A Phase 1/2, Open-label Study to Evaluate the Safety and Antitumor Activity of MEDI0680 (AMP-514) in Combination With MEDI4736 and MEDI0680 Monotherapy in Subjects With Select Advanced Malignancies

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2016 by MedImmune LLC
Sponsor:
Information provided by (Responsible Party):
MedImmune LLC
ClinicalTrials.gov Identifier:
NCT02118337
First received: April 11, 2014
Last updated: June 7, 2016
Last verified: June 2016
  Purpose
To evaluate the safety, tolerability and antitumor activity of MEDI0680 (AMP-514) given in combination with MEDI4736 and MEDI0680 monotherapy.

Condition Intervention Phase
Select Advanced Malignancies
Biological: MEDI0680
Biological: MEDI4736
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 1/2, Open-label Study to Evaluate the Safety and Antitumor Activity of MEDI0680 (AMP-514) in Combination With MEDI4736 and MEDI0680 Monotherapy in Subjects With Select Advanced Malignancies

Resource links provided by NLM:


Further study details as provided by MedImmune LLC:

Primary Outcome Measures:
  • Dose Escalation: Number of subjects with adverse events [ Time Frame: From first dose of study drugs until 90 days after the last dose of study drugs ] [ Designated as safety issue: Yes ]
    Assessed by number of subjects with AEs and SAEs

  • Dose Expansion: Antitumor activity [ Time Frame: From first dose of study drug through study completion ] [ Designated as safety issue: No ]
    Determination of antitumor activity based on investigator assessed response using RECIST v1.1


Secondary Outcome Measures:
  • Dose Escalation: Antitumor activity of MEDI0680 in combination with MEDI4736 in subjects with select advanced malignancies [ Time Frame: From first dose of study drugs through study completion ] [ Designated as safety issue: No ]
    Determination of antitumor activity based on investigator assessed response using RECIST v1.1

  • Dose Expansion: Safety of MEDI0680 Monotherapy and in combination with MEDI4736 [ Time Frame: From first dose through 90 days after last dose of study drugs ] [ Designated as safety issue: Yes ]
    To be assessed by number of subjects with AEs and SAEs

  • Dose Expansion: Antitumor activity of MEDI0680 monotherapy and in combination with MEDI4736 [ Time Frame: From the time of first dose through study completion ] [ Designated as safety issue: No ]
    Determination of antitumor activity based on blinded independent central review assessed response using RECIST v1.1

  • Both Phases: Pharmacokinetics of MEDI0680 monotherapy and in combination with MEDI4736 and MEDI4736 in combination with MEDI0680 [ Time Frame: From first dose until 12 months after the last dose ] [ Designated as safety issue: No ]
    Pharmacokinetics as measured by drug concentration in serum

  • Both Phases: Immunogenicity of MEDI0680 and MEDI4736 [ Time Frame: From first dose of study drugs until 12 months after last dose of study drugs ] [ Designated as safety issue: No ]
    Immunogenicity as measured by presence of detectable ADAs

  • PD-L1 as a predictive biomarker [ Time Frame: From first dose of study drug through study completion ] [ Designated as safety issue: No ]
    PD-L1 expression on the tumor membrane and tumor-infiltrating immune cells within the tumor microenvironment


Estimated Enrollment: 150
Study Start Date: May 2014
Estimated Study Completion Date: January 2019
Estimated Primary Completion Date: January 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Dose Escalation
Dose Escalation of MEDI0680 and MEDI4736 in combination
Biological: MEDI0680
anti-PD-1
Biological: MEDI4736
anti-PD-L1
Experimental: Dose Expansion Arm 1
MEDI0680 in combination with MEDI4736 at the selected dose from dose-escalation
Biological: MEDI0680
anti-PD-1
Biological: MEDI4736
anti-PD-L1
Experimental: Dose Expansion Arm 2
MEDI0680 Monotherapy at the selected dose from dose-escalation
Biological: MEDI0680
anti-PD-1

Detailed Description:
This is a multicenter, open-label, dose-escalation, and dose expansion study of MEDI0680 given alone and in combination with MEDI4736 to evaluate the safety, tolerability, pharmacokinetic (PK), immunogenicity, and antitumor activity in adult subjects with select advanced malignancies.
  Eligibility

Ages Eligible for Study:   18 Years to 99 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Must be 18 years or older
  • Eastern Cooperative Oncology Group performance status of 0-1
  • Adequate organ function
  • No more than 1 prior line of therapy

Exclusion Criteria:

  • Concurrent enrollment in another clinical study, unless in follow-up period or it is an observational study
  • Concurrent chemotherapy, immunotherapy, biologic, or hormonal therapy for cancer treatment
  • Prior treatment with immunotherapy
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02118337

Contacts
Contact: AstraZeneca Clinical Study Information Center 1-877-240-9479 information.center@astrazeneca.com
Contact: AstraZeneca Cancer Study Locator Service 1-877-400-4656 AstraZeneca@emergingmed.com

Locations
United States, California
Research Site Recruiting
Los Angeles, California, United States
United States, Florida
Research Site Recruiting
Tampa, Florida, United States
United States, New Jersey
Research Site Recruiting
Hackensack, New Jersey, United States
United States, New York
Research Site Recruiting
New York, New York, United States
United States, Oregon
Research Site Recruiting
Portland, Oregon, United States
United States, South Carolina
Research Site Recruiting
Charleston, South Carolina, United States
United States, Utah
Research Site Withdrawn
Salt Lake City, Utah, United States
United States, Washington
Research Site Recruiting
Seattle, Washington, United States
United States, West Virginia
Research Site Not yet recruiting
Morgantown, West Virginia, United States
Sponsors and Collaborators
MedImmune LLC
  More Information

Responsible Party: MedImmune LLC
ClinicalTrials.gov Identifier: NCT02118337     History of Changes
Other Study ID Numbers: D6020C00001 
Study First Received: April 11, 2014
Last Updated: June 7, 2016
Health Authority: United States: Food and Drug Administration

Keywords provided by MedImmune LLC:
select advanced malignancies

Additional relevant MeSH terms:
Neoplasms
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 23, 2016