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ERK1/2 Inhibitor

LY3214996 for Melanoma

Phase 1
Waitlist Available
Research Sponsored by Eli Lilly and Company
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Have advanced or metastatic cancer (solid tumors) and be an appropriate candidate for experimental therapy.
Part B (No Longer Enrolling Participants): Have advanced or metastatic cancer with an activating mitogen-activated protein kinase pathway alteration, BRAF mutant metastatic melanoma refractory to or relapsed after treatment with RAF and/or MEK inhibitors, metastatic melanoma with a NRAS mutation, or BRAF mutant NSCLC.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to date of death from any cause (estimated up to 2 years)
Awards & highlights

Study Summary

This trial is testing a new cancer drug to see if it is safe and effective when used alone or with other drugs.

Eligible Conditions
  • Cancer
  • Melanoma
  • Non-Small Cell Lung Cancer
  • Colorectal Cancer

Eligibility Criteria

Inclusion Criteria

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

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to date of death from any cause (estimated up to 2 years)
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to date of death from any cause (estimated up to 2 years) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of Participants with LY3214996 Dose Limiting Toxicities (DLTs)
Secondary outcome measures
Disease Control Rate (DCR): Percentage of Participants who Exhibit Stable Disease (SD), CR or PR
Duration of Response (DoR)
Objective Response Rate (ORR): Percentage of Participants With a Complete (CR) or Partial Response (PR)
+10 more

Trial Design

8Treatment groups
Experimental Treatment
Group I: LY3214996 Dose ExpansionExperimental Treatment1 Intervention
LY3214996 given orally (once a day) during each 21 day cycle.
Group II: LY3214996 Dose EscalationExperimental Treatment1 Intervention
LY3214996 given orally once a day (or twice a day) for 21 days.
Group III: LY3214996 + Nab-Paclitaxel + GemcitabineExperimental Treatment3 Interventions
Dose Escalation and Expansion- LY3214996 given orally (dose timing will be determined) and nab-paclitaxel given intravenously (IV) on day 1, 8, and 15 and gemcitabine IV on day 1, 8, and 15 during each 28 day cycle.
Group IV: LY3214996 + MidazolamExperimental Treatment2 Interventions
(Preliminary Drug-Drug Interactions [DDI]) LY3214996 given orally (once a day) and midazolam given orally on cycle 1 day 1 and cycle 1 day 16 (21 day cycles except cycle 1 only = 22 days).
Group V: LY3214996 + Encorafenib + CetuximabExperimental Treatment3 Interventions
Dose Escalation and Expansion- LY3214996 given orally, encorafenib given orally and cetuximab given IV.
Group VI: LY3214996 + AbemaciclibExperimental Treatment2 Interventions
Dose Escalation and Expansion- LY3214996 given orally (dose timing will be determined) and abemaciclib given orally (single dose given during lead in period) twice a day every 12 hours during 21 day cycle.
Group VII: Japan Part 2Experimental Treatment2 Interventions
LY3214996 given orally and abemaciclib given orally.
Group VIII: Japan Part 1Experimental Treatment1 Intervention
LY3214996 given orally.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Gemcitabine
FDA approved
LY3214996
2019
Completed Phase 2
~270
Midazolam
FDA approved
Abemaciclib
FDA approved
Paclitaxel
FDA approved
Encorafenib
FDA approved
Cetuximab
FDA approved

Find a Location

Who is running the clinical trial?

Eli Lilly and CompanyLead Sponsor
2,605 Previous Clinical Trials
3,199,460 Total Patients Enrolled
10 Trials studying Melanoma
1,198 Patients Enrolled for Melanoma
Study DirectorEli Lilly and Company
1,338 Previous Clinical Trials
403,635 Total Patients Enrolled
4 Trials studying Melanoma
922 Patients Enrolled for Melanoma

Frequently Asked Questions

~25 spots leftby Mar 2025