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Summary

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

Description

Summary

The purpose of this study is to determine the maximum tolerated dose and the safety profile of MEDI4736 in combination with dabrafenib and trametinib or with trametinib alone in subjects with metastatic or unresectable melanoma with BRAF-mutation positive or Wild Type BRAF, respectively.

Official Title

A Phase 1 Open-label Study of Safety and Tolerability of MEDI4736 in Subjects With Metastatic or Unresectable Melanoma in Combination With Dabrafenib and Trametinib or With Trametinib Alone

Keywords

Melanoma Metastatic or Unresectable Melanoma, MEDI4736, dafrafenib, trametinib, BRAF-mutation positive, wild-type BRAF, PD-L1, PD-1 Trametinib Dabrafenib Antibodies, Monoclonal

Eligibility

You can join if…

Open to people ages 18 years and up

  • Adults >/= 18 years old
  • Histologically confirmed cutaneous melanoma that is either Stage IIIc (unresectable)or Stage IV (metastatic) and determined to be BRAF V600E or V600K mutation-positive(cohort A) or mutation-negative (cohorts B and C)
  • ECOG performance status of 0 or 1
  • Measurable disease by radiographic or physical examination
  • Adequate organ and marrow function
  • Willingness to provide consent for biopsies positive or BRAF WT measurable disease,Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, and adequate organ and marrow function

You CAN'T join if...

  • Prior treatment with a BRAF inhibitor or MEK inhibitor
  • Any prior Grade ≥ 3 immune-related adverse event while receiving immunotherapy
  • Active or prior documented autoimmune disease within the past 2 years
  • History of or current risk for retinal vein occlusion (RVO) or central serous retinopathy (CSR)
  • History of or current cardiovascular risk including myocardial infarction, ≥ Class II congestive heart failure, uncontrolled arrhythmias, or refractory hypertension
  • Active, untreated CNS metastases
  • Women who are pregnant or lactating

Locations

  • Research Site
    Los Angeles, California, 90095, United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
MedImmune LLC
ID
NCT02027961
Phase
Phase 1/2
Lead Scientist
Alain Algazi
Study Type
Interventional
Last Updated
May 1, 2017