Etude : CLXH254C12201 /



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Acronyme / Nom
Situation thérapeutique
Traitement
Cadre réglementaire
MÀJ
Présentation de l'étude
Acronyme / Nom : CLXH254C12201

Situation thérapeutique : Métastatique ou localement avancé

Traitement : Thérapie ciblée

Cadre réglementaire : RIPH1

Dernière MÀJ : 30/11/2021
Titre
Spécialité(s)
CIM10 - Localisation(s)
Informations principales
Titre : A Randomized, Open-label, Multi-arm, Two-part, Phase II Study to Assess Efficacy and Safety of Multiple LXH254 Combinations in Patients With Previously Treated Unresectable or Metastatic BRAFV600 or NRAS Mutant Melanoma

Spécialité : Peau
Localisation : C43 - Mélanome malin de la peau
Schéma
Phase
Stade
Ligne(s)
Informations complémentaires
Schéma : STUDY ARMS:
- Experimental: LXH254 + LTT462

- Experimental: LXH254 + trametinib

- Experimental: LXH254 + ribociclib

MAIN OBJECTIVE:
To evaluate the anti-tumor efficacy of LXH254 in combination with novel agents including LTT462, trametinib, ribociclib in participants with previously treated unresectable or metastatic, BRAFV600 or NRAS mutant melanoma as measured by objective response rate.

SECONDARY OBJECTIVES:
- To characterize the safety and tolerability of each combination arm
- To further evaluate the efficacy of each combination arm

Phase : II

Stade : Localement avancé à Métastatique

2, 3, 4
Informations libres de droit
Critères d'inclusion
Critères de non-inclusion
Informations libres de droit
Critères d'inclusion et de non-inclusion
Critères d'inclusion : - Male or female must be ≥ 12 years
- For adolescents only (12-17 years): body weight > 40kg
- Histologically confirmed unresectable or metastatic cutaneous melanoma
- Previously treated for unresectable or metastatic melanoma:

- Participants with NRAS mutation:
* Participants must have received prior systemic therapy for unresectable or metastatic melanoma with an anti-PD-1/PD-L1 checkpoint inhibitor as a single agent or in combination with anti-CTLA-4. No additional systemic treatment is allowed for unresectable or metastatic melanoma
* A maximum of two prior lines of systemic immunotherapy for unresectable or metastatic melanoma are allowed
* The last dose of prior therapy (anti-PD-1, anti-PD-L1 or anti-CTLA-4) must have been received more than four weeks before randomization
* Participants must have documented confirmed progressive disease as per RECIST v1.1 while on/after treatment with checkpoint inhibitor therapy. The last progression must have occurred within 12 weeks prior to randomization in the study

- Participants with BRAFV600 mutant disease:
* Participants must have received prior systemic therapy for unresectable or metastatic melanoma with anti-PD-1/PD-L1 as a single agent or in combination with anti-CTLA-4. Additionally, participants must have received targeted therapy with a RAFi as a single agent or in combination with a MEKi as the last prior therapy. No additional systemic treatment is allowed for advanced or metastatic melanoma
* A maximum of three prior lines of systemic therapy for unresectable or metastatic melanoma are allowed
*- The last dose of targeted therapy (last prior therapy) must have been received more than 2 weeks prior to randomization
* Participants must have documented progressive disease as per RECIST v1.1 while on/after treatment with targeted therapy. The last progression must have occurred within 12 weeks prior to randomization in the study

---Other protocol-defined inclusion criteria may apply.---

Critères de non-inclusion : - Treatment with any of the following anti-cancer therapies prior to the first dose of study treatment within the stated timeframes:
∙ ≤ 4 weeks for radiation therapy or ≤ 2 weeks for limited field radiation for palliation prior to the first dose of study treatment.
∙ ≤ 4 weeks or ≤ 5 half-life (whichever is shorter) for small molecule therapeutics.
∙ ≤ 4 weeks for any immunotherapy treatment including immune checkpoint inhibitors.
- Participants participating in additional parallel investigational drug or medical device studies.
- All primary central nervous system (CNS) tumors or symptomatic CNS metastases that are neurologically unstable
- 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 syndromes).
- Patients receiving proton pump inhibitors (PPI) which cannot be discontinued 3 days prior to the start study treatment and for the duration of the study.
- Any medical condition that would, in the investigator's judgment, prevent the patient's participation in the clinical study due to safety concerns or compliance with clinical study procedures.

---Other protocol-defined inclusion/exclusion criteria may apply---
NCT
Promoteur
Coordonnateur
Informations relatives au promoteur
NCT :
NCT04417621
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

Statut de l'essai : OUVERT

MAJ : 19/01/2021