Study Description
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. 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).
Interventions
lenalidomide
VAY736
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 for NHL)
- Must have measurable disease and ECOG of 0 to 2
Exclusion Criteria:
- Baseline laboratory results outside of protocol defined ranges
- Patients with primary CNS 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
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