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NCT02716805 · ClinicalTrials.gov registry record · Phase 1
Phase 1 Study of Tremelimumab, Durvalumab, High-dose Chemotherapy, + Autologous Stem Cell Transplant
A Phase 1 study, sponsored by Ludwig Institute for Cancer Research.
- Terminated
- Registry status
- Phase 1
- Development phase
- 6
- Enrollment target
NCT02716805: Clinical Trial Phase 1 study, sponsored by Ludwig Institute for Cancer Research.
NCT02716805 is a Phase 1 study that was terminated before completion, run by Ludwig Institute for Cancer Research. The registered enrollment target is 6 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (90% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02716805, a Phase 1 study, was terminated before completion, sponsored by Ludwig Institute for Cancer Research.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 6 participants
- Enrollment target
Study Summary
This was a Phase 1, open-label, multicenter, study of checkpoint inhibitor therapy (tremelimumab ± durvalumab) prior to and following autologous stem cell transplant (ASCT) and high-dose melphalan in subjects with multiple myeloma who were at a high risk for relapse, were eligible for ASCT, and had available cryopreserved stem cells. Primary study objectives were to determine the safety and tolerability of study treatment. Further objectives were to evaluate the clinical efficacy and biologic activity of the regimen.
Primary Outcome
Toxicity was graded in accordance with the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 4.03. Treatment-emergent adverse events (TEAEs) were reported based on clinical laboratory tests, physical examinations, and vital signs from the time of enrollment through the end of the study period. DLTs were assessed from the first dose of study drug through the Cycle 2 administration of tremelimumab ± durvalumab post ASCT. DLTs were defined per protocol
Interventions
- DRUG Melphalan
- DRUG Durvalumab
- DRUG Tremelimumab
- BIOLOGICAL Prevnar-13
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 6 participants |
| Start Date | 2016-12-13 |
| Est. Completion | 2018-02-16 |
| Phase | Phase 1 |
Why NCT02716805 stopped before completion
NCT02716805 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 6 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (90% lower).
The record links to 0 conditions, and to 4 interventions - of which Melphalan is the first listed.
NCT02716805 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02716805 about?
NCT02716805 is a clinical study titled "Phase 1 Study of Tremelimumab, Durvalumab, High-dose Chemotherapy, + Autologous Stem Cell Transplant". This was a Phase 1, open-label, multicenter, study of checkpoint inhibitor therapy (tremelimumab ± durvalumab) prior to and following autologous stem cell transplant (ASCT) and high-dose melphalan in subjects with multiple myeloma who were at a high risk for relapse, were eligible for ASCT, and had ...
What is the current status of trial NCT02716805?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 6 participants. The study started on 2016-12-13. Estimated completion is 2018-02-16.
What interventions are being tested in trial NCT02716805?
The interventions under investigation include: Melphalan (DRUG), Durvalumab (DRUG), Tremelimumab (DRUG), Prevnar-13 (BIOLOGICAL).
Who is sponsoring clinical trial NCT02716805?
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 NCT02716805's enrollment target sits among peer trials
6 1974th of 2000 higher than 12 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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