VAY736 + Antineoplastic Agents for Non-Hodgkin's Lymphoma

Recruiting in Palo Alto (17 mi)

+14 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: Novartis Pharmaceuticals

No Placebo Group

Trial Summary

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.

Eligibility Criteria

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

See 6 more

Treatment Details

Interventions

VAY736 (Monoclonal Antibodies)

Trial OverviewThe 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.

Participant Groups

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)