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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 is a Phase 1 study that has completed, run by Ludwig Institute for Cancer Research. The registered enrollment target is 104 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01975831
The ClinicalTrials.gov registry entry for NCT01975831 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 104 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Ludwig Institute for Cancer Research, which has 30 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Durvalumab is the first listed.
NCT01975831 reports 0 study locations.
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.
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