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INCAGN02385 for Melanoma

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
MelanomaINCAGN02385 - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

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.

Eligible Conditions
  • Melanoma

Treatment Effectiveness

Effectiveness Progress

1 of 3

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1
Infusion of TBio-4101 TIL
1
NIZ985
1
Novocure Optune

Study Objectives

10 Primary · 3 Secondary · Reporting Duration: Every 8 weeks for first 12 months, and every 12 weeks until disease progression; aprroximately 24 months

Month 24
Phase 1 and 2 : Participants with treatment-emergent adverse events (TEAE)
Therapeutic procedure
Therapeutic procedure
Month 24
Phase 1: Disease Control Rate (DCR)
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)
Phase 2 Cohort A and B: Progression-free Survival (PFS)
Month 24
Phase 1 : Objective Response Rate
Phase 1 : Progression Free Survival
Phase 2 : Disease Control Rate
Phase 2 : Duration of Response
Phase 2 : Objective Response Rate

Trial Safety

Safety Progress

1 of 3

Similar Trials

1
Infusion of TBio-4101 TIL
1
NIZ985
1
Novocure Optune

Trial Design

7 Treatment Groups

Phase 2 Cohort B
1 of 7
Phase 1 Part 1
1 of 7
Phase 1 Part 2
1 of 7
Phase 1 Part 3
1 of 7
Phase 1 Part 4
1 of 7
Phase 2 Cohort A
1 of 7
Phase 2
1 of 7

Experimental Treatment

146 Total Participants · 7 Treatment Groups

Primary Treatment: INCAGN02385 · No Placebo Group · Phase 1 & 2

Phase 2 Cohort BExperimental Group · 3 Interventions: INCMGA00012., INCAGN02390, INCAGN02385 · Intervention Types: Drug, Drug, Drug
Phase 1 Part 1Experimental Group · 2 Interventions: INCAGN02390, INCAGN02385 · Intervention Types: Drug, Drug
Phase 1 Part 2Experimental Group · 3 Interventions: INCMGA00012., INCAGN02390, INCAGN02385 · Intervention Types: Drug, Drug, Drug
Phase 1 Part 3Experimental Group · 3 Interventions: INCMGA00012., INCAGN02390, INCAGN02385 · Intervention Types: Drug, Drug, Drug
Phase 1 Part 4Experimental Group · 3 Interventions: INCMGA00012., INCAGN02390, INCAGN02385 · Intervention Types: Drug, Drug, Drug
Phase 2 Cohort AExperimental Group · 3 Interventions: INCMGA00012., INCAGN02390, INCAGN02385 · Intervention Types: Drug, Drug, Drug
Phase 2Experimental Group · 3 Interventions: INCMGA00012., INCAGN02390, INCAGN02385 · Intervention Types: Drug, Drug, Drug
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

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: every 8 weeks for first 12 months, and every 12 weeks until disease progression; aprroximately 24 months

Who is running the clinical trial?

Incyte CorporationLead Sponsor
315 Previous Clinical Trials
46,374 Total Patients Enrolled
10 Trials studying Melanoma
2,075 Patients Enrolled for Melanoma

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You must have had known BRAF V600 mutation status.
Participants must have fresh biopsy available after completing prior PD-(L)1 therapy or be willing and able to safely undergo pretreatment tumor biopsies (core or excisional).
You have previously untreated, histologically confirmed Stage III (unresectable) or IV melanoma.
You have had no prior systemic therapy for unresectable or metastatic melanoma.
References

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