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RP3 + Nivolumab for Solid Tumors

Phase 1
Waitlist Available
Research Sponsored by Replimune Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Have an Eastern Cooperative Oncology Group (ECOG) performance status 0-1
At least one injectable tumor ≥ 1 cm in longest diameter or injectable tumors which in aggregate are ≥ 1 cm in longest diameter (or shortest diameter for lymph nodes)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 years since first patient in
Awards & highlights

Study Summary

This trial is testing a new cancer drug, RP3, to see if it is safe and effective when used alone or in combination with another cancer drug.

Who is the study for?
Adults with advanced solid tumors who've exhausted standard treatments or can't tolerate them, and have at least one measurable tumor. Participants must be in good physical condition (ECOG 0-1), provide tumor biopsy samples, and not have neurological tumors or certain viral infections.Check my eligibility
What is being tested?
The study is testing RP3 alone and combined with Nivolumab to find the safest dose for Phase 2 trials. It's an early-stage trial (Phase 1) involving adults with advanced solid tumors to assess safety, tolerability, and optimal dosing.See study design
What are the potential side effects?
Potential side effects are not detailed here but may include typical reactions related to immune therapies such as fatigue, flu-like symptoms, skin reactions, potential organ inflammation due to immune response, and infection risks.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am fully active or restricted in physically strenuous activity but can do light work.
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I have a tumor that can be injected and is at least 1 cm big.
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I have a tumor that can be injected and is at least 1 cm big.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 years since first patient in
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 years since first patient in for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence and severity of serious adverse events (SAEs)
Incidence and severity of treatment emergent adverse events (TEAEs)
Incidence of TEAEs ≥ Grade 3
+3 more
Secondary outcome measures
Change in HSV-1 antibody levels
Incidence of clearance of RP3 from blood and urine
Median duration of response
+9 more

Trial Design

3Treatment groups
Experimental Treatment
Group I: Seronegative cohortExperimental Treatment1 Intervention
Doses of RP3 (IT) in HSV seronegative participants.
Group II: Dose escalation of RP3 - superficial and/or deep/visceral tumorsExperimental Treatment1 Intervention
Dose escalation of RP3 alone in 2 cohorts with intratumoral (IT) injections including use of imaging guided injection for deep tumors.
Group III: Dose combination of RP3 and anti-PD1 therapy - superficial and/or deep/visceral tumorsExperimental Treatment2 Interventions
Dose combination of RP3 and anti-PD1 therapy. IT injections of RP3 including use of imaging guided injection for deep tumors.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nivolumab
2014
Completed Phase 3
~4750

Find a Location

Who is running the clinical trial?

Replimune Inc.Lead Sponsor
10 Previous Clinical Trials
1,212 Total Patients Enrolled
Bristol-Myers SquibbIndustry Sponsor
2,645 Previous Clinical Trials
4,130,876 Total Patients Enrolled
Johannes Wolff, MDStudy DirectorReplimune Inc.
2 Previous Clinical Trials
63 Total Patients Enrolled

Media Library

anti-PD1 monoclonal antibody (Other) Clinical Trial Eligibility Overview. Trial Name: NCT04735978 — Phase 1
Solid Tumors Research Study Groups: Dose escalation of RP3 - superficial and/or deep/visceral tumors, Dose combination of RP3 and anti-PD1 therapy - superficial and/or deep/visceral tumors, Seronegative cohort
Solid Tumors Clinical Trial 2023: anti-PD1 monoclonal antibody Highlights & Side Effects. Trial Name: NCT04735978 — Phase 1
anti-PD1 monoclonal antibody (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04735978 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the key aims of this clinical experiment?

"The primary endpoint of the trial, assessed from Day 1 up to 30 days after last dose, is the rate of Treatment-Emergent Adverse Events grade 3 or above. Secondary objectives include percentage of biological activity as determined by individual tumor responses (erythema, necrosis, inflammation; changes in injected/uninjected tumors); Percentage of HSV-1 seronegative patients with TEAEs and one & two year Overall Survival rates."

Answered by AI

To what extent can RP3 endanger individuals?

"Since this is an early-phase study, the safety rating of RP3 was assessed to be a 1 due to limited evidence in support of its efficacy and security."

Answered by AI

Is there an ongoing recruitment process for this scientific experiment?

"As per clinicaltrials.gov, this medical experiment is presently searching for study members. The trial was initially advertised on December 29th 2020 and the most recent update took place on October 19th 2022."

Answered by AI

What is the current cap on enrollees for this trial?

"Affirmative. Clinicaltrials.gov displays evidence that this experiment, which was originally made available on December 29th 2020, is still accepting participants. The research team aims to sign up 123 trialists from 1 distinct medical facility."

Answered by AI

Who else is applying?

What state do they live in?
Texas
How old are they?
18 - 65
What site did they apply to?
MD Anderson Cancer Center
What portion of applicants met pre-screening criteria?
Did not meet criteria
Recent research and studies
clinicaltrials.govStudy
Study of RP3 Monotherapy and RP3 in Combination With Nivolumab in Patients With Solid Tumours
2020. "Study of RP3 Monotherapy and RP3 in Combination With Nivolumab in Patients With Solid Tumours". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04735978.
~28 spots leftby May 2025
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