RP2-001-18 – A Study Evaluating RP2 Given Alone and in Combination with Nivolumab in Patients with Solid Tumors

Clinical Trials.gov: https://clinicaltrials.gov/ct2/show/NCT04336241

Identifier: NCT04336241

This is a Phase 1 clinical trial to study the investigational oncolytic immunotherapy RP2 given both alone and in combination with nivolumab to patients with solid tumors. 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.

Key eligibility criteria

You may be eligible for this study if you meet the following conditions:
• Have a non-neurological solid tumor
• Have had your cancer progress on standard therapy or could not tolerate the side effects of standard therapy
• Are at least 18 years old
• Have not been treated with a prior oncolytic immunotherapy

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

This study has 2 parts, dose escalation and dose expansion. Patients will be placed in either a dose escalation or dose expansion group. The first part of the study explores appropriate doses to give to patients, while the second part uses the RP2 dose identified in part 1 and combines with nivolumab. Please note that part 1 (dose escalation) is complete. Every patient going forward will be given RP2 and nivolumab in combination.

Part 1 (Completed): In part 1, different doses of RP2 were given to patients once every 2 weeks. This study let the researchers determine the best dose of RP2 to be used in the second part of the study.

Part 2 (Ongoing): In the second part of the study, patients will receive RP2 in combination with another drug, nivolumab, every 2 weeks for about 3.5 months, then nivolumab would be given every 4 weeks for up to an additional 20 months. Patients may also receive up to 8 extra doses of RP2 in combination with nivolumab if the treatment helps to further shrink the tumor within 20 months. Researchers will look at the safety of the drugs and whether the tumors shrink. This will let the researchers determine whether RP2 is safe to give with nivolumab.

The study has different sections. They are:

Part 1 – RP2 Alone

Initial ScreeningUp to 28 days
Treatment PeriodApproximately 2 months
Follow-up PeriodAbout 4 months after the last dose of study drug

Part 2 – RP2 and nivolumab

Initial ScreeningUp to 28 days
Treatment PeriodApproximately 2 years
Follow-up PeriodAbout 3 months after the 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: +44 1235 242 488

RP2 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.