Trial Search Results

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

The purpose of this study is to evaluate how well PDR001 in combination with dabrafenib and trametinib vs. placebo in combination with dabrafenib and trametinib might work in treating patients with melanoma.

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

Novartis Pharmaceuticals

Stanford Investigator(s):

Intervention(s):

  • Biological: Spartalizumab (PDR001)
  • Other: Placebo
  • Drug: Dabrafenib
  • Drug: Trametinib

Phase:

Phase 3

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

   - 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.

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