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NCT01975831 · ClinicalTrials.gov registry record · Phase 1
A Phase 1 Study to Evaluate MEDI4736 in Combination With Tremelimumab
A Phase 1 study, sponsored by Ludwig Institute for Cancer Research.
- Completed
- Registry status
- Phase 1
- Development phase
- 104
- Enrollment target
NCT01975831: Completed Phase 1 study, sponsored by Ludwig Institute for Cancer Research.
NCT01975831 is a Phase 1 study that has completed, run by Ludwig Institute for Cancer Research. The registered enrollment target is 104 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (73% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01975831, a Phase 1 study, has completed, sponsored by Ludwig Institute for Cancer Research.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 104 participants
- Enrollment target
Study Summary
This was a Phase 1, open-label, nonrandomized, multicenter study of durvalumab and tremelimumab in subjects with advanced cancers who were not eligible for, declined, or failed standard treatment. The primary study objective was to determine the maximum tolerated dose (MTD) and safety profile of the durvalumab and tremelimumab combination. Secondary objectives were to evaluate the pharmacokinetics (PK) and immunogenicity of durvalumab and tremelimumab, and the antitumor activity (tumor response, progression-free survival \[PFS\], and overall survival \[OS\]) of the durvalumab and tremelimumab combination. (Note: Collection of PK and immunogenicity samples was removed by amendment; analysis was not done.) Exploratory objectives were to evaluate the biological activity of the durvalumab and tremelimumab combination.
Primary Outcome
Toxicity was graded in accordance with the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 4.03. Adverse events (AEs) were reported based on clinical laboratory tests, vital sign and weight measurements, physical examinations, performance status evaluations, electrocardiograms, magnetic resonance imaging, and any other medically indicated assessments, including subject interviews, from the time informed consent is signed through 90 days after the l
Interventions
- DRUG Durvalumab
- DRUG Tremelimumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 104 participants |
| Start Date | 2013-12-19 |
| Est. Completion | 2021-07-02 |
| Phase | Phase 1 |
What the finished NCT01975831 record still lists
NCT01975831 is an interventional study that assigns participants to a tested intervention. The registered 104 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 (73% higher).
The record links to 0 conditions, and to 2 interventions - of which Durvalumab is the first listed.
NCT01975831 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01975831 about?
NCT01975831 is a clinical study titled "A Phase 1 Study to Evaluate MEDI4736 in Combination With Tremelimumab". This was a Phase 1, open-label, nonrandomized, multicenter study of durvalumab and tremelimumab in subjects with advanced cancers who were not eligible for, declined, or failed standard treatment. The primary study objective was to determine the maximum tolerated dose (MTD) and safety profile of the...
What is the current status of trial NCT01975831?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 104 participants. The study started on 2013-12-19. Estimated completion is 2021-07-02.
What interventions are being tested in trial NCT01975831?
The interventions under investigation include: Durvalumab (DRUG), Tremelimumab (DRUG).
Who is sponsoring clinical trial NCT01975831?
This trial is sponsored by Ludwig Institute for Cancer Research, which has 30 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01975831's enrollment target sits among peer trials
104 536th of 2000 higher than 1,460 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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