← Back to Search

MAPK pathway inhibitors

Stage 1 Dose selection Lead-in Arm 1 for Melanoma

Phase 3

Recruiting

Research Sponsored by Erasca, Inc.

Eligibility Criteria Checklist

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

Must have

Age ≥ 18 years

ECOG performance status 0, 1 or 2

Timeline

Screening 3 weeks

Treatment Varies

Follow Up assessed up to 24 months from time of first dose

Awards & highlights

Study Summary

This trial aims to find the best dose of naporafenib + trametinib for Stage 1 and then compare the survival outcomes of patients with NRAS-mutant melanoma who receive

Who is the study for?

This trial is for adults over 18 with unresectable or metastatic cutaneous melanoma, including acral type, that has an NRAS mutation. Participants must have progressed on anti-PD-1/L1 therapy within the last 6 months and be able to take oral medication. They need at least one measurable lesion and a performance status of 0, 1, or 2.Check my eligibility

What is being tested?

The study is in two stages: first to find the best dose of naporafenib plus trametinib; second to see if this combo improves survival compared to standard treatments (dacarbazine, temozolomide, or just trametinib) in patients with NRAS-mutant melanoma.See study design

What are the potential side effects?

Potential side effects may include those common to cancer therapies such as fatigue, nausea, skin rash, liver function changes and other organ-related issues. Specific side effects related to Naporafenib and Trametinib will be monitored.

Eligibility Criteria

Inclusion Criteria

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

Select...

I am 18 years old or older.

Select...

I can care for myself and am up and about more than 50% of my waking hours.

Select...

My melanoma cannot be removed by surgery and may have spread.

Select...

My cancer has an NRAS mutation confirmed by a certified lab test.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ assessed up to 24 months from time of first dose

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~assessed up to 24 months from time of first dose

This trial's timeline: 3 weeks for screening, Varies for treatment, and assessed up to 24 months from time of first dose for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Stage 1:To select the optimal dose of naporafenib + trametinib to be studied in Stage 2

Stage 2: To compare PFS and OS for patients who are randomized to receive the combination of naporafenib + trametinib to that of patients who receive physician's choice of therapy (dacarbazine, temozolomide, or trametinib monotherapy)

Secondary outcome measures

Adverse Events

Area under the curve (AUC):Stage 1 only

Disease Control Rate (DCR)

+5 more

Other outcome measures

Disease Control Rate (DCR) for CNS disease in participants

Duration of Response (DOR) for CNS disease in participants

Overall Response Rate (ORR) for CNS disease in participants

Trial Design

5Treatment groups

Experimental Treatment

Active Control

Group I: Stage 2 Arm AExperimental Treatment2 Interventions

Naporafenib + Trametinib Naporafenib (ERAS-254) BID oral administration with Trametinib QD at the dose selected in Stage 1

Group II: Stage 1 Dose selection Lead-in Arm 2Experimental Treatment2 Interventions

Naporafenib + Trametinib Naporafenib (ERAS-254) 400 mg administered orally twice daily (BID) Trametinib 0.5 mg once daily (QD)

Group III: Stage 1 Dose selection Lead-in Arm 1Experimental Treatment2 Interventions

Naporafenib + Trametinib Naporafenib (ERAS-254) 100 mg administered orally twice daily (BID) Trametinib 1 mg once daily (QD)

Group IV: Stage 1 Dose selection Lead-in Arm 3 Trametinib monotherapyActive Control1 Intervention

Trametinib 2 mg once daily (QD)

Group V: Stage 2 Arm B - Physician's ChoiceActive Control3 Interventions

Dacarbazine 1000 mg/m2 intravenously (IV) on Day 1 of each 21-day cycle OR Temozolomide 200 mg/m2/day PO on Day 1 to Day 5 of each 28-day cycle OR Trametinib monotherapy, 2 mg PO QD

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Trametinib

2014

Completed Phase 2

~1550

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Erasca, Inc.Lead Sponsor

7 Previous Clinical Trials

693 Total Patients Enrolled

Joyce AntalStudy DirectorClinical Development

2 Previous Clinical Trials

126 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Can individuals who have surpassed their 80th year of life participate in this medical research study?

"Prospective participants eligible for this investigation must be between the ages of 18 and 99. The research includes 50 studies involving individuals under 18 years old and another set comprising 700 studies focusing on patients over the age of 65."

Answered by AI

Do I meet the requirements to be considered as a potential candidate for this medical study?

"The research seeks to recruit 470 individuals aged between 18 and 99, diagnosed with melanoma. To be considered for participation, candidates must meet the subsequent prerequisites: Capable and willing to provide written consent, Age ≥ 18 years old, Availability of tumor tissue samples collected within the last five years before enrollment confirmed during Screening - these can be submitted pre or post-enrollment for exploratory biomarker analysis., ECOG performance status should be at a level of 0,1 or 2; Presence of measurable lesion in accordance with RECIST v1.1 criteria is necessary., Ability to ingest oral medications is required., Cruc"

Answered by AI

What is the primary goal of this medical study?

"The objective of this research, spanning approximately Study Day 1 through Day 29, is to compare Progression-Free Survival (PFS) and Overall Survival (OS) outcomes between patients randomly assigned to receive either the naporafenib + trametinib combination or standard therapy choices like dacarbazine, temozolomide, or trametinib alone. Additionally, secondary measures encompass assessing Quality of Life using the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire [QLQ]-C30 subscales along with PRO CTCAE® symptom items targeting potential cutaneous toxicities in"

Answered by AI

What is the safety profile of Stage 2 Arm A in individuals?

"Our team at Power has assigned a safety rating of 3 to Stage 2 Arm A, given that this trial is in Phase 3 and there is existing efficacy data along with substantial safety data."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study to Assess Naporafenib (ERAS-254) Administered With Trametinib in Patients With NRAS-mutant Melanoma (SEACRAFT-2)

2024. "A Study to Assess Naporafenib (ERAS-254) Administered With Trametinib in Patients With NRAS-mutant Melanoma (SEACRAFT-2)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06346067.

All > Nashville