Copanlisib Hydrochloride and Nivolumab in Treating Patients With Recurrent or Refractory Diffuse Large B-cell Lymphoma or Primary Mediastinal Large B-cell Lymphoma
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|ClinicalTrials.gov Identifier: NCT03484819|
Recruitment Status : Recruiting
First Posted : April 2, 2018
Last Update Posted : January 22, 2020
|Condition or disease||Intervention/treatment||Phase|
|Recurrent Diffuse Large B-Cell Lymphoma Recurrent Primary Mediastinal (Thymic) Large B-Cell Cell Lymphoma Refractory Diffuse Large B-Cell Lymphoma Refractory Primary Mediastinal (Thymic) Large B-Cell Cell Lymphoma||Drug: Copanlisib Drug: Copanlisib Hydrochloride Biological: Nivolumab||Phase 2|
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).
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.
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||106 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||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|
|Actual Study Start Date :||October 19, 2018|
|Estimated Primary Completion Date :||October 1, 2021|
|Estimated Study Completion Date :||October 1, 2021|
Experimental: Treatment (copanlisib hydrochloride, nivolumab)
Patients receive copanlisib hydrochloride 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.
Drug: Copanlisib Hydrochloride
- Objective response rate [ Time Frame: Up to 5.5 years ]Will be estimated by the number of successes divided by the total number of evaluable patients. Confidence intervals for the true success proportion will be calculated according to the approach of Duffy and Santner.
- Incidence of adverse events [ Time Frame: Up to 2 years ]The maximum grade for each type of adverse event will be recorded for each patient, and frequency tables will be reviewed to determine patterns. Additionally, the relationship of the adverse event(s) to the study treatment will be taken into consideration.
- Progression free survival [ Time Frame: From registration to relapse or death due to any cause, assessed up to 5 years ]Will be estimated using the method of Kaplan-Meier. In addition, the progression-free survival rate at 5 years after registration will be reported.
- Duration of response [ Time Frame: Up to 2 years ]Will be estimated using the method of Kaplan-Meier.
- Overall survival time [ Time Frame: From registration to death due to any cause, assessed up to 2 years ]Will be estimated using the method of Kaplan-Meier.
- Lymph3Cx Cell-of-Origin (COO) molecular subtyping assay for primary mediastinal B cell lymphoma (PMBCL) and diffuse large B cell lymphoma (DLBCL) subtypes [ Time Frame: Up to 5.5 years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03484819
|United States, Iowa|
|University of Iowa/Holden Comprehensive Cancer Center||Recruiting|
|Iowa City, Iowa, United States, 52242|
|Contact: Site Public Contact 800-237-1225|
|Principal Investigator: Umar Farooq|
|United States, Kentucky|
|University of Kentucky/Markey Cancer Center||Recruiting|
|Lexington, Kentucky, United States, 40536|
|Contact: Site Public Contact 859-257-3379|
|Principal Investigator: Maxwell Krem|
|United States, Minnesota|
|Rochester, Minnesota, United States, 55905|
|Contact: Site Public Contact 855-776-0015|
|Principal Investigator: Nabila N. Bennani|
|Principal Investigator:||Nabila N Bennani||Mayo Clinic Cancer Center LAO|