Study of VAY736 as Single Agent and in Combination With Select Antineoplastic Agents in Patients With Non-Hodgkin Lymphoma
A Phase Ib, Multi-center, Open-label Dose Escalation and Expansion Platform Study of VAY736 as Single Agent and in Combination With Select Antineoplastic Agents in Patients With Non-Hodgkin Lymphoma (NHL)
ClinicalTrials.gov Identifier: NCT04903197
Novartis Reference Number: CVAY736J12101
Last Update: Mar 23, 2023
All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation.
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.
Interventions
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
Study Locations
Contacts
Have a question?
Call 1-888-669-6682 or email [email protected]