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

• ClinicalTrials.gov Identifier: NCT02118337
• Recruitment Status: Completed
• First Posted: April 21, 2014
• Results First Posted: June 1, 2021
• Last Update Posted: June 1, 2021
• Sponsor: MedImmune LLC
• Information provided by (Responsible Party): MedImmune LLC

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Select Advanced Malignancies; Kidney Cancer; Clear Cell Renal Cell Carcinoma	Biological: MEDI0680; Biological: Durvalumab; Biological: Nivolumab	Phase 1; Phase 2

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 participants with selected advanced malignancies.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 97 participants
• 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
• Actual Study Start Date: May 19, 2014
• Actual Primary Completion Date: March 17, 2020
• Actual Study Completion Date: March 17, 2020

Arms and Interventions

Arm	Intervention/treatment
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: 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: 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: 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: 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: 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: 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: 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: 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: 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: 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: 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: 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: 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: 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: 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: Nivolumab; Participants will receive IV infusion of nivolumab 240 mg Q2W in dose-expansion phase.

Outcome Measures

Primary Outcome Measures :

1. Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) in Dose-escalation Phase [ Time Frame: Day 1 through 90 days post end of treatment (approximately 5 years 10 months) ]
   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.
2. Number of Participants With Abnormal Clinical Laboratory Parameters Reported as TEAEs in Dose-escalation Phase [ Time Frame: Day 1 through 90 days post end of treatment (approximately 5 years 10 months) ]
   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.
3. Number of Participants With Abnormal Vital Signs and Physical Examinations Reported as TEAES in Dose-escalation Phase [ Time Frame: Day 1 through 90 days post end of treatment (approximately 5 years 10 months) ]
   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.
4. Number of Participants With Abnormal Electrocardiograms (ECGs) Reported as TEAEs in Dose-escalation Phase [ Time Frame: Day 1 through 90 days post end of treatment (approximately 5 years 10 months) ]
   Number of participants in dose-escalation phase with abnormal ECG parameters reported as TEAEs are reported.
5. 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 [ Time Frame: From baseline (Day -42 to Day -1) through disease progression or end of treatment (approximately 5 years 10 months) ]
   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.

Secondary Outcome Measures :

1. Best Overall Response (BOR) Based on Investigator-assessed RECIST v1.1 in Dose-expansion Phase [ Time Frame: From baseline (Day -42 to Day -1) through disease progression or end of treatment (approximately 5 years 10 months) ]
   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.
2. Disease Control Rate (DCR) Based on Investigator-assessed RECIST v1.1 in Dose-expansion Phase [ Time Frame: From baseline (Day -42 to Day -1) through disease progression or end of treatment (approximately 5 years 10 months) ]
   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.
3. Time to Response (TTR) Based on Investigator-assessed RECIST v1.1 in Dose-expansion Phase [ Time Frame: From baseline (Day -42 to Day -1) through disease progression or end of treatment (approximately 5 years 10 months) ]
   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.
4. Duration of Response (DoR) Based on Investigator-assessed RECIST v1.1 in Dose-expansion Phase [ Time Frame: From baseline (Day -42 to Day -1) through disease progression or end of treatment (approximately 5 years 10 months) ]
   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.
5. Progression Free Survival (PFS) Based on Investigator-assessed RECIST v1.1 in Dose-expansion Phase [ Time Frame: From baseline (Day -42 to Day -1) through disease progression or end of treatment (approximately 5 years 10 months) ]
   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.
6. Overall Survival in Dose-expansion Phase [ Time Frame: From baseline (Day -42 to Day -1) through disease progression or end of treatment (approximately 5 years 10 months) ]
   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.
7. BOR Based on Investigator-assessed Modified RECIST v1.1 in Dose-escalation Phase [ Time Frame: From baseline (Day -42 to Day -1) through disease progression or EOT (approximately 12 months for each participant) ]
   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.
8. ORR Based on Investigator-assessed Modified RECIST v1.1 in Dose-escalation Phase [ Time Frame: From baseline (Day -42 to Day -1) through disease progression or EOT (approximately 12 months for each participant) ]
   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.
9. DCR Based on Investigator-assessed Modified RECIST v1.1 in Dose-escalation Phase [ Time Frame: From baseline (Day -42 to Day -1) through disease progression or EOT (approximately 12 months for each participant) ]
   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.
10. TTR Based on Investigator-assessed Modified RECIST v1.1 in Dose-escalation Phase [ Time Frame: From baseline (Day -42 to Day -1) through disease progression or EOT (approximately 12 months for each participant) ]
    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.
11. DoR Based on Investigator-assessed Modified RECIST v1.1 in Dose-escalation Phase [ Time Frame: From baseline (Day -42 to Day -1) through disease progression or EOT (approximately 12 months for each participant) ]
    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.
12. PFS Based on Investigator-assessed Modified RECIST v1.1 in Dose-escalation Phase [ Time Frame: From baseline (Day -42 to Day -1) through disease progression or EOT (approximately 12 months for each participant) ]
    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.
13. OS in Dose-escalation Phase [ Time Frame: From baseline (Day -42 to Day -1) through disease progression or EOT (approximately 12 months for each participant) ]
    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.
14. Number of Participants With TEAEs and TESAEs in Dose-expansion Phase [ Time Frame: Day 1 through 90 days post end of treatment (approximately 5 years 10 months) ]
    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.
15. Number of Participants With Abnormal Clinical Laboratory Parameters Reported as TEAEs in Dose-expansion Phase [ Time Frame: Day 1 through 90 days post end of treatment (approximately 5 years 10 months) ]
    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.
16. Number of Participants With Abnormal Vital Signs and Physical Examinations Reported as TEAEs in Dose-expansion Phase [ Time Frame: Day 1 through 90 days post end of treatment (approximately 5 years 10 months) ]
    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.
17. Number of Participants With Abnormal ECGs Reported as TEAEs in Dose-expansion Phase [ Time Frame: Day 1 through 90 days post end of treatment (approximately 5 years 10 months) ]
    Number of participants in dose-expansion phase with abnormal ECG parameters reported as TEAEs are reported.
18. 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 [ Time Frame: From baseline (Day -42 to Day -1) through disease progression or end of treatment (approximately 5 years 10 months) ]
19. 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) [ Time Frame: 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) ]
20. Serum Concentration of MEDI0680 in Dose-escalation and Dose-expansion Phases [ Time Frame: Pre-dose and end of infusion on Cycle 1 Day 1, Cycle 1 Day 15, and Cycle 2 Day 1 ]
    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.
21. Serum Concentration of Durvalumab in Dose-escalation and Dose-expansion Phases [ Time Frame: Pre-dose and end of infusion on Cycle 1 Day 1, Cycle 1 Day 15, and Cycle 2 Day 1 ]
    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.
22. Number of Participants With Positive Anti-drug Antibodies (ADA) to MEDI0680 in Dose-escalation and Dose-expansion Phases [ Time Frame: 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) ]
    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).
23. Number of Participants With Positive ADA to Durvalumab in Dose-escalation and Dose-expansion Phases [ Time Frame: 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) ]
    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).
24. ORR for Participants With Programmed Cell Death Ligand 1 (PD-L1) Status Positive and Negative in Dose-expansion Phase [ Time Frame: From baseline (Day -42 to Day -1) through disease progression or end of treatment (approximately 5 years 10 months) ]
    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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 99 Years (Adult, Older Adult)
• 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

