drugset / Trial / NCT04431635
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
Phase 1
Terminated
6 enrolled
University of Michigan Rogel Cancer Center
Bayer · collabBig Ten Cancer Research Consortium · collabBristol-Myers Squibb · collabUniversity of Michigan · collab
NaSingle-groupOpen-labelTreatment
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)
Timeline
- Start
- 2020-06-15
- Primary completion
- 2023-11-14
- Completion
- 2023-11-14
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Copanlisib | Small molecule | — | Intravenous |
| Subject | Nivolumab | Monoclonal antibody | — | Intravenous |
| Subject | Rituximab | Monoclonal antibody | — | Intravenous |