Trial · NCT02118337
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
NCT02118337, Phase 1, Phase 2, Completed, MedImmune LLC; results first posted 2021-06-01
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. 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. Trials, record NCT02118337. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02118337
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- 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
- NCT number
- NCT02118337
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 97 participants, actual
- Lead sponsor
- MedImmune LLC
- Conditions
- Select Advanced Malignancies, Kidney Cancer, Clear Cell Renal Cell Carcinoma
- Interventions
- MEDI0680, Durvalumab, Nivolumab
- First posted
- 2014-04-21
- Last updated
- 2021-06-01
- Results first posted
- 2021-06-01
Source ClinicalTrials.gov
Registered outcomes29
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) in Dose-escalation Phase | 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. |
| Primary | Number of Participants With Abnormal Clinical Laboratory Parameters Reported as TEAEs in Dose-escalation Phase | 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. |
| Primary | Number of Participants With Abnormal Vital Signs and Physical Examinations Reported as TEAES in Dose-escalation Phase | 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. |
| Primary | Number of Participants With Abnormal Electrocardiograms (ECGs) Reported as TEAEs in Dose-escalation Phase | 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. |
| Primary | 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 | 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 | Best Overall Response (BOR) Based on Investigator-assessed RECIST v1.1 in Dose-expansion Phase | 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. |
| Secondary | Disease Control Rate (DCR) Based on Investigator-assessed RECIST v1.1 in Dose-expansion Phase | 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. |
| Secondary | Time to Response (TTR) Based on Investigator-assessed RECIST v1.1 in Dose-expansion Phase | 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. |
| Secondary | Duration of Response (DoR) Based on Investigator-assessed RECIST v1.1 in Dose-expansion Phase | 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. |
| Secondary | Progression Free Survival (PFS) Based on Investigator-assessed RECIST v1.1 in Dose-expansion Phase | 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. |
1 to 10 of 29Source ClinicalTrials.gov
See all 29 registered outcomesOutcomes29
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) in Dose-escalation Phase | Day 1 through 90 days post end of treatment (approximately 5 years 10 months) | As-treated population included those participants who received any study drug (MEDI0680, durvalumab, or nivolumab) and grouped according to actual treatment received. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Abnormal Clinical Laboratory Parameters Reported as TEAEs in Dose-escalation Phase | Day 1 through 90 days post end of treatment (approximately 5 years 10 months) | As-treated population included those participants who received any study drug (MEDI0680, durvalumab, or nivolumab) and grouped according to actual treatment received. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Abnormal Vital Signs and Physical Examinations Reported as TEAES in Dose-escalation Phase | Day 1 through 90 days post end of treatment (approximately 5 years 10 months) | As-treated population included those participants who received any study drug (MEDI0680, durvalumab, or nivolumab) and grouped according to actual treatment received. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Abnormal Electrocardiograms (ECGs) Reported as TEAEs in Dose-escalation Phase | Day 1 through 90 days post end of treatment (approximately 5 years 10 months) | As-treated population included those participants who received any study drug (MEDI0680, durvalumab, or nivolumab) and grouped according to actual treatment received. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | 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 | From baseline (Day -42 to Day -1) through disease progression or end of treatment (approximately 5 years 10 months) | As-treated population included those participants who received any study drug (MEDI0680, durvalumab, or nivolumab) and grouped according to actual treatment received. | Percentage of participants | NUMBER |
| SECONDARY | Best Overall Response (BOR) Based on Investigator-assessed RECIST v1.1 in Dose-expansion Phase | From baseline (Day -42 to Day -1) through disease progression or end of treatment (approximately 5 years 10 months) | As-treated population included those participants who received any study drug (MEDI0680, durvalumab, or nivolumab) and grouped according to actual treatment received. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Disease Control Rate (DCR) Based on Investigator-assessed RECIST v1.1 in Dose-expansion Phase | From baseline (Day -42 to Day -1) through disease progression or end of treatment (approximately 5 years 10 months) | As-treated population included those participants who received any study drug (MEDI0680, durvalumab, or nivolumab) and grouped according to actual treatment received. | Percentage of participants | NUMBER |
| SECONDARY | Time to Response (TTR) Based on Investigator-assessed RECIST v1.1 in Dose-expansion Phase | From baseline (Day -42 to Day -1) through disease progression or end of treatment (approximately 5 years 10 months) | As-treated population included those participants who received any study drug (MEDI0680, durvalumab, or nivolumab) and grouped according to actual treatment received. The TTR was analyzed for those participants who achieved OR. | Months | MEDIAN |
