Etude : COMBI-APlus /



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Acronyme
Nom
Traitement
Type d'étude
MÀJ
Présentation de l'étude
Acronyme : COMBI-APlus

Nom :

Traitement : Adjuvant

Type d'étude : Ciblage moléculaire / Innovation thérapeutique

Dernière MÀJ : 21/10/2019
Titre
Spécialité(s)
CIM10 - Localisation(s)
Informations principales
Titre : Open-label, Phase IIIb Study of Dabrafenib in COMBInation With Trametinib in the Adjuvant Treatment of Stage III BRAF V600 Mutation-positive Melanoma After Complete Resection to Evaluate the Impact on Pyrexia Related Outcomes of an Adapted Pyrexia AE-management Algorithm (Plus)

Spécialité : Peau
Localisation : C43 - Mélanome malin de la peau
Schéma
Phase
Stade
Ligne(s)
Informations complémentaires
Schéma : This is an open-label Phase IIIb study of dabrafenib in combination with trametinib in the adjuvant treatment of melanoma after complete resection to evaluate the impact on pyrexia related outcomes of an adapted pyrexia AE-management algorithm, as well as safety, efficacy and health-related outcomes.

Approximately 600 subjects will be enrolled to receive dabrafenib (150 mg BID) and trametinib (2 mg once daily) combination therapy for 12 months. At enrollment, subjects will be instructed on the pyrexia management algorithm.

This study consists of two Periods for Enrolled subjects:
- Treatment Period - subjects will receive up to 12 months of treatment.
- Follow-up Period - subjects will be followed through 24 months from their first dose date for relapse, and through end of study for overall survival. Follow-up will start once treatment is complete or is prematurely discontinued and continue through the end of the study, regardless of disease recurrence.

Phase : III

Stade : Localement avancé

1
Critères d'inclusion
Critères de non-inclusion
Critères d'inclusion et de non-inclusion
Critères d'inclusion : - Completely resected histologically confirmed cutaneous melanoma stage IIIA (LN metastasis >1 mm), IIIB, IIIC, IIID [AJCC (ed 8)]
- V600E/K mutation positive using a validated local test
- Subjects presenting with initial resectable lymph node recurrence after a diagnosis of Stage I or II melanoma are eligible.
- Subjects who have previously had Stage III melanoma at any time are not eligible.
- Subjects with an unknown primary melanoma are not eligible.
- Recovered from definitive surgery (e.g. no uncontrolled wound infections or indwelling drains).
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1

Critères de non-inclusion : - Uveal or mucosal melanoma
- Evidence of metastatic disease including unresectable in-transit metastasis
- Received any prior adjuvant or neoadjuvant treatment, including but not limited to chemotherapy, checkpoint inhibitors, targeted therapy [e.g., BRAF and/or MEK inhibitors], biologic therapy, vaccine therapy, investigational treatment, or radiotherapy for melanoma
- Malignant disease, other than that being treated in this study. Exceptions to this exclusion include the following: malignancies that were treated curatively and have not recurred within 2 years prior to study treatment; completely resected basal cell and squamous cell skin cancers and any completely resected carcinoma in situ
- History or current evidence of cardiovascular risk
- A history or current evidence/risk of retinal vein occlusion (RVO) or central serous retinopathy
NCT
Promoteur
Coordonnateur
Informations relatives au promoteur
NCT :
NCT03551626
Promoteur :
Novartis Pharmaceuticals
Type de sponsor : Industriel
00000 HORS FRANCE

Coordonnateur :
Centre investigateur
Investigateur
TEC / ARC / IDE
État
MÀJ
Informations relatives aux investigateurs
Centre investigateur :
Centre Hospitalier Universitaire de Lille - 2 Avenue Oscar Lambret - 59000 LILLE

Investigateur :
Professeur Laurent MORTIER

TEC / ARC / IDE :
Benoît MINART
benoit.minart@
chru-lille.fr
03 20 44 64 15

Ouverture de l'essai : CLOS

MAJ : 21/10/2019