Triple Immunotherapy for Advanced Cancer

Recruiting in Palo Alto (17 mi)

+21 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Waitlist Available

Sponsor: Incyte Corporation

No Placebo Group

Trial Summary

What is the purpose of this trial?The study will determine Recommended Phase 2 Dose for all study drugs, based on the safety and tolerability of the following combinations: INCAGN02385 + INCAGN02390 and INCAGN02385 + INCAGN02390 + INCMGA00012.

Eligibility Criteria

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.

Inclusion Criteria

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

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

I have melanoma that has not been treated and cannot be surgically removed.

+2 more

Exclusion Criteria

I haven't taken any cancer drugs or experimental medications recently.

I have an active hepatitis B or C infection.

You have been diagnosed with HIV.

+23 more

Participant Groups

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.

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.