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Checkpoint Inhibitor

RP1 + Nivolumab for Cancer (IGNYTE Trial)

Phase 2
Recruiting
Research Sponsored by Replimune Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Subjects with anti-PD1 failed cutaneous melanoma: has confirmed progressive disease while on anti-PD1 treatment for at least 8 weeks and documented BRAF mutation status
Have provided a former tumor pathology specimen or be willing to supply a new tumor sample from a biopsy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 26 months
Awards & highlights

IGNYTE Trial Summary

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

Who is the study for?
This trial is for adults with advanced skin cancer, melanoma, Lynch syndrome, or non-small cell lung cancer who have measurable disease and are in good physical condition (ECOG PS 0-1). Participants must have previously failed treatments including anti-PD1/PD-L1 therapy. They should be able to provide a tumor sample and not have a history of certain viral infections or heart diseases.Check my eligibility
What is being tested?
The study is testing RP1 alone and combined with nivolumab to find the safest dose that works best (MTD/RP2D) against solid tumors. It's an early-phase trial where everyone gets treatment: some just get RP1, others get it with nivolumab.See study design
What are the potential side effects?
Possible side effects include typical immune-related reactions like inflammation in various organs due to immune system activation by these therapies. There may also be injection site reactions from RP1 and general symptoms such as fatigue.

IGNYTE Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My skin cancer worsened on anti-PD1 treatment for 8+ weeks and I know my BRAF status.
Select...
I can provide a sample of my tumor for testing.
Select...
I have at least one tumor that can be measured and injected.
Select...
My NSCLC worsened despite treatment with anti-PD1/PD-L1 therapy.
Select...
My tumor is MSI-H/dMMR and has not improved with specific immune therapy.
Select...
I have advanced skin cancer not treatable by surgery and progressed after 8 weeks of anti-PD1/PD-L1 treatment.
Select...
I am fully active or restricted in physically strenuous activity but can do light work.

IGNYTE Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~26 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 26 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D) of RP1
Percentage of adverse events (AEs)
Percentage of dose limiting toxicities (DLTs)
+2 more
Secondary outcome measures
Median duration of response
Median overall survival
Median progression-free survival
+3 more

IGNYTE Trial Design

10Treatment groups
Experimental Treatment
Group I: RP1(IT) and nivolumab (IV) in anti-PD1/PD-L1 Failed NSCLCExperimental Treatment2 Interventions
Doses of RP1 (IT) in superficial or deep tumors with nivolumab (IV) in subjects with non small cell lung cancer who have been previously treated with anti-PD1/PD-L1 therapy
Group II: RP1(IT) and nivolumab (IV) in anti-PD1/PD-L1 Failed NMSCExperimental Treatment2 Interventions
Doses of RP1 (IT) in superficial or deep tumors with nivolumab (IV) in subjects with non-melanoma skin cancer who have been previously treated with anti-PD1/PD-L1 therapy
Group III: RP1(IT) and nivolumab (IV) in anti-PD1 Failed Cutaneous MelanomaExperimental Treatment2 Interventions
Doses of RP1 (IT) in superficial or deep tumors with nivolumab (IV) in subjects with cutaneous melanoma who have been previously treated with anti-PD1 therapy
Group IV: RP1 (IT) and nivolumab (IV) in melanomaExperimental Treatment2 Interventions
Doses of RP1 (IT) in superficial or deep tumors with nivolumab (IV) in subjects with melanoma
Group V: RP1 (IT) and nivolumab (IV) in NMSCExperimental Treatment2 Interventions
Doses of RP1 (IT) in superficial or deep tumors with nivolumab (IV) in subjects with non-melanoma skin cancer
Group VI: RP1 (IT) and nivolumab (IV) in MSI-H/dMMR solid tumorsExperimental Treatment2 Interventions
Doses of RP1 (IT) in superficial or deep tumors with nivolumab (IV) in subjects with MSI-H or dMMR solid tumors
Group VII: Dose expansion of RP1 and nivolumab (IV) in superficial tumorsExperimental Treatment2 Interventions
Doses of RP1 (IT) in superficial tumors with nivolumab (IV)
Group VIII: Dose expansion of RP1 and nivolumab (IV) in deep/visceral tumorsExperimental Treatment2 Interventions
Doses of RP1 (IT) in deep/visceral tumors with nivolumab (IV)
Group IX: Dose escalation of RP1 by intratumoral (IT) injection in superficial tumorsExperimental Treatment1 Intervention
Dose escalation of RP1 alone in 3 cohorts with IT injections in superficial tumors
Group X: Dose escalation of RP1 by intratumoral (IT) injection in deep/visceral tumorsExperimental Treatment1 Intervention
Dose escalation of RP1 alone in 3 cohorts with IT injections in deep/visceral tumors
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
nivolumab
2016
Completed Phase 3
~4960

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The most common treatments for Non-Small Cell Lung Cancer (NSCLC) include targeted therapies, immunotherapies, and chemotherapy. Oncolytic viruses like RP1 work by selectively infecting and killing cancer cells while stimulating an anti-tumor immune response. Nivolumab, a PD-1 inhibitor, blocks the programmed cell death protein 1 (PD-1) pathway, which cancer cells exploit to evade immune detection. By inhibiting this pathway, Nivolumab enhances the body's immune response against cancer cells. These mechanisms are crucial for NSCLC patients as they offer targeted approaches that can improve survival rates and quality of life by effectively managing the disease with potentially fewer side effects compared to traditional chemotherapy.
Emerging therapeutic agents for lung cancer.

Find a Location

Who is running the clinical trial?

Replimune Inc.Lead Sponsor
10 Previous Clinical Trials
995 Total Patients Enrolled
Jeannie Hou, MDStudy DirectorReplimune Inc.
2 Previous Clinical Trials
296 Total Patients Enrolled

Media Library

Nivolumab (Checkpoint Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03767348 — Phase 2
Non-Small Cell Lung Cancer Research Study Groups: RP1(IT) and nivolumab (IV) in anti-PD1 Failed Cutaneous Melanoma, RP1 (IT) and nivolumab (IV) in NMSC, RP1(IT) and nivolumab (IV) in anti-PD1/PD-L1 Failed NMSC, RP1 (IT) and nivolumab (IV) in MSI-H/dMMR solid tumors, RP1(IT) and nivolumab (IV) in anti-PD1/PD-L1 Failed NSCLC, Dose escalation of RP1 by intratumoral (IT) injection in superficial tumors, Dose escalation of RP1 by intratumoral (IT) injection in deep/visceral tumors, Dose expansion of RP1 and nivolumab (IV) in superficial tumors, Dose expansion of RP1 and nivolumab (IV) in deep/visceral tumors, RP1 (IT) and nivolumab (IV) in melanoma
Non-Small Cell Lung Cancer Clinical Trial 2023: Nivolumab Highlights & Side Effects. Trial Name: NCT03767348 — Phase 2
Nivolumab (Checkpoint Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03767348 — Phase 2
~16 spots leftby Nov 2024