Summary

for people ages 18 years and up (full criteria)
at Orange, California and other locations
study started
estimated completion

Description

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

Official Title

A Randomized, Double-blind, Placebo-controlled, Phase III Study Comparing the Combination of PDR001, Dabrafenib and Trametinib Versus Placebo, Dabrafenib and Trametinib in Previously Untreated Patients With Unresectable or Metastatic BRAF V600 Mutant Melanoma

Keywords

MelanomaSpartalizumab (PDR001)dabrafenibtrametinibimmunotherapyPD 1 inhibitoranti PD1PD-1anti-PD-1combination treatmentmalignant skin cancerskin cancerBRAF V600unresectable BRAF V600 mutated melanomametastatic BRAF V600 mutated melanoma

Eligibility

You can join if…

Open to people ages 18 years and up

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

You CAN'T join if...

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.

Locations

  • UC Irvine Medical Center SCin progress, not accepting new patients
    OrangeCalifornia92868United States
  • California Cancer Associates for Research and Excellence SC-2in progress, not accepting new patients
    San DiegoCalifornia92024United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Novartis Pharmaceuticals
ID
NCT02967692
Phase
Phase 3
Study Type
Interventional
Last Updated