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

Authors
Category Primary study
Registry of Trialsclinicaltrials.gov
Year 2022
The purpose of this study is to assess the safety and tolerability of zilovertamabvedotin as monotherapy and in combination in participants with select B‐cell lymphomasincluding mantle cell lymphoma (MCL), Richter's transformation lymphoma (RTL), follicularlymphoma (FL), and chronic lymphocytic leukemia (CLL). This study will also evaluatezilovertamab vedotin as monotherapy and in combination with respect to objective responserate. ‐ Cohort A: Participants with relapsed or refractory MCL relapsed or refractorydisease after at least 2 prior systemic therapies including a Bruton's tyrosinekinase inhibition/inhibitor (BTKi), and post therapy chimeric antigen receptor T(CAR‐T) cell therapy or ineligible for CAR‐T cell therapy ‐ Cohort B: Participants with relapsed or refractory RT disease after at least 1 priorsystemic therapy ‐ Cohort C: Participants with relapsed or refractory MCL relapsed or refractorydisease after at least 1 prior systemic therapy and no prior exposure to anon‐covalent BTKi ‐ Cohort D: Participants with relapsed or refractory FL and CLL relapsed or refractorydisease after at least 2 prior systemic therapies and have no other availabletherapy ‐ Cohort E: Participants with relapsed or refractory FL after at least 2 priorsystemic therapies and have no other available therapyThe primary study hypothesis is that zilovertamab vedotin monotherapy has an increasedObjective Response Rate (ORR) per Lugano Response Criteria as assessed by blindedindependent central review (BICR).As of Amendment 07, Cohort D is closed to enrollment of participants with CLL andenrollment of participants into Arm 2 (zilovertamab vedotin at Dose 2 on Days 1 & 8 ofeach 3 Week Cycle (Q2/3W)).As of Amendment 09, no additional participants with RT will be enrolled in Cohort B;however, those currently enrolled will continue with study intervention treatment (ifapplicable) until a protocol specified discontinuation criterion is met. Cohort E will beclosed, as no participants with FL have been treated in this cohort.
Epistemonikos ID: e1629d5bcd67200fd1679301d21e6dbba1eda07d
First added on: May 13, 2024