Informations générales (source: ClinicalTrials.gov)
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]
Interventional
Phase 3
Erasca, Inc. (Voir sur ClinicalTrials)
avril 2024
décembre 2028
05 avril 2025
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).
Etablissements
| Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CLCC INSTITUT GUSTAVE ROUSSY | Contact (sur clinicalTrials) | ||||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| APHP - Hopital Saint Louis - 9001 - Paris - France | Contact (sur clinicalTrials) | ||||
| Assistance Publique Hopitaux de Marseille (AP-HM) - Hopital de la Timone - 13005 - Marseille - France | Contact (sur clinicalTrials) | ||||
| Centre Hospitalier du Mans - 72000 - Le Mans - France | Contact (sur clinicalTrials) | ||||
| Centre Hospitalier Lyon-Sud - 69310 - Lyon - France | Contact (sur clinicalTrials) | ||||
| Centre Hospitalier Universitaire (CHU) de Bordeaux - Hospitalier Saint-Andre - 33075 - Bordeaux - France | Contact (sur clinicalTrials) | ||||
| CHRU de Lille - Hôpital Claude Huriez - 59000 - Lille - France | Contact (sur clinicalTrials) | ||||
| CHU Dijon Bourgogne - Hopital Francois Mitterand (Hopital du Bocage) - 21079 - Dijon - France | Contact (sur clinicalTrials) | ||||
| Hospital Ambroise Pairs - 75010 - Paris - France | Contact (sur clinicalTrials) | ||||
Critères
Tous
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
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
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