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

Study identifier:CD-ON-MEDI4736-1161

ClinicalTrials.gov identifier:NCT02027961

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

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

Medical condition

Melanoma

Phase

Phase 1

Healthy volunteers

Study drug

Dabrafenib, Trametinib

Sex

All

Actual Enrollment

Study type

Interventional

Age

18 Years +

Date

Study Start Date: 20 Dec 2013

Primary Completion Date: 24 Apr 2018

Study Completion Date: 24 Apr 2018

Study design

Allocation: Non-randomized
Endpoint Classification: Safety
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Verification:

Verified 01 Mar 2021 by MedImmune, LLC

Collaborators

Inclusion and exclusion criteria

Location

Research Site

Scottsdale, AZ, United States, 85258

Location

Research Site

Miami Beach, FL, United States, 33140

Location

Research Site

Los Angeles, CA, United States, 90095

Location

Research Site

Toronto, ON, Canada, M5G 2M9

Location

Research Site

Montreal, QC, Canada, H3A 1A1

Location

Research Site

Boston, MA, United States, 02114

Location

Research Site

St Louis, MO, United States, 63110

Location

Research Site

Chicago, IL, United States, 60611

Arms	Assigned Interventions
Experimental: Cohort A1: Durvalumab (3 mg/kg) + Dabrafenib +Trametinib Participants will receive intravenous (IV) dose of 3 milligrams per kilogram (mg/kg) durvalumab every 2 weeks (Q2W) from Day 1 up to 12 months along with oral 150 mg dabrafenib capsule twice daily (BID) and oral 2 mg trametinib tablet once daily (QD) until confirmed disease progression (PD), initiation of alternate cancer therapy, unacceptable toxicity, withdrawal of consent, or other reasons to discontinue treatment. Post-durvalumab treatment period, participants who developed PD and meet the criteria for re-administration, will receive durvalumab 3 mg/kg up to an additional 12 months and continued the treatment of dabrafenib and trametinib.	Biological/Vaccine: 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.
Experimental: Cohort A2: Durvalumab (10 mg/kg) + Dabrafenib +Trametinib Participants will receive IV dose of 10 mg/kg durvalumab Q2W from Day 1 up to 12 months along with oral doses of dabrafenib 150 mg capsule BID and trametinib 2 mg tablet QD until confirmed PD, initiation of alternate cancer therapy, unacceptable toxicity, withdrawal of consent, or other reasons to discontinue treatment. Post-durvalumab treatment period, participants who developed PD and meet the criteria for re-administration, will receive durvalumab 10 mg/kg up to an additional 12 months and continued the treatment of dabrafenib and trametinib.	Biological/Vaccine: 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.
Experimental: Cohort B: Durvalumab (10 mg/kg) +Trametinib (Concurrent) Participants will receive concurrent doses of IV 10 mg/kg durvalumab Q2W from Day 1 up to 12 months along with oral dose of trametinib 2 mg tablet QD until confirmed PD, initiation of alternate cancer therapy, unacceptable toxicity, withdrawal of consent, or other reasons to discontinue treatment. Post-durvalumab treatment period, participants who developed PD and meet the criteria for re-administration, will receive durvalumab 10 mg/kg up to an additional 12 months and continued the treatment of trametinib.	Biological/Vaccine: Durvalumab Intravenous dose of 3 or 10 mg/kg durvalumab. Drug: Trametinib Oral dose of 2 mg trametinib tablet.
Experimental: Cohort C: Durvalumab (10 mg/kg) +Trametinib (Sequential) Participants will receive sequential doses of oral trametinib tablet 2 mg QD from Day 1 to Day 42 and IV durvalumab 10 mg/kg Q2W starting from Day 29 (Week 5) up to 12 months. Post-durvalumab treatment period, participants who developed PD and meet the criteria for re-administration, will receive durvalumab 10 mg/kg up to an additional 12 months.	Biological/Vaccine: Durvalumab Intravenous dose of 3 or 10 mg/kg durvalumab. Drug: Trametinib Oral dose of 2 mg trametinib tablet.

Documents available

Trial Results Summaries
Available here

Contacts

Contact

AstraZeneca Clinical Study Information Center

1-877-240-9479

information.center@astrazeneca.com

Contact Backup

AstraZeneca Cancer Study Locator Service

1-877-400-4656

AstraZeneca@emergingmed.com

Investigators

Principal Investigator

MedImmune LLC

MedImmune

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

Official Title

Medical condition

Phase

Healthy volunteers

Study drug

Sex

Actual Enrollment

Study type

Age

Date

Study design

Verification:

Sponsors

Collaborators

Inclusion Criteria

Exclusion Criteria

Research Site

Research Site

Research Site

Research Site

Research Site

Research Site

Research Site

Research Site

Documents available

Trial Results Summaries

Contacts

Contact

Contact Backup

Investigators

Principal Investigator