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
NCT ID: NCT02118337
Last Updated: 2021-06-01
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1/PHASE2
97 participants
INTERVENTIONAL
2014-05-19
2020-03-17
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Nivolumab
Participants will receive IV infusion of nivolumab 240 mg Q2W in dose-expansion phase.
Interventions
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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.
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.
Nivolumab
Participants will receive IV infusion of nivolumab 240 mg Q2W in dose-expansion phase.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Eastern Cooperative Oncology Group performance status of 0-1
* Adequate organ function
* At least 1 prior line of therapy
Exclusion Criteria
* Concurrent chemotherapy, immunotherapy, biologic, or hormonal therapy for cancer treatment
* Prior treatment with immunotherapy
18 Years
99 Years
ALL
No
Sponsors
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MedImmune LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Laura Chow, MD
Role: PRINCIPAL_INVESTIGATOR
University of Washington
Omid Hamid, MD
Role: PRINCIPAL_INVESTIGATOR
The Angeles Clinic
Jhanelle Gray, MD
Role: PRINCIPAL_INVESTIGATOR
Moffitt Cancer Center
Rachel Sanborn, MD
Role: PRINCIPAL_INVESTIGATOR
Providence Cancer Center
Mohamad Salkeni, MD
Role: PRINCIPAL_INVESTIGATOR
Mary Babb Randolph Cancer Center
Monika Joshi, MD
Role: PRINCIPAL_INVESTIGATOR
Penn State Hershey Cancer Institute
Robert Alter, MD
Role: PRINCIPAL_INVESTIGATOR
John Theurer Cancer Center
Raid Aljumaily, MD
Role: PRINCIPAL_INVESTIGATOR
Peggy Charles Stephenson Cancer Center
Jason Chesney, MD
Role: PRINCIPAL_INVESTIGATOR
Brown Cancer Center
Fernando Quevedo, MD
Role: PRINCIPAL_INVESTIGATOR
Mayo Clinic
Martin Voss, MD
Role: PRINCIPAL_INVESTIGATOR
Memorial Sloan Kettering Cancer Center
Johanna Bendell
Role: PRINCIPAL_INVESTIGATOR
SCRI Development Innovations, LLC
Elizabeth Henry
Role: PRINCIPAL_INVESTIGATOR
Loyola Univ. Medical Center
Lionel Lewis
Role: PRINCIPAL_INVESTIGATOR
Dartmouth-Hitchcock Medical Center
Brian Rini
Role: PRINCIPAL_INVESTIGATOR
The Cleveland Clinic
Peter Van Veldhuizen
Role: PRINCIPAL_INVESTIGATOR
Menorah Medical Center tour
Locations
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Research Site
Los Angeles, California, United States
Research Site
Tampa, Florida, United States
Research Site
Overland Park, Kansas, United States
Research Site
Louisville, Kentucky, United States
Research Site
Rochester, Minnesota, United States
Research Site
Hackensack, New Jersey, United States
Research Site
New York, New York, United States
Research Site
Cleveland, Ohio, United States
Research Site
Oklahoma City, Oklahoma, United States
Research Site
Portland, Oregon, United States
Research Site
Hershey, Pennsylvania, United States
Research Site
Nashville, Tennessee, United States
Research Site
Seattle, Washington, United States
Research Site
East Bentleigh, , Australia
Research Site
Frankston, , Australia
Research Site
Toronto, Ontario, Canada
Research Site
Montreal, Quebec, Canada
Research Site
Bordeaux, , France
Research Site
Dijon, , France
Research Site
Marseille, , France
Research Site
Paris, , France
Research Site
Villejuif, , France
Research Site
Amsterdam, , Netherlands
Research Site
Groningen, , Netherlands
Research Site
Cambridge, , United Kingdom
Research Site
Cardiff, , United Kingdom
Research Site
Southampton, , United Kingdom
Countries
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References
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Voss MH, Azad AA, Hansen AR, Gray JE, Welsh SJ, Song X, Kuziora M, Meinecke L, Blando J, Achour I, Wang Y, Walcott FL, Oosting SF. A Randomized Phase II Study of MEDI0680 in Combination with Durvalumab versus Nivolumab Monotherapy in Patients with Advanced or Metastatic Clear-cell Renal Cell Carcinoma. Clin Cancer Res. 2022 Jul 15;28(14):3032-3041. doi: 10.1158/1078-0432.CCR-21-4115.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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Other Identifiers
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D6020C00001
Identifier Type: -
Identifier Source: org_study_id
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