Education and Training
A Study of the Anti-PD1 Antibody PDR001, in Combination With Dabrafenib and Trametinib in Advanced Melanoma
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
Stanford is currently not accepting patients for this trial.
Stanford Investigator(s):
Intervention(s):
- other: Placebo
- drug: Dabrafenib
- drug: Trametinib
- biological: Spartalizumab
Eligibility
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
- Measurable disease according to RECIST 1.1
- 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
- Measurable disease according to RECIST 1.1
- 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
- Measurable disease according to RECIST 1.1
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
- Neoadjuvant and/or adjuvant therapy for melanoma completed less than 6 months prior to
enrollmen
- Radiation therapy within 4 weeks prior to start of study treatment
- Active autoimmune disease, and/or history of autoimmune disease(s) that required
treatment
Parts 2 & 3: Biomarker cohort & double-blind, randomized, placebo-controlled part
- Subjects with uveal or mucosal melanoma
- Prior systemic anti-cancer treatment for unresectable or metastatic melanoma
- Neoadjuvant and/or adjuvant therapy for melanoma completed less than 6 months prior to
enrollment
- Radiation therapy within 4 weeks prior to start of study treatment
- Clinically active cerebral melanoma metastasis.
- Active autoimmune disease, and/or history of autoimmune disease(s) that required
treatment
Other protocol-defined Inclusion/Exclusion may apply.
Ages Eligible for Study
18 Years - N/A
Genders Eligible for Study
All
Not currently accepting new patients for this trial
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
CCTO
650-725-9810
Not Recruiting