Squamous Cell Carcinoma of Head and NeckPhase 2NCT05743270
Study of RP3 in Combination With Nivolumab and Other Therapy in Patients With Locoregionally Advanced or Recurrent SCCHN
A Phase 2 study testing RP3, CCRT(concurrent chemoradiation therapy) and carboplatin and paclitaxel in people with Squamous Cell Carcinoma of Head and Neck and Locally Advanced Head and Neck Squamous Cell Carcinoma, run by Replimune, Inc. at 34 sites in 8 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Squamous Cell Carcinoma of Head and Neck, Locally Advanced Head and Neck Squamous Cell Carcinoma, Recurrent Head and Neck Squamous Cell Carcinoma
- What is being tested?
- RP3, CCRT(concurrent chemoradiation therapy) and carboplatin and paclitaxel
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 34 sitesin 8 countries
- Study dates
- 30 Jan 2024to 1 Jun 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 17Show fewer
- 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.
Who cannot join
- 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
Show all 27Show fewer
- 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).
- Previously received multiple courses of irradiation to the same anatomic site unless such patient has nondoubly-irradiated, measurable, injectable lesions, which are the only lesions to be used as target lesions (for nodal disease, only lesions in nodal basins that have been previously irradiated just once or not irradiated at all may be injected and/or used as target lesions).
- Note: Other protocol defined inclusion/exclusion criteria apply for each cohort
Trial locations and contacts
34 sites in 8 countries.
34 sites in 8 countries
United States12 sites
University of Cincinnati Medical Center
Cincinnati, Ohio, 45219
Cleveland Clinic
Cleveland, Ohio, 44195
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242
University of California San Diego, UCSD
La Jolla, California, 92037
USC Norris Comprehensive Cancer Center
Los Angeles, California, 90033
UCLA Medicine Division of Hematology-Oncology
Los Angeles, California, 90095
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
Sarah Cannon Research Institute
Nashville, Tennessee, 37203
Thomas Jefferson University City Center and Abington
Philadelphia, Pennsylvania, 19107
University of Pittsburgh Medical Center, UPMC
Pittsburgh, Pennsylvania, 15232
University of Washington / Fred Hutchinson Cancer Center
Seattle, Washington, 98109
Jefferson Health Abington Asplunhd Cancer Pavillion
Willow Grove, Pennsylvania, 19090
France5 sites
Centre Georges Francois Leclerc, Department of Oncology
Dijon, 21079
Centre Leon Berard
Lyon, 69008
Assistance Publique Hopitaux De Marseille
Marseille, 13005
CHU Nimes, Instiut de Cancerologie du Gard, Medical Oncology
Nîmes, 30029
Institut Gustave Roussy Paris
Villejuif, 94805
Germany5 sites
Charite University Hospital of Berlin, Comprehensive Cancer Center
Berlin, 12203
Universitatsklinik Jena Klinik und Poliklinik fur Hals-, Nasen - und Ohrenheilkunde
Jena, 07747
University Hospital Leipzig Clinic and Polyclinic for otorhinolaryngology
Leipzig, 04103
LMU Klinikum, Medizinische Klinik und Poliklinikum III
Munich, 81377
Universitatsklinikum Ulm
Ulm, 89075
Spain5 sites
Vall d'Hebron University Hospital, Vall d' Hebron Institute of Oncology (VHIO)
Barcelona, 08035
La Paz Univeristy Hospital, Universidad Autonoma de Madrid
Madrid, 28046
Hospital Universitario HM Sanchinarro
Madrid, 28050
Clinica Universitaria de Navarra
Pamplona, 31008
Fundacion Instituto Valenciano de Oncologia
Valencia, 46009
Czechia3 sites
University Hospital Olomouc
Olomouc, 779 00
FN Kralovske Vinohrady
Prague, 100 00
Fakultni Thomayerova Nemocnice
Prague, 140 59
Greece2 sites
University General Hospital Attikon
Chaïdári, 12462
Agios Lukas Hospital
Thessaloniki, 55236
Poland1 site
Szpital Specjalistyczny im Ludwika Rydygiera w Krakowie sp z oo, Department of Clinical Oncology
Krakow, 31-826
United Kingdom1 site
The Royal Marsden NHS Foundation Trust
London, SW3 6JJ
About this study
Official title: 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
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.
Read the 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
- Squamous Cell Carcinoma of Head and Neck, Locally Advanced Head and Neck Squamous Cell Carcinoma, Recurrent Head and Neck Squamous Cell Carcinoma
- Being tested
- RP3, CCRT(concurrent chemoradiation therapy), carboplatin and paclitaxel, nivolumab
- Keywords
- Squamous cell carcinomas of head and neck, Immunotherapy, Immuno-oncology, Oncolytic virus, Oncolytic immuno-gene therapy
- Medical subject headings
- Squamous Cell Carcinoma of Head and Neck
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RP3Biological
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 paclitaxelOther
chemotherapeutic agents
nivolumabBiological
anti-PD1 monoclonal antibody
| Study group | Role | What they receive |
|---|---|---|
| LA Cohort: RP3 in combination with CCRT followed by nivolumab in Locally Advanced SCCHN | Experimental | 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. Receives: Biological: RP3; Other: CCRT(concurrent chemoradiation therapy); Biological: nivolumab |
| LA Cohort: concurrent chemoradiation therapy in Patients With Locoregionally Advanced SCCHN | Active comparator | standard-of-care CCRT (defined as intensity-modulated radiation therapy [IMRT] and cisplatin Receives: Other: CCRT(concurrent chemoradiation therapy) |
| R/M Cohort:RP3 in combination with carboplatin, paclitaxel and then nivolumab in R/M SCCHN | Experimental | 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. Receives: Biological: RP3; Other: carboplatin and paclitaxel; Biological: nivolumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
LA Cohort: Progression-free Survival
Progression-free survival is defined as the time from the first day of study treatment to the date of progression of disease, which was subsequently confirmed, or death by any cause, whichever occurs first
Measured: From Day 1 to documented progression of disease (up to 3 years)
R/M Cohort: Objective Response Rate
Percentage of subjects achieving objective response (complete response + partial response)
Measured: From Day 1 to documented progression of disease (up to 3 years)
Secondary outcomes (20)
LA Cohort: Progression-free Survival Rates at 6 and 12 Months
Progression-free survival is defined as the time from the first day of study treatment to the date of progression of disease, which was subsequently confirmed, or death by any cause, whichever occurs first
Measured: From Day 1 to documented progression of disease (up to 12 months)
LA Cohort: Overall Survival Rate at 1, 2, and 3 Years
Overall survival is defined as the time from the first day of study treatment to the date of death by any cause
Measured: From Day 1 to date of death by any cause (up to 3 years)
LA Cohort: Overall Response Rate and Metabolic Overall Response Rate
Overall Response Rate is the percentage of subjects achieving objective response (complete response + partial response) Metabolic overall response rate is the percentage of subjects achieving objective metabolic response (complete metabolic response + partial metabolic response)
Measured: From Day 1 to documented progression of disease (up to 3 years)
LA Cohort: Complete Response Rate and Metabolic Complete Response Rate at 5-and 8-months Following of Initiation of Radiation Following of Initiation of Radiation
Complete response rate is the percentage of subjects achieving complete response
Metabolic complete response rate is the percentage of subjects achieving metabolic complete response
Measured: From Day 1 to documented progression of disease (up to 8Months Following of Initiation of Radiation)
LA Cohort: Proportion of Patients Achieving No-Evidence-of-Disease Status by Any Means (Including Salvage Surgery)
No-evidence-of-disease is defined as no evidence of malignancy at any site
Measured: From Day 1 to end of study (up to 3 years)
LA Cohort: Cumulative Incidence of Locoregional Failure
Locoregional Failure is defined as tumor growth or disease infiltration or spread at the primary tumor location and/or at anatomic areas of local and/or regional disease.
Measured: From Day 1 to end of study (up to 3 years)
LA Cohort: Cumulative Incidence of Distant Metastatic Failure
Distant metastatic failure is defined as growth of metastases or new appearance of metastases in lung, bone, liver, other distant organs, and/or distant lymph node stations.
