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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.

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I can provide a sample of my tumor for testing.

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I have at least one tumor that can be measured and injected.

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My NSCLC worsened despite treatment with anti-PD1/PD-L1 therapy.

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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 weeks3 visits

Treatment ~ Varies

Follow Up ~ 26 months

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

0 / 7Eligibility criteria met

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

Frequently Asked Questions

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

What adverse effects could result from using the RP1 drug regimen?

"RP1's safety was considered to be a 2 out of 3 due to the fact that this Phase 2 trial has collected some data regarding its security, but not yet any information on if it is efficacious."

Answered by AI

Has research involving RP1 been pursued in any other medical experiments?

"RP1 was initially evaluated at Local Institution during 2012, and since then 250 studies have been completed. Currently, there are 718 active trials underway; a great majority of these research initiatives take place in the city of Houston, Texas."

Answered by AI

How many venues are currently hosting this research endeavor?

"25 clinical trial sites are operating for this research project, such as The University of Texas MD Anderson Cancer Center in Houston and Seattle Cancer Care Alliance-University of Washington in Seattle. Additionally, there are countless other places participating throughout the country, like the University of Southern California in Los Angeles."

Answered by AI

What is the ultimate goal of this research endeavor?

"This study, with a timeline of about two years, is assessing the Percentage of serious adverse events (SAEs). Secondary aims include analyzing the Percentage of complete response (CR), Median overall survival rate, and Median progression-free survival duration."

Answered by AI

Are there any enrolment opportunities in this clinical trial?

"Affirmative. Clinicaltrials.gov's listings demonstrate that this research effort is presently enrolling participants, with the initial posting on September 20th 2017 and a recent update made on October 24th 2022. 300 individuals at 25 different trial sites are required for completion of the study."

Answered by AI

Does this research endeavor represent a groundbreaking approach to treatment?

"At present, RP1 has 718 active medical studies that are taking place across 49 nations and 2354 cities. The initial clinical trial for this drug was organized by Ono Pharmaceutical Co. Ltd in 2012; it included 659 participants and reached Phase 1 & 2 of the approval process. Since then, 250 further trials have been accomplished."

Answered by AI

To what extent is this clinical trial being participated in by patients?

"In order to meet the study's requirements, 300 qualified patients must join. These participants may seek out their local clinical trial sites including The University of Texas MD Anderson Cancer Center in Houston, TX and Seattle Cancer Care Alliance-University of Washington in Seattle, WA."

Answered by AI