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

Part of paid clinical trials in La Jolla, California.

Sponsor
Replimune, Inc.
Study ID
NCT05743270
Phase
PHASE2
Status
Withdrawn

Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • RP3 — BIOLOGICAL
    Genetically modified herpes simplex type 1 virus
  • CCRT(concurrent chemoradiation therapy) — OTHER
    CCRT consisting of intensity modulated radiation therapy combined with a cis-platinum
  • carboplatin and paclitaxel — OTHER
    chemotherapeutic agents
  • nivolumab — BIOLOGICAL
    anti-PD1 monoclonal antibody

Study Details

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.

Key Dates

Start date
Jan 30, 2024
Status verified
Mar 2025
Primary completion
Mar 1, 2026
Completion
Jun 1, 2026

Study Design

Enrollment
0 participants (actual)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: LA Cohort: RP3 in combination with CCRT followed by nivolumab in Locally Advanced SCCHN
    RP3 will be administered via direct intratumoral injection or via CT, ultrasound, or laryngoscopy guided intratumoral injection into superficial, subcutaneous (SC), or nodal lesions and into deeper lesions, including visceral lesions.
  • Active Comparator: LA Cohort: concurrent chemoradiation therapy in Patients With Locoregionally Advanced SCCHN
    standard-of-care CCRT (defined as intensity-modulated radiation therapy \[IMRT\] and cisplatin
  • Experimental: R/M Cohort:RP3 in combination with carboplatin, paclitaxel and then nivolumab in R/M SCCHN
    RP3 will be administered via direct intratumoral injection or via CT, ultrasound, or laryngoscopy guided intratumoral injection into superficial, subcutaneous (SC), or nodal lesions and into deeper lesions, including visceral lesions.

Primary Outcome Measure

LA Cohort: Progression-free Survival [ Time Frame: From Day 1 to documented progression of disease (up to 3 years) ]

Locations (12)

FacilityCityStateZIPSite coordinators
University of California San Diego, UCSDLa JollaCalifornia92037-
UCLA Medicine Division of Hematology-OncologyLos AngelesCalifornia90095-
USC Norris Comprehensive Cancer CenterLos AngelesCalifornia90033-
University of Iowa Hospitals and ClinicsIowa CityIowa52242-
University of Cincinnati Medical CenterCincinnatiOhio45219-
Cleveland ClinicClevelandOhio44195-
Thomas Jefferson University City Center and AbingtonPhiladelphiaPennsylvania19107-
University of Pittsburgh Medical Center, UPMCPittsburghPennsylvania15232-
Jefferson Health Abington Asplunhd Cancer PavillionWillow GrovePennsylvania19090-
Sarah Cannon Research InstituteNashvilleTennessee37203-
University of Washington / Fred Hutchinson Cancer CenterSeattleWashington98109-
Medical College of WisconsinMilwaukeeWisconsin53226-

Find similar trials in La Jolla, CA

By research site
University of California San Diego, UCSD· La Jolla, CAUCLA Medicine Division of Hematology-Oncology· Los Angeles, CAUSC Norris Comprehensive Cancer Center· Los Angeles, CAUniversity of Iowa Hospitals and Clinics· Iowa City, IAUniversity of Cincinnati Medical Center· Cincinnati, OHCleveland Clinic· Cleveland, OH

Related Studies