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.
Eligible Conditions
- Advanced Solid Tumors
Treatment Effectiveness
Effectiveness Progress
Study Objectives
6 Primary · 12 Secondary · Reporting Duration: Up to 3 years since first patient in
7 months
Recommended phase 2 dose (RP2D) of RP3
Month 24
Percentage of biologic activity
Day 100
Percentage of HSV-1 seronegative patients with TEAEs
Day 100
Incidence of clearance of RP3 from blood and urine
Percentage of participants with detectable RP3.
Day 43
Change in HSV-1 antibody levels
Day 730
One-year and 2-year OS rates
Day 1
Progression-free survival by Investigator review
Day 30
Incidence of dose limiting toxicities (DLTs) during the DLT period
Day 60
Incidence and severity of serious adverse events (SAEs)
Incidence and severity of treatment emergent adverse events (TEAEs)
Incidence of TEAEs ≥ Grade 3
Year 2
Percentage of complete response (CR)
Percentage of partial response (PR)
Percentage of stable disease (SD)
Year 2
Percentage of events requiring withdrawal
Year 3
Median duration of response
Percentage of objective overall response rate (ORR)
Trial Safety
Safety Progress
Trial Design
3 Treatment Groups
Dose combination of RP3 and anti-PD1 therapy - superficial and/or deep/visceral ...
1 of 3
Dose escalation of RP3 - superficial and/or deep/visceral tumors
1 of 3
Seronegative cohort
1 of 3
Experimental Treatment
123 Total Participants · 3 Treatment Groups
Primary Treatment: RP3 · No Placebo Group · Phase 1
Dose combination of RP3 and anti-PD1 therapy - superficial and/or deep/visceral tumorsExperimental Group · 3 Interventions: anti-PD1 monoclonal antibody, RP3, Nivolumab · Intervention Types: Biological, Biological, Biological
Dose escalation of RP3 - superficial and/or deep/visceral tumors
Biological
Experimental Group · 1 Intervention: RP3 · Intervention Types: BiologicalSeronegative cohort
Biological
Experimental Group · 1 Intervention: RP3 · Intervention Types: BiologicalTreatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nivolumab
2014
Completed Phase 3
~5260
Trial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 3 years since first patient in
Who is running the clinical trial?
Replimune Inc.Lead Sponsor
4 Previous Clinical Trials
581 Total Patients Enrolled
Bristol-Myers SquibbIndustry Sponsor
2,496 Previous Clinical Trials
3,930,204 Total Patients Enrolled
Henry Castro, MDStudy DirectorReplimune Inc.
1 Previous Clinical Trials
65 Total Patients Enrolled
Chris Ahlers, MDStudy DirectorReplimune Inc.
2 Previous Clinical Trials
101 Total Patients Enrolled
Johannes Wolff, MDStudy DirectorReplimune Inc.
2 Previous Clinical Trials
63 Total Patients Enrolled
Eligibility Criteria
Age 18+ · All Participants · 6 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:You have 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).
You have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
Who else is applying?
What state do they live in?
| Texas | 100.0% |
How old are they?
| 18 - 65 | 100.0% |
What site did they apply to?
| MD Anderson Cancer Center | 100.0% |
What portion of applicants met pre-screening criteria?
| Did not meet criteria | 100.0% |
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Conditions
Cancer Related
Treatments