Trials / Active Not Recruiting
Active Not RecruitingNCT03884998
Copanlisib and Nivolumab in Treating Patients With Richter's Transformation or Transformed Indolent Non-Hodgkin Lymphoma
A Phase I Study of PI3Kα,δ Inhibitor Copanlisib in Combination With PD-1 Antagonist Nivolumab in Patients With Transformed Chronic Lymphocytic Leukemia (Richter's Transformation) or Non-Hodgkin Lymphoma
- Status
- Active Not Recruiting
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 27 (actual)
- Sponsor
- City of Hope Medical Center · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This phase I trial studies the best dose and how well copanlisib when given together with nivolumab works in treating patients with Richter's transformation or transformed indolent non-Hodgkin lymphoma. Copanlisib 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 and nivolumab may work better in treating patients with Richter's transformation or transformed non-Hodgkin lymphoma.
Detailed description
PRIMARY OBJECTIVE: I. To evaluate the maximum-tolerated dose (MTD) of copanlisib administered in combination with nivolumab in patients with transformed chronic lymphocytic leukemia (CLL)/non-Hodgkin's lymphoma (NHL). SECONDARY OBJECTIVE: I. To evaluate the preliminary efficacy of copanlisib administered in combination with nivolumab in patients with transformed CLL/NHL. EXPLORATORY OBJECTIVES: I. To evaluate the T-cell repertoire and activation patterns following dual targeting of PI3K and PD-1. II. To establish if PD-1/PD-L 1 expression correlates with response to the combination of copanlisib and nivolumab. OUTLINE: This is a dose-escalation study of copanlisib. Patients receive copanlisib intravenously (IV) over 60 minutes on days 1, 8, and 15 and nivolumab IV over 30 minutes on days 1 and 15. Treatment repeats every 28 days for up to 24 cycles in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up every 3 months for 1 year.
Conditions
- Chronic Lymphocytic Leukemia
- Diffuse Large B-Cell Lymphoma
- Follicular Lymphoma
- Indolent Non-Hodgkin Lymphoma
- Lymphoplasmacytic Lymphoma
- Marginal Zone Lymphoma
- Richter Syndrome
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Copanlisib | Given IV |
| BIOLOGICAL | Nivolumab | Given IV |
Timeline
- Start date
- 2019-02-26
- Primary completion
- 2026-11-04
- Completion
- 2026-11-04
- First posted
- 2019-03-21
- Last updated
- 2025-12-30
Locations
3 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03884998. Inclusion in this directory is not an endorsement.