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