VAY736 + Antineoplastic Agents for Non-Hodgkin's Lymphoma

Recruiting at 14 trial locations

Overseen By Novartis Pharmaceuticals

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Novartis Pharmaceuticals

Must be taking: Anti-CD20 therapy

Must not be taking: Monoclonal antibodies

Disqualifiers: CNS lymphoma, Cardiac disease, HIV, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

18 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Who Is on the Research Team?

Novartis Institutes of Biomedical Research

Principal Investigator

Novartis Institutes of Biomedical Research

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

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

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

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

Exclusion Criteria

Pregnant or nursing (lactating) women

I am HIV positive.

Baseline laboratory results outside of protocol defined ranges

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation

Investigational drug VAY736 was explored alone or in combination with lenalidomide to identify the maximum tolerated dose/recommended dose (MTD/RD) in patients with NHL.

4 years

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• VAY736

Trial Overview 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.

How Is the Trial Designed?

Group I: Arm 2B Experimental Treatment 2 Interventions

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

Group II: Arm 2A Experimental Treatment 2 Interventions

VAY736 + lenalidomide dose escalation in patients with DLBCL, follicular lymphoma (FL), mantle cell lymphoma (MCL) and marginal zone lymphoma (MZL).

Group III: Arm 1B Experimental Treatment 1 Intervention

VAY736 single agent dose expansion in patients with DLBCL. This arm was not conducted.

Group IV: Arm 1A Experimental Treatment 1 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)

Who Is Running the Clinical Trial?

Novartis Pharmaceuticals

Lead Sponsor

Trials

2,963

Recruited

4,275,000+

Founded

1996

Headquarters

Basel, Switzerland

Known For

Precision medicine

Top Products

Gleevec, Cosentyx, Entresto, Kisqali

Dr. Vas Narasimhan

Novartis Pharmaceuticals

Chief Executive Officer since 2018

MD from Harvard Medical School

Dr. Shreeram Aradhye

Novartis Pharmaceuticals

Chief Medical Officer since 2021

MD

Bristol-Myers Squibb

Industry Sponsor

Trials

2,731

Recruited

4,127,000+

Headquarters

New York City, USA

Known For

Oncology & Cardiovascular

Top Products

Eliquis, Opdivo, Revlimid, Orencia

Christopher Boerner

Bristol-Myers Squibb

Chief Executive Officer since 2023

PhD in Business Administration from the Haas School of Business, University of California, Berkeley; BA in Economics and History from Washington University in St. Louis

Deepak L. Bhatt

Bristol-Myers Squibb

Chief Medical Officer since 2024

MD from Yale University; MSc in Clinical Epidemiology from the University of Pennsylvania