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NCT02340975 · ClinicalTrials.gov registry record · Phase 1
A Phase 1b/2 Study of MEDI4736 With Tremelimumab, MEDI4736 or Tremelimumab Monotherapy in Gastric or GEJ Adenocarcinoma
A Phase 1 study, sponsored by MedImmune.
- Completed
- Registry status
- Phase 1
- Development phase
- 114
- Enrollment target
NCT02340975: Completed Phase 1 study, sponsored by MedImmune.
NCT02340975 is a Phase 1 study that has completed, run by MedImmune. The registered enrollment target is 114 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (90% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02340975, a Phase 1 study, has completed, sponsored by MedImmune.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 114 participants
- Enrollment target
Study Summary
This is a randomized, multicenter, open-label, dose-exploration and dose-expansion study to evaluate the safety, tolerability, antitumor activity, PK, pharmacodynamics, and immunogenicity of MEDI4736 in combination with tremelimumab, MEDI4736 monotherapy or tremelimumab monotherapy in participants with metastatic or recurrent gastric or gastroesophageal junction adenocarcinoma.
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. A serious adverse event (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. TEAEs are defined as events present at base
Interventions
- BIOLOGICAL Tremelimumab
- BIOLOGICAL MEDI4736
- BIOLOGICAL MEDI4736 + tremelimumab
- BIOLOGICAL MEDI4736+tremelimumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 114 participants |
| Start Date | 2015-03-31 |
| Est. Completion | 2019-04-29 |
| Phase | Phase 1 |
What the finished NCT02340975 record still lists
NCT02340975 is an interventional study that assigns participants to a tested intervention. The registered 114 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (90% higher).
The record links to 0 conditions, and to 4 interventions - of which Tremelimumab is the first listed.
NCT02340975 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02340975 about?
NCT02340975 is a clinical study titled "A Phase 1b/2 Study of MEDI4736 With Tremelimumab, MEDI4736 or Tremelimumab Monotherapy in Gastric or GEJ Adenocarcinoma". This is a randomized, multicenter, open-label, dose-exploration and dose-expansion study to evaluate the safety, tolerability, antitumor activity, PK, pharmacodynamics, and immunogenicity of MEDI4736 in combination with tremelimumab, MEDI4736 monotherapy or tremelimumab monotherapy in participants w...
What is the current status of trial NCT02340975?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 114 participants. The study started on 2015-03-31. Estimated completion is 2019-04-29.
What interventions are being tested in trial NCT02340975?
The interventions under investigation include: Tremelimumab (BIOLOGICAL), MEDI4736 (BIOLOGICAL), MEDI4736 + tremelimumab (BIOLOGICAL), MEDI4736+tremelimumab (BIOLOGICAL).
Who is sponsoring clinical trial NCT02340975?
This trial is sponsored by MedImmune, which has 210 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02340975's enrollment target sits among peer trials
114 507th of 2000 higher than 1,493 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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