A Phase 1/2, Open-label Study to Evaluate the Safety and Antitumor Activity of MEDI0680 (AMP-514) in Combination with Durvalumab versus Nivolumab Monotherapy in Participants with Select Advanced Malignancies
Study identifier:D6020C00001
ClinicalTrials.gov identifier:NCT02118337
EudraCT identifier:N/A
CTIS identifier:N/A
Study Complete
Official Title
A Phase 1/2, Open-label Study to Evaluate the Safety and Antitumor Activity of MEDI0680 (AMP-514) in Combination with Durvalumab versus Nivolumab Monotherapy in Subjects with Select Advanced Malignancies
Medical condition
select advanced malignancies
Phase
Phase 1/2
Healthy volunteers
No
Study drug
-
Sex
All
Actual Enrollment
97
Study type
Interventional
Age
18 Years - 99 Years
Date
Study Start Date: 19 May 2014
Primary Completion Date: 17 Mar 2020
Study Completion Date: 17 Mar 2020
Study design
Allocation: Randomized
Endpoint Classification: Safety/Efficacy
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Verification:
Verified 01 May 2021 by MedImmune, LLC
Sponsors
MedImmune, LLC
Collaborators
-
Inclusion and exclusion criteria
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No locations available
| Arms | Assigned Interventions |
|---|---|
| Experimental: MEDI0680 0.1 mg/kg + Durvalumab 3 mg/kg Participants in dose-escalation phase will receive IV infusion of MEDI0680 0.1 mg/kg and durvalumab 3 mg/kg every 2 weeks (Q2W) for up to 12 months. | Biological/Vaccine: MEDI0680 Participants will receive IV infusion of MEDI0680 0.1 or 0.5 or 2.5 or 10 or 20 mg/kg Q2W in dose-escalation phase and 20 mg/kg Q2W in dose-expansion phase. Other Name: AMP-514 Biological/Vaccine: Durvalumab Participants will receive IV infusion of durvalumab 3 and 10 mg Q2W in dose-escalation phase and 750 mg Q2W in dose-expansion phase. |
| Experimental: MEDI0680 0.1 mg/kg + Durvalumab 10 mg Participants in dose-escalation phase will receive IV infusion of MEDI0680 0.1 mg/kg and durvalumab 10 mg/kg Q2W for up to 12 months. | Biological/Vaccine: MEDI0680 Participants will receive IV infusion of MEDI0680 0.1 or 0.5 or 2.5 or 10 or 20 mg/kg Q2W in dose-escalation phase and 20 mg/kg Q2W in dose-expansion phase. Other Name: AMP-514 Biological/Vaccine: Durvalumab Participants will receive IV infusion of durvalumab 3 and 10 mg Q2W in dose-escalation phase and 750 mg Q2W in dose-expansion phase. |
| Experimental: MEDI0680 0.5 mg/kg + Durvalumab 10 mg Participants in dose-escalation phase will receive IV infusion of MEDI0680 0.5 mg/kg and durvalumab 10 mg/kg Q2W for up to 12 months. | Biological/Vaccine: MEDI0680 Participants will receive IV infusion of MEDI0680 0.1 or 0.5 or 2.5 or 10 or 20 mg/kg Q2W in dose-escalation phase and 20 mg/kg Q2W in dose-expansion phase. Other Name: AMP-514 Biological/Vaccine: Durvalumab Participants will receive IV infusion of durvalumab 3 and 10 mg Q2W in dose-escalation phase and 750 mg Q2W in dose-expansion phase. |
| Experimental: MEDI0680 2.5 mg/kg + Durvalumab 10 mg Participants in dose-escalation phase will receive IV infusion of MEDI0680 2.5 mg/kg and durvalumab 10 mg/kg Q2W for up to 12 months. | Biological/Vaccine: MEDI0680 Participants will receive IV infusion of MEDI0680 0.1 or 0.5 or 2.5 or 10 or 20 mg/kg Q2W in dose-escalation phase and 20 mg/kg Q2W in dose-expansion phase. Other Name: AMP-514 Biological/Vaccine: Durvalumab Participants will receive IV infusion of durvalumab 3 and 10 mg Q2W in dose-escalation phase and 750 mg Q2W in dose-expansion phase. |
| Experimental: MEDI0680 10 mg/kg + Durvalumab 10 mg Participants in dose-escalation phase will receive IV infusion of MEDI0680 10 mg/kg and durvalumab 10 mg/kg Q2W for up to 12 months. | Biological/Vaccine: MEDI0680 Participants will receive IV infusion of MEDI0680 0.1 or 0.5 or 2.5 or 10 or 20 mg/kg Q2W in dose-escalation phase and 20 mg/kg Q2W in dose-expansion phase. Other Name: AMP-514 Biological/Vaccine: Durvalumab Participants will receive IV infusion of durvalumab 3 and 10 mg Q2W in dose-escalation phase and 750 mg Q2W in dose-expansion phase. |
| Experimental: MEDI0680 20 mg/kg + Durvalumab 10 mg Participants in dose-escalation phase will receive IV infusion of MEDI0680 20 mg/kg and durvalumab 10 mg/kg Q2W for up to 12 months. | Biological/Vaccine: MEDI0680 Participants will receive IV infusion of MEDI0680 0.1 or 0.5 or 2.5 or 10 or 20 mg/kg Q2W in dose-escalation phase and 20 mg/kg Q2W in dose-expansion phase. Other Name: AMP-514 Biological/Vaccine: Durvalumab Participants will receive IV infusion of durvalumab 3 and 10 mg Q2W in dose-escalation phase and 750 mg Q2W in dose-expansion phase. |
| Experimental: MEDI0680 20 mg/kg Participants in dose-expansion phase will receive IV infusion of MEDI0680 20 mg/kg Q2W until unacceptable toxicity, confirmed disease progression, development of other reason for treatment discontinuation, or for a maximum of 2 years, whichever occurred first. | Biological/Vaccine: MEDI0680 Participants will receive IV infusion of MEDI0680 0.1 or 0.5 or 2.5 or 10 or 20 mg/kg Q2W in dose-escalation phase and 20 mg/kg Q2W in dose-expansion phase. Other Name: AMP-514 |
| Experimental: MEDI0680 20 mg/kg + Durvalumab 750 mg Participants in dose-expansion phase will receive IV infusion of MEDI0680 20 mg/kg and durvalumab 750 mg/kg Q2W until unacceptable toxicity, confirmed disease progression, development of other reason for treatment discontinuation, or for a maximum of 2 years, whichever occurred first. | Biological/Vaccine: MEDI0680 Participants will receive IV infusion of MEDI0680 0.1 or 0.5 or 2.5 or 10 or 20 mg/kg Q2W in dose-escalation phase and 20 mg/kg Q2W in dose-expansion phase. Other Name: AMP-514 Biological/Vaccine: Durvalumab Participants will receive IV infusion of durvalumab 3 and 10 mg Q2W in dose-escalation phase and 750 mg Q2W in dose-expansion phase. |
| Active Comparator: Nivolumab 240 mg Participants in dose-expansion phase will receive IV infusion of nivolumab 240 mg Q2W until unacceptable toxicity, confirmed disease progression, development of other reason for treatment discontinuation, or for a maximum of 2 years, whichever occurred first. | Biological/Vaccine: Nivolumab Participants will receive IV infusion of nivolumab 240 mg Q2W in dose-expansion phase. |
Contacts
Investigators
Principal Investigator
Laura Chow
University of Washington
