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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT02118337
Registration number
NCT02118337
Ethics application status
Date submitted
11/04/2014
Date registered
21/04/2014
Date last updated
1/06/2021
Titles & IDs
Public 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 Participants With Select Advanced Malignancies
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Scientific 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
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Secondary ID [1]
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0
D6020C00001
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Select Advanced Malignancies
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0
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Kidney Cancer
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0
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Clear Cell Renal Cell Carcinoma
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Condition category
Condition code
Cancer
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0
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0
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Kidney
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Other interventions - MEDI0680
Other interventions - Durvalumab
Other interventions - Nivolumab
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.
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.
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.
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.
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.
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.
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.
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.
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.
Other interventions: 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 interventions: 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.
Other interventions: Nivolumab
Participants will receive IV infusion of nivolumab 240 mg Q2W in dose-expansion phase.
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Intervention code [1]
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Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) in Dose-escalation Phase
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Assessment method [1]
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An adverse event (AE) is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. The TEAEs are defined as events present at baseline that worsened in intensity after administration of study drug or events absent at baseline that emerged after administration of study drug.
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Timepoint [1]
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Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
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Primary outcome [2]
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Number of Participants With Abnormal Clinical Laboratory Parameters Reported as TEAEs in Dose-escalation Phase
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Assessment method [2]
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Number of participants in dose-escalation phase with abnormal clinical laboratory parameters reported as TEAEs are reported. Abnormal clinical laboratory parameters are defined as any abnormal finding during analysis of serum chemistry, hematology, coagulation, and urine.
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Timepoint [2]
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Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
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Primary outcome [3]
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Number of Participants With Abnormal Vital Signs and Physical Examinations Reported as TEAES in Dose-escalation Phase
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Assessment method [3]
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Number of participants in dose-escalation phase with abnormal vital signs reported as TEAEs are reported. Abnormal vital signs is defined as any abnormal finding in the vital sign parameters (blood pressure, heart rate, body temperature, and respiratory rate). Abnormal physical examination findings are defined as any abnormal finding in the following body systems: head and neck, respiratory, cardiovascular, gastrointestinal, urogenital, musculoskeletal, neurological, psychiatric, dermatological, hematologic/lymphatic, and endocrine systems, and weight.
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Timepoint [3]
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Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
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Primary outcome [4]
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Number of Participants With Abnormal Electrocardiograms (ECGs) Reported as TEAEs in Dose-escalation Phase
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Assessment method [4]
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Number of participants in dose-escalation phase with abnormal ECG parameters reported as TEAEs are reported.
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Timepoint [4]
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Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
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Primary outcome [5]
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Objective Response Rate (ORR) Based on Investigator-assessed Response Using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) in Dose-expansion Phase
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Assessment method [5]
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The ORR is defined as best overall response of confirmed complete response (CR) or confirmed partial response (PR) based on RECIST v1.1. The CR is defined as disappearance of all target and non-target lesions and no new lesions. The PR is defined as >= 30% decrease in the sum of diameters of target lesions (compared to baseline) and no new non-target lesion. A confirmed CR or PR is defined as 2 CRs or 2 PRs that were separated by at least 4 weeks with no evidence of progression in-between.
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Timepoint [5]
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From baseline (Day -42 to Day -1) through disease progression or end of treatment (approximately 5 years 10 months)
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Secondary outcome [1]
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Best Overall Response (BOR) Based on Investigator-assessed RECIST v1.1 in Dose-expansion Phase
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Assessment method [1]
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The BOR includes CR, PR, stable disease (SD), progressive disease (PD), and non-evaluable (NE) based on RECIST v1.1. The CR is defined as disappearance of all target and non-target lesions and no new lesions. The PR is defined as >= 30% decrease in the sum of diameters of target lesions (compared to baseline) and no new nontarget lesion. The PD is defined at least 20% decrease in the sum of diameters of target lesions (compared to baseline) and/or new lesion. The SD is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for disease progression. The NE is defined as either when no or only a subset of lesion measurements are made at an assessment.
