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
No
Study drug
Dabrafenib, Trametinib
Sex
All
Actual Enrollment
68
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
Sponsors
MedImmune, LLC
Collaborators
-
Inclusion and exclusion criteria
Loading...
No locations available
| 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. |
Contacts
Investigators
Principal Investigator
MedImmune LLC
MedImmune
