MK-2140-006
A Study of Zilovertamab Vedotin as Monotherapy and in Combination in Participants With Aggressive and Indolent B-cell Malignancies
Active, Not Recruiting
Trial Purpose
The purpose of this study is to assess the safety and tolerability of zilovertamab vedotin as monotherapy and in combination 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 respect to objective response rate.
* Cohort A: Participants with relapsed or refractory 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
* Cohort B: Participants with relapsed or refractory RT disease after at least 1 prior systemic therapy
* Cohort C: Participants with relapsed or refractory MCL relapsed or refractory disease after at least 1 prior systemic therapy and no prior exposure to a non-covalent BTKi
* Cohort D: Participants with relapsed or refractory FL and CLL relapsed or refractory disease after at least 2 prior systemic therapies and have no other available therapy
* Cohort E: Participants with relapsed or refractory FL 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).
As of Amendment 07, Cohort D is closed to enrollment of participants with CLL and enrollment of participants into Arm 2 (zilovertamab vedotin at Dose 2 on Days 1 & 8 of each 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 (if applicable) until a protocol specified discontinuation criterion is met. Cohort E will be closed, as no participants with FL have been treated in this cohort.
View more trial information on ClinicalTrials.gov
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National Trial Reference NumberNational Trial Reference NumberA unique identification code given to each clinical trial record registered on ClinicalTrials.gov. Also called the ClinicalTrials.gov identifier. | NCT05458297 |
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MSD Protocol ID |
MK-2140-006 |
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Conditions |
Chronic Lymphocytic Leukemia, Follicular Lymphoma, Mantle Cell Lymphoma, Richter Transformation Lymphoma |
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Age Range |
18+ |
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SexSexSex assigned at birth. Sex is distinct from gender-based eligibility. | ALL |
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Trial PhaseTrial PhaseThe stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the trial’s objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions. | 2 |
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Start Date End Date |
2022-07-21 2029-05-17 |
Study Details
Patient Participation
Only a qualified healthcare professional can determine if you are eligible to take part in a clinical trial.
Conditions
Chronic Lymphocytic Leukemia, Follicular Lymphoma, Mantle Cell Lymphoma, Richter Transformation Lymphoma
Trