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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 Participants With Select Advanced Malignancies

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. Read our disclaimer for details.
 
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:
Information provided by (Responsible Party):
MedImmune LLC

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.

Layout table for study information
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


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.




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.



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.


Layout table for eligibility information
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

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


Locations
Layout table for location information
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
Layout table for investigator information
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

Additional Information:
Layout table for additonal information
Responsible Party: MedImmune LLC
ClinicalTrials.gov Identifier: NCT02118337    
Other Study ID Numbers: D6020C00001
First Posted: April 21, 2014    Key Record Dates
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.
URL: https://astrazenecagroup-dt.pharmacm.com/DT/Home
Keywords provided by MedImmune LLC:
select advanced malignancies,
kidney cancer,
clear cell renal cell carcinoma
Additional relevant MeSH terms:
Layout table for 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