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NCT02118337 · ClinicalTrials.gov registry record · Phase 1
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
A Phase 1 study of Kidney Cancer and Clear Cell Renal Cell Carcinoma, sponsored by MedImmune.
- Completed
- Registry status
- Phase 1
- Development phase
- 97
- Enrollment target
- 20
- Study locations
NCT02118337: Completed Phase 1 study of Kidney Cancer and Clear Cell Renal Cell Carcinoma, sponsored by MedImmune.
NCT02118337 is a Phase 1 study of Kidney Cancer and Clear Cell Renal Cell Carcinoma that has completed, run by MedImmune. The registered enrollment target is 97 participants, below the 879-participant average among 60 other Kidney Cancer trials with a reported enrollment target (89% lower). The trial reports 20 study locations across 16 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02118337, a Phase 1 study of Kidney Cancer and Clear Cell Renal Cell Carcinoma, has completed, sponsored by MedImmune.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 97 participants
- Enrollment target
- 20
- Study locations
Study 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.
Primary Outcome
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
Conditions Studied
Interventions
- BIOLOGICAL Durvalumab
- BIOLOGICAL Nivolumab
- BIOLOGICAL MEDI0680
Study Locations (20)
Other
- Research Site - East Bentleigh
- Research Site - Frankston
- Research Site - Bordeaux
- Research Site - Dijon
- Research Site - Marseille
California
- Research Site - Los Angeles
Florida
- Research Site - Tampa
Kansas
- Research Site - Overland Park
Kentucky
- Research Site - Louisville
Minnesota
- Research Site - Rochester
New Jersey
- Research Site - Hackensack
New York
- Research Site - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 97 participants |
| Start Date | 2014-05-19 |
| Est. Completion | 2020-03-17 |
| Phase | Phase 1 |
What the finished NCT02118337 record still lists
NCT02118337 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 97 participants, a relatively small participant target, below the 879-participant average among 60 other Kidney Cancer trials with a reported enrollment target (89% lower).
The record links to 3 conditions, with Kidney Cancer appearing as the primary indexed condition, and to 3 interventions - of which Durvalumab is the first listed.
NCT02118337 names 20 study sites across 16 states, led by Other, California, Florida.
Frequently Asked Questions
What is clinical trial NCT02118337 about?
NCT02118337 is a clinical study titled "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". To evaluate the Safety and Antitumor Activity of MEDI0680 (AMP-514) in Combination with Durvalumab versus Nivolumab Monotherapy in Participants with Select Advanced Malignancies.
What is the current status of trial NCT02118337?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 97 participants. The study started on 2014-05-19. Estimated completion is 2020-03-17.
What conditions does trial NCT02118337 study?
This clinical trial studies the following conditions: Kidney Cancer, Clear Cell Renal Cell Carcinoma, Select Advanced Malignancies.
What interventions are being tested in trial NCT02118337?
The interventions under investigation include: Durvalumab (BIOLOGICAL), Nivolumab (BIOLOGICAL), MEDI0680 (BIOLOGICAL).
Who is sponsoring clinical trial NCT02118337?
This trial is sponsored by MedImmune, which has 210 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02118337 being conducted?
This trial has 20 study locations across California, Florida, Kansas, Kentucky, Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Kidney Cancer
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT02118337's enrollment target sits among peer trials
97 27th of 60 higher than 34 of 60 other Kidney Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Kidney Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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