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

NCT05743270 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2025-03-11

No results posted yet for this study

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.

Conditions

  • Squamous Cell Carcinoma of Head and Neck
  • Locally Advanced Head and Neck Squamous Cell Carcinoma
  • Recurrent Head and Neck Squamous Cell Carcinoma

Interventions

BIOLOGICAL

RP3

Genetically modified herpes simplex type 1 virus

OTHER

CCRT(concurrent chemoradiation therapy)

CCRT consisting of intensity modulated radiation therapy combined with a cis-platinum

OTHER

carboplatin and paclitaxel

chemotherapeutic agents

BIOLOGICAL

nivolumab

anti-PD1 monoclonal antibody

Sponsors & Collaborators

Principal Investigators

  • David Cohan, MD/FACS · Replimune Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-01-30
Primary Completion
2026-03-01
Completion
2026-06-01
FDA Drug
Yes

Countries

  • United States
  • Czechia
  • France
  • Germany
  • Greece
  • Poland
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
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 NCT05743270 on ClinicalTrials.gov