Non Hodgkin Lymphoma Clinical Trial
Study of VAY736 as Single Agent and in Combination With Select Antineoplastic Agents in Patients With Non-Hodgkin Lymphoma
The purpose of this study is to assess the safety, tolerability, pharmacokinetics (PK), immunogenicity and preliminary efficacy of VAY736 alone or in combination with other therapies in patients with NHL in a platform trial.
The primary objective of the study is to evaluate the safety and tolerability in patients with NHL and identify a maximum tolerated dose (MTD) and/or recommended dose (RD) of VAY736 single agent and in combination with other anti-cancer therapies.
This is a phase I/Ib, multi-center, open-label study with multiple treatment arms in an adaptive study design. The study is comprised of a dose escalation part and dose expansion part.
In dose escalation, the investigational drug VAY736 will be explored alone or in combination with partner therapies. Increasing doses of VAY736 alone or in combination will be given to small groups of patients to identify the MTD/RD in patients with NHL. In dose expansion, some or all the treatments from dose escalation will be tested at the recommended doses in patients with NHL. The initial combination partner is lenalidomide. Other combination partners may be added in the future by protocol amendment. The study is expected to be approximately 4 years in duration (from enrollment of first patient to discontinuation of last patient).
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
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
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
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There are 14 Locations for this study
Melbourne Victoria, 3004, Australia
Shanghai Shanghai, 20003, China
Tianjin Tianjin, 30002, China
Koeln , 50937, Germany
Brescia BS, 25123, Italy
Milano MI, 20133, Italy
Rozzano MI, 20089, Italy
Koto ku Tokyo, 135 8, Japan
Yamagata , 990 9, Japan
Seoul , 03080, Korea, Republic of
Seoul , 05505, Korea, Republic of
Madrid , 28041, Spain
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