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Timepoint [1]
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From baseline (Day -42 to Day -1) through disease progression or end of treatment (approximately 5 years 10 months)
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Secondary outcome [2]
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Disease Control Rate (DCR) Based on Investigator-assessed RECIST v1.1 in Dose-expansion Phase
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Assessment method [2]
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The DCR is defined as a BOR of confirmed CR, confirmed PR, or SD based on RECIST v1.1. A confirmed CR is defined as two CRs (disappearance of all target and non-target lesions and no new lesions) that were separated by at least 4 weeks with no evidence of progression in-between. A confirmed PR is defined as two PRs (>= 30% decrease in the sum of diameters of target lesions compared to baseline and no new non-target lesion) that were separated by at least 4 weeks with no evidence of progression in-between. The SD is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for disease progression. The DCR at >= 8 weeks and >=24 weeks are reported.
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Timepoint [2]
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0
From baseline (Day -42 to Day -1) through disease progression or end of treatment (approximately 5 years 10 months)
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Secondary outcome [3]
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Time to Response (TTR) Based on Investigator-assessed RECIST v1.1 in Dose-expansion Phase
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Assessment method [3]
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The TTR is defined as the time from the first dose of treatment until the first documentation of a subsequently confirmed OR (confirmed CR or confirmed PR) based on RECIST v1.1. A confirmed CR is defined as two CRs (disappearance of all target and non-target lesions and no new lesions) that were separated by at least 4 weeks with no evidence of progression in-between. A confirmed PR is defined as two PRs (>= 30% decrease in the sum of diameters of target lesions compared to baseline and no new non-target lesion) that were separated by at least 4 weeks with no evidence of progression in-between. The TTR was estimated using Kaplan-Meier method.
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Timepoint [3]
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From baseline (Day -42 to Day -1) through disease progression or end of treatment (approximately 5 years 10 months)
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Secondary outcome [4]
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Duration of Response (DoR) Based on Investigator-assessed RECIST v1.1 in Dose-expansion Phase
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Assessment method [4]
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The DoR is defined as the duration from the first documentation of OR (confirmed CR or confirmed PR) to the first documented disease progression based on RECIST v1.1 or death due to any cause, whichever occurred first. A confirmed CR is defined as two CRs (disappearance of all target and non-target lesions and no new lesions) that were separated by at least 4 weeks with no evidence of progression in-between. A confirmed PR is defined as two PRs (>= 30% decrease in the sum of diameters of target lesions compared to baseline and no new non-target lesion) that were separated by at least 4 weeks with no evidence of progression in-between. The PD is defined at least 20% decrease in the sum of diameters of target lesions (compared to baseline) and/or new lesion. The DoR was estimated using Kaplan-Meier method.
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Timepoint [4]
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From baseline (Day -42 to Day -1) through disease progression or end of treatment (approximately 5 years 10 months)
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Secondary outcome [5]
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Progression Free Survival (PFS) Based on Investigator-assessed RECIST v1.1 in Dose-expansion Phase
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Assessment method [5]
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The PFS is defined as the time from the start of study treatment until the first documentation of disease progression based on RECIST v1.1 or death due to any cause, whichever occurred first. The PFS was estimated using Kaplan-Meier method.
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Timepoint [5]
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0
From baseline (Day -42 to Day -1) through disease progression or end of treatment (approximately 5 years 10 months)
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Secondary outcome [6]
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Overall Survival in Dose-expansion Phase
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Assessment method [6]
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The OS is defined as the time from the start of study treatment until death due to any cause. The OS was estimated using Kaplan-Meier method.
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Timepoint [6]
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From baseline (Day -42 to Day -1) through disease progression or end of treatment (approximately 5 years 10 months)
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Secondary outcome [7]
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BOR Based on Investigator-assessed Modified RECIST v1.1 in Dose-escalation Phase
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Assessment method [7]
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The BOR includes CR, PR, SD, PD, and NE per Modified RECIST v1.1. The CR is defined as disappearance of all target and non-target lesions and no new lesions. The PR is defined as >= 30% decrease in the sum of diameters of target lesions (compared to baseline) and no new nontarget lesion. The PD is defined at least 20% decrease in the sum of diameters of target lesions (compared to baseline) and/or new lesion. The SD is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for disease progression. The NE is defined as either when no or only a subset of lesion measurements are made at an assessment.
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Timepoint [7]
0
0
From baseline (Day -42 to Day -1) through disease progression or EOT (approximately 12 months for each participant)
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Secondary outcome [8]
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ORR Based on Investigator-assessed Modified RECIST v1.1 in Dose-escalation Phase
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Assessment method [8]
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The ORR is defined as best overall response of confirmed CR or confirmed PR based on modified RECIST v1.1. The CR is defined as disappearance of all target and non-target lesions and no new lesions. The PR is defined as >= 30% decrease in the sum of diameters of target lesions (compared to baseline) and no new non-target lesion. A confirmed CR or PR is defined as 2 CRs or 2 PRs that were separated by at least 4 weeks with no evidence of progression in-between.
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Timepoint [8]
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0
From baseline (Day -42 to Day -1) through disease progression or EOT (approximately 12 months for each participant)
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Secondary outcome [9]
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DCR Based on Investigator-assessed Modified RECIST v1.1 in Dose-escalation Phase
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Assessment method [9]
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The DCR is defined as a BOR of confirmed CR, confirmed PR, or SD based on modified RECIST v1.1. A confirmed CR is defined as two CRs (disappearance of all target and non-target lesions and no new lesions) that were separated by at least 4 weeks with no evidence of progression in-between. A confirmed PR is defined as two PRs (>= 30% decrease in the sum of diameters of target lesions compared to baseline and no new non-target lesion) that were separated by at least 4 weeks with no evidence of progression in-between. The SD is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for disease progression. The DCR at >= 8 weeks and >=24 weeks are reported.
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Timepoint [9]
0
0
From baseline (Day -42 to Day -1) through disease progression or EOT (approximately 12 months for each participant)
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Secondary outcome [10]
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0
TTR Based on Investigator-assessed Modified RECIST v1.1 in Dose-escalation Phase
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Assessment method [10]
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The TTR is defined as the time from the first dose of treatment until the first documentation of a subsequently confirmed OR (confirmed CR or confirmed PR) based on modified RECIST v1.1. A confirmed CR is defined as two CRs (disappearance of all target and non-target lesions and no new lesions) that were separated by at least 4 weeks with no evidence of progression in-between. A confirmed PR is defined as two PRs (>= 30% decrease in the sum of diameters of target lesions compared to baseline and no new non-target lesion) that were separated by at least 4 weeks with no evidence of progression in-between. The TTR was estimated using Kaplan-Meier method.
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Timepoint [10]
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0
From baseline (Day -42 to Day -1) through disease progression or EOT (approximately 12 months for each participant)
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Secondary outcome [11]
0
0
DoR Based on Investigator-assessed Modified RECIST v1.1 in Dose-escalation Phase
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Assessment method [11]
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The DoR is defined as the duration from the first documentation of OR (confirmed CR or confirmed PR) to the first documented disease progression based on modified RECIST v1.1 or death due to any cause, whichever occurred first. A confirmed CR is defined as two CRs (disappearance of all target and non-target lesions and no new lesions) that were separated by at least 4 weeks with no evidence of progression in-between. A confirmed PR is defined as two PRs (>= 30% decrease in the sum of diameters of target lesions compared to baseline and no new non-target lesion) that were separated by at least 4 weeks with no evidence of progression in-between. The PD is defined at least 20% decrease in the sum of diameters of target lesions (compared to baseline) and/or new lesion. The DoR was estimated using Kaplan-Meier method.
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Timepoint [11]
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0
From baseline (Day -42 to Day -1) through disease progression or EOT (approximately 12 months for each participant)
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Secondary outcome [12]
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PFS Based on Investigator-assessed Modified RECIST v1.1 in Dose-escalation Phase
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Assessment method [12]
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The PFS is defined as the time from the start of study treatment until the first documentation of disease progression based on modified RECIST v1.1 or death due to any cause, whichever occurred first. The PFS was estimated using Kaplan-Meier method.
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Timepoint [12]
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0
From baseline (Day -42 to Day -1) through disease progression or EOT (approximately 12 months for each participant)
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Secondary outcome [13]
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0
OS in Dose-escalation Phase
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Assessment method [13]
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0
The OS is defined as the time from the start of study treatment until death due to any cause. The OS was estimated using Kaplan-Meier method.
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Timepoint [13]
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0
From baseline (Day -42 to Day -1) through disease progression or EOT (approximately 12 months for each participant)
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Secondary outcome [14]
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Number of Participants With TEAEs and TESAEs in Dose-expansion Phase
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Assessment method [14]
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An AE is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. The TEAEs are defined as events present at baseline that worsened in intensity after administration of study drug or events absent at baseline that emerged after administration of study drug.
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Timepoint [14]
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Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
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Secondary outcome [15]
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Number of Participants With Abnormal Clinical Laboratory Parameters Reported as TEAEs in Dose-expansion Phase
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Assessment method [15]
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Number of participants in dose-expansion phase with abnormal clinical laboratory parameters reported as TEAEs are reported. Abnormal clinical laboratory parameters defined as any abnormal finding during analysis of serum chemistry, hematology, coagulation, and urine.
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Timepoint [15]
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Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
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Secondary outcome [16]
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Number of Participants With Abnormal Vital Signs and Physical Examinations Reported as TEAEs in Dose-expansion Phase
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Assessment method [16]
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Number of participants in dose-expansion phase with abnormal vital signs reported as TEAEs are reported. Abnormal vital signs is defined as any abnormal finding in the vital sign parameters (blood pressure, heart rate, body temperature, and respiratory rate). Abnormal physical examination findings are defined as any abnormal finding in the following body systems: head and neck, respiratory, cardiovascular, gastrointestinal, urogenital, musculoskeletal, neurological, psychiatric, dermatological, hematologic/lymphatic, and endocrine systems, and weight.
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Timepoint [16]
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Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
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Secondary outcome [17]
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Number of Participants With Abnormal ECGs Reported as TEAEs in Dose-expansion Phase
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Assessment method [17]
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Number of participants in dose-expansion phase with abnormal ECG parameters reported as TEAEs are reported.
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Timepoint [17]
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0
Day 1 through 90 days post end of treatment (approximately 5 years 10 months)
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Secondary outcome [18]
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0
Antitumor Activity of MEDI0680 and Durvalumab Versus Nivolumab Monotherapy in Immunotherapy-Naïve Participants With Advanced or Metastatic Clear-cell Renal Cell Carcinoma (ccRCC) Based on Blinded Independent Central Review (BICR) in Dose-expansion Phase
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Assessment method [18]
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0
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Timepoint [18]
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0
From baseline (Day -42 to Day -1) through disease progression or end of treatment (approximately 5 years 10 months)
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Secondary outcome [19]
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Percent Change From Baseline in Tumor Size in Dose-escalation Phase (Based on Investigator-assessed Modified RECIST v1.1) and Dose-expansion Phase (Based on Investigator-assessed RECIST v1.1)
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Assessment method [19]
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0
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Timepoint [19]
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From baseline (Day -42 to Day -1) through disease progression or EOT (approximately 12 months for each participant for dose-escalation phase and approximately 5 years 10 months for dose-expansion phase)
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Secondary outcome [20]
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Serum Concentration of MEDI0680 in Dose-escalation and Dose-expansion Phases
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Assessment method [20]
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Serum concentration of MEDI0680 were assessed using parameters Cmin (pre-dose) and Cmax (end of infusion), where Cmin was trough concentration and Cmax was peak concentration.
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Timepoint [20]
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Pre-dose and end of infusion on Cycle 1 Day 1, Cycle 1 Day 15, and Cycle 2 Day 1
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Secondary outcome [21]
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Serum Concentration of Durvalumab in Dose-escalation and Dose-expansion Phases
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Assessment method [21]
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Serum concentration of durvalumab were assessed using parameters Cmin (pre-dose) and Cmax (end of infusion), where Cmin was trough concentration and Cmax was peak concentration.
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Timepoint [21]
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Pre-dose and end of infusion on Cycle 1 Day 1, Cycle 1 Day 15, and Cycle 2 Day 1
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Secondary outcome [22]
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Number of Participants With Positive Anti-drug Antibodies (ADA) to MEDI0680 in Dose-escalation and Dose-expansion Phases
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Assessment method [22]
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Number of participants with positive ADAs to MEDI0680 are reported. Persistent positive is defined as positive at >= 2 post-baseline assessments (with >= 16 weeks between first and last positive) or positive at last post-baseline assessment. Transient positive is defined as negative at last post-baseline assessment and positive at only one post-baseline assessment or at >=2 post-baseline assessments (with <16 weeks between first and last positive).
