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NCT02519348 · ClinicalTrials.gov registry record · Phase 2
A Study of Durvalumab or Tremelimumab Monotherapy, or Durvalumab in Combination With Tremelimumab or Bevacizumab in Advanced Hepatocellular Carcinoma
A Phase 2 study of Hepatocellular Carcinoma, sponsored by MedImmune.
- Active
- Registry status
- Phase 2
- Development phase
- 433
- Enrollment target
- 20
- Study locations
NCT02519348: Active Phase 2 study of Hepatocellular Carcinoma, sponsored by MedImmune.
NCT02519348 is a Phase 2 study of Hepatocellular Carcinoma that is active but no longer recruiting, run by MedImmune. The registered enrollment target is 433 participants, above the 254-participant average among 145 other Hepatocellular Carcinoma trials with a reported enrollment target (70% higher). The trial reports 20 study locations across 14 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02519348, a Phase 2 study of Hepatocellular Carcinoma, is active but no longer recruiting, sponsored by MedImmune.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 433 participants
- Enrollment target
- 20
- Study locations
Study Summary
This is a multicenter, open-label, stratified, randomized study to evaluate the safety, tolerability, antitumor activity, pharmacokinetics, pharmacodynamics, and immunogenicity of durvalumab or tremelimumab monotherapy, or durvalumab in combination with tremelimumab or bevacizumab in advanced hepatocellular carcinoma.
Primary Outcome
A DLT was defined as treatment-related toxicity that occurred during DLT evaluation period including: any Grade 4 immune-related adverse event (irAE), any Grade 3 colitis or any Grade 3 noninfectious pneumonitis irrespective of duration, any \>= Grade 2 pneumonitis that does not resolve to \<= Grade 1 within 7 days of initiation of maximal supportive care, any other Grade 3 irAE (excluding colitis or pneumonitis) that does not downgrade to Grade 2 within 7 days after onset of the event despite o
Conditions Studied
Interventions
- BIOLOGICAL Durvalumab
- BIOLOGICAL Bevacizumab
- BIOLOGICAL Tremelimumab
Study Locations (20)
Other
- Research Site - Hangzhou
- Research Site - Nanjing
- Research Site - Shanghai
- Research Site - Hong Kong
Florida
- Research Site - Jacksonville
- Research Site - Tampa
New York
- Research Site - New York
- Research Site - Stony Brook
Pennsylvania
- Research Site - Philadelphia
- Research Site - Philadelphia
Arizona
- Research Site - Phoenix
California
- Research Site - San Francisco
Connecticut
- Research Site - New Haven
Indiana
- Research Site - Indianapolis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 433 participants |
| Start Date | 2015-10-19 |
| Est. Completion | 2026-04-01 |
| Phase | Phase 2 |
What the registry record for NCT02519348 still lists
NCT02519348 is an interventional study that assigns participants to a tested intervention. The registered 433 participants enrollment target is mid-sized for trials with a published cap, above the 254-participant average among 145 other Hepatocellular Carcinoma trials with a reported enrollment target (70% higher).
The record links to 1 condition, with Hepatocellular Carcinoma appearing as the primary indexed condition, and to 3 interventions - of which Durvalumab is the first listed.
NCT02519348 names 20 study sites across 14 states, led by Other, Florida, New York.
Frequently Asked Questions
What is clinical trial NCT02519348 about?
NCT02519348 is a clinical study titled "A Study of Durvalumab or Tremelimumab Monotherapy, or Durvalumab in Combination With Tremelimumab or Bevacizumab in Advanced Hepatocellular Carcinoma". This is a multicenter, open-label, stratified, randomized study to evaluate the safety, tolerability, antitumor activity, pharmacokinetics, pharmacodynamics, and immunogenicity of durvalumab or tremelimumab monotherapy, or durvalumab in combination with tremelimumab or bevacizumab in advanced hepato...
What is the current status of trial NCT02519348?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 433 participants. The study started on 2015-10-19. Estimated completion is 2026-04-01.
What conditions does trial NCT02519348 study?
This clinical trial studies the following conditions: Hepatocellular Carcinoma.
What interventions are being tested in trial NCT02519348?
The interventions under investigation include: Durvalumab (BIOLOGICAL), Bevacizumab (BIOLOGICAL), Tremelimumab (BIOLOGICAL).
Who is sponsoring clinical trial NCT02519348?
This trial is sponsored by MedImmune, which has 210 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02519348 being conducted?
This trial has 20 study locations across Arizona, California, Connecticut, Florida, Indiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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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 NCT02519348's enrollment target sits among peer trials
433 30th of 145 higher than 116 of 145 other Hepatocellular Carcinoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Hepatocellular Carcinoma 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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