Study of VAY736 as Single Agent and in Combination With Select Antineoplastic Agents in Patients With Non-Hodgkin Lymphoma
Non-Hodgkin Lymphoma, Diffuse Large B Cell Lymphoma, Follicular Lymphoma, Mantle Cell Lymphoma, Marginal Zone Lymphoma
About this trial
This is an interventional treatment trial for Non-Hodgkin Lymphoma, Diffuse Large B Cell Lymphoma, Follicular Lymphoma, Mantle Cell Lymphoma, Marginal Zone Lymphoma focused on measuring VAY736, ianalumab, lenalidomide, CC-99282, golcadomide, BMS-986369, non-Hodgkin lymphoma, NHL, Diffuse large B cell lymphoma, DLBCL, Follicular lymphoma, FL, Mantle cell lymphoma, MCL, Marginal zone lymphoma, MZL
Eligibility Criteria
Inclusion Criteria:
- Adult patients with confirmed diagnosis of relapsed/refractory B-cell NHL with all subtypes of DLBCL, follicular lymphoma (FL), marginal zone lymphoma (MZL) and mantle cell lymphoma (MCL) per WHO 2016 criteria. Patients in subtype arm e.g. DLBCL must have confirmed diagnosis of relapsed/refractory DLBCL.
- Received and failed or be intolerant to standard of care therapy (at least two prior lines, including an anti-CD20 therapy, but no more than 5 prior lines)
- Must have measurable disease and ECOG of 0 to 2
- Must have a site of disease amenable to biopsy and be a candidate for tumor biopsy and be willing to undergo study required biopsies at screening and during therapy
Exclusion Criteria:
- Baseline laboratory results outside of protocol defined ranges
- Presence of history of central nervous system involvement by lymphoma
- History of hypersensitivity to VAY736 or any drugs in similar chemical classes (e.g. monoclonal antibodies)
- Impaired cardiac function or clinically significant cardiac disease
- History of or current interstitial lung disease or pneumonitis grade 2 or higher
- HIV infection
- Active hepatitis C infection and/or hepatitis B infection
- Pregnant or nursing (lactating) women
- Women of child-bearing potential unless they are using highly effective methods of contraception
Other Inclusion/Exclusion criteria may apply
Sites / Locations
- City of Hope National Med CtrRecruiting
- The Ohio State University James Cancer Hospital &Recruiting
- MD Anderson Cancer CenterRecruiting
- Novartis Investigative SiteRecruiting
- Novartis Investigative SiteRecruiting
- Novartis Investigative SiteRecruiting
- Novartis Investigative SiteRecruiting
- Novartis Investigative SiteRecruiting
- Novartis Investigative SiteRecruiting
- Novartis Investigative SiteRecruiting
- Novartis Investigative SiteRecruiting
- Novartis Investigative Site
- Novartis Investigative SiteRecruiting
- Novartis Investigative SiteRecruiting
- Novartis Investigative SiteRecruiting
- Novartis Investigative SiteRecruiting
- Novartis Investigative SiteRecruiting
- Novartis Investigative SiteRecruiting
- Novartis Investigative SiteRecruiting
- Novartis Investigative SiteRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Arm 1A
Arm 1B
Arm 2A
Arm 2B
Arm 3A
Arm 3B
VAY736 single agent dose escalation in patients with NHL subtypes of diffuse large B-cell lymphoma (DLBCL), follicular lymphoma (FL), mantle cell lymphoma (MCL), marginal zone lymphoma (MZL)
VAY736 single agent dose expansion in patients with DLBCL
VAY736 + lenalidomide dose escalation in patients with DLBCL, follicular lymphoma (FL), mantle cell lymphoma (MCL) and marginal zone lymphoma (MZL)
VAY736 + lenalidomide dose expansion in patients with DLBCL
VAY736 + CC-99282 dose escalation in patients with NHL subtypes of DLBCL, follicular lymphoma (FL), mantle cell lymphoma (MCL) and marginal zone lymphoma (MZL)
VAY736 + CC-99282 dose expansion in patients with DLBCL