Locations

United States, California

Research Site

Los Angeles, California, United States, 90025

United States, Florida

Research Site

Tampa, Florida, United States, 33612

United States, Kansas

Research Site

Overland Park, Kansas, United States, 66209

United States, Kentucky

Research Site

Louisville, Kentucky, United States, 40202

United States, Minnesota

Research Site

Rochester, Minnesota, United States, 55905

United States, New Jersey

Research Site

Hackensack, New Jersey, United States, 07601

United States, New York

Research Site

New York, New York, United States, 10065

United States, Ohio

Research Site

Cleveland, Ohio, United States, 44195

United States, Oklahoma

Research Site

Oklahoma City, Oklahoma, United States, 73104

United States, Oregon

Research Site

Portland, Oregon, United States, 97213

United States, Pennsylvania

Research Site

Hershey, Pennsylvania, United States, 17033-0850

United States, Tennessee

Research Site

Nashville, Tennessee, United States, 37203

United States, Washington

Research Site

Seattle, Washington, United States, 98109

Australia

Research Site

East Bentleigh, Australia, 3165

Research Site

Frankston, Australia, 3199

Canada, Ontario

Research Site

Toronto, Ontario, Canada, M5G 2M9

Canada, Quebec

Research Site

Montreal, Quebec, Canada, H3T 1E2

France

Research Site

Bordeaux, France, 33075

Research Site

Dijon, France, 21079

Research Site

Marseille, France, 13009

Research Site

Paris Cedex 15, France, 75908

Research Site

Villejuif, France, 94805

Netherlands

Research Site

Amsterdam, Netherlands, 1066 CX

Research Site

Groningen, Netherlands, 9713 GZ

United Kingdom

Research Site

Cambridge, United Kingdom, CB2 0QQ

Research Site

Cardiff, United Kingdom, CF14 2TL

Research Site

Southampton, United Kingdom, SO16 6YD

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: Monika Joshi, MD; Penn State Hershey Cancer Institute
• Principal Investigator: Robert Alter, 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: Fernando Quevedo, MD; Mayo Clinic
• Principal Investigator: Martin Voss, MD; Memorial Sloan Kettering Cancer Center
• Principal Investigator: Johanna Bendell; SCRI Development Innovations, LLC
• Principal Investigator: Elizabeth Henry; Loyola Univ. Medical Center
• Principal Investigator: Lionel Lewis; Dartmouth-Hitchcock Medical Center
• Principal Investigator: Brian Rini; The Cleveland Clinic
• Principal Investigator: Peter Van Veldhuizen; Menorah Medical Center tour

  Study Documents (Full-Text)

Documents provided by MedImmune LLC:

Study Protocol  [PDF] March 29, 2017

Statistical Analysis Plan  [PDF] March 6, 2018

More Information

Additional Information:

Redacted Protocol D6020C00001 

Redacted SAP D6020C00001 

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: MedImmune LLC
• ClinicalTrials.gov Identifier: NCT02118337
• Other Study ID Numbers: D6020C00001
• First Posted: April 21, 2014
• Results First Posted: June 1, 2021
• Last Update Posted: June 1, 2021
• Last Verified: May 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• Plan Description: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
• Supporting Materials: Study Protocol; Statistical Analysis Plan (SAP)
• Time Frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
• Access Criteria: When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
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Keywords provided by MedImmune LLC:

select advanced malignancies,; kidney cancer,; clear cell renal cell carcinoma

Additional relevant MeSH terms:

Neoplasms; Carcinoma, Renal Cell; Kidney Neoplasms; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Adenocarcinoma; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Kidney Diseases; Urologic Diseases; Nivolumab; Durvalumab; Antineoplastic Agents, Immunological; Antineoplastic Agents; Immune Checkpoint Inhibitors; Molecular Mechanisms of Pharmacological Action