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.