Etude : COMBI I / PDR001F2301



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

Nom : PDR001F2301

Traitement : Métastasique ou localement avancé

Type d'étude : Hors ciblage moléculaire

Dernière MÀJ : 06/02/2018
Titre
Spécialité(s)
CIM10 - Localisation(s)
Informations principales
Titre : Etude de phase III, randomisée, en double aveugle, contrôlée par placebo, comparant l’association PDR001/dabrafenib/trametinib à l’association placebo/dabrafenib/trametinib chez des patients atteints de mélanome non résécable ou métastatique, porteurs d’une mutation BRAF V600, sans traitement antérieur 

Spécialité : Peau
Localisation : C43 - Mélanome malin de la peau
Schéma
Phase
Stade
Ligne(s)
Informations complémentaires
Schéma : A Randomized, Double-blind, Placebo-controlled, Phase III Study Comparing the Combination of PDR001, Dabrafenib and Trametinib Versus Placebo, Dabrafenib and Trametinib in Previously Untreated Patients With Unresectable or Metastatic BRAF V600 Mutant Melanoma

2 arms:

- Experimental: Investigational treatment arm
Part 1: Safety run-in Up to 18 evaluable patients with previously untreated unresectable or metastatic BRAF V600 mutated melanoma will be enrolled and treated at different dose levels to determine the recommended Phase 3 regimen of PDR001 in combination with dabrafenib and trametinib.

Part 2: Biomarker cohort Approximately 20 patients with previously unresectable or metastatic BRAF V600 mutated melanoma will be enrolled to describe changes in the immune microenvironment and biomarker modulations

Part 3: Randomized double blind Approximately 500 patients with previously untreated unresectable and metastatic BRAF V600 mutated melanoma will be enrolled to compare the anti-tumor activity of PDR001 in combination with dabrafenib and trametinib versus placebo plus dabrafenib and trametinib.

- Placebo Comparator: Placebo comparator arm
Matching placebo in combination with dabrafenib and trametinib

Phase : III

Stade : NA

1
Critères d'inclusion
Critères de non-inclusion
Critères d'inclusion et de non-inclusion
Critères d'inclusion : - Part 1: Safety run-in
-> Histologically confirmed, unresectable or metastatic melanoma with BRAF V600 mutation
-> Aspartate transaminase (AST) < 2.5× ULN and Alanine transaminase (ALT) < 2.5× ULN
-> ECOG performance status ≤ 1

- Part 2: Biomarker cohort
-> Histologically confirmed, unresectable or metastatic melanoma with BRAF V600 mutation
-> At least two cutaneous or subcutaneous or nodal lesions for tumor sample collection
-> ECOG performance status ≤ 2

- Part 3: Double-blind, randomized, placebo-controlled part
-> Histologically confirmed, unresectable or metastatic melanoma with BRAF V600 mutation
-> ECOG performance status ≤ 2

Critères de non-inclusion : - Part 1: Safety run-in
-> Subjects with uveal or mucosal melanoma
-> Any history of CNS metastases
-> Prior systemic anti-cancer treatment for unresectable or metastatic melanoma
-> Prior loco-regional treatment for unresectable or metastatic melanoma in the last 6 month
-> Prior neoadjuvant and/or adjuvant therapy for melanoma completed less than 6 months
-> Radiation therapy within 4 weeks prior to start of study treatment
-> Active, known, suspected or a documented history of autoimmune disease

- Parts 2 & 3: Biomarker cohort & double-blind, randomized, placebo-controlled part
-> Subjects with uveal or mucosal melanoma
-> Clinically active cerebral melanoma metastasis
-> Prior systemic anti-cancer treatment for unresectable or metastatic melanoma
-> Prior loco-regional treatment for unresectable or metastatic melanoma in the last 6 month
-> Prior neoadjuvant and/or adjuvant therapy for melanoma completed less than 6 months
-> Radiation therapy within 4 weeks prior to start of study treatment
-> Active, known, suspected or a documented history of autoimmune disease
Other protocol-defined Inclusion/Exclusion may apply.
NCT
Promoteur
Coordonnateur
Informations relatives au promoteur
NCT :
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 :
CHU de Caen - Avenue de la Côte de Nacre - 14033 Caen Cedex - 14000 CAEN

Investigateur :
Andreea STEFAN

TEC / ARC / IDE :
Esther LEBRETON
lebreton-e@
chu-caen.fr

Ouverture de l'essai : CLOS

MAJ : 13/02/2019