AzTrials
AzTrials

Merkel Cell CarcinomaPhase 1/2ARTACUSNCT04349436

Study to Investigate the Efficacy and Safety of RP1 in Adult Patients With Organ Transplants and Advanced Skin Malignancies

A Phase 1/2 study testing RP1, intra-tumoral injection, oncolytic virus in people with Merkel Cell Carcinoma and Basal Cell Carcinoma, run by Replimune, Inc. at 24 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

The purpose of this study is to assess the safety and efficacy of RP1 (administered into the tumor) in 90 patients who have received an organ transplant in the past and currently have skin cancer. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
RP1, intra-tumoral injection, oncolytic virus
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
69 participants
Where
24 sitesUnited States
Study dates
15 May 2020to Nov 2029
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

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

  • Voluntary agreement to provide written informed consent prior to any study procedures and the willingness and ability to comply with all aspects of the protocol and understand the risk to their organ allograft.
  • Male or female at birth and at least 18 years of age prior to signing informed consent.
  • Solid organ or allogeneic hematopoietic cell transplant patients with histologically or cytologically confirmed recurrent, cutaneous malignancies including locally advanced CSCC, metastatic (to skin, soft tissue, or lymph nodes) or locally advanced BCC, metastatic or locally advanced MCC, and melanoma.
  • Patients must have progressed or experienced recurrence from previous local resection and/or prior radiation.
  • Documentation from the patient's transplant physician confirming that the patient's allograft is stable. For dual transplant recipients, a failure of 1 of the transplanted organs is allowed.
  • Patients for whom surgical or radiation treatment of lesions is contraindicated or are considered to be inoperable.
Show all 24Show fewer
  • Patients must have at least 1 measurable tumor of at least 1 cm in longest diameter. All measurable lesions identified at screening must be injectable and planned to be injected during the course of the study.
  • ECOG performance status of at most 1.
  • Adequate allograft function as determined by functional testing and as confirmed by the transplant clinician.
  • For renal transplant recipients, patients must have serum creatinine increase of < 30% mean increase over the past 6 months.
  • For lung transplant recipients, patients must have stable forced exploratory volume in 1 second (FEV1) of at least 50% predicted with no more than a 10% decline in the absolute FEV1 over the past 12 months.
  • For cardiac transplant recipients, patients must have:
  • ci. At least 50% ejection fraction with not more than an absolute change of 5% over the past 12 months. If the absolute change in ejection fraction is greater than 5% and there is no clinical suspicion for rejection by the transplant center, left ventricular ejection fraction (LVEF) stability needs to be shown by a repeat echo within 28 days after the most recent ECHO.
  • cii. No evidence of hemodynamically or angiographically significant cardiac allograft vasculopathy (CAV) (i.e., patients must not have CAV2 or CAV3), or no ischemia by appropriate diagnostic imaging over the past 12 months.
  • For patients with stable pancreas transplant, amylase and lipase should be ≤ 3 x upper limit of normal (ULN) for at least 6 months prior to enrollment.
  • Adequate hepatic function
  • Adequate renal function as indicated by a serum creatinine or estimated glomerular filtration rate (eGFR) determined based on the Chronic Kidney Disease-Epidemiology Collaboration equation.
  • Adequate hematologic function
  • Adequate coagulation parameters
  • Anticipated life expectancy > 6 months.
  • Have provided either formalin-fixed, paraffin-embedded (FFPE) tissue block and/or unstained tumor tissue sections, obtained within 90 days prior to enrollment, with an associated pathology report, which must be submitted to the central laboratory for inclusion or a fresh excisional, incisional, or core needle biopsy taken prior to dosing on C1D1 if an archival biopsy (collected within 90 days prior to enrollment) is not available.
  • Female and male patients (at birth) who meet the following criteria:
  • Female patients are eligible if not pregnant or breastfeeding and if one of the following applies 1) is a woman of non-childbearing potential (WNCBP) OR 2) is a woman of childbearing potential (WOCBP) and must agree to use a highly effective contraception method during the treatment period and for at least 90 days after last dose of RP1.
  • Male patients are eligible if they agree to the following during the study intervention period and for at least 90 days after the last dose of RP1: refrain from donating fresh unwashed semen plus either be abstinent from intercourse where pregnancy can occur OR must agree to use external condom and advise their partner to use a highly effective method of contraception.

