Overview

This trial is active, not recruiting.

Condition melanoma
Treatments medi4736, dabrafenib, trametinib
Phase phase 1/phase 2
Targets PD-1, BRAF, MEK
Sponsor MedImmune LLC
Start date December 2013
End date April 2017
Trial size 69 participants
Trial identifier NCT02027961, CD-ON-MEDI4736-1161

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Dabrafenib/Trametinib/MEDI4736
medi4736
MEDI4736
dabrafenib
Dabrafenib
trametinib
Trametinib
(Experimental)
Trametinib/MEDI4736
medi4736
MEDI4736
trametinib
Trametinib
(Experimental)
Trametinib/MEDI4736
medi4736
MEDI4736
trametinib
Trametinib

Primary Outcomes

Measure
Maximum Tolerated Dose/Safety
time frame: 90 days after the last dose of MEDI4736

Secondary Outcomes

Measure
Antitumor Activity
time frame: 90 days after the last dose of investigational product
Antitumor Activity
time frame: 90 days after the last dose of investigational product
Pharmacokinetic of MEDI4736
time frame: 90 days after the last dose of MEDI4736
Pharmacokinetic of MEDI4736
time frame: 90 days after the last dose of MEDI4736
Immunogenicity of MEDI4736
time frame: 90 days after the last dose of MEDI4736

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - 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 Exclusion Criteria: - 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

Additional Information

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
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by MedImmune LLC.