Measured: From Day 1 to end of study (up to 3 years)
LA Cohort: Duration of Clinical Benefit
Duration of clinical benefit is defined as the time from the first day of study treatment to last progression of disease, which was subsequently confirmed or with no further follow-up for response, or death due to any cause, whichever occurs first, for subjects who achieve complete response, partial response, or stable disease
Measured: From Day 1 to documented progression of disease (up to 3 years)
LA Cohort: Summary of Patient-Reported Outcomes Measured by FACT-HNSI-22
FACT-HNSI-22 is a Functional Assessment of Cancer Therapy Head \& Neck Cancer Symptom Index which consists of 22 items. Each item is scored in a 5 point Likert-type scale: 0=Not at all, 1=A little bit, 2=Some-what, 3=Quite a bit, and 4=Very much. The higher the score, the worse the patient outcome.
Measured: From Day 1 to 52 Weeks.
LA Cohort: Summary of Patient-Reported Outcomes Measured by EQ-5D-5L
EQ-5D-5L is a self-assessed, health related, quality of life questionnaire which consists of 2 pages: EQ-5D descriptive system and EQ visual analogue scale (EQ VAS). The EQ-5D descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The EQ VAS records the patient's self-rated health on a vertical visual analogue scale which is numbered from 0 to 100. 0 means the worst health the patient can imagine. 100 means the best health the patient can imagine. The higher the score, the better the patient outcome.
Measured: From Day 1 to 52 Weeks
LA Cohort: Frequency, Nature, and Severity of TEAEs and SAEs
Percentage of subjects with TEAEs and SAEs
Measured: From Screening through 60 days after last dose of RP3, or 100 days after last dose of nivolumab, or 28 days after last dose of either cisplatin, carboplatin, or paclitaxel, whichever occurs last
R/M Cohort: Progression-free Survival
Progression-free survival is defined as the time from the first day of study treatment to the date of progression of disease, which was subsequently confirmed, or death by any cause, whichever occurs first
Measured: From Day 1 to documented progression of disease (up to 3 years)
R/M Cohort: Progression-free Survival Rates at 6 and 12 Months
Progression-free survival is defined as the time from the first day of study treatment to the date of progression of disease, which was subsequently confirmed, or death by any cause, whichever occurs first
Measured: From Day 1 to documented progression of disease (up to 12 months)
R/M Cohort: Overall Survival Rates at 1, 2, and 3 Years
Overall survival is defined as the time from the first day of study treatment to the date of death by any cause
Measured: From Day 1 to date of death by any cause (up to 3 years)
R/M Cohort: Duration of Response
Duration of response is defined as the time from documented response until the date of progression of disease, which was subsequently confirmed or with no further follow-up, or death due to any cause, whichever occurs first
Measured: From Day 1 to documented progression of disease (up to 3 years)
R/M Cohort: Duration of Clinical Benefit
Duration of clinical benefit is defined as the time from the first day of study treatment to last progression of disease, which was subsequently confirmed or with no further follow-up for response, or death due to any cause, whichever occurs first, for subjects who achieve complete response, partial response, or stable disease
Measured: From Day 1 to documented progression of disease (up to 3 years)
R/M Cohort: Complete Response Rate
Percentage of subjects achieving a complete response
Measured: From Day 1 to documented progression of disease (up to 3 years)
R/M Cohort: Disease Control Rate
Percentage of patients achieving complete response, partial response, or stable disease
Measured: From Day 1 to documented progression of disease (up to 3 years)
R/M Cohort: Number of Patients Who Undergo Attempted Definitive Resection
Number of Patients Who Undergo Attempted Definitive Resection
Measured: From Day 1 to end of study (up to 3 years)
R/M Cohort: Frequency, Nature, and Severity of TEAEs and SAEs
Percentage of subjects with TEAEs and SAEs
Measured: From Screening through 60 days after last dose of RP3, or 100 days after last dose of nivolumab, or 28 days after last dose of either cisplatin, carboplatin, or paclitaxel, whichever occurs last
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2023
- Study start30 Jan 2024 (estimated)
- Primary completion1 Mar 2026 (estimated)
- Study completion1 Jun 2026 (estimated)
Why it stopped: Sponsor decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Squamous Cell Carcinoma of Head and NeckStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Replimune, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Bristol-Myers Squibb
- Responsible party
- Sponsor
- Investigators
- David Cohan, MD/FACS, Study director, Replimune, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05743270
- Sponsor's protocol ID
- RP3-002
- Status last verified
- Mar 2025
- First submitted
- 8 Feb 2023
- Last updated
- 11 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05743270
- Acronym / sponsor ID
- RP3-002
- Conditions
- Squamous Cell Carcinoma of Head and Neck, Locally Advanced Head and Neck Squamous Cell Carcinoma, Recurrent Head and Neck Squamous Cell Carcinoma
- Keywords
- Squamous cell carcinomas of head and neck, Immunotherapy, Immuno-oncology, Oncolytic virus, Oncolytic immuno-gene therapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Sponsor decision
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Replimune, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Bristol-Myers Squibb
- Study start
- 30 Jan 2024 (estimated)
- Primary completion
- 1 Mar 2026 (estimated)
- Study completion
- 1 Jun 2026 (estimated)
- First posted
- 24 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| LA Cohort: RP3 in combination with CCRT followed by nivolumab in Locally Advanced SCCHN | Experimental | Biological: RP3, Other: CCRT(concurrent chemoradiation therapy), Biological: nivolumabRP3 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. |
| LA Cohort: concurrent chemoradiation therapy in Patients With Locoregionally Advanced SCCHN | Active comparator | Other: CCRT(concurrent chemoradiation therapy)standard-of-care CCRT (defined as intensity-modulated radiation therapy [IMRT] and cisplatin |
| R/M Cohort:RP3 in combination with carboplatin, paclitaxel and then nivolumab in R/M SCCHN | Experimental | Biological: RP3, Other: carboplatin and paclitaxel, Biological: nivolumabRP3 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- 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.
Key exclusion criteria (27 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RP3Genetically modified herpes simplex type 1 virus | Biological | LA Cohort: RP3 in combination with CCRT followed by nivolumab in Locally Advanced SCCHN, R/M Cohort:RP3 in combination with carboplatin, paclitaxel and then nivolumab in R/M SCCHN |
| CCRT(concurrent chemoradiation therapy)CCRT consisting of intensity modulated radiation therapy combined with a cis-platinum | Other | LA Cohort: RP3 in combination with CCRT followed by nivolumab in Locally Advanced SCCHN, LA Cohort: concurrent chemoradiation therapy in Patients With Locoregionally Advanced SCCHN |
| carboplatin and paclitaxelchemotherapeutic agents | Other | R/M Cohort:RP3 in combination with carboplatin, paclitaxel and then nivolumab in R/M SCCHN |
| nivolumabanti-PD1 monoclonal antibody | Biological | LA Cohort: RP3 in combination with CCRT followed by nivolumab in Locally Advanced SCCHN, R/M Cohort:RP3 in combination with carboplatin, paclitaxel and then nivolumab in R/M SCCHN |
Primary outcome
LA Cohort: Progression-free Survival
Time frame: From Day 1 to documented progression of disease (up to 3 years)
Progression-free survival is defined as the time from the first day of study treatment to the date of progression of disease, which was subsequently confirmed, or death by any cause, whichever occurs first
R/M Cohort: Objective Response Rate
Time frame: From Day 1 to documented progression of disease (up to 3 years)
Percentage of subjects achieving objective response (complete response + partial response)
20 secondary outcomes
LA Cohort: Progression-free Survival Rates at 6 and 12 Months
Time frame: From Day 1 to documented progression of disease (up to 12 months)
LA Cohort: Overall Survival Rate at 1, 2, and 3 Years
Time frame: From Day 1 to date of death by any cause (up to 3 years)
LA Cohort: Overall Response Rate and Metabolic Overall Response Rate
Time frame: From Day 1 to documented progression of disease (up to 3 years)
LA Cohort: Complete Response Rate and Metabolic Complete Response Rate at 5-and 8-months Following of Initiation of Radiation Following of Initiation of Radiation
Time frame: From Day 1 to documented progression of disease (up to 8Months Following of Initiation of Radiation)
LA Cohort: Proportion of Patients Achieving No-Evidence-of-Disease Status by Any Means (Including Salvage Surgery)
Time frame: From Day 1 to end of study (up to 3 years)
LA Cohort: Cumulative Incidence of Locoregional Failure
Time frame: From Day 1 to end of study (up to 3 years)
LA Cohort: Cumulative Incidence of Distant Metastatic Failure
Time frame: From Day 1 to end of study (up to 3 years)
LA Cohort: Duration of Clinical Benefit
Time frame: From Day 1 to documented progression of disease (up to 3 years)
LA Cohort: Summary of Patient-Reported Outcomes Measured by FACT-HNSI-22
Time frame: From Day 1 to 52 Weeks.
LA Cohort: Summary of Patient-Reported Outcomes Measured by EQ-5D-5L
Time frame: From Day 1 to 52 Weeks
LA Cohort: Frequency, Nature, and Severity of TEAEs and SAEs
Time frame: From Screening through 60 days after last dose of RP3, or 100 days after last dose of nivolumab, or 28 days after last dose of either cisplatin, carboplatin, or paclitaxel, whichever occurs last
R/M Cohort: Progression-free Survival
Time frame: From Day 1 to documented progression of disease (up to 3 years)
R/M Cohort: Progression-free Survival Rates at 6 and 12 Months
Time frame: From Day 1 to documented progression of disease (up to 12 months)
R/M Cohort: Overall Survival Rates at 1, 2, and 3 Years
Time frame: From Day 1 to date of death by any cause (up to 3 years)
R/M Cohort: Duration of Response
Time frame: From Day 1 to documented progression of disease (up to 3 years)
R/M Cohort: Duration of Clinical Benefit
Time frame: From Day 1 to documented progression of disease (up to 3 years)
R/M Cohort: Complete Response Rate
Time frame: From Day 1 to documented progression of disease (up to 3 years)
R/M Cohort: Disease Control Rate
Time frame: From Day 1 to documented progression of disease (up to 3 years)
R/M Cohort: Number of Patients Who Undergo Attempted Definitive Resection
Time frame: From Day 1 to end of study (up to 3 years)
R/M Cohort: Frequency, Nature, and Severity of TEAEs and SAEs
Time frame: From Screening through 60 days after last dose of RP3, or 100 days after last dose of nivolumab, or 28 days after last dose of either cisplatin, carboplatin, or paclitaxel, whichever occurs last
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2025.
Related trials for Squamous Cell Carcinoma of Head and Neck
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingPhase 2
Proton Spatially Fractionated Radiotherapy or Photon Stereotactic Body Radiotherapy in Combination With Pembrolizumab Before Surgery for the Treatment of Locally Advanced and Radiation-Naive Locoregionally Recurrent Oral Cavity Cancer, OSPRI Trial
Locally Advanced Oral Cavity Squamous Cell Carcinoma, Locally Recurrent Oral Cavity Squamous Cell Carcinoma
RecruitingObservational study
Multicenter Prospective Cohort on Esophageal Endoscopic Submucosal Dissection
Superficial Esophageal Cancer, Oesophageal Adenocarcinoma
RecruitingPhase 1/2
Docetaxel and SX-682 in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma, Salivary Gland Carcinoma, and Advanced Prostate Cancer
Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma
Not yet recruiting
Tumoral Versus Luminal Microbiome in Head and Neck Squamous Cell Carcinoma
Squamous Cell Cancer of Head and Neck (SCCHN)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Cohan, MD/FACS study director
Replimune, Inc.
34 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing RP3, CCRT(concurrent chemoradiation therapy) and carboplatin and paclitaxel in people with Squamous Cell Carcinoma of Head and Neck and Locally Advanced Head and Neck Squamous Cell Carcinoma, run by Replimune, Inc. at 34 sites in 8 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 11 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 34 sites in United States, France, Germany, Spain, Czechia and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
LA Cohort: Progression-free Survival (time frame: From Day 1 to documented progression of disease (up to 3 years)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2025.