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Phase 1 Safety and Tolerability of MEDI4736 in Combination With Dabrafenib and Trametinib or With Trametinib Alone

NCT02027961 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 68

Last updated 2019-05-17

No results posted yet for this study

Summary

The purpose of this study is to determine the maximum tolerated dose and characterize the safety profile of durvalumab (MEDI4736) in combination with dabrafenib and trametinib or with trametinib alone in participants with metastatic or unresectable melanoma with BRAF-mutation positive or wild-type (WT) BRAF, respectively.

Conditions

Interventions

BIOLOGICAL

Durvalumab

Intravenous dose of 3 or 10 mg/kg durvalumab.

DRUG

Dabrafenib

Oral dose of 150 mg dabrafenib capsule.

DRUG

Trametinib

Oral dose of 2 mg trametinib tablet.

Sponsors & Collaborators

  • MedImmune LLC

    lead INDUSTRY

Principal Investigators

  • MedImmune LLC · MedImmune LLC

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-12-20
Primary Completion
2018-04-24
Completion
2018-04-24
FDA Drug
Yes

Countries

  • United States
  • Canada
  • France
  • Italy

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02027961 on ClinicalTrials.gov