Advanced or Metastatic NRAS-mutant MelanomaPhase 3NCT06346067
A Study to Assess Naporafenib (ERAS-254) Administered With Trametinib in Patients With NRAS-mutant Melanoma (SEACRAFT-2)
A Phase 3 study testing Naporafenib, Dacarbazine and Temozolomide in people with Advanced or Metastatic NRAS-mutant Melanoma, run by Erasca, Inc. at 59 sites in 9 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Advanced or Metastatic NRAS-mutant Melanoma
- What is being tested?
- Naporafenib, Dacarbazine and Temozolomide
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 59 sitesin 9 countries
- Study dates
- 29 Apr 2024to Dec 2028
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Willing and able to provide written informed consent
- Age ≥ 18 years
- Histologically or cytologically confirmed unresectable or metastatic cutaneous (includes acral) melanoma.
- 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.
- 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.
- 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.
Show all 9Show fewer
- ECOG performance status 0, 1 or 2
- Presence of at least 1 measurable lesion according to RECIST v1.1
- Able to swallow oral medication.
Who cannot join
- Patients with uveal or mucosal melanoma
- Prior therapy with an ERK-, MEK-, RAF-, or RAS-inhibitor
- 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)
- 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)
- LVEF <50%
- Symptomatic CNS metastases that are neurologically unstable. Patients with controlled CNS metastases are eligible.
- 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.
- Are pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the trial
Trial locations and contacts
59 sites in 9 countries.
59 sites in 9 countries
United States21 sites
Texas Oncology- Austin Midtown
Austin, Texas, 78705
Massachusetts General Hospital
Boston, Massachusetts, 02114
Cleveland Clinic Foundation
Cleveland, Ohio, 44195
Texas Oncology - Baylor Charles A. Sammons Cancer Center
Dallas, Texas, 75246
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, 48201
The Melanoma and Skin Care Institute
Englewood, Colorado, 80113
The University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
Mayo Clinic - Florida
Jacksonville, Florida, 70121
Ochsner Clinic Foundation
Jefferson, Louisiana, 70121
University of Kansas Cancer Center
Kansas City, Kansas, 66205
University of Wisconsin
Madison, Wisconsin, 53792
University of Miami Sylvester Cancer
Miami, Florida, 33136
SCRI Oncology Partners (formerly Tennessee Oncology)
Nashville, Tennessee, 37203
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Virginia Oncology Associates
Norfolk, Virginia, 23502-1871
Mayo Clinic - Arizona
Phoenix, Arizona, 85054
Mayo Clinic
Rochester, Minnesota, 70121
The University of Utah - Huntsman Cancer Institute (HCI)
Salt Lake City, Utah, 84112
University of California, San Francisco
San Francisco, California, 94143
Fred Hutchinson Cancer Center
Seattle, Washington, 98109
Washington University School of Medicine
St Louis, Missouri, 63110
France9 sites
Centre Hospitalier Universitaire (CHU) de Bordeaux - Hospitalier Saint-Andre
Bordeaux, 33075
CHU Dijon Bourgogne - Hopital Francois Mitterand (Hopital du Bocage)
Dijon, 21079
Centre Hospitalier du Mans
Le Mans, 72000
CHRU de Lille - Hôpital Claude Huriez
Lille, 59000
Centre Hospitalier Lyon-Sud
Lyon, 69310
Assistance Publique Hopitaux de Marseille (AP-HM) - Hopital de la Timone
Marseille, 13005
Hospital Ambroise Pairs
Paris, 75010
APHP - Hopital Saint Louis
Paris, 9001
CLCC Institute Gustave Roussy
Villejuif, 94805
Australia6 sites
Peter MacCallum Cancer Institute
Melbourne, Victoria, 3000
Alfred Hospital
Melbourne, 3004
Hollywood Private Hospital
Nedlands, Western Australia, 6009
Tasman Health Care
Southport, Queensland, 4215
Calvary Mater Newcastle
Waratah, New South Wales, 2298
Princess Alexandra Hospital
Woolloongabba, Queensland, 4102
Spain6 sites
Hospital Universitari Vall d'Hebron - Vall d'Hebron Institut d'Oncologia (VHIO)
Barcelona, 08035
Hospital Clinic de Barcelona
Barcelona, 08036
Hospital General Universitario Gregorio Marañón
Madrid, 28007
Hospital Universitario Ramon y Cajal
Madrid, 28034
Hospital HM Sanchinarro
Madrid, 28050
Hospital Universitario Central de Asturias
Oviedo, 33011
United Kingdom5 sites
Sarah Cannon Research Institute - HCA Healthcare
City of London, London, W1G 6AD
Royal Devon and Exeter Hospital
Exeter, EX25DW
The Royal Marsden NHS Foundation Trust
London, SM2 5PT
Christie Hospital
Manchester, M20 4GJ
Royal Preston Hospital
Preston, Lancashire, PR29H
Italy4 sites
Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) - Ospedale San Raffaele (HSR) (Istituto Scientifico Universitario Sa
Milan, 20132
IRCCS Istituto Nazionale Tumori Regina Elena
Roma, 00144
Istituto Dermopatico dell Immacolata IDI-IRCCS
Roma, 00167
Azienda Sanitaria Universitaria del Friuli Centrale
Udine, 33100
Czechia3 sites
Masarykuv Onkologicky Ustav-MOU
Brno, 65653
Fakultni nemocnice Hradec Kralove
Nový Hradec Králové, 50005
Sanatorium Profesora Arenbergera
Prague, 1502
Netherlands3 sites
Isala Ziekenhuis
Amsterdam, 8025
Leids Universitair Medisch Centrum
Leiden, 2333 ZC
Radboud University
Nijmegen, 6525 GA
Canada2 sites
Queen Elizabeth II Health Sciences Centre
Halifax, Nova Scotia, B3J 3R4
McGill University Health Centre
Montreal, Quebec, H4A3J1
About this study
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]
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).
Read the 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.
- Being tested
- Naporafenib, Dacarbazine, Temozolomide, Trametinib
- Keywords
- Melanoma, NRAS Mutant, Cutaneous Melanoma
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NaporafenibDrug
Also called ERAS-254, LXH254
Naporafenib (ERAS-254) is an experimental Pan-Raf inhibitor
DacarbazineDrug
Also called DTIC
Dacarbazine IV - Day 1
TemozolomideDrug
Also called Temodar, TMZ
Temozolomide 200 mg/m2/day PO on Day 1 to Day 5 of each 28-day cycle
TrametinibDrug
Also called Mekinist
Trametinib is an FDA approved anticancer medication that targets MEK1 and MEK2.
| Study group | Role | What they receive |
|---|---|---|
| Stage 1 Dose selection Lead-in Arm 1 | Experimental | Naporafenib + Trametinib Naporafenib (ERAS-254) 100 mg administered orally twice daily (BID) Trametinib 1 mg once daily (QD) Receives: Drug: Naporafenib; Drug: Trametinib |
| Stage 1 Dose selection Lead-in Arm 2 | Experimental | Naporafenib + Trametinib Naporafenib (ERAS-254) 400 mg administered orally twice daily (BID) Trametinib 0.5 mg once daily (QD) Receives: Drug: Naporafenib; Drug: Trametinib |
| Stage 1 Dose selection Lead-in Arm 3 Trametinib monotherapy | Active comparator | Trametinib 2 mg once daily (QD) Receives: Drug: Trametinib |
| Stage 2 Arm A | Experimental | Naporafenib + Trametinib Naporafenib (ERAS-254) BID oral administration with Trametinib QD at the dose selected in Stage 1 Receives: Drug: Naporafenib; Drug: Trametinib |
| Stage 2 Arm B - Physician's Choice | Active comparator | * 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 Receives: Drug: Dacarbazine; Drug: Temozolomide; Drug: Trametinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stage 1:To select the optimal dose of naporafenib + trametinib to be studied in Stage 2
Incidence and severity of treatment-emergent AEs and serious AEs
Measured: Assessed up to 6 months from time of first dose
Stage 1:To select the optimal dose of naporafenib + trametinib to be studied in Stage 2
Objective response rate (ORR) based on assessment of radiographic imaging RECIST v1.1
Measured: Assessed up to 6 months from time of first dose
Stage 1:To select the optimal dose of naporafenib + trametinib to be studied in Stage 2
Maximum plasma concentration of ERAS-254 and trametinib
Measured: Study Day 1 up to Day 29
Stage 1:To select the optimal dose of naporafenib + trametinib to be studied in Stage 2
Time to achieve maximum plasma concentration of ERAS-254 and trametinib
Measured: Study Day 1 up to Day 29
Stage 1:To select the optimal dose of naporafenib + trametinib to be studied in Stage 2
Area under the plasma concentration-time curve
Measured: Study Day 1 up to Day 29
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)
- Progression free survival (PFS) based on assessment of radiographic imaging per RECIST v1.1
- Survival status
Measured: Assessed up to 24 months from time of first dose
Secondary outcomes (8)
Adverse Events
Incidence and severity of treatment-emergent AEs and serious AEs
Measured: Assessed up to 24 months from time of first dose
Duration of Response (DOR)
Based on assessment of radiographic imaging per RECIST version 1.1
Measured: Assessed up to 24 months from time of first dose]
Time to Response (TTR)
Based on assessment of radiographic imaging per RECIST version 1.1
Measured: Assessed up to 24 months from time of first dose]
Disease Control Rate (DCR)
Based on assessment of radiographic imaging per RECIST version 1.1
Measured: Assessed up to 24 months from time of first dose]
Overall Response Rate (ORR)
Based on the assessment of radiographic imaging per RECIST version 1.1
Measured: Assessed up to 24 months from time of first dose
Plasma concentration (Cmax):Stage 1 only
Maximum plasma concentration of ERAS-254 and trametinib
Measured: Study Day 1 up to Day 29
Area under the curve (AUC):Stage 1 only
Area under the plasma concentration-time curve
Measured: Study Day 1 up to Day 29
Quality of Life: To assess disease and treatment-related QOL in patients with NRASm melanoma.
Using the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire [QLQ]-C30 subscales and PRO CTCAE® symptom items specific to the potential cutaneous toxicities.
Measured: Assessed up to 24 months from time of first dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2024
- Study start29 Apr 2024
- Primary completionApr 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced or Metastatic NRAS-mutant MelanomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- Erasca, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Joyce Antal, Study director, Clinical Development
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06346067
- Sponsor's protocol ID
- ERAS-254-02
- Status last verified
- Feb 2026
- First submitted
- 17 Mar 2024
- Last updated
- 27 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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]
- ClinicalTrials.gov ID
- NCT06346067
- Acronym / sponsor ID
- ERAS-254-02
- Keywords
- Melanoma, NRAS Mutant, Cutaneous Melanoma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 78 participants (actual)
- Lead sponsor
- Erasca, Inc.Industry (pharma, biotech, devices)
- Study start
- 29 Apr 2024 (actual)
- Primary completion
- Apr 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 3 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Stage 1 Dose selection Lead-in Arm 1 | Experimental | Drug: Naporafenib, Drug: TrametinibNaporafenib + Trametinib Naporafenib (ERAS-254) 100 mg administered orally twice daily (BID) Trametinib 1 mg once daily (QD) |
| Stage 1 Dose selection Lead-in Arm 2 | Experimental | Drug: Naporafenib, Drug: TrametinibNaporafenib + Trametinib Naporafenib (ERAS-254) 400 mg administered orally twice daily (BID) Trametinib 0.5 mg once daily (QD) |
| Stage 1 Dose selection Lead-in Arm 3 Trametinib monotherapy | Active comparator | Drug: TrametinibTrametinib 2 mg once daily (QD) |
| Stage 2 Arm A | Experimental | Drug: Naporafenib, Drug: TrametinibNaporafenib + Trametinib Naporafenib (ERAS-254) BID oral administration with Trametinib QD at the dose selected in Stage 1 |
| Stage 2 Arm B - Physician's Choice | Active comparator | Drug: Dacarbazine, Drug: Temozolomide, Drug: Trametinib* 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 |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Willing and able to provide written informed consent
- Age ≥ 18 years
- Histologically or cytologically confirmed unresectable or metastatic cutaneous (includes acral) melanoma.
- 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.
- 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.
Key exclusion criteria (8 listed)
- Patients with uveal or mucosal melanoma
- Prior therapy with an ERK-, MEK-, RAF-, or RAS-inhibitor
- 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)
- 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)
- LVEF <50%
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NaporafenibAlso: ERAS-254, LXH254Naporafenib (ERAS-254) is an experimental Pan-Raf inhibitor | Drug | Stage 1 Dose selection Lead-in Arm 1, Stage 1 Dose selection Lead-in Arm 2, Stage 2 Arm A |
| DacarbazineAlso: DTICDacarbazine IV - Day 1 | Drug | Stage 2 Arm B - Physician's Choice |
| TemozolomideAlso: Temodar, TMZTemozolomide 200 mg/m2/day PO on Day 1 to Day 5 of each 28-day cycle | Drug | Stage 2 Arm B - Physician's Choice |
| TrametinibAlso: MekinistTrametinib is an FDA approved anticancer medication that targets MEK1 and MEK2. | Drug | Stage 1 Dose selection Lead-in Arm 1, Stage 1 Dose selection Lead-in Arm 2, Stage 1 Dose selection Lead-in Arm 3 Trametinib monotherapy, Stage 2 Arm A, Stage 2 Arm B - Physician's Choice |
Primary outcome
Stage 1:To select the optimal dose of naporafenib + trametinib to be studied in Stage 2
Time frame: Assessed up to 6 months from time of first dose
Incidence and severity of treatment-emergent AEs and serious AEs
Stage 1:To select the optimal dose of naporafenib + trametinib to be studied in Stage 2
Time frame: Assessed up to 6 months from time of first dose
Objective response rate (ORR) based on assessment of radiographic imaging RECIST v1.1
Stage 1:To select the optimal dose of naporafenib + trametinib to be studied in Stage 2
Time frame: Study Day 1 up to Day 29
Maximum plasma concentration of ERAS-254 and trametinib
Stage 1:To select the optimal dose of naporafenib + trametinib to be studied in Stage 2
Time frame: Study Day 1 up to Day 29
Time to achieve maximum plasma concentration of ERAS-254 and trametinib
Stage 1:To select the optimal dose of naporafenib + trametinib to be studied in Stage 2
Time frame: Study Day 1 up to Day 29
Area under the plasma concentration-time curve
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)
Time frame: Assessed up to 24 months from time of first dose
* Progression free survival (PFS) based on assessment of radiographic imaging per RECIST v1.1 * Survival status
8 secondary outcomes
Adverse Events
Time frame: Assessed up to 24 months from time of first dose
Duration of Response (DOR)
Time frame: Assessed up to 24 months from time of first dose]
Time to Response (TTR)
Time frame: Assessed up to 24 months from time of first dose]
Disease Control Rate (DCR)
Time frame: Assessed up to 24 months from time of first dose]
Overall Response Rate (ORR)
Time frame: Assessed up to 24 months from time of first dose
Plasma concentration (Cmax):Stage 1 only
Time frame: Study Day 1 up to Day 29
Area under the curve (AUC):Stage 1 only
Time frame: Study Day 1 up to Day 29
Quality of Life: To assess disease and treatment-related QOL in patients with NRASm melanoma.
Time frame: Assessed up to 24 months from time of first dose
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2026.
- Individual participant dataSharing planned: No
Related trials for Advanced or Metastatic NRAS-mutant Melanoma
RecruitingPhase 2
Belvarafenib in Combination With Cobimetinib in Patients With Locally Advanced or Metastatic NRAS-Mutant Melanoma
Advanced or Metastatic Melanoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joyce Antal study director
Clinical Development
59 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Naporafenib, Dacarbazine and Temozolomide in people with Advanced or Metastatic NRAS-mutant Melanoma, run by Erasca, Inc. at 59 sites in 9 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 27 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 59 sites in United States, France, Australia, Spain, United Kingdom and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stage 1:To select the optimal dose of naporafenib + trametinib to be studied in Stage 2 (time frame: Assessed up to 6 months from time of first dose). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2026.