| Titre |
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 |
| Protocole ID |
SEACRAFT-2 |
| ClinicalTrials.gov ID |
NCT06346067 |
| Type(s) de cancer |
Mélanome |
| Phase |
Phase III |
| Type étude |
Clinique |
| Médicament |
Naporafenib + tramétinib versus thérapie au choix du clinicien (dacarbazine, temozolomide ou tramétinib monothérapie) |
| Institution |
CIUSSS DU CENTRE-OUEST-DE-L'ILE-DE-MONTREAL
 HOPITAL GENERAL JUIF SIR MORTIMER B.DAVIS
3755 rue de la Côte Ste. Catherine, Montréal, QC, H3T 1E2
|
| Ville |
Montréal |
| Investigateur(trice) principal(e) |
Dr Wilson Miller
|
| Coordonnateur(trice) |
Mitra Rezaie
514-340-8222 poste 23744
|
| Statut |
 Actif en recrutement |
| Critètes d'éligibilité |
- 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.
- ECOG performance status 0, 1 or 2
- Presence of at least 1 measurable lesion according to RECIST v1.1
- Able to swallow oral medication.
|
| Critètes d'exclusion |
- 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
|
Groupe d'étude en oncologie du Québec