Zilovertamab Vedotin for Lymphoma

Recruiting at 71 trial locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Merck Sharp & Dohme Corp.

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

The purpose of this study is to evaluate zilovertamab vedotin with respect to objective response rate and duration of response per Lugano Response Criteria as assessed by blinded independent central review (BICR). Safety and tolerability will also be evaluated in this Phase 2, single arm, interventional study.

Research Team

Medical Director

Principal Investigator

Merck Sharp & Dohme LLC

Eligibility Criteria

This trial is for people with a type of cancer called Diffuse Large B-Cell Lymphoma (DLBCL) who have tried at least two treatments and are not eligible or didn't improve after stem cell transplant or CAR-T therapy. They should be able to do daily activities, have good organ function, measurable cancer signs on scans, and confirmed DLBCL diagnosis.

Inclusion Criteria

My organs are functioning well.

My DLBCL has not responded to at least 2 treatments, including a stem cell transplant or I'm ineligible for one.

I either did not respond to CAR-T therapy or am not eligible for it.

Exclusion Criteria

I have a history of hepatitis B or active hepatitis C.

I have had an organ transplant.

I have been diagnosed with HIV.

Treatment Details

Interventions

• MK-2140 (zilovertamab vedotin) (Monoclonal Antibodies)

Trial Overview The study tests Zilovertamab Vedotin (MK-2140) in patients with DLBCL to see how well it works and how long the effects last. It's a Phase 2 trial where everyone gets the same treatment, and doctors check if tumors shrink using special criteria while also watching for any safety issues.

Participant Groups

Group I: Arm B Experimental Treatment 1 Intervention

Participants will receive treatment with zilovertamab vedotin 2.25 mg/kg via intravenous (IV) infusion on Day 1 of each 21-day cycle (every 3 weeks (Q3W)) until documented disease progression or any other discontinuation criterion is met.

Group II: Arm A Experimental Treatment 1 Intervention

Participants will receive treatment with zilovertamab vedotin 2.5 mg/kg via intravenous (IV) infusion on Day 1 of each 21-day cycle (every 3 weeks (Q3W)) until documented disease progression or any other discontinuation criterion is met.

Who Is Running the Clinical Trial?

Merck Sharp & Dohme Corp.

Lead Sponsor

Trials

2,287

Recruited

4,582,000+

Chirfi Guindo

Merck Sharp & Dohme Corp.

Chief Medical Officer

Engineering degree from Ecole Centrale de Paris, MBA from New York University Stern School of Business

Robert M. Davis

Merck Sharp & Dohme Corp.

Chief Executive Officer since 2021

J.D. from Northwestern University Pritzker School of Law, MBA from Northwestern University Kellogg Graduate School of Management, Bachelor's in Finance from Miami University

Merck Sharp & Dohme LLC

Lead Sponsor

Trials

4,096

Recruited

5,232,000+

Chirfi Guindo

Merck Sharp & Dohme LLC

Chief Marketing Officer since 2022

Degree in Engineering from Ecole Centrale de Paris, MBA from New York University Stern School of Business

Robert M. Davis

Merck Sharp & Dohme LLC

Chief Executive Officer since 2021

JD from Northwestern University Pritzker School of Law, MBA from Northwestern University Kellogg Graduate School of Management, Bachelor's in Finance from Miami University