A Phase 1B/2 Study of RP1 in Solid Organ Transplant Patients With Advanced Cutaneous Malignancies (ARTACUS)
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ClinicalTrials.gov Identifier: NCT04349436 |
Recruitment Status :
Recruiting
First Posted : April 16, 2020
Last Update Posted : February 1, 2023
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Condition or disease | Intervention/treatment | Phase |
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Cutaneous Squamous Cell Carcinoma Merkel Cell Carcinoma Basal Cell Carcinoma Melanoma | Biological: RP1, intra-tumoral injection, oncolytic virus | Phase 1 Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 65 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Intervention Model Description: | RP1 injection |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | An Open-Label, Multicenter, Phase 1B/2 Study of RP1 in Solid Organ and Hematopoietic Cell Transplant Recipients With Advanced Cutaneous Malignancies |
Actual Study Start Date : | May 15, 2020 |
Estimated Primary Completion Date : | September 2027 |
Estimated Study Completion Date : | January 2028 |

Arm | Intervention/treatment |
---|---|
Experimental: RP1, intra-tumoral injection, oncolytic virus
RP1 administered as an intra-tumoral injection every 2 weeks.
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Biological: RP1, intra-tumoral injection, oncolytic virus
Genetically modified herpes simplex type 1 virus |
- Primary Safety Outcome Measure [ Time Frame: 36 months ]Assess the safety and tolerability of single-agent RP1 in solid organ transplant patients with cutaneous malignancies by incidence of subjects with treatment-emergent adverse events
- Primary Efficacy Outcome Measure [ Time Frame: 36 months ]The objective response rate (ORR) according to investigator assessment using modified RECIST version 1.1.
- Incidence of subjects with treatment-emergent adverse events greater than or equal to Grade 3 [ Time Frame: 36 months ]
- Incidence of subjects with Serious adverse events (SAEs) [ Time Frame: 36 months ]
- Incidence of subjects with fatal adverse events [ Time Frame: 36 months ]
- Treatment-emergent adverse events requiring withdrawal from IP and incidence of organ allograft rejection [ Time Frame: 36 months ]
- Duration of response (DOR) by investigator among subjects who experience Complete Response (CR) or Progressive Disease (PD) [ Time Frame: 36 months ]
- CR rate by investigator assessment [ Time Frame: 36 months ]
- Disease control rate (DCR) by investigator review [ Time Frame: 36 months ]
- Clinical benefit rate defined as the rate of Complete Response (CR), Partial Response (PR), or Stable Disease (SD) [ Time Frame: 36 months ]
- Progression Free Survival (PFS) by investigator review Duration of clinical benefit (DOCB) during active treatment and for up to one year after last treatment by investigator review [ Time Frame: 36 months ]
- Overall survival (OS) at one year and two years [ Time Frame: 36 months ]
- 3-year survival rate of subjects [ Time Frame: 36 months ]
- Quality of life (QoL), as determined by patient-reported outcomes [ Time Frame: 36 months ]
- Biologic activity as assessed by changes in individual tumor sizes, erythema, inflammation and necrosis [ Time Frame: 36 months ]Percentage of patients with biopsy-proven clinical rejection and percentage of patients who require an increase in immune suppressive therapy, during active treatment and for up to 1 year after last treatment
- Disease-free Survival [ Time Frame: 36 months ]
- To asses the efficacy of RP1 as determined by ORR in all transplant recipients treated, by investigator review [ Time Frame: 36 months ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Key Inclusion Criteria:
- 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.
- Patients with histologically or cytologically confirmed recurrent, locally advanced or metastatic (to skin, soft tissue or lymph nodes) cutaneous malignancies, including CSCC, basal cell carcinoma, Merkel cell carcinoma, and melanoma
- Patients must have progressed following local resection, prior radiation, topical or systemic therapies.
- Documentation from the patient's transplant physician confirming that the patient's allograft is stable.
- Patients for whom surgical or radiation treatment of lesions is contraindicated.
- At least 1 lesion that is measurable and injectable by study criteria (tumor of ≥1cm in longest diameter or ≥1.5 cm in shortest diameter for lymph nodes).
- Eastern Cooperative Oncology Group (ECOG) performance status ≤1.
- Anticipated life expectancy > 6 months
- Baseline ECG without evidence of acute ischemia.
- All patients must consent to provide archived or newly obtained tumor material (either formalin-fixed, paraffin-embedded [FFPE] block or 20 unstained slides).
Key Exclusion Criteria:
- Prior treatment with an oncolytic therapy.
- Patients with visceral metastases.
- Patients with active herpetic infections or prior complications of HSV-1 infection (e.g., herpetic keratitis or encephalitis).
- Patients with a history of organ graft rejection within 12 months.
- Had systemic infection requiring intravenous (IV) antibiotics or anti-virals, or other serious infection within 60 days prior to dosing.
- Patients who require intermittent or chronic use of systemic (oral or intravenous) anti-virals with known anti-herpetic activity (e.g., acyclovir) unless for organ allograft preservation.
- Patients requiring CTLA-4-Ig medications.
- Ongoing or recent (within 5 years) evidence of significant autoimmune disease that required treatment with systemic immunosuppressive treatments beyond that required for maintenance allograft rejection prevention. The following are not exclusionary: vitiligo, childhood asthma that has resolved, type 1 diabetes, residual hypothyroidism that requires only hormone replacement, or psoriasis that does not require systemic treatment.
- Active infection with hepatitis B virus (HBV), hepatitis C virus (HCV) or human immunodeficiency virus (HIV).
- Any history of transplant-related viral infections, such as BKV, EBV or CMV, within 3 months of study entry. Patients with a history of hepatitis B or C virus must have undetectable viral load within 3 months of study entry.
- Patients with a condition requiring an increase in the patient's usual immunosuppressive medications within 60 days of study treatment.
- Known active CNS metastases and/or carcinomatous meningitis.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04349436
Contact: Clinical Trials at Replimune | 1-781-222-9570 | Clinicaltrials@replimune.com |
United States, California | |
University of California, San Diego | Recruiting |
La Jolla, California, United States, 92093 | |
Principal Investigator: Gregory Daniels, MD | |
University of California, Los Angeles | Recruiting |
Los Angeles, California, United States, 90024 | |
Principal Investigator: Wanxing Chai-Ho, MD | |
UCSF, Helen Diller Family Comprehensive Cancer Center | Recruiting |
San Francisco, California, United States, 94143 | |
Principal Investigator: Katy Tsai, MD | |
United States, Colorado | |
University of Colorado Cancer Center School of Medicine | Recruiting |
Aurora, Colorado, United States, 80045 | |
Principal Investigator: Theresa Medina, MD | |
United States, Florida | |
University of Miami Sylvester Comprehensive Cancer Center | Recruiting |
Miami, Florida, United States, 33136 | |
Principal Investigator: Jennifer Tang | |
United States, Illinois | |
University of Chicago | Recruiting |
Chicago, Illinois, United States, 60637 | |
Principal Investigator: Diana Bolotin, MD | |
United States, New York | |
Columbia University Medical Center | Recruiting |
New York, New York, United States, 10032 | |
Principal Investigator: Shaheer Khan, DO | |
Rochester Dermatologic Surgery | Recruiting |
New York, New York, United States, 14564 | |
Contact: Ibrahim Sherrif | |
United States, North Carolina | |
Duke University | Recruiting |
Durham, North Carolina, United States, 27708 | |
Principal Investigator: Meenal Kheterpal, MD | |
United States, Ohio | |
University of Cincinnati | Recruiting |
Cincinnati, Ohio, United States, 45267 | |
Principal Investigator: Trisha Wise-Draper, MD | |
The Ohio State University Comprehensive Cancer Center | Recruiting |
Columbus, Ohio, United States, 43210 | |
Principal Investigator: Claire Verschraegen, MD | |
United States, Pennsylvania | |
University of Pittsburgh Medical Center | Recruiting |
Pittsburgh, Pennsylvania, United States, 15213 | |
Principal Investigator: Jason Luke, MD | |
United States, Texas | |
MD Anderson Cancer Center | Recruiting |
Houston, Texas, United States, 77030 | |
Principal Investigator: Michael Migden, MD | |
United States, Virginia | |
VCU Massey Cancer Center | Recruiting |
Richmond, Virginia, United States, 23298 | |
Principal Investigator: Andrew Poklepovic, MD |
Study Director: | Jeannie Hou, MD | Replimune Inc. |
Responsible Party: | Replimune Inc. |
ClinicalTrials.gov Identifier: | NCT04349436 |
Other Study ID Numbers: |
RPL-003-19 |
First Posted: | April 16, 2020 Key Record Dates |
Last Update Posted: | February 1, 2023 |
Last Verified: | January 2023 |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Carcinoma, Merkel Cell Carcinoma Carcinoma, Basal Cell Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Neuroendocrine Tumors Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal |
Neoplasms, Nerve Tissue Neoplasms, Basal Cell Polyomavirus Infections DNA Virus Infections Virus Diseases Infections Tumor Virus Infections Carcinoma, Neuroendocrine Adenocarcinoma |