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NCT06346067 | RECRUITING | Advanced or Metastatic NRAS-mutant Melanoma

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

Erasca, Inc.

Brief 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).

Condition or disease

Advanced or Metastatic NRAS-mutant Melanoma

Intervention/treatment

Naporafenib

Dacarbazine

Temozolomide

Trametinib

Phase

PHASE3

Detailed Description:

SEACRAFT-2 is a global, Phase III, open-label, randomized study to assess the efficacy and safety of naporafenib administered with trametinib compared to physician's choice of therapy (dacarbazine, temozolomide, or trametinib monotherapy) in patients with unresectable or metastatic NRAS mutant melanoma who have progressed on, or are intolerant to, an anti-programmed death-1 ligand 1 (PD 1/L1)-based regimen. The study will consist of 2 stages: dose optimization in Stage 1 and the Phase 3 portion in Stage 2. A total of approximately 470 eligible patients will be randomized to receive study drug(s) in this study across 2 stages.

Study Type : INTERVENTIONAL
Estimated Enrollment : 470 participants
Masking : NONE
Primary Purpose : TREATMENT
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]
Actual Study Start Date : 2024-04-29
Estimated Primary Completion Date : 2028-04
Estimated Study Completion Date : 2028-12

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years to 99 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
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
A Study to Assess Naporafenib (ERAS-254) Administered With Trametinib in Patients With NRAS-mutant Melanoma (SEACRAFT-2)

Location Details

NCT06346067

Please Choose a site

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, Arizona

Mayo Clinic - Arizona

Phoenix, Arizona, United States, 85054

RECRUITING

United States, California

University of California, San Francisco

San Francisco, California, United States, 94143

RECRUITING

United States, Colorado

The Melanoma and Skin Care Institute

Englewood, Colorado, United States, 80113

RECRUITING

United States, Florida

Mayo Clinic - Florida

Jacksonville, Florida, United States, 70121

RECRUITING

United States, Florida

University of Miami Sylvester Cancer

Miami, Florida, United States, 33136

RECRUITING

United States, Kansas

University of Kansas Cancer Center

Kansas City, Kansas, United States, 66205

ACTIVE NOT RECRUITING

United States, Louisiana

Ochsner Clinic Foundation

Jefferson, Louisiana, United States, 70121

RECRUITING

United States, Massachusetts

Massachusetts General Hospital

Boston, Massachusetts, United States, 02114

RECRUITING

United States, Road cancer

Barbara Ann Karmanos Cancer Institute

Detroit, Road cancer, United States, 48201

RECRUITING

United States, Minnesota

Mayo Clinic

Rochester, Minnesota, United States, 70121

RECRUITING

United States, Missouri

Washington University School of Medicine

Saint Louis, Missouri, United States, 63110

RECRUITING

United States, New York

Memorial Sloan Kettering Cancer Center

New York, New York, United States, 10065

RECRUITING

United States, Ohio

Cleveland Clinic Foundation

Cleveland, Ohio, United States, 44195

RECRUITING

United States, Tennessee

SCRI Oncology Partners (formerly Tennessee Oncology)

Nashville, Tennessee, United States, 37203

RECRUITING

United States, Texas

Texas Oncology- Austin Midtown

Austin, Texas, United States, 78705

RECRUITING

United States, Texas

Texas Oncology - Baylor Charles A. Sammons Cancer Center

Dallas, Texas, United States, 75246

RECRUITING

United States, Texas

The University of Texas MD Anderson Cancer Center

Houston, Texas, United States, 77030

RECRUITING

United States, Utah

The University of Utah - Huntsman Cancer Institute (HCI)

