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LAG-3 Inhibitor

Triple Immunotherapy for Advanced Cancer

Phase 1 & 2

Waitlist Available

Research Sponsored by Incyte Corporation

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Phase 1 Parts 1-4: Participants with locally advanced or metastatic solid tumors that have failed available therapies, including anti-PD-(L)1 therapy if applicable, or who are intolerant to, or ineligible for standard treatment

Phase 2, Cohort A: Participant with unresectable/metastatic melanoma, whose disease failed prior anti-PD-(L)1 therapy and meeting specific criteria

Must not have

Known active HBV or HCV infection or risk of reactivation of HBV or HCV

Known active brain or CNS metastases including carcinomatous meningitis

Timeline

Screening 3 weeks

Treatment Varies

Follow Up every 8 weeks for first 12 months, and every 12 weeks until disease progression; approximately 24 months

Awards & highlights

Summary

This trial will find the best dose of 3 drugs to treat patients with advanced solid tumors. The drugs will be given together and the side effects will be monitored.

Who is the study for?

This trial is for adults with advanced solid tumors that have not responded to standard treatments or who cannot tolerate them. It includes those with untreated metastatic melanoma (Cohort B) and those whose melanoma failed anti-PD-(L)1 therapy (Cohort A). Participants must be in good physical condition, willing to prevent pregnancy, and have no history of severe reactions to the study drugs.Check my eligibility

What is being tested?

The trial is testing combinations of three drugs: INCMGA00012 (Anti-PD-1), INCAGN02385 (Anti-LAG-3), and INCAGN02390 (Anti-TIM-3). The goal is to find the safest and most tolerable doses for these drug combinations in treating select advanced cancers.See study design

What are the potential side effects?

Potential side effects may include immune-related reactions due to the enhancement of the body's immune response against cancer cells. This can sometimes cause inflammation in various organs, fatigue, skin issues, digestive problems, liver toxicity, hormonal gland problems like thyroid dysfunction, and other immune-mediated conditions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My cancer has spread, and standard treatments or immunotherapy haven't worked or aren't suitable for me.

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My melanoma cannot be surgically removed and didn't respond to previous anti-PD-(L)1 therapy.

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I am fully active or can carry out light work.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have an active hepatitis B or C infection.

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I have active brain or CNS cancer spread.

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I have another cancer that is getting worse or needs treatment.

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I am taking medication to suppress my immune system due to an autoimmune disease.

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I had side effects from previous immunotherapy.

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I have not received a live vaccine in the last 30 days.

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My cancer spread to other parts and responded differently to immunotherapy.

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I have been treated with drugs targeting LAG-3 or TIM-3.

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I am on long-term steroids.

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I have had an organ transplant.

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I am not pregnant or breastfeeding.

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I have a lung condition not caused by an infection.

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I stopped my anti-PD-(L)1 therapy because it worked as well as it could.

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I have or had eye melanoma.

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I have heart problems that affect my daily activities.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ every 8 weeks for first 12 months, and every 12 weeks until disease progression; approximately 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~every 8 weeks for first 12 months, and every 12 weeks until disease progression; approximately 24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and every 8 weeks for first 12 months, and every 12 weeks until disease progression; approximately 24 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

Phase 2 Cohort A and B: Disease Control Rate (DCR)

Phase 2 Cohort A and B: Duration of Response (DOR)

Phase 2 Cohort A and B: Objective Response Rate (ORR)

+2 more

Secondary outcome measures

Phase 1 : Objective Response Rate

Phase 1 : Progression Free Survival

Phase 1: Disease Control Rate (DCR)

Trial Design

6Treatment groups

Experimental Treatment

Group I: Phase 2 Cohort BExperimental Treatment3 Interventions

Phase 2 will determine preliminary efficacy and proof of concept for the combination of INCAGN02385 + INCAGN02390 + INCMGA00012. INCAGN02385 will be administered first intravenously followed by INCAGN02390 and INCMGA00012

Group II: Phase 2 Cohort AExperimental Treatment3 Interventions

Group III: Phase 1 Part 4Experimental Treatment3 Interventions

Part 1 will confirm the safety of INCAGN02385 + INCAGN02390 + INCMGA00012 in combination.

Group IV: Phase 1 Part 3Experimental Treatment3 Interventions

Part 1 will confirm the safety of INCAGN02385 + INCAGN02390 + INCMGA00012 when used in combination.

Group V: Phase 1 Part 2Experimental Treatment3 Interventions

Part 2 will confirm the safety of the triple combination of INCAGN02385 + INCAGN02390 + INCMGA00012, following confirmation of the safety of the doublet in Part 1. INCAGN02385 will be administered first intravenously followed by INCAGN02390 and INCMGA00012.

Group VI: Phase 1 Part 1Experimental Treatment2 Interventions

Part 1 will confirm the safety of INCAGN02385 and INCAGN02390 when used in combination. INCAGN02385 will be administered first intravenously followed by INCAGN02390.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

INCAGN02390

2018

Completed Phase 1

~40

INCAGN02385

2018

Completed Phase 1

~30

0 / 18Eligibility criteria met

Find a Location

Who is running the clinical trial?

Incyte CorporationLead Sponsor

373 Previous Clinical Trials

55,718 Total Patients Enrolled

11 Trials studying Melanoma

2,041 Patients Enrolled for Melanoma

Media Library

INCAGN02385 (LAG-3 Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04370704 — Phase 1 & 2

Melanoma Research Study Groups: Phase 2 Cohort B, Phase 1 Part 3, Phase 1 Part 4, Phase 1 Part 1, Phase 1 Part 2, Phase 2 Cohort A

Melanoma Clinical Trial 2023: INCAGN02385 Highlights & Side Effects. Trial Name: NCT04370704 — Phase 1 & 2

INCAGN02385 (LAG-3 Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04370704 — Phase 1 & 2

~12 spots leftby Aug 2025

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