Trial intelligence / Profile preview

PRGN-2009 With Pembrolizumab Before Standard Treatment in Newly Diagnosed HPV-Associated Oropharyngeal Cancer

NCT05996523Phase 2

Key facts

Status: Active, not recruiting
Start: Nov 2023
Primary completion: May 2025
Countries: 1
Sponsor: National Cancer Institute
Modality: Viral Vectors, Vaccines & Immunotherapeutics

Drugs: PRGN-2009
Conditions: oropharyngeal squamous cell carcinoma (OPSCC)

Overview

Phase 2, open-label, single-arm trial of PRGN-2009 in oropharyngeal squamous cell carcinoma (OPSCC), sponsored by National Cancer Institute. Primary endpoint: Percentage of Participants That Had a 2-fold Increase of Cluster of Differentiation 3 (CD3+) Tumor Infiltrating T Cells in Biopsies Performed Post-treatment Compared to Pre-treatment. Started Nov 2023; status: active, not recruiting.

Design

1 arm

Study design: Non-randomizedOpen-labelSingle group

PRGN 5x10^11 Viral Particles Subcutaneously Plus Pembrolizumab 200mg Intravenous
PRGN 5x10^11 Viral Particles (VP) subcutaneous (SC) plus pembrolizumab 200mg intravenous (IV) as induction/ neoadjuvant therapy

Who it enrols

Adults with newly diagnosed Stage I-III p16-positive oropharyngeal squamous cell carcinoma planned for definitive therapy, with measurable disease and adequate organ function.

Endpoints

Primary

Percentage of Participants That Had a 2-fold Increase of Cluster of Differentiation 3 (CD3+) Tumor Infiltrating T Cells in Biopsies Performed Post-treatment Compared to Pre-treatment

Secondary

Overall Survival at 3 Years Compared With Historical Cohort3 years
Overall Survival at 3 Years3 years
Number of Treatment-related Serious Adverse Events (AE) of Grades 1, 2, 3, 4 and/or 5 Along With the AE Term2 months
Percentage of 2-fold Increase in Cluster of Differentiation (CD3+) Tumor Infiltrating Lymphocytes (TILs) Post-treatment Compared to Pre-treatment in This Trial Compared to Participants Receiving…
Relapse Free Survival (RFS) Rate at 3 Years3 years

Beyond the preview

Go deeper on NCT05996523.

Full results, competitive context and analysis are in the Gosset platform.

Full results & analysis

Available in the Gosset platform where reported.

Competitive context

Available in the Gosset platform where reported.

Bring the full picture into focus.

See how Gosset can support your research on NCT05996523.