Salt Lake City, Utah, United States, 84112

RECRUITING

United States, Virginia

Virginia Oncology Associates

Norfolk, Virginia, United States, 23502-1871

RECRUITING

United States, Washington

Fred Hutchinson Cancer Center

Seattle, Washington, United States, 98109

RECRUITING

United States, Wisconsin

University of Wisconsin

Madison, Wisconsin, United States, 53792

RECRUITING

Australia, New South Wales

Calvary Mater Newcastle

Waratah, New South Wales, Australia, 2298

RECRUITING

Australia, Queensland

Tasman Health Care

Southport, Queensland, Australia, 4215

RECRUITING

Australia, Queensland

Princess Alexandra Hospital

Woolloongabba, Queensland, Australia, 4102

RECRUITING

Australia, Victoria

Peter MacCallum Cancer Institute

Melbourne, Victoria, Australia, 3000

RECRUITING

Australia, Western Australia

Hollywood Private Hospital

Nedlands, Western Australia, Australia, 6009

RECRUITING

Australia,

Alfred Hospital

Melbourne, Australia, 3004

RECRUITING

Canada, New Scotia

Queen Elizabeth II Health Sciences Centre

Halifax, Nova Scotia, Canada, B3J 3R4

RECRUITING

Canada, Quebec

McGill University Health Centre

Montréal, Quebec, Canada, E 4 is 1

RECRUITING

Czechia,

Masarykuv oncologically constitution

Brno, Czechia, 65653

RECRUITING

Czechia,

Faculty Hospital Hradec Kralove

New Hradec Králové, Czechia, 50005

RECRUITING

Czechia,

Professor Arenberger Sanatorium

Prague, Czechia, 1502

RECRUITING

France,

University Hospital Center (CHU) in Bordeaux - Saint -Andre hospitalier

Bordeaux, France, 33075

RECRUITING

France,

CHU Dijon Bourgogne - HOPITAL FRANCOIS MITTERRAND (HOPITAL DU BOCAGE)

Dijon, France, 21079

RECRUITING

France,

Le Mans Hospital Center

Le Mans, France, 72000

RECRUITING

France,

CHRU de Lille - CLAUDE HUSPULY HURIER

Lille, France, 59000

RECRUITING

France,

Lyon-Sud Hospital Center

Lyon, France, 69310

RECRUITING

France,

Public assistance Hospitals from Marseille (AP -HM) - Hospital of the Timone

Marseille, France, 13005

RECRUITING

France,

Ambroise Paris Hospital

Paris, France, 75010

RECRUITING

France,

APHP - Hospital Saint Louis

Paris, France, 9001

RECRUITING

France,

CLCC Institute Gustave Roussy

Villejuif, France, 94805

RECRUITING

Italy,

Institute of scientific hospitalization and care (IRCCS) - San Raffaele Hospital (HSR) (Sa University Scientific Institute

Milan, Italy, 20132

RECRUITING

Italy,

IRCCS National Cancer Institute Regina Elena

Roma, Italy, 00144

RECRUITING

Italy,

Dermopathic Institute of the Immacolata Idi-Irccs

Roma, Italy, 00167

RECRUITING

Italy,

University Healthcare Company of Friuli Centrale

Udine, Italy, 33100

RECRUITING

Netherlands,

Isala Hospital

Amsterdam, Netherlands, 8025

RECRUITING

Netherlands,

Leiden University Medical Center

Leiden, Netherlands, 2333 ZC

RECRUITING

Netherlands,

Radboud University

Nijmegen, Netherlands, 6525 GA

ACTIVE NOT RECRUITING

Spain,

Vall d'Hebron University Hospital - Vall d'Hebron Institute of Oncology (VHIO)

Barcelona, Spain, 08035

RECRUITING

Spain,

Clinic Hospital in Barcelona

Barcelona, Spain, 08036

RECRUITING

Spain,

Gregorio Marañón University General Hospital

Madrid, Spain, 28007

RECRUITING

Spain,

Ramon and Cajal University Hospital

Madrid, Spain, 28034

RECRUITING

Spain,

Hospital HM Sanchinarro

Madrid, Spain, 28050

ACTIVE NOT RECRUITING

Spain,

Central University Hospital of Asturias

Oviedo, Spain, 33011

RECRUITING

United Kingdom, Lancashire

Royal Preston Hospital

Preston, Lancashire, United Kingdom, Brightness

RECRUITING

United Kingdom, London

Sarah Cannon Research Institute - HCA Healthcare

City of London, London, United Kingdom, W1G 6AD

RECRUITING

United Kingdom,

Royal Devon and Exeter Hospital

Exeter, United Kingdom, EX25DW

ACTIVE NOT RECRUITING

United Kingdom,

The Royal Marsden NHS Foundation Trust

London, United Kingdom, SM2 5pt

ACTIVE NOT RECRUITING

United Kingdom,

Christie Hospital

Manchester, United Kingdom, M20 4g