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Timepoint [22]
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Cycle 1 Day 1, Cycle 2 Day 1, Cycle 5 Day 1, Cycle 8 Day 1, Cycle 11 Day 1, 90 and 180 days post end of treatment (approximately 5 years and 10 months)
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Secondary outcome [23]
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Number of Participants With Positive ADA to Durvalumab in Dose-escalation and Dose-expansion Phases
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Assessment method [23]
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Number of participants with positive ADA to durvalumab are reported. Persistent positive is defined as positive at >= 2 post-baseline assessments (with >= 16 weeks between first and last positive) or positive at last post-baseline assessment. Transient positive is defined as negative at last post-baseline assessment and positive at only one post-baseline assessment or at >=2 post-baseline assessments (with <16 weeks between first and last positive).
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Timepoint [23]
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0
Cycle 1 Day 1, Cycle 2 Day 1, Cycle 5 Day 1, Cycle 8 Day 1, Cycle 11 Day 1, 90 and 180 days post end of treatment (approximately 5 years and 10 months)
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Secondary outcome [24]
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0
ORR for Participants With Programmed Cell Death Ligand 1 (PD-L1) Status Positive and Negative in Dose-expansion Phase
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Assessment method [24]
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ORR for participants with PD-L1 status positive and negative are reported. The ORR is defined as best overall response of confirmed CR or confirmed PR based on RECIST v1.1. The CR is defined as disappearance of all target and non-target lesions and no new lesions. The PR is defined as >= 30% decrease in the sum of diameters of target lesions (compared to baseline) and no new non-target lesion. A confirmed CR or PR is defined as 2 CRs or 2 PRs that were separated by at least 4 weeks with no evidence of progression in-between.
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Timepoint [24]
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From baseline (Day -42 to Day -1) through disease progression or end of treatment (approximately 5 years 10 months)
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Eligibility
Key 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
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Minimum age
18
Years
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Maximum age
99
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 1/Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
19/05/2014
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
17/03/2020
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Sample size
Target
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Accrual to date
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Final
97
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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Research Site - East Bentleigh
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Recruitment hospital [2]
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Research Site - Frankston
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Recruitment postcode(s) [1]
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0
3165 - East Bentleigh
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Recruitment postcode(s) [2]
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0
3199 - Frankston
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Recruitment outside Australia
Country [1]
0
0
United States of America
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State/province [1]
0
0
California
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Country [2]
0
0
United States of America
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State/province [2]
0
0
Florida
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Country [3]
0
0
United States of America
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State/province [3]
0
0
Kansas
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Country [4]
0
0
United States of America
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State/province [4]
0
0
Kentucky
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Country [5]
0
0
United States of America
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State/province [5]
0
0
Minnesota
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Country [6]
0
0
United States of America
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State/province [6]
0
0
New Jersey
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Country [7]
0
0
United States of America
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State/province [7]
0
0
New York
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Country [8]
0
0
United States of America
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State/province [8]
0
0
Ohio
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Country [9]
0
0
United States of America
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State/province [9]
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Oklahoma
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United States of America
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Oregon
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Pennsylvania
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Washington
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Canada
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Ontario
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Quebec
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France
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Bordeaux
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France
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Dijon
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France
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Marseille
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France
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Paris Cedex 15
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France
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Villejuif
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Netherlands
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Amsterdam
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Netherlands
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Groningen
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United Kingdom
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Cambridge
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United Kingdom
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Cardiff
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United Kingdom
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Southampton
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
MedImmune LLC
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Ethics approval
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Summary
Brief summary
To evaluate the Safety and Antitumor Activity of MEDI0680 (AMP-514) in Combination with
Durvalumab versus Nivolumab Monotherapy in Participants with Select Advanced Malignancies.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT02118337
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Public notes
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Contacts
Principal investigator
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Laura Chow, MD
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University of Washington
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Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT02118337
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