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

Study drug

Sex

All

Actual Enrollment

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

Collaborators

Inclusion and exclusion criteria

Location

Research Site

Los Angeles, CA, United States, 90025

Location

Research Site

Tampa, FL, United States, 33612

Location

Research Site

Seattle, WA, United States, 98109

Location

Research Site

Portland, OR, United States, 97213

Location

Research Site

Hackensack, NJ, United States, 07601

Location

Research Site

Hershey, PA, United States, 17033-0850

Location

Research Site

Louisville, KY, United States, 40202

Location

Research Site

Oklahoma City, OK, United States, 73104

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.

Documents available

Redacted Protocol D6020C00001
Download
Redacted SAP D6020C00001
Download
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

Laura Chow

University of Washington

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

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

Redacted Protocol D6020C00001

Redacted SAP D6020C00001

Trial Results Summaries

Contacts

Contact

Contact Backup

Investigators

Principal Investigator