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

Withdrawn before enrolling · Phase 2

Conditions studied: Squamous Cell Carcinoma of Head and Neck, Locally Advanced Head and Neck Squamous Cell Carcinoma, Recurrent Head and Neck Squamous Cell Carcinoma

In brief

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 facts

Study ID

NCT05743270

Run by

Replimune, Inc.

People needed

0

Starts

2024-01-30

Expected to finish

2026-06-01

Last updated by the study team

2025-03-11

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Histological diagnosis of squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx, or larynx or of a lymph node(s) anywhere in levels I to V of the neck that has been excluded clinically from association with cancer from a non-head and neck site
• All patients Must be willing to consent to provide archival or fresh tumor biopsy samples obtained within 60 days prior to initiation of study treatment. Patients must also consent to provide on-treatment biopsies as per protocol.
• At least 1 measurable lesion of ≥ 1 cm in longest diameter (or shortest diameter for lymph nodes), in accordance with RECIST.
• At least injectable tumors of at least 1 cm in aggregate overall longest diameter.
• Have an Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 -1.
• Locally Advanced Cohort Only
• patients must not be amenable to surgery with curative intent
• Previously untreated high-risk disease meeting at least 1 of the following criteria:
• Oral cavity, hypopharynx, larynx, oropharynx (p16 negative): Stage III/ IV Note: Cancers of the oral cavity, hypopharynx, and larynx are eligible irrespective of p16 status. These patients will not be stratified by p16 status.
• For p16 positive oropharynx cancers, patients must have either
• T3 and/or N2 or greater disease with active smoking and/or greater than 20 pack year smoking history OR
• T4 and/or N3 disease irrespective of tobacco use
• SCCHN of unknown primary Stage III/IV irrespective of p16 status or smoking status.
• Eligible for definitive CCRT with curative intent.
• R/M Cohort Only
• Has recurrent or metastatic SCCHN eligible for first line systemic therapy for R/M disease.
• Has a PD-L1 CPS <20.

You may not qualify if…

• Primary tumors of nasopharynx, paranasal sinuses, nasal passages, salivary gland, thyroid or parathyroid gland, or skin.
• Tumors with histopathology indicating the tumor has sarcomatous, sarcomatoid, verrucous, mixed, undifferentiated, or otherwise nonsquamous components.
• Has an airway that is not deemed safe and stable on flexible fiberoptic laryngoscopy (FFL) performed by a head \& neck cancer specialist within 7 days of first RP3 injection.
• Has a baseline serum albumin (at Screening) <2.5 g/dL and/or evidence of cachexia or muscle wasting during physical exam at Screening.
• Known acute or chronic hepatitis B or acute or chronic hepatitis C
• Systemic infection requiring intravenous (IV) antibiotics
• Active significant herpetic infections or prior complications of HSV-1 infection (eg, herpetic keratitis or encephalitis)
• History of interstitial lung disease.
• History of (noninfectious) pneumonitis that required steroids or has current pneumonitis.
• Patients who require intermittent or chronic use of systemic (oral or IV) antivirals with known antiherpetic activity (eg, acyclovir).
• Administration of live vaccine within 28 days prior to the first dose of study treatment.
• History of allergy or sensitivity to study drug components or prior monoclonal antibody treatment.
• History of life-threatening toxicity related to prior immune treatment or any other antibody or drug specifically targeting T-cell co-stimulation or immune checkpoint pathways
• History of viral infections according to the protocol
• Treatment with botanical preparations within 2 weeks prior to treatment.
• Major surgery ≤ 2 weeks prior to starting study treatment.
• LA Cohort only
• Has received prior radiotherapy for SCCHN.
• Has received any prior systemic therapy for SCCHN.
• R/M cohort only
• Is eligible for radiation and/or surgery with curative intent.
• Has received systemic therapy for recurrence or new (ie, not present at the time of initial diagnosis) metastases of SCCHN.
• Received a paclitaxel-containing regimen as part of frontline treatment (prior to R/M disease) with a documented best response of stable disease (SD) or PD (patients who achieved a partial response [PR] or CR are eligible).
• Received a carboplatin-containing regimen as part of frontline treatment (prior to R/M disease) with a documented best response of SD or PD (patients who achieved PR or CR are eligible).
• Patients with known intolerance to carbo-platinum and/or paclitaxel, including hypersensitivity to Cremophor® EL (polyoxyethylated castor oil).

Where it is running

• University of California San Diego, UCSD — La Jolla, California, United States
• USC Norris Comprehensive Cancer Center — Los Angeles, California, United States
• UCLA Medicine Division of Hematology-Oncology — Los Angeles, California, United States
• University of Iowa Hospitals and Clinics — Iowa City, Iowa, United States
• University of Cincinnati Medical Center — Cincinnati, Ohio, United States
• Cleveland Clinic — Cleveland, Ohio, United States
• Thomas Jefferson University City Center and Abington — Philadelphia, Pennsylvania, United States
• University of Pittsburgh Medical Center, UPMC — Pittsburgh, Pennsylvania, United States
• Jefferson Health Abington Asplunhd Cancer Pavillion — Willow Grove, Pennsylvania, United States
• Sarah Cannon Research Institute — Nashville, Tennessee, United States
• University of Washington / Fred Hutchinson Cancer Center — Seattle, Washington, United States
• Medical College of Wisconsin — Milwaukee, Wisconsin, United States
• University Hospital Olomouc — Olomouc, Czechia
• FN Kralovske Vinohrady — Prague, Czechia
• Fakultni Thomayerova Nemocnice — Prague, Czechia
• Centre Georges Francois Leclerc, Department of Oncology — Dijon, France
• Centre Leon Berard — Lyon, France
• Assistance Publique Hopitaux De Marseille — Marseille, France
• CHU Nimes, Instiut de Cancerologie du Gard, Medical Oncology — Nîmes, France
• Institut Gustave Roussy Paris — Villejuif, France
• Charite University Hospital of Berlin, Comprehensive Cancer Center — Berlin, Germany
• Universitatsklinik Jena Klinik und Poliklinik fur Hals-, Nasen - und Ohrenheilkunde — Jena, Germany
• University Hospital Leipzig Clinic and Polyclinic for otorhinolaryngology — Leipzig, Germany
• LMU Klinikum, Medizinische Klinik und Poliklinikum III — Munich, Germany
• Universitatsklinikum Ulm — Ulm, Germany

Full record on ClinicalTrials.gov

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