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Study of VAY736 as Single Agent and in Combination With Select Antineoplastic Agents in Patients With Non-Hodgkin Lymphoma

PHASE1RECRUITING

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.

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Study details:

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).

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Eligibility criteria

Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.

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

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Eligibility

Age eligible for study : 18 and older

Healthy volunteers accepted : No

Gender eligible for study: All

Things to know

Study dates

Study start: 2022-01-24

Primary completion: 2026-10-30

Study completion finish: 2026-10-30

Study type

TREATMENT

Phase

PHASE1

Trial ID

NCT04903197

Intervention or treatment

DRUG: VAY736

DRUG: lenalidomide

Conditions

• Non-Hodgkin Lymphoma, Diffuse Large B Cell Lymphoma, Follicular Lymphoma, Mantle Cell Lymphoma, Marginal Zone Lymphoma

Image related to Non-Hodgkin Lymphoma, Diffuse Large B Cell Lymphoma, Follicular Lymphoma, Mantle Cell Lymphoma, Marginal Zone Lymphoma

Condition: Non-Hodgkin Lymphoma, Diffuse Large B Cell Lymphoma, Follicular Lymphoma, Mantle Cell Lymphoma, Marginal Zone Lymphoma
DRUG: VAY736 and other drugs
Melbourne, Victoria, Australia
Sponsor: Novartis Pharmaceuticals

You may be eligible to participate in this trial based on your search. Check eligibility by answering some questions.

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Find a site

Closest Location:

Novartis Investigative Site

Research sites nearby

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Novartis Investigative Site
Melbourne, Victoria, Australia

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: Arm 1A 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)	DRUG: VAY736 VAY736 is a fully human IgG1 monoclonal antibody (mAb) which targets the B cell activating factor receptor (BAFF-R) expressed on the surface of differentiated B cells and modulates their function.
EXPERIMENTAL: Arm 1B VAY736 single agent dose expansion in patients with DLBCL	DRUG: VAY736 VAY736 is a fully human IgG1 monoclonal antibody (mAb) which targets the B cell activating factor receptor (BAFF-R) expressed on the surface of differentiated B cells and modulates their function.
EXPERIMENTAL: Arm 2A VAY736 + lenalidomide dose escalation in patients with DLBCL, follicular lymphoma (FL), mantle cell lymphoma (MCL) and marginal zone lymphoma (MZL). Enrollment has been halted in this arm.	DRUG: VAY736 VAY736 is a fully human IgG1 monoclonal antibody (mAb) which targets the B cell activating factor receptor (BAFF-R) expressed on the surface of differentiated B cells and modulates their function.
EXPERIMENTAL: Arm 2B VAY736 + lenalidomide dose expansion in patients with DLBCL. This arm will not be conducted.	DRUG: VAY736 VAY736 is a fully human IgG1 monoclonal antibody (mAb) which targets the B cell activating factor receptor (BAFF-R) expressed on the surface of differentiated B cells and modulates their function.

What is the study measuring?

Primary outcome

Primary Outcome Measure	Primary Outcome Description	Primary Outcome Time Frame
Incidence and nature of dose limiting toxicities (DLTs)	Safety and tolerability	28 days (first cycle of treatment)
Incidence of Adverse events (AEs) and serious adverse events (SAEs)	Incidence of AEs and SAEs is defined as number of participants with AEs and SAEs, including changes from baseline in vital signs, electrocardiograms (ECGs) and laboratory results qualifying and reported as AEs.	4 years
Number of patients with dose interruptions and dose reductions	Safety and tolerability	4 years
Dose intensity	Safety and tolerability	4 years

Secondary outcome

Secondary Outcome Measure	Secondary Outcome Description	Secondary Outcome Time Frame
Overall response rate (ORR)	Efficacy will be assessed by Lugano Classification (FDG-PET/CT scans)	4 years
Best overall response (BOR) rate	Efficacy will be assessed by Lugano Classification (FDG-PET/CT scans)	4 years
Area under curve (AUC) for VAY736 and combination partners	PK parameters will be derived from serum concentrations	4 years
Maximum observed drug concentration after single dose administration (Cmax) for VAY736 and combination partners	PK parameters will be derived from serum concentrations	4 years
Change from baseline in anti-drug antibodies (ADA)	Blood samples will be collected to detect change in levels of antibodies to VAY736	Baseline, 4 years

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References

Clinical Trials Gov: Study of VAY736 as Single Agent and in Combination With Select Antineoplastic Agents in Patients With Non-Hodgkin Lymphoma