and PD-1 inhibition (LVGN3616 or nivolumab) in patients with resectable Human Papillomavirus (HPV)-negative mucosal head/neck squamous cell carcinoma (HNSCC). This protocol proposes to study the safety and immunological effects of LVGN7409, a CD40 agonistic antibody, when administered in combination with PD-1 inhibition prior to surgical resection.

Conditions

Interventions

DRUG

PD-1inhibitor - LVGN 3616

Administration of one dose of LVGN 3616 - 300mg. Commercially available PD-1 inhibitor may be substituted.

DRUG

CD 40 Agonist - LVGN 7409

Administration of one dose of LVGN 7409 - 1mg/kg

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-07-02
Primary Completion
2028-03-01
Completion
2028-03-01
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases
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 NCT06159621 on ClinicalTrials.gov