What side effects are associated with this type of intervention?

Common treatments for Squamous Cell Carcinoma (SCC) include surgery, radiation therapy, and chemotherapy. Side effects of these treatments can vary. Surgery may lead to pain, infection, and scarring. Radiation therapy often causes skin irritation, fatigue, and changes in skin color. Chemotherapy can result in nausea, vomiting, hair loss, and increased risk of infection. Oncolytic virus therapies like RP1, which are being studied for SCC, generally aim to selectively infect and kill cancer cells while sparing normal cells. Known side effects of oncolytic virus therapies can include flu-like symptoms, injection site reactions, and mild to moderate fatigue.

What prior FDA approvals exist?

The FDA has approved several treatments for Squamous Cell Carcinoma (SCC), particularly focusing on advanced or metastatic cases. Notably, pembrolizumab (Keytruda) and nivolumab (Opdivo) are immune checkpoint inhibitors that have been approved for recurrent or metastatic SCC. These drugs work by enhancing the body's immune response against cancer cells. While oncolytic virus therapies like RP1 are still under investigation, they represent a novel approach by directly lysing cancer cells and stimulating an anti-tumor immune response. Other approved treatments include cetuximab (Erbitux), an EGFR inhibitor, which is often used in combination with chemotherapy. These therapies highlight the trend towards leveraging the immune system to combat SCC.

What other types of research exist?

Promising novel alternatives to RP1 for Squamous Cell Carcinoma patients include Reolysin (oncolytic reovirus therapy) and combination therapies involving oncolytic viruses with immunotherapy or chemotherapy. Additionally, dose-reduced radiation therapy combined with cisplatin has shown potential in clinical trials for HPV-associated oropharyngeal squamous cell carcinoma, which may be relevant for SCC treatment strategies.

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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

Must not have

Patients with a history of organ graft rejection within 12 months

Patients requiring CTLA-4-Ig medications

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 36 months

Awards & highlights

No Placebo-Only Group

Summary

This trial tests RP1, a modified virus, in organ transplant recipients with advanced skin cancer. RP1 works by killing cancer cells and boosting the immune system to fight the cancer. The HIV-1 accessory protein Vpr has been shown to induce cell cycle arrest and kill tumor cells by apoptosis.

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.

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.

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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My skin cancer has returned or spread to my skin, soft tissue, or lymph nodes.

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My condition worsened after surgery, radiation, or other treatments.

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Surgery or radiation for my lesions is not recommended.

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I am fully active or can carry out light work.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have not had an organ transplant rejection in the last year.

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I need medication that targets my immune system.

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I have active brain metastases or carcinomatous meningitis.

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I haven't needed IV antibiotics or had a serious infection in the last 60 days.

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I do not have active hepatitis B, hepatitis C, or HIV.

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I have previously received treatment with a virus that kills cancer cells.

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My cancer has spread to my internal organs.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 36 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~36 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 36 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Primary Efficacy Outcome Measure

Primary Safety Outcome Measure

Secondary study objectives

Biologic activity as assessed by changes in individual tumor sizes, erythema, inflammation and necrosis

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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.

0 / 11Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Squamous Cell Carcinoma (SCC) include surgery, radiation therapy, and systemic therapies such as chemotherapy and immunotherapy. Oncolytic virus therapy, like RP1, represents a novel approach where genetically modified viruses selectively infect and kill cancer cells while stimulating an anti-tumor immune response. This dual mechanism is particularly significant for SCC patients as it not only directly reduces tumor burden but also enhances the body's immune system to recognize and attack residual cancer cells, potentially leading to more durable responses and fewer recurrences.

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