NCT03484819

Copanlisib Hydrochloride and Nivolumab in Treating Patients With Recurrent or Refractory Diffuse Large B-cell Lymphoma or Primary Mediastinal Large B-cell Lymphoma

Phase 2 Study of Copanlisib in Combination With Nivolumab in Subjects With Relapsed/Refractory Diffuse Large B-Cell Lymphoma and Primary Mediastinal Large B-Cell Lymphoma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: National Cancer Institute (NCI) · NIH
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

PRIMARY OBJECTIVE: I. To assess overall response rate (ORR) defined as complete response rate (CR) plus partial response rate (PR) (ORR = CR + PR) of the combination of copanlisib hydrochloride (copanlisib) and nivolumab in patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) and primary mediastinal large B-cell lymphoma (PMBCL). SECONDARY OBJECTIVES: I. To evaluate the safety of the combination of nivolumab and copanlisib in patients with relapsed/refractory DLBCL and PMBCL. II. To determine the progression free survival, duration of response, complete response rate and overall survival of the combination of copanlisib and nivolumab in patients with relapsed or refractory DLBCL and PMBCL. CORRELATIVE STUDY OBJECTIVES: I. To characterize the effects of the copanlisib and nivolumab combination regimen on tumor cells, tumor microenvironment and the immune response in relapsed/refractory DLBCL and PMBCL. II. To assess predictors of response of the combination in relapsed/refractory DLBCL and PMBCL. OUTLINE: Patients receive copanlisib hydrochloride intravenously (IV) over 1 hour on days 1, 8 and 15 of cycles 1-8 and days 1 and 15 of subsequent cycles. Patients also receive nivolumab IV over 30 minutes on days 1 and 15 of cycles 1-8 and on day 1 of subsequent cycles. Cycles repeat every 28 days for up to 2 years in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up for up to 100 days.

Conditions

• Recurrent Diffuse Large B-Cell Lymphoma
• Recurrent Primary Mediastinal Large B-Cell Lymphoma
• Refractory Diffuse Large B-Cell Lymphoma
• Refractory Primary Mediastinal Large B-Cell Lymphoma

Interventions

Type	Name	Description
DRUG	Copanlisib Hydrochloride	Given IV
BIOLOGICAL	Nivolumab	Given IV

Timeline

• Start date: 2019-12-13
• Primary completion: 2022-11-18
• Completion: 2024-08-14
• First posted: 2018-04-02
• Last updated: 2025-03-03
• Results posted: 2024-01-23

Locations

15 sites across 1 country: United States

Regulatory

• FDA-regulated drug study