Non-melanoma skin cancers

ARTACUS – A Study Evaluating RP1 for the Treatment of Cutaneous Malignancies in Patients Who Have Had a Kidney, Liver, Heart, Lung, and/or a Hematopoietic Cell Transplant.

Clinical Trials.gov: https://clinicaltrials.gov/ct2/show/NCT04349436

Identifier: NCT04349436

This is a Phase 1B/2 clinical trial to study the effects of the investigational oncolytic immunotherapy RP1 for the treatment of cutaneous malignancies in patients who underwent either a kidney, liver, heart, lung, or hematopoietic cell transplantation. Researchers will study the safety of this treatment in patients and also evaluate its ability to shrink tumors.



Who is this study for?

This study is for patients who have had either a kidney or liver transplant and have advanced cutaneous squamous cell carcinoma (CSCC).

Key eligibility criteria

You may be eligible for this study if you meet the following conditions:
• Have recurrent, locally advanced or metastatic CSCC
• Have at least 1 measurable lesion
• Have had a kidney or liver transplant
• Are at least 18 years old
• Do not have an active viral infection, including from HSV-1, hepatitis B (HBV), hepatitis C (HCV) or HIV

Please note that there are additional criteria that must be met in order to participate in this study. Consult with your doctor to determine if you are eligible.

What to expect during the study

Patients will receive RP1 dose every 2 weeks for about one year.

The study has different sections. They are:

Initial ScreeningUp to 28 days
Treatment PeriodAbout 12 months
Follow-up PeriodUp to 3 years after your first dose of RP1

IMPORTANT: Only your doctor can determine whether or not you are eligible to participate in this clinical study. Please note that if you decide to participate in the study, you can also choose to stop at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.

Contact Email: clinicaltrials@replimune.com
Contact Phone Number: +1 (781) 222 9570

Replimune’s investigational products and their uses are investigational, have not been proven to be safe and have not been approved by the United States Food and Drug Administration (FDA), the European Medicines Agency (EMA) or any other regulatory authority.

IGNYTE – A Study Evaluating RP1 Given in Combination with Nivolumab in Patients with Solid Tumors

Clinical Trials.gov: https://clinicaltrials.gov/ct2/show/study/NCT03767348

Identifier: NCT03767348

This is a Phase 1/2 clinical trial to study the investigational oncolytic immunotherapy RP1 given in combination with nivolumab. Researchers will study the safety of this treatment in these patients and also evaluate its ability to shrink tumors.



Who is this study for?

This study is for patients with advanced solid tumors including anti-PD1 failed melanoma, nonmelanoma skin cancer (NMSC), microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) solid tumors and non-small cell lung cancer (NSCLC).

Key eligibility criteria

You may be eligible for this study if you meet the following conditions:
• Are at least 18 years old
• Have not been treated with a prior oncolytic immunotherapy
• Have not had a history of certain viral infections including from hepatitis B (HBV), hepatitis C (HCV) or HIV

Please note that there are additional criteria that must be met in order to participate in this study. Consult with your doctor to determine if you are eligible.

What to expect during the study

You will be given a single dose of RP1 and then 2 weeks later be given RP1 in combination with nivolumab every 2 weeks for approximately 3 months. Nivolumab would continue to be given every 4 weeks for up to an additional 20 months. After completing the initial course of RP1, RP1 may be reinitiated for patients who meet protocol specified criteria. Researchers will look at the safety of the drugs and whether the tumor(s) shrink. This will let the researchers determine whether RP1 is safe to give with nivolumab and whether this combination could be effective in treating your type of cancer.

The study has different sections. They are:

Initial ScreeningUp to 28 days
Treatment PeriodApproximately 2 years
Follow-up PeriodUp to 3 months after your last dose of study drug

IMPORTANT: Only your doctor can determine whether or not you are eligible to participate in this clinical study. Please note that if you decide to participate in the study, you can also choose to stop at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.

Contact Email: clinicaltrials@replimune.com

Contact Phone Number: +1 (781) 222 9570 (US); +44 1235 242 488 (UK)

RP1 and its use in combination with nivolumab is investigational, has not been proven to be safe and has not been approved by the United States Food and Drug Administration (FDA), the European Medicines Agency (EMA) or any other regulatory authority.

CERPASS – A Study of Cemiplimab Given Alone Versus in Combination with the Oncolytic Immunotherapy RP1 to Treat Advanced Cutaneous Squamous Cell Carcinoma

Clinical Trials.gov: https://clinicaltrials.gov/ct2/show/NCT04050436

Identifier: NCT04050436

This is a randomized Phase 2 clinical trial to compare the effects of cemiplimab alone versus a combination of cemiplimab and the investigational oncolytic immunotherapy RP1. Researchers will study the effectiveness of these treatments against tumors and how long the effect lasts for.



Who is this study for?

This study is for patients with locally advanced or metastatic cutaneous squamous cell carcinoma (CSCC).

Key eligibility criteria

You may be eligible for this study if you meet the following conditions:
• Have locally advanced or metastatic CSCC
• Have at least 1 measurable lesion
• Are at least 18 years old
• Have not been treated with a prior oncolytic immunotherapy or other immune modulating agents
• No active autoimmune disease
• Do not have an active viral infection, including from HSV-1, hepatitis B (HBV), hepatitis C (HCV) or HIV

Please note that there are additional criteria that must be met in order to participate in this study. Consult with your doctor to determine if you are eligible.

What to expect during the study:

There are two randomly assigned groups of patients in this study. Patients in one group will receive cemiplimab alone, and patients in the other group will receive the cemiplimab in combination with RP1. This is a 2:1 randomization, meaning you have a greater likelihood of being assigned to the group receiving both cemiplimab and RP1.

If you are in the group receiving only cemiplimab, you will receive an intravenous (IV) infusion every 3 weeks for about 12 months.

If you are in the group receiving cemiplimab and RP1, you will receive a single dose of RP1 and then every 3 weeks you will receive cemiplimab and RP1 for approximately 8 months. After that, you will receive an IV infusion of cemiplimab every 3 weeks for 4 additional months (12 months total). Patients who benefit from the treatment but have residual disease may also receive up to an additional 8 extra doses of RP1 in combination with cemiplimab.

The study has different sections. They are:

Initial ScreeningUp to 28 days
Treatment PeriodApproximately 12 months
Follow-up PeriodUp to 6 months after the last dose of trial drug
Long-Term
Follow-up Period
Every 3 months for up to 3 years after you start therapy

IMPORTANT: Only your doctor can determine whether or not you are eligible to participate in this clinical study. Please note that if you decide to participate in the study, you can also choose to stop at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.

Contact Email: clinicaltrials@replimune.com
Contact Phone Number: +1 (781) 222 9570

RP1 and its use in combination with cemiplimab is investigational, has not been proven to be safe and has not been approved by the United States Food and Drug Administration (FDA), the European Medicines Agency (EMA) or any other regulatory authority.