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NCT04431635 · ClinicalTrials.gov registry record · Phase 1
Dose De-escalation Study of the PI3k Alpha/Delta Inhibitor, Copanlisib Given in Combination With the Immunotherapeutic Agents, Nivolumab and Rituximab in Patients With Relapsed/Refractory Indolent Lymphoma
A Phase 1 study, sponsored by University of Michigan Rogel Cancer Center.
- Terminated
- Registry status
- Phase 1
- Development phase
- 6
- Enrollment target
NCT04431635: Clinical Trial Phase 1 study, sponsored by University of Michigan Rogel Cancer Center.
NCT04431635 is a Phase 1 study that was terminated before completion, run by University of Michigan Rogel Cancer Center. 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
NCT04431635, a Phase 1 study, was terminated before completion, sponsored by University of Michigan Rogel Cancer Center.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 6 participants
- Enrollment target
Study Summary
Patients with relapsed or refractory follicular or marginal zone lymphoma who have received at least one prior line of therapy will receive * Copanlisib IV: day 1, 8, 15 every 28 days * Nivolumab IV: Cycle 1 days 1 and 15; then day 1 only * Rituximab IV: Cycle 1 days 1, 8, 15, 22; then day 1 (C2-6); then Q2 cycles (8-12)
Primary Outcome
To estimate the MTD (Maximum Tolerated Dose) of copanlisib given in combination with nivolumab and rituximab
Interventions
- DRUG Rituximab
- DRUG Nivolumab
- DRUG Copanlisib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 6 participants |
| Start Date | 2020-06-15 |
| Est. Completion | 2023-11-14 |
| Phase | Phase 1 |
Why NCT04431635 stopped before completion
NCT04431635 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 3 interventions - of which Rituximab is the first listed.
NCT04431635 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04431635 about?
NCT04431635 is a clinical study titled "Dose De-escalation Study of the PI3k Alpha/Delta Inhibitor, Copanlisib Given in Combination With the Immunotherapeutic Agents, Nivolumab and Rituximab in Patients With Relapsed/Refractory Indolent Lymphoma". Patients with relapsed or refractory follicular or marginal zone lymphoma who have received at least one prior line of therapy will receive * Copanlisib IV: day 1, 8, 15 every 28 days * Nivolumab IV: Cycle 1 days 1 and 15; then day 1 only * Rituximab IV: Cycle 1 days 1, 8, 15, 22; then day 1 (C2-6)...
What is the current status of trial NCT04431635?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 6 participants. The study started on 2020-06-15. Estimated completion is 2023-11-14.
What interventions are being tested in trial NCT04431635?
The interventions under investigation include: Rituximab (DRUG), Nivolumab (DRUG), Copanlisib (DRUG).
Who is sponsoring clinical trial NCT04431635?
This trial is sponsored by University of Michigan Rogel Cancer Center, which has 292 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04431635'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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