RP1 for Non-Small Cell Lung Cancer

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Non-Small Cell Lung Cancer+6 MoreRP1 - Biological
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing a new drug to see if it is safe and effective in treating advanced solid tumors.

Eligible Conditions
  • Non-Small Cell Lung Cancer
  • Non-melanoma Skin Cancer
  • Lynch Syndrome
  • Microsatellite Instability
  • Skin Cancer
  • Cancer

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

5 Primary · 6 Secondary · Reporting Duration: 26 months

20 weeks
Maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D) of RP1
Percentage of biologic activity
Percentage subjects with detectable RP1
26 months
Median duration of response
Median overall survival
Median progression-free survival
Percentage of adverse events (AEs)
Percentage of complete response (CR)
Percentage of dose limiting toxicities (DLTs)
Percentage of overall response rate (ORR)
Percentage of serious adverse events (SAEs)

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Trial Design

10 Treatment Groups

Dose expansion of RP1 and nivolumab (IV) in superficial tumors
1 of 10
RP1 (IT) and nivolumab (IV) in NMSC
1 of 10
Dose expansion of RP1 and nivolumab (IV) in deep/visceral tumors
1 of 10
Dose escalation of RP1 by intratumoral (IT) injection in superficial tumors
1 of 10
Dose escalation of RP1 by intratumoral (IT) injection in deep/visceral tumors
1 of 10
RP1 (IT) and nivolumab (IV) in melanoma
1 of 10
RP1(IT) and nivolumab (IV) in anti-PD1/PD-L1 Failed NSCLC
1 of 10
RP1 (IT) and nivolumab (IV) in MSI-H/dMMR solid tumors
1 of 10
RP1(IT) and nivolumab (IV) in anti-PD1 Failed Cutaneous Melanoma
1 of 10
RP1(IT) and nivolumab (IV) in anti-PD1/PD-L1 Failed NMSC
1 of 10

Experimental Treatment

300 Total Participants · 10 Treatment Groups

Primary Treatment: RP1 · No Placebo Group · Phase 2

Dose expansion of RP1 and nivolumab (IV) in superficial tumorsExperimental Group · 2 Interventions: RP1, nivolumab · Intervention Types: Biological, Biological
RP1 (IT) and nivolumab (IV) in NMSCExperimental Group · 2 Interventions: RP1, nivolumab · Intervention Types: Biological, Biological
Dose expansion of RP1 and nivolumab (IV) in deep/visceral tumorsExperimental Group · 2 Interventions: RP1, nivolumab · Intervention Types: Biological, Biological
Dose escalation of RP1 by intratumoral (IT) injection in superficial tumors
Biological
Experimental Group · 1 Intervention: RP1 · Intervention Types: Biological
Dose escalation of RP1 by intratumoral (IT) injection in deep/visceral tumors
Biological
Experimental Group · 1 Intervention: RP1 · Intervention Types: Biological
RP1 (IT) and nivolumab (IV) in melanomaExperimental Group · 2 Interventions: RP1, nivolumab · Intervention Types: Biological, Biological
RP1(IT) and nivolumab (IV) in anti-PD1/PD-L1 Failed NSCLCExperimental Group · 2 Interventions: RP1, nivolumab · Intervention Types: Biological, Biological
RP1 (IT) and nivolumab (IV) in MSI-H/dMMR solid tumorsExperimental Group · 2 Interventions: RP1, nivolumab · Intervention Types: Biological, Biological
RP1(IT) and nivolumab (IV) in anti-PD1 Failed Cutaneous MelanomaExperimental Group · 2 Interventions: RP1, nivolumab · Intervention Types: Biological, Biological
RP1(IT) and nivolumab (IV) in anti-PD1/PD-L1 Failed NMSCExperimental Group · 2 Interventions: RP1, nivolumab · Intervention Types: Biological, Biological
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nivolumab
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 26 months

Who is running the clinical trial?

Replimune Inc.Lead Sponsor
4 Previous Clinical Trials
404 Total Patients Enrolled
Jeannie Hou, MDStudy DirectorReplimune Inc.
2 Previous Clinical Trials
245 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 9 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have measurable disease, according to RECIST v1.1 criteria.
You have provided a tumor specimen or are willing to supply a new tumor specimen from a biopsy.
You have an ECOG PS of 0-1.