Who cannot join

  • Prior treatment with an oncolytic therapy or checkpoint inhibitor.
  • Patients with visceral metastases.
  • Active significant herpetic infections or prior complications of HSV-1 infection (e.g., herpetic keratitis or encephalitis). Patients requiring use of systemic (oral/intravenous [IV]) antiviral agents with known antiherpetic activity.
  • Patients requiring concurrent treatment with cytotoxic T-lymphocyte antigen 4-Ig (CTLA-4-Ig) medications.
  • Had systemic infection requiring IV antibiotics or other serious infection within 14 days prior to dosing.
  • Patients with an active, known, or suspected autoimmune disease that requires systemic immunosuppressive treatment beyond immunosuppressive medications required for maintenance of allograft rejection prevention.
Show all 19Show fewer
  • Patients with a history of any positive test result for hepatitis B virus (HBV) or hepatitis C virus (HCV) indicating the presence of the virus, or human immunodeficiency virus (HIV) positive. Patients with a history of HBV or HCV must have undetectable viral load within 3 months of study entry.
  • A history of transplant-related viral infections such as BK virus (BKV), Epstein-Barr virus (EBV), or cytomegalovirus (CMV) requiring treatment or modification to immunosuppression within 3 months of study entry.
  • Had clinically significant cardiovascular disease within 6 months from first dose of RP1, including New York Heart Association Class III or IV congestive heart failure, unstable angina, myocardial infarction or stroke/transient ischemic attack or significant cardiac arrhythmias associated with hemodynamic instability.
  • Radiation therapy within 14 days of first dose of RP1, or topical or any systemic therapy within 30 days of the first dose of RP1.
  • Documented history of allergic reactions or acute hypersensitivity reaction attributed to RP1 or to any of the excipients.
  • Females who have a positive serum beta-human chorionic gonadotropin (β-hCG) test for pregnancy (at screening within 72 hours before dosing), or a positive urine pregnancy test on C1D1.
  • Any active malignancy within 3 years of the date of first planned dose of RP1, except for the specific cancer under investigation in this study and tumors with negligible risk of metastasis or death.
  • Any acute or chronic psychiatric problems, alcohol abuse, or substance abuse disorders that, in the opinion of the investigator, would interfere with the patient's ability to comply with the requirements of the study.
  • Any co-morbidity, physical examination finding, metabolic dysfunction, or clinical laboratory abnormality that, in the opinion of the investigator, renders the patient unsuitable for participation due to safety risks or potential to affect interpretation of results of the study.
  • Treatment with botanical preparations (e.g., herbal supplements or traditional Chinese medicines) intended for general health support or to treat the disease under study within 2 weeks prior to the first dose and throughout the study.
  • Has received a live vaccine within 30 days prior to the first dose of study drug. Note: Available COVID-19 vaccines do not contain live virus.
  • Active or history of leptomeningeal disease or brain metastasis.
  • Active graft versus host disease greater than Grade 1 within the last 12 months requiring systemic treatment.

Trial locations and contacts

24 sites in 1 country.

24 sites in 1 country

United States24 sites

  • University of Colorado Cancer Center School of Medicine

    Aurora, Colorado, 80045

  • Dana Farber Cancer Institute

    Boston, Massachusetts, 02215

  • University of North Carolina Lineberger Comprehensive Cancer Center

    Chapel Hill, North Carolina, 27599

  • University of Cincinnati

    Cincinnati, Ohio, 45267

  • The Cleveland Clinic Foundation

    Cleveland, Ohio, 44195

  • The Ohio State University Comprehensive Cancer Center

    Columbus, Ohio, 43210

  • University of Texas Southwestern

    Dallas, Texas, 75235

  • Duke University

    Durham, North Carolina, 27708

  • Inova Schar Cancer Institute

    Fairfax, Virginia, 22031

  • MD Anderson Cancer Center

    Houston, Texas, 77030

  • Mayo Clinic Florida

    Jacksonville, Florida, 32224

  • University of Tennessee Medical Center at Knoxville

    Knoxville, Tennessee, 37920

  • University of California, San Diego

    La Jolla, California, 92093

  • University of California, Los Angeles

    Los Angeles, California, 90024

  • University of Miami Sylvester Comprehensive Cancer Center

    Miami, Florida, 33136

  • Rochester Dermatologic Surgery

    New York, New York, 14564

  • Medical Dermatology Specialists

    Phoenix, Arizona, 85006

  • Mayo Clinic Arizona

    Phoenix, Arizona, 85054

  • University of Pittsburgh Medical Center

    Pittsburgh, Pennsylvania, 15213

  • Oregon Health and Science University

    Portland, Oregon, 97239

  • Mayo Clinic Rochester

    Rochester, Minnesota, 55905

  • UCSF, Helen Diller Family Comprehensive Cancer Center

    San Francisco, California, 94143

  • Washington University in St. Louis

    St Louis, Missouri, 63110

  • Moffitt Cancer Center

    Tampa, Florida, 33612

Other trials in United States

About this study

Official title: An Open-Label, Multicenter, Phase 1B/2 Study of RP1 in Solid Organ and Hematopoietic Cell Transplant Recipients With Advanced Cutaneous Malignancies (ARTACUS)

The purpose of this study is to assess the safety and efficacy of RP1 (administered into the tumor) in 90 patients who have received an organ transplant in the past and currently have skin cancer. The skin cancer is either locally advanced (large tumors in the skin, muscles or nerves) or metastatic (spread to other parts of the body).

This study will consist of a 28-day Screening Period, a Treatment Period, and a Follow-up Period. During the Treatment Period, patients will be dosed with RP1 every two weeks for up to 2 years (104 weeks). Tumor measurements will be done approximately every 8 weeks (and additionally if needed) until progressive disease, start of subsequent anticancer therapy, or completion/discontinuation of the study. During the Follow-up Period, patients will visit the clinic at 30, 60, and 100-150 days after their last dose of RP1 for safety and quality of life assessments. Patients will continue follow-up for up to 3 years from the day of the last patient's first dose.

