RECRUITING

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

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Conditions

Advanced or Metastatic NRAS-mutant MelanomaMelanomaNRAS MutantCutaneous Melanoma

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

Stage 1: To select the optimal dose of naporafenib + trametinib to be studied in Stage 2. Stage 2: To compare progression free survival (PFS) and overall survival (OS) for patients with NRAS-mutant (NRASm) melanoma who are randomized to receive the combination of naporafenib + trametinib to that of patients who are randomized to physician's choice of therapy (dacarbazine, temozolomide, or trametinib monotherapy).

Official Title

A Randomized, Open-label Phase III Study in Patients With Previously Treated Unresectable or Metastatic NRAS Mutant Cutaneous Melanoma Comparing the Combination of Naporafenib + Trametinib to Physician's Choice of Therapy (Dacarbazine, Temozolomide or Trametinib Monotherapy) With a Dose Optimization lead-in [SEACRAFT-2]

Quick Facts

Study Start:2024-04-29
Study Completion:2028-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06346067

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 99 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Willing and able to provide written informed consent
  2. 2. Age ≥ 18 years
  3. 3. Histologically or cytologically confirmed unresectable or metastatic cutaneous (includes acral) melanoma.
  4. 4. Documentation of an NRAS mutation (tumor tissue or blood) prior to first dose of study drug(s) as determined locally with an analytically validated assay in a certified testing laboratory.
  5. 5. Archival tumor tissue collected within 5 years prior to enrollment must be confirmed to be available at the time of Screening, which may be submitted before or after enrollment for exploratory biomarker analysis.
  6. 6. Must have received an anti-PD-1/L1 based regimen (monotherapy or combination). Patient must have documented disease progression either while receiving therapy or within 12 weeks of last dose of the most recent anti-PD-1/L1 based regimen; the patient is eligible if they have received other therapies between the most recent anti-PD-1/L1 based regimen and enrollment.
  7. 7. ECOG performance status 0, 1 or 2
  8. 8. Presence of at least 1 measurable lesion according to RECIST v1.1
  9. 9. Able to swallow oral medication.
  1. 1. Patients with uveal or mucosal melanoma
  2. 2. Prior therapy with an ERK-, MEK-, RAF-, or RAS-inhibitor
  3. 3. Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of study drug(s) (e.g., ulcerative diseases, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, small bowel resection)
  4. 4. History or current evidence of retinal vein occlusion (RVO) or current risk factors for RVO (e.g., uncontrolled glaucoma or ocular hypertension, history of hyperviscosity or hypercoagulability syndrome)
  5. 5. LVEF \<50%
  6. 6. Symptomatic CNS metastases that are neurologically unstable. Patients with controlled CNS metastases are eligible.
  7. 7. Patients receiving treatment with herbal medicine known to cause liver toxicity, which cannot be discontinued 7 days prior to first dose of study drug(s) and for the duration of the study.
  8. 8. Are pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the trial

Contacts and Locations

Study Contact

Erasca Clinical Team
CONTACT
1-858-465-6511
clinicaltrials@erasca.com

Principal Investigator

Joyce Antal
STUDY_DIRECTOR
Clinical Development

Study Locations (Sites)

University of California, San Francisco
San Francisco, California, 94143
United States
The Melanoma and Skin Care Institute
Englewood, Colorado, 80113
United States
University of Miami Sylvester Cancer
Miami, Florida, 33136
United States
University of Kansas Cancer Center
Kansas City, Kansas, 66205
United States
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, 48201
United States
Washington University School of Medicine
Saint Louis, Missouri, 63110
United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
United States
Cleveland Clinic Foundation
Cleveland, Ohio, 44195
United States
SCRI Oncology Partners (formerly Tennessee Oncology)
Nashville, Tennessee, 37203
United States
Texas Oncology- Austin Midtown
Austin, Texas, 78705
United States
Texas Oncology - Baylor Charles A. Sammons Cancer Center
Dallas, Texas, 75246
United States
The University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
United States
Virginia Oncology Associates
Norfolk, Virginia, 23502-1871
United States
Fred Hutchinson Cancer Center
Seattle, Washington, 98109
United States
University of Wisconsin
Madison, Wisconsin, 53792
United States

Collaborators and Investigators

Sponsor: Erasca, Inc.

  • Joyce Antal, STUDY_DIRECTOR, Clinical Development

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-04-29
Study Completion Date2028-12

Study Record Updates

Study Start Date2024-04-29
Study Completion Date2028-12

Terms related to this study

Keywords Provided by Researchers

  • Melanoma
  • NRAS Mutant
  • Cutaneous Melanoma

Additional Relevant MeSH Terms

  • Advanced or Metastatic NRAS-mutant Melanoma