| SECONDARY | Duration of Response (DoR) Based on Investigator-assessed RECIST v1.1 in Dose-expansion Phase | From baseline (Day -42 to Day -1) through disease progression or end of treatment (approximately 5 years 10 months) | As-treated population included those participants who received any study drug (MEDI0680, durvalumab, or nivolumab) and grouped according to actual treatment received. The DoR was analyzed for those participants who achieved OR. | Months | MEDIAN |
| SECONDARY | Progression Free Survival (PFS) Based on Investigator-assessed RECIST v1.1 in Dose-expansion Phase | From baseline (Day -42 to Day -1) through disease progression or end of treatment (approximately 5 years 10 months) | As-treated population included those participants who received any study drug (MEDI0680, durvalumab, or nivolumab) and grouped according to actual treatment received. | Months | MEDIAN |
1 to 10 of 29Source ClinicalTrials.gov
See all 29 outcomesResults by group648
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) in Dose-escalation Phase | MEDI0680 0.1 mg/kg + Durvalumab 3 mg | Any TEAE | 4 | Participants | |
| Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) in Dose-escalation Phase | MEDI0680 0.1 mg/kg + Durvalumab 10 mg | Any TEAE | 5 | Participants | |
| Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) in Dose-escalation Phase | MEDI0680 0.5 mg/kg + Durvalumab 10 mg | Any TEAE | 3 | Participants | |
| Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) in Dose-escalation Phase | MEDI0680 2.5 mg/kg + Durvalumab 10 mg | Any TEAE | 3 | Participants | |
| Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) in Dose-escalation Phase | MEDI0680 10 mg/kg + Durvalumab 10 mg | Any TEAE | 9 | Participants | |
| Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) in Dose-escalation Phase | MEDI0680 20 mg/kg + Durvalumab 10 mg | Any TEAE | 6 | Participants | |
| Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) in Dose-escalation Phase | MEDI0680 0.1 mg/kg + Durvalumab 3 mg | Any TESAE | 1 | Participants | |
| Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) in Dose-escalation Phase | MEDI0680 0.1 mg/kg + Durvalumab 10 mg | Any TESAE | 1 | Participants | |
| Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) in Dose-escalation Phase | MEDI0680 0.5 mg/kg + Durvalumab 10 mg | Any TESAE | 1 | Participants | |
| Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) in Dose-escalation Phase | MEDI0680 2.5 mg/kg + Durvalumab 10 mg | Any TESAE | 2 | Participants |
1 to 10 of 648Source ClinicalTrials.gov
See all 648 results by groupParticipant flow27
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | MEDI0680 0.1 mg/kg + Durvalumab 3 mg | 4 | |
| Overall Study | STARTED | MEDI0680 0.1 mg/kg + Durvalumab 10 mg | 5 | |
| Overall Study | STARTED | MEDI0680 0.5 mg/kg + Durvalumab 10 mg | 3 | |
| Overall Study | STARTED | MEDI0680 2.5 mg/kg + Durvalumab 10 mg | 3 | |
| Overall Study | STARTED | MEDI0680 10 mg/kg + Durvalumab 10 mg | 9 | |
| Overall Study | STARTED | MEDI0680 20 mg/kg + Durvalumab 10 mg | 6 | |
| Overall Study | STARTED | MEDI0680 20 mg/kg | 4 | |
| Overall Study | STARTED | MEDI0680 20 mg/kg + Durvalumab 750 mg | 42 | |
| Overall Study | STARTED | Nivolumab 240 mg | 21 | |
| Overall Study | COMPLETED | MEDI0680 0.1 mg/kg + Durvalumab 3 mg | 0 |
1 to 10 of 27Source ClinicalTrials.gov
See all 27 participant flowAdverse events3,654
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | MEDI0680 0.1 mg/kg + Durvalumab 3 mg | 0 | 4 | 0 |
| other | Anaemia | Blood and lymphatic system disorders | MEDI0680 0.1 mg/kg + Durvalumab 10 mg | 0 | 5 | 0 |
| other | Anaemia | Blood and lymphatic system disorders | MEDI0680 0.5 mg/kg + Durvalumab 10 mg | 1 | 3 | 2 |
| other | Anaemia | Blood and lymphatic system disorders | MEDI0680 2.5 mg/kg + Durvalumab 10 mg | 1 | 3 | 1 |
| other | Anaemia | Blood and lymphatic system disorders | MEDI0680 10 mg/kg + Durvalumab 10 mg | 3 | 9 | 5 |
| other | Anaemia | Blood and lymphatic system disorders | MEDI0680 20 mg/kg + Durvalumab 10 mg | 0 | 6 | 0 |
| other | Anaemia | Blood and lymphatic system disorders | MEDI0680 20 mg/kg | 1 | 4 | 2 |
| other | Anaemia | Blood and lymphatic system disorders | MEDI0680 20 mg/kg + Durvalumab 750 mg | 6 | 42 | 10 |
| other | Anaemia | Blood and lymphatic system disorders | Nivolumab 240 mg | 5 | 21 | 29 |
| other | Iron deficiency anaemia | Blood and lymphatic system disorders | MEDI0680 0.1 mg/kg + Durvalumab 3 mg | 0 | 4 | 0 |
1 to 10 of 3,654Source ClinicalTrials.gov
See all 3,654 adverse eventsAdverse event totals27
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | MEDI0680 0.1 mg/kg + Durvalumab 3 mg | 2 | 4 |
| Total, all-cause mortality | MEDI0680 0.1 mg/kg + Durvalumab 10 mg | 2 | 5 |
| Total, all-cause mortality | MEDI0680 0.5 mg/kg + Durvalumab 10 mg | 1 | 3 |
| Total, all-cause mortality | MEDI0680 2.5 mg/kg + Durvalumab 10 mg | 2 | 3 |
| Total, all-cause mortality | MEDI0680 10 mg/kg + Durvalumab 10 mg | 5 | 9 |
| Total, all-cause mortality | MEDI0680 20 mg/kg + Durvalumab 10 mg | 1 | 6 |
| Total, all-cause mortality | MEDI0680 20 mg/kg | 2 | 4 |
| Total, all-cause mortality | MEDI0680 20 mg/kg + Durvalumab 750 mg | 9 | 42 |
| Total, all-cause mortality | Nivolumab 240 mg | 4 | 21 |
| Total, other adverse events | MEDI0680 0.1 mg/kg + Durvalumab 3 mg | 4 | 4 |
1 to 10 of 27Source ClinicalTrials.gov
See all 27 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 35507017 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02118337
GET https://conductscience.org/api/trials/v1/NCT02118337/registered?page=2