Read the detailed description

RP1 is a genetically modified herpes simplex type 1 virus that is designed to directly destroy tumors and to generate an anti-tumor immune response. This is a Phase 1B/2, open label, multicenter, study evaluating the objective response rate and the safety and tolerability of RP1 in adult hepatic, renal, heart, lung, other solid organs, and/or hematopoietic cell transplant recipients who subsequently experienced advanced or metastatic cutaneous malignancies. Patients will be dosed with RP1 by direct or ultrasound guided intra-tumoral injection into superficial, subcutaneous, or nodal tumors. No transplanted organs will be injected.

Being tested
RP1, intra-tumoral injection, oncolytic virus
Keywords
Oncolytic virus, Oncolytic Immuno-gene therapy, Carcinoma, Skin cancer, Locally Advanced CSCC, MCC, BCC
Medical subject headings
Carcinoma, Merkel Cell, Carcinoma, Basal Cell, Neoplasms, Carcinoma, Skin Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RP1, intra-tumoral injection, oncolytic virusBiological

    Genetically modified herpes simplex type 1 virus

Study groups in NCT04349436
Study groupRoleWhat they receive
RP1, intra-tumoral injection, oncolytic virusExperimentalRP1 administered as an intra-tumoral injection every 2 weeks.
Receives: Biological: RP1, intra-tumoral injection, oncolytic virus

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Primary Objective for Patients with Locally Advances CSCC (laCSCC)

    The effect of RP1 on objective response rate (ORR) as assessed by Independnet Central Review (ICR) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1)

    Measured: 36 months

  2. Primary Efficacy Objective for Patients with Other Skin Cancers

    The effect of RP1 on ORR as assessed by investigator review per modified RECIST 1.1 (mRECIST 1.1)

    Measured: 36 months

  3. Primary Safety Objective for Patients with Other Skin Cancers

    The safety and tolerability of single-agent RP1 in solid organ transplant patients with other skin cancers as assessed by incidence of patients with treatment-emergent adverse events (TEAEs) and by incidence of patients with biopsy-proven allograft rejection.

    Measured: 36 months

Secondary outcomes (8)

  1. Duration of Response (DOR) for Patients with laCSCC

    The effect of RP1 on the time from onset of response to disease progression (PD) or death in patients who achieve a Complete Response (CR) or Partial Response (PR) as assessed by ICR per RECIST 1.1

    Measured: 36 months

  2. Progression-Free Survival (PFS) for Patients with laCSCC

    The effect of RP1 on the time from the first study treatment to first evidence of disease progression or death as assessed by ICR per RECIST 1.1

    Measured: 36 months

  3. Disease Control Rate (DCR) for Patients with laCSCC

    The effect of RP1 on the proportion of patients achieving confirmed response (either CR or PR) or Stable Disease (SD) for at least 6 weeks as assessed by ICR per RECIST 1.1

    Measured: 36 months

  4. ORR for Patients with laCSCC by investigator review

    The effect of RP1 on the proportion of patients with confirmed best overall response of CR or PR as assessed by investigator review per RECIST 1.1

    Measured: 36 months

  5. Efficacy parameters for Patients with laCSCC by investigator review

    The effect of RP1 on DOR, PFS, and DCR as assessed by investigator review per RECIST 1.1

    Measured: 36 months

  6. Overall Survival for Patients with laCSCC

    The effect of RP1 on the time from first study treatment to death from any cause

    Measured: 36 months

  7. Secondary Safety Objective for Patients with laCSCC

    The safety and tolerability of single-agent RP1 in solid organ transplant patients with laCSCC as assessed by incidence of patients with TEAEs and by incidence of patients with biopsy-proven allograft rejection.

    Measured: 36 months

  8. Secondary Objective for Patients with Other Skin Cancers

    The effect of RP1 on DOR and PFS as assessed by investigator review per mRECIST 1.1. The effect of RP1 on OS.

    Measured: 36 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Apr 2020
  2. Study start15 May 2020
  3. Primary completionJul 2029 (estimated)
  4. Study completionNov 2029 (estimated)

Resources

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 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
RP1 injection
Masking
None (open label)
Enrolment
69 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04349436
Sponsor's protocol ID
RPL-003-19
Acronym
ARTACUS
Status last verified
Apr 2026
First submitted
14 Apr 2020
Last updated
22 Apr 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing RP1, intra-tumoral injection, oncolytic virus in people with Merkel Cell Carcinoma and Basal Cell Carcinoma, run by Replimune, Inc. at 24 sites in United States.

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 24 inclusion and 19 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: under way, not looking for participants, as of the sponsor's last update on 22 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 24 sites in United States. 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 combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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?

This study is still under way. Results are not available in the source record yet.

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?

Primary Objective for Patients with Locally Advances CSCC (laCSCC) (time frame: 36 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04349436.

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 22 Apr 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in