Clinical Trials Directory

Trials / Withdrawn

WithdrawnNCT05743270

Study of RP3 in Combination With Nivolumab and Other Therapy in Patients With Locoregionally Advanced or Recurrent SCCHN

A Phase 2, Open-label, Multicenter Study Investigating Oncolytic Immunotherapy in Combination With Other Therapy in Patients With Locoregionally Advanced or Recurrent Squamous Cell Carcinoma of the Head and Neck

Status
Withdrawn
Phase
Phase 2
Study type
Interventional
Enrollment
0 (actual)
Sponsor
Replimune, Inc. · Industry
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

This is a Phase 2, multicenter, open-label, 2-cohort (Locoregionally Advanced Cohort or Recurrent/Metastatic Cohort) study evaluating RP3 in combination with concurrent chemoradiation therapy (CCRT) followed by nivolumab (for the LA Cohort) or combined with chemotherapy and nivolumab (for the R/M Cohort) in patients with advanced, inoperable squamous cell carcinomas of the head and neck (SCCHN), including of the oral cavity, oropharynx, hypopharynx, larynx, or unknown primary.

Detailed description

RP3 is a genetically modified herpes simplex type 1 virus (HSV-1) that expresses exogenous genes (anti-CTLA-4 antibody, CD40 ligand and h4-1BBL) designed to directly kill tumor cells and generate a systemic anti-tumor immune response

Conditions

Interventions

TypeNameDescription
BIOLOGICALRP3Genetically modified herpes simplex type 1 virus
OTHERCCRT(concurrent chemoradiation therapy)CCRT consisting of intensity modulated radiation therapy combined with a cis-platinum
OTHERcarboplatin and paclitaxelchemotherapeutic agents
BIOLOGICALnivolumabanti-PD1 monoclonal antibody

Timeline

Start date
2024-01-30
Primary completion
2026-03-01
Completion
2026-06-01
First posted
2023-02-24
Last updated
2025-03-11

Locations

34 sites across 8 countries: United States, Czechia, France, Germany, Greece, Poland, Spain, United Kingdom

Regulatory

Source: ClinicalTrials.gov record NCT05743270. Inclusion in this directory is not an endorsement.