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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
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
Study 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 belowSelect...
My cancer has spread, and standard treatments or immunotherapy haven't worked or aren't suitable for me.
Select...
My melanoma cannot be surgically removed and didn't respond to previous anti-PD-(L)1 therapy.
Select...
I am fully active or can carry out light work.
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
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 moreSecondary 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
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 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
Find a Location
Who is running the clinical trial?
Incyte CorporationLead Sponsor
364 Previous Clinical Trials
55,104 Total Patients Enrolled
11 Trials studying Melanoma
2,041 Patients Enrolled for Melanoma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I haven't taken any cancer drugs or experimental medications recently.My cancer has spread, and standard treatments or immunotherapy haven't worked or aren't suitable for me.I have an active hepatitis B or C infection.You have been diagnosed with HIV.My side effects from previous treatments are mild or approved by the medical monitor.I have active brain or CNS cancer spread.I have not taken antibiotics or antifungal/antiviral drugs in the last 7 days.My melanoma cannot be surgically removed and didn't respond to previous anti-PD-(L)1 therapy.I have another cancer that is getting worse or needs treatment.I am taking medication to suppress my immune system due to an autoimmune disease.I had side effects from previous immunotherapy.I have melanoma that has not been treated and cannot be surgically removed.I have not received a live vaccine in the last 30 days.My cancer spread to other parts and responded differently to immunotherapy.I have not received colony-stimulating factors in the last 14 days.I have been treated with drugs targeting LAG-3 or TIM-3.I haven't received any cancer treatment recently.I am on long-term steroids.I have had an organ transplant.I am not pregnant or breastfeeding.You have had or currently have a heart test (ECG) that shows a significant problem, according to the doctor.I stopped anti-PD-(L)1 therapy due to side effects and my cancer has worsened.I have a lung condition not caused by an infection.I stopped my anti-PD-(L)1 therapy because it worked as well as it could.I have not had major chest radiation or palliative radiation within the specified times before starting the study treatment.I have or had eye melanoma.I have heart problems that affect my daily activities.I am fully active or can carry out light work.
Research Study Groups:
This trial has the following groups:- Group 1: Phase 2 Cohort B
- Group 2: Phase 1 Part 3
- Group 3: Phase 1 Part 4
- Group 4: Phase 1 Part 1
- Group 5: Phase 1 Part 2
- Group 6: Phase 2 Cohort A
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many medical facilities in North America are currently executing this research?
"This clinical trial has 10 different medical sites that are offering the medication, such as Md Anderson Cancer Center At Cooper in Bethesda, Cancer Center For Blood Disorders in Seattle and University of Washington - Seattle Cancer Care Alliance in New york."
Answered by AI
Has there been other research conducted utilizing INCAGN02385?
"At the present moment, there are 26 active clinical trials researching INCAGN02385 with 3 of them in Phase 3. Most studies for this medication are centered around A CORUÑA and Virginia; nonetheless, research is also taking place across 810 other locations worldwide."
Answered by AI
Is this research effort still taking on new participants?
"Based on the latest records available online, this clinical trial is now seeking out potential participants. The original posting date of this study was July 27th 2020 and it was recently updated on October 25th 2022."
Answered by AI
Is this a pioneering endeavor in clinical research?
"INCAGN02385 has been subject to medical research since 2016, when it was first funded by Incyte Corporation. The Phase 1 drug approval for this medication followed the initial study of 325 patients in that year. Currently, 26 trials are active for INCAGN02385 across 117 cities and 43 nations around the world."
Answered by AI
What is the recruitment capacity for this research undertaking?
"Affirmative. Per clinicaltrials.gov, the study initiated on July 27th 2020 and is still open to applicants as of October 25th 2022. 10 sites are seeking a total of 146 participants."
Answered by AI
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