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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

This study is currently recruiting participants.
Verified July 2017 by MedImmune LLC
Sponsor:
ClinicalTrials.gov Identifier:
NCT02118337
First Posted: April 21, 2014
Last Update Posted: July 13, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
MedImmune LLC
  Purpose
To evaluate the Safety and Antitumor Activity of MEDI0680 (AMP-514) in Combination with Durvalumab versus Nivolumab Monotherapy in Subjects with Select Advanced Malignancies.

Condition Intervention Phase
Select Advanced Malignancies Biological: MEDI0680 Biological: Durvalumab Biological: Nivolumab Phase 1 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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 Durvalumab Versus Nivolumab 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 ]
    Assessed by number of subjects with AEs and SAEs

  • Dose Expansion: Antitumor activity [ Time Frame: From first dose of study drug through study completion ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    PD-L1 expression on the tumor membrane and tumor-infiltrating immune cells within the tumor microenvironment


Estimated Enrollment: 96
Actual Study Start Date: May 19, 2014
Estimated Study Completion Date: January 29, 2021
Estimated Primary Completion Date: January 29, 2021 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 0.1 mg/kg MEDI0680 Q2W; 3 mg/kg durvalumab Q2W
MEDI0680 and Durvalumab in combination
Biological: MEDI0680
anti-PD-1
Biological: Durvalumab
anti-PD-L1
Active Comparator: Nivolumab
Nivolumab monotherapy at the selected dose
Biological: Nivolumab
anti PD-1
Experimental: 0.5 mg/kg MEDI0680 Q2W; 10 mg/kg durvalumab Q2W
MEDI0680 and Durvalumab combination
Biological: MEDI0680
anti-PD-1
Biological: Durvalumab
anti-PD-L1
Experimental: 0.1 mg/kg MEDI0680 Q2W; 10 mg/kg durvalumab Q2W
MEDI0680 and Durvalumab in combination
Biological: MEDI0680
anti-PD-1
Biological: Durvalumab
anti-PD-L1
Experimental: 2.5 mg/kg MEDI0680 Q2W; 10 mg/kg durvalumab Q2W
MEDI0680 and Durvalumab in combination
Biological: MEDI0680
anti-PD-1
Biological: Durvalumab
anti-PD-L1
Experimental: 10 mg/kg MEDI0680 Q2W; 10 mg/kg durvalumab Q2W
MEDI0680 and Durvalumab in combination
Biological: MEDI0680
anti-PD-1
Biological: Durvalumab
anti-PD-L1
Experimental: 20 mg/kg MEDI0680 Q2W; 10 mg/kg durvalumab Q2W
MEDI0680 and Durvalumab in combination
Biological: MEDI0680
anti-PD-1
Biological: Durvalumab
anti-PD-L1
Experimental: 20 mg/kg MEDI0680 Q2W; 750 mg durvalumab Q2W
MEDI0680 and Durvalumab in combination
Biological: MEDI0680
anti-PD-1

Detailed Description:
This is a multicenter, open-label, Phase 1/2 study to evaluate the safety, tolerability, PK, immunogenicity, and antitumor activity of MEDI0680 in combination with durvalumab or nivolumab monotherapy in adult immunotherapy-naïve subjects with selected advanced malignancies.
  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 99 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
  • At least 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

  Show 19 Study Locations
Sponsors and Collaborators
MedImmune LLC
Investigators
Principal Investigator: Laura Chow, MD University of Washington
Principal Investigator: Omid Hamid, MD The Angeles Clinic
Principal Investigator: Jhanelle Gray, MD Moffitt Cancer Center
Principal Investigator: Rachel Sanborn, MD Providence Cancer Center
Principal Investigator: Mohamad Salkeni, MD Mary Babb Randolph Cancer Center
Principal Investigator: Carolyn Britten, MD Medical University of South Carolina, Hollings Cancer Center
Principal Investigator: Monika Joshi, MD Penn State Hershey Cancer Institute
Principal Investigator: Martin Gutierrez, MD John Theurer Cancer Center
Principal Investigator: Raid Aljumaily, MD Peggy Charles Stephenson Cancer Center
Principal Investigator: Jason Chesney, MD Brown Cancer Center
Principal Investigator: Thai Ho, MD Mayo Clinic
Principal Investigator: Fernando Quevedo, MD Mayo Clinic
Principal Investigator: Martin Voss, MD Memorial Sloan Kettering Cancer Center
  More Information

Responsible Party: MedImmune LLC
ClinicalTrials.gov Identifier: NCT02118337     History of Changes
Other Study ID Numbers: D6020C00001
First Submitted: April 11, 2014
First Posted: April 21, 2014
Last Update Posted: July 13, 2017
Last Verified: July 2017

Keywords provided by MedImmune LLC:
select advanced malignancies

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