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Monoclonal Antibodies

VAY736 + Antineoplastic Agents for Non-Hodgkin's Lymphoma

Phase 1

Recruiting

Research Sponsored by Novartis Pharmaceuticals

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Must have measurable disease and ECOG of 0 to 2

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.

Must not have

HIV infection

Patients with primary CNS lymphoma

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 4 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new drug for safety, how well it works, and how it affects the body. It will be given to patients with NHL alone or with other therapies.

Who is the study for?

This trial is for adults with certain types of B-cell Non-Hodgkin Lymphoma that have tried at least two prior treatments without success. Participants must be able to undergo biopsies and have a performance status allowing daily activity. Excluded are those with central nervous system lymphoma, severe heart or lung conditions, HIV, active hepatitis infections, or women who could become pregnant and aren't using contraception.

What is being tested?

The study tests the safety and effectiveness of VAY736 alone or combined with other drugs (CC-99282, lenalidomide) in patients with relapsed/refractory Non-Hodgkin Lymphoma. It will evaluate how the body processes these drugs and their preliminary effects on the disease.

What are the potential side effects?

Potential side effects may include allergic reactions to monoclonal antibodies like VAY736, changes in blood counts or immune responses due to lenalidomide or CC-99282 therapy. Specific side effect profiles will depend on individual patient factors.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have cancer that can be measured and I can care for myself.

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I have a type of B-cell NHL that has come back or didn't respond to treatment.

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I have tried at least two treatments for my NHL, including one targeting CD20, without success.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am HIV positive.

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I have been diagnosed with lymphoma in my brain or spinal cord.

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I have or had serious lung inflammation.

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I have heart problems that affect my daily activities.

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I have an active hepatitis B or C infection.

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I am allergic to VAY736 or similar drugs like monoclonal antibodies.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 4 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~4 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Dose intensity

Incidence and nature of dose limiting toxicities (DLTs)

Incidence of Adverse events (AEs) and serious adverse events (SAEs)

+1 more

Secondary study objectives

Area under curve (AUC) for VAY736 and combination partners

Best overall response (BOR) rate

Change from baseline in anti-drug antibodies (ADA)

+2 more

Side effects data

From 2018 Phase 2 trial • 27 Patients • NCT02149420

75%

Infusion related reaction

33%

Nasopharyngitis

17%

Headache

Fatigue

Back pain

Rash

Cystitis

Conjunctivitis

Sinusitis

Iron deficiency anaemia

Myalgia

Gastroenteritis

Gastrointestinal infection

Influenza

100%

80%

60%

40%

20%

Study treatment Arm

VAY736 10mg/kg

VAY736 3mg/kg

Placebo

Open Label VAY736 10mg/kg

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

4Treatment groups

Experimental Treatment

Group I: Arm 2BExperimental Treatment2 Interventions

VAY736 + lenalidomide dose expansion in patients with DLBCL. This arm will not be conducted.

Group II: Arm 2AExperimental Treatment2 Interventions

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.

Group III: Arm 1BExperimental Treatment1 Intervention

VAY736 single agent dose expansion in patients with DLBCL

Group IV: Arm 1AExperimental Treatment1 Intervention

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)

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

VAY736

2014

Completed Phase 3

~790

lenalidomide

2012

Completed Phase 3

~3370