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

For more information about the IGNYTE study, please see Clinical Trials.gov:

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 currently in Phase 2 and is for patients with a diagnosis of Stage IIIb-IV unresectable melanoma, microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) solid tumors, non-melanoma skin cancer (NMSC), and non-small cell lung cancer (NSCLC).

Key eligibility criteria

You may be eligible for this study if you meet the following conditions:
• Are capable of giving signed informed consent which includes willingness to comply with the requirements and restrictions listed in the informed consent form.
• Are at least 18 years old.
• Have at least 1 measurable tumor of ≥1 cm in longest diameter (or ≥1.5 cm shortest diameter for lymph nodes) and injectable lesions which in aggregate comprise ≥ 1 cm in longest diameter.
• Have a life expectancy of at least 3 months.
• Have not received prior treatment with an oncolytic virus therapy.
• Have no acute or chronic active hepatitis B and C virus infection, nor known history of hepatitis B, nor known active hepatitis C virus, nor HIV infection.
• Have no systemic infection requiring intravenous (IV) antibiotics nor other serious infection within 14 days prior to dosing.
• Have no history of interstitial lung disease.

What to expect during the study

The Phase 2 portion of this study is still enrolling the following two cohorts:
• Anti-PD-1 failed NMSC
• MSI-H or dMMR

Dosing of RP1 will start on Day 1 and will be administered every two weeks for up to eight cycles (approximately 4 months). After the first dose of RP1, dosing will be given with concurrent nivolumab infusion every two weeks followed by dosing every four weeks for up to an additional twenty months.

Patients may also receive additional courses of RP1 if they meet the protocol specified criteria for RP1 dose re-initiation.

The Phase 2 portion of study has different sections. They are:

ScreeningUp to 28 days
Treatment PeriodApproximately 2 years
Follow-up Period3 years from last patient enrolled

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.

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.