A Study of Zilovertamab Vedotin (MK-2140) as Monotherapy and in Combination With Nemtabrutinib (MK-1026) in Participants With Aggressive and Indolent B-cell Malignancies (MK-2140-006)

• Status: Not yet recruiting
• Trial end date: 2027-04-26

Summary

The purpose of this study is to assess the safety and tolerability of zilovertamab vedotin as monotherapy and in combination with nemtabrutinib in participants with select B-cell lymphomas including mantle cell lymphoma (MCL), Richter's transformation lymphoma (RTL), follicular lymphoma (FL), and chronic lymphocytic leukemia (CLL). This study will also evaluate zilovertamab vedotin as monotherapy and in combination with nemtabrutinib with respect to objective response rate.

• MCL: relapsed or refractory disease after at least 2 prior systemic therapies including a Bruton's tyrosine kinase inhibition/inhibitor (BTKi), and post therapy chimeric antigen receptor T (CAR-T) cell therapy or ineligible for CAR-T cell therapy

• RT: relapsed or refractory disease after at least 1 prior systemic therapy

• MCL: relapsed or refractory disease after at least 1 prior systemic therapy and no prior exposure to a non-covalent BTKi

• FL and CLL: relapsed or refractory disease after at least 2 prior systemic therapies and have no other available therapy

The primary study hypothesis is that zilovertamab vedotin monotherapy has an increased Objective Response Rate (ORR) per Lugano Response Criteria as assessed by blinded independent central review (BICR).

• Phase: Phase 2

Details

• Lead Sponsor: Merck Sharp & Dohme LLC