Copanlisib and Nivolumab in Treating Patients With Richter's Transformation or Transformed Indolent Non-Hodgkin Lymphoma
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ClinicalTrials.gov Identifier: NCT03884998 |
Recruitment Status :
Active, not recruiting
First Posted : March 21, 2019
Last Update Posted : January 5, 2024
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Tracking Information | |||||
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First Submitted Date ICMJE | March 19, 2019 | ||||
First Posted Date ICMJE | March 21, 2019 | ||||
Last Update Posted Date | January 5, 2024 | ||||
Actual Study Start Date ICMJE | February 26, 2019 | ||||
Estimated Primary Completion Date | July 16, 2024 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE |
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Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Pre-specified Outcome Measures |
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Original Other Pre-specified Outcome Measures |
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Descriptive Information | |||||
Brief Title ICMJE | Copanlisib and Nivolumab in Treating Patients With Richter's Transformation or Transformed Indolent Non-Hodgkin Lymphoma | ||||
Official Title ICMJE | 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 | ||||
Brief 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. |
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Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Phase 1 | ||||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE |
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Intervention ICMJE |
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Study Arms ICMJE | Experimental: Treatment (copanlisib and nivolumab)
Patients receive copanlisib 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 12 cycles in the absence of disease progression or unacceptable toxicity.
Interventions:
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Active, not recruiting | ||||
Actual Enrollment ICMJE |
27 | ||||
Original Estimated Enrollment ICMJE |
15 | ||||
Estimated Study Completion Date ICMJE | July 16, 2024 | ||||
Estimated Primary Completion Date | July 16, 2024 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries ICMJE | United States | ||||
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Administrative Information | |||||
NCT Number ICMJE | NCT03884998 | ||||
Other Study ID Numbers ICMJE | 20066 NCI-2018-01880 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) ) STUDY00018655 20066 ( Other Identifier: City of Hope Medical Center ) P30CA033572 ( U.S. NIH Grant/Contract ) |
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Has Data Monitoring Committee | Not Provided | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE | Not Provided | ||||
Current Responsible Party | City of Hope Medical Center | ||||
Original Responsible Party | Alexey Danilov, OHSU Knight Cancer Institute, Principal Investigator | ||||
Current Study Sponsor ICMJE | City of Hope Medical Center | ||||
Original Study Sponsor ICMJE | OHSU Knight Cancer Institute | ||||
Collaborators ICMJE | National Cancer Institute (NCI) | ||||
Investigators ICMJE |
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PRS Account | City of Hope Medical Center | ||||
Verification Date | January 2024 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |