A Study to Assess Naporafenib (ERAS-254) Administered With Trametinib in Patients With NRAS-mutant Melanoma (SEACRAFT-2)
NCT ID: NCT06346067
Last Updated: 2025-01-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
470 participants
INTERVENTIONAL
2024-04-29
2028-12-31
Brief Summary
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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).
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Detailed Description
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A total of approximately 470 eligible patients will be randomized to receive study drug(s) in this study across 2 stages.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Stage 1 Dose selection Lead-in Arm 1
Naporafenib + Trametinib Naporafenib (ERAS-254) 100 mg administered orally twice daily (BID) Trametinib 1 mg once daily (QD)
Naporafenib
Naporafenib (ERAS-254) is an experimental Pan-Raf inhibitor
Trametinib
Trametinib is an FDA approved anticancer medication that targets MEK1 and MEK2.
Stage 1 Dose selection Lead-in Arm 2
Naporafenib + Trametinib Naporafenib (ERAS-254) 400 mg administered orally twice daily (BID) Trametinib 0.5 mg once daily (QD)
Naporafenib
Naporafenib (ERAS-254) is an experimental Pan-Raf inhibitor
Trametinib
Trametinib is an FDA approved anticancer medication that targets MEK1 and MEK2.
Stage 1 Dose selection Lead-in Arm 3 Trametinib monotherapy
Trametinib 2 mg once daily (QD)
Trametinib
Trametinib is an FDA approved anticancer medication that targets MEK1 and MEK2.
Stage 2 Arm A
Naporafenib + Trametinib Naporafenib (ERAS-254) BID oral administration with Trametinib QD at the dose selected in Stage 1
Naporafenib
Naporafenib (ERAS-254) is an experimental Pan-Raf inhibitor
Trametinib
Trametinib is an FDA approved anticancer medication that targets MEK1 and MEK2.
Stage 2 Arm B - Physician's Choice
* 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
Dacarbazine
Dacarbazine IV - Day 1
Temozolomide
Temozolomide 200 mg/m2/day PO on Day 1 to Day 5 of each 28-day cycle
Trametinib
Trametinib is an FDA approved anticancer medication that targets MEK1 and MEK2.
Interventions
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Naporafenib
Naporafenib (ERAS-254) is an experimental Pan-Raf inhibitor
Dacarbazine
Dacarbazine IV - Day 1
Temozolomide
Temozolomide 200 mg/m2/day PO on Day 1 to Day 5 of each 28-day cycle
Trametinib
Trametinib is an FDA approved anticancer medication that targets MEK1 and MEK2.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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.
Exclusion Criteria
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
18 Years
99 Years
ALL
No
Sponsors
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Erasca, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Joyce Antal
Role: STUDY_DIRECTOR
Clinical Development
Locations
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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 - Hôpital 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
Countries
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Central Contacts
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Other Identifiers
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ERAS-254-02
Identifier Type: -
Identifier Source: org_study_id
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