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ACTIVE NOT RECRUITING

NCT06346067

PHASE3

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

Sponsor: Erasca, Inc.

View on ClinicalTrials.gov

Summary

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]

Key Details

Gender

All

Age Range

18 Years - 99 Years

Study Type

INTERVENTIONAL

Enrollment

Start Date

2024-04-29

Completion Date

2028-12

Last Updated

2026-02-27

Healthy Volunteers

Conditions

Advanced or Metastatic NRAS-mutant Melanoma

Interventions

DRUG

Naporafenib

Naporafenib (ERAS-254) is an experimental Pan-Raf inhibitor

DRUG

Dacarbazine

Dacarbazine IV - Day 1

DRUG

Temozolomide

Temozolomide 200 mg/m2/day PO on Day 1 to Day 5 of each 28-day cycle

DRUG

Trametinib

Trametinib is an FDA approved anticancer medication that targets MEK1 and MEK2.

Key Inclusion Criteria: 1. Willing and able to provide written informed consent 2. Age ≥ 18 years 3. Histologically or cytologically confirmed unresectable or metastatic cutaneous (includes acral) melanoma. 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. 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. 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. ECOG performance status 0, 1 or 2 8. Presence of at least 1 measurable lesion according to RECIST v1.1 9. Able to swallow oral medication. Key Exclusion Criteria: 1. Patients with uveal or mucosal melanoma 2. Prior therapy with an ERK-, MEK-, RAF-, or RAS-inhibitor 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. 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. LVEF \<50% 6. Symptomatic CNS metastases that are neurologically unstable. Patients with controlled CNS metastases are eligible. 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. Are pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the trial

Locations (59)

Mayo Clinic - Arizona

Phoenix, Arizona, United States

University of California, San Francisco

San Francisco, California, United States

The Melanoma and Skin Care Institute

Englewood, Colorado, United States

Mayo Clinic - Florida

Jacksonville, Florida, United States

University of Miami Sylvester Cancer

Miami, Florida, United States

University of Kansas Cancer Center

Kansas City, Kansas, United States

Ochsner Clinic Foundation

Jefferson, Louisiana, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

Barbara Ann Karmanos Cancer Institute

Detroit, Michigan, United States

Mayo Clinic

Rochester, Minnesota, United States

Washington University School of Medicine

St Louis, Missouri, United States

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Cleveland Clinic Foundation

Cleveland, Ohio, United States

SCRI Oncology Partners (formerly Tennessee Oncology)

Nashville, Tennessee, United States

Texas Oncology- Austin Midtown

Austin, Texas, United States

Texas Oncology - Baylor Charles A. Sammons Cancer Center

Dallas, Texas, United States

The University of Texas MD Anderson Cancer Center

Houston, Texas, United States

The University of Utah - Huntsman Cancer Institute (HCI)

Salt Lake City, Utah, United States

Virginia Oncology Associates

Norfolk, Virginia, United States

Fred Hutchinson Cancer Center

Seattle, Washington, United States

University of Wisconsin

Madison, Wisconsin, United States

Calvary Mater Newcastle

Waratah, New South Wales, Australia

Tasman Health Care

Southport, Queensland, Australia

Princess Alexandra Hospital

Woolloongabba, Queensland, Australia

Peter MacCallum Cancer Institute

Melbourne, Victoria, Australia

Hollywood Private Hospital

Nedlands, Western Australia, Australia

Alfred Hospital

Melbourne, Australia

Queen Elizabeth II Health Sciences Centre

Halifax, Nova Scotia, Canada

McGill University Health Centre

Montreal, Quebec, Canada

Masarykuv Onkologicky Ustav-MOU

Brno, Czechia

Fakultni nemocnice Hradec Kralove

Nový Hradec Králové, Czechia

Sanatorium Profesora Arenbergera

Prague, Czechia

Centre Hospitalier Universitaire (CHU) de Bordeaux - Hospitalier Saint-Andre

Bordeaux, France

CHU Dijon Bourgogne - Hopital Francois Mitterand (Hopital du Bocage)

Dijon, France

Centre Hospitalier du Mans

Le Mans, France

CHRU de Lille - HÃ´pital Claude Huriez

Lille, France

Centre Hospitalier Lyon-Sud

Lyon, France

Assistance Publique Hopitaux de Marseille (AP-HM) - Hopital de la Timone

Marseille, France

Hospital Ambroise Pairs

Paris, France

APHP - Hopital Saint Louis

Paris, France

CLCC Institute Gustave Roussy

Villejuif, France

Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) - Ospedale San Raffaele (HSR) (Istituto Scientifico Universitario Sa

Milan, Italy

IRCCS Istituto Nazionale Tumori Regina Elena

Roma, Italy

Istituto Dermopatico dell Immacolata IDI-IRCCS

Roma, Italy

Azienda Sanitaria Universitaria del Friuli Centrale

Udine, Italy

Isala Ziekenhuis

Amsterdam, Netherlands

Leids Universitair Medisch Centrum

Leiden, Netherlands

Radboud University

Nijmegen, Netherlands

Hospital Universitari Vall d'Hebron - Vall d'Hebron Institut d'Oncologia (VHIO)

Barcelona, Spain

Hospital Clinic de Barcelona

Barcelona, Spain

Hospital General Universitario Gregorio Marañón

Madrid, Spain

Hospital Universitario Ramon y Cajal

Madrid, Spain

Hospital HM Sanchinarro

Madrid, Spain

Hospital Universitario Central de Asturias

Oviedo, Spain

Royal Preston Hospital

Preston, Lancashire, United Kingdom

Sarah Cannon Research Institute - HCA Healthcare

City of London, London, United Kingdom

Royal Devon and Exeter Hospital

Exeter, United Kingdom

The Royal Marsden NHS Foundation Trust

London, United Kingdom

Christie Hospital

Manchester, United Kingdom

Clinical Research Directory

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

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (59)