Your session is about to expire
← Back to Search
Virus Therapy
RP1 for Advanced Skin Cancer in Transplant Patients (ARTACUS Trial)
Phase 1 & 2
Recruiting
Research Sponsored by Replimune Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 36 months
Awards & highlights
ARTACUS Trial Summary
This trial is investigating whether a new drug is effective and safe for people with advanced skin cancer who have had organ transplants. Up to 65 people will be enrolled, and the trial will last for 3 years.
Who is the study for?
This trial is for organ transplant recipients with a life expectancy over 6 months, who have advanced skin cancers not treatable by surgery or radiation. Participants must have stable grafts, provide tumor samples, and have at least one measurable cancer lesion. They should be in good physical condition (ECOG ≤1) and not had certain infections or increased immunosuppression recently.Check my eligibility
What is being tested?
The study tests RP1, an oncolytic virus given through direct tumor injection to see how well it works (response rate) and its safety in up to 65 patients with skin cancers post-organ transplant. The trial includes screening, treatment for about a year, and two years of follow-up.See study design
What are the potential side effects?
Potential side effects are not explicitly listed but may include typical reactions associated with oncolytic viruses such as flu-like symptoms, fatigue, fever, chills, nausea or pain at the injection site due to immune system activation.
ARTACUS Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My skin cancer has returned or spread to my skin, soft tissue, or lymph nodes.
Select...
My condition worsened after surgery, radiation, or other treatments.
Select...
Surgery or radiation for my lesions is not recommended.
Select...
I am fully active or can carry out light work.
ARTACUS Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 36 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~36 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence of subjects with Serious adverse events (SAEs)
Incidence of subjects with fatal adverse events
Incidence of subjects with treatment-emergent adverse events greater than or equal to Grade 3
+3 moreSecondary outcome measures
3-year survival rate of subjects
Biologic activity as assessed by changes in individual tumor sizes, erythema, inflammation and necrosis
CR rate by investigator assessment
+8 moreARTACUS Trial Design
1Treatment groups
Experimental Treatment
Group I: RP1, intra-tumoral injection, oncolytic virusExperimental Treatment1 Intervention
RP1 administered as an intra-tumoral injection every 2 weeks.
Find a Location
Who is running the clinical trial?
Replimune Inc.Lead Sponsor
10 Previous Clinical Trials
1,270 Total Patients Enrolled
Jeannie Hou, MDStudy DirectorReplimune Inc.
2 Previous Clinical Trials
571 Total Patients Enrolled
Henry Castro, MDStudy DirectorReplimune Inc.
1 Previous Clinical Trials
123 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I haven't needed more immunosuppressants in the last 2 months.I agree to participate in the study and follow all its requirements.Your initial heart test does not show signs of a recent heart problem.You currently have an active herpes infection or have had serious complications from a previous herpes infection.I have not had an organ transplant rejection in the last year.I need medication that targets my immune system.I have an autoimmune disease but it's not severe and hasn't needed strong medication in the last 5 years.I have active brain metastases or carcinomatous meningitis.My skin cancer has returned or spread to my skin, soft tissue, or lymph nodes.My condition worsened after surgery, radiation, or other treatments.Surgery or radiation for my lesions is not recommended.I am fully active or can carry out light work.I have a tumor or lymph node that can be measured and is large enough for the study.I use anti-viral medication regularly, not for organ transplant care.I have not had transplant-related viral infections recently and my hepatitis B or C is under control.I haven't needed IV antibiotics or had a serious infection in the last 60 days.I do not have active hepatitis B, hepatitis C, or HIV.I have previously received treatment with a virus that kills cancer cells.My cancer has spread to my internal organs.
Research Study Groups:
This trial has the following groups:- Group 1: RP1, intra-tumoral injection, oncolytic virus
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the sample size of this experiment?
"Affirmative. Details found on clinicaltrials.gov demonstrate that this medical investigation, which commenced recruiting patients on May 15th 2020, is currently enrolling subjects. 65 individuals must be recruited from 14 separate trial centres."
Answered by AI
Is enrollment open for this particular clinical research?
"Per the information hosted on clinicaltrials.gov, this medical trial is presently recruiting participants, with initial posting taking place on May 15th 2020 and subsequent editing occurring October 17th 2022."
Answered by AI
Are any other healthcare facilities facilitating this trial within the state?
"Rochester Dermatologic Surgery in New york, Columbia University Medical Center in Pittsburgh and Houston's University of Pittsburgh Medical Centre are 3 sites that are operating for this trial. Additionally 11 other locations have been allocated to help facilitate the research."
Answered by AI
Recent research and studies
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger