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

March 7, 2025 updated by: Replimune Inc.

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Withdrawn

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Czechia
      • Olomouc, Czechia, 779 00
        • University Hospital Olomouc
      • Prague, Czechia, 140 59
        • Fakultni Thomayerova nemocnice
      • Praha, Czechia, 100 00
        • FN Kralovske Vinohrady
  • France
      • Dijon, France, 21079
        • Centre Georges Francois Leclerc, Department of Oncology
      • Lyon, France, 69008
        • Centre Léon Bérard
      • Marseille, France, 13005
        • Assistance Publique Hôpitaux de Marseille
      • Nîmes, France, 30029
        • CHU Nimes, Instiut de Cancerologie du Gard, Medical Oncology
      • Villejuif, France, 94805
        • Institut Gustave Roussy Paris
  • Germany
      • Berlin, Germany, 12203
        • Charite University Hospital of Berlin, Comprehensive Cancer Center
      • Jena, Germany, 07747
        • Universitatsklinik Jena Klinik und Poliklinik fur Hals-, Nasen - und Ohrenheilkunde
      • Leipzig, Germany, 04103
        • University Hospital Leipzig Clinic and Polyclinic for otorhinolaryngology
      • Munich, Germany, 81377
        • LMU Klinikum, Medizinische Klinik und Poliklinikum III
      • Ulm, Germany, 89075
        • Universitätsklinikum Ulm
  • Greece
      • Chaïdári, Greece, 12462
        • University General Hospital Attikon
      • Thessaloníki, Greece, 55236
        • Agios Lukas Hospital
  • Poland
      • Kraków, Poland, 31-826
        • Szpital Specjalistyczny im Ludwika Rydygiera w Krakowie sp z oo, Department of Clinical Oncology
  • Spain
      • Barcelona, Spain, 08035
        • Vall d'Hebron University Hospital, Vall d' Hebron Institute of Oncology (VHIO)
      • Madrid, Spain, 28050
        • Hospital Universitario HM Sanchinarro
      • Madrid, Spain, 28046
        • La Paz Univeristy Hospital, Universidad Autonoma de Madrid
      • Pamplona, Spain, 31008
        • Clinica Universitaria de Navarra
      • Valencia, Spain, 46009
        • Fundación Instituto Valenciano de Oncología
  • United Kingdom
      • London, United Kingdom, SW3 6JJ
        • The Royal Marsden NHS Foundation Trust
  • United States
    • California
      • La Jolla, California, United States, 92037
        • University of California San Diego, UCSD
      • Los Angeles, California, United States, 90033
        • USC Norris Comprehensive Cancer Center
      • Los Angeles, California, United States, 90095
        • UCLA Medicine Division of Hematology-Oncology
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • University of Iowa Hospitals and Clinics
    • Ohio
      • Cincinnati, Ohio, United States, 45219
        • University of Cincinnati Medical Center
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Thomas Jefferson University City Center and Abington
      • Pittsburgh, Pennsylvania, United States, 15232
        • University of Pittsburgh Medical Center, UPMC
      • Willow Grove, Pennsylvania, United States, 19090
        • Jefferson Health Abington Asplunhd Cancer Pavillion
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • Sarah Cannon Research Institute
    • Washington
      • Seattle, Washington, United States, 98109
        • University of Washington / Fred Hutchinson Cancer Center
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • Medical College of Wisconsin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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).
  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
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
Biological: nivolumab
anti-PD1 monoclonal antibody
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
Other: CCRT(concurrent chemoradiation therapy)
CCRT consisting of intensity modulated radiation therapy combined with a cis-platinum
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.
Biological: RP3
Genetically modified herpes simplex type 1 virus
Biological: nivolumab
anti-PD1 monoclonal antibody
Other: carboplatin and paclitaxel
chemotherapeutic agents

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
From Day 1 to documented progression of disease (up to 3 years)
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)
From Day 1 to documented progression of disease (up to 3 years)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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)
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
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)
Overall survival is defined as the time from the first day of study treatment to the date of death by any cause
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)
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)
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)

Complete response rate is the percentage of subjects achieving complete response

Metabolic complete response rate is the percentage of subjects achieving metabolic complete response
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)
No-evidence-of-disease is defined as no evidence of malignancy at any site
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)
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.
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)
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.
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)
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
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.
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.
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
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.
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
Percentage of subjects with TEAEs and SAEs
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)
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
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)
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
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)
Overall survival is defined as the time from the first day of study treatment to the date of death by any cause
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)
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
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)
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
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)
Percentage of subjects achieving a complete response
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)
Percentage of patients achieving complete response, partial response, or stable disease
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)
Number of Patients Who Undergo Attempted Definitive Resection
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
Percentage of subjects with TEAEs and SAEs
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Replimune Inc.

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Bristol-Myers Squibb

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: David Cohan, MD/FACS, Replimune Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 30, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 8, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 21, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 24, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 7, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • RP3-002

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

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