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NCT03484819 · ClinicalTrials.gov registry record · Phase 2
Copanlisib Hydrochloride and Nivolumab in Treating Patients With Recurrent or Refractory Diffuse Large B-cell Lymphoma or Primary Mediastinal Large B-cell Lymphoma
A Phase 2 study, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 2
- Development phase
- 12
- Enrollment target
NCT03484819: Completed Phase 2 study, sponsored by National Cancer Institute (NCI).
NCT03484819 is a Phase 2 study that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 12 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (91% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03484819, a Phase 2 study, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 12 participants
- Enrollment target
Study Summary
This phase II trial studies how well copanlisib hydrochloride and nivolumab work in treating patients with diffuse large B-cell lymphoma or primary mediastinal large B-cell lymphoma that has come back (recurrent) or does not responded to the treatment (refractory). Copanlisib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving copanlisib hydrochloride and nivolumab may work better in treating patients with diffuse large B-cell lymphoma or primary mediastinal large B-cell lymphoma compared to standard of care.
Primary Outcome
Will be estimated by the number of successes divided by the total number of evaluable patients. A success is defined as a patient that reports a confirmed complete or partial response according to Lugano criteria.
Interventions
- BIOLOGICAL Nivolumab
- DRUG Copanlisib Hydrochloride
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2019-12-13 |
| Est. Completion | 2024-08-14 |
| Phase | Phase 2 |
What the finished NCT03484819 record still lists
NCT03484819 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 12 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (91% lower).
The record links to 0 conditions, and to 2 interventions - of which Nivolumab is the first listed.
NCT03484819 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03484819 about?
NCT03484819 is a clinical study titled "Copanlisib Hydrochloride and Nivolumab in Treating Patients With Recurrent or Refractory Diffuse Large B-cell Lymphoma or Primary Mediastinal Large B-cell Lymphoma". This phase II trial studies how well copanlisib hydrochloride and nivolumab work in treating patients with diffuse large B-cell lymphoma or primary mediastinal large B-cell lymphoma that has come back (recurrent) or does not responded to the treatment (refractory). Copanlisib hydrochloride may stop ...
What is the current status of trial NCT03484819?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 12 participants. The study started on 2019-12-13. Estimated completion is 2024-08-14.
What interventions are being tested in trial NCT03484819?
The interventions under investigation include: Nivolumab (BIOLOGICAL), Copanlisib Hydrochloride (DRUG).
Who is sponsoring clinical trial NCT03484819?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03484819's enrollment target sits among peer trials
12 1948th of 2000 higher than 34 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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