A Study of the Anti-PD1 Antibody PDR001, in Combination With Dabrafenib and Trametinib in Advanced Melanoma

• Status: Active, not recruiting
• Trial end date: 2023-07-17
• Target enrollment: 0
• Participant gender: All

Summary

To evaluate the safety and efficacy of the combination of an anti-PD-1 antibody (Spartalizumab (PDR001)), a BRAF inhibitor (dabrafenib) and a MEK inhibitor (trametinib) in unresectable or metastatic BRAF V600 mutant melanoma

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis Pharmaceuticals
• Treatments: Dabrafenib; Spartalizumab; Trametinib

Criteria

Inclusion criteria 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

Exclusion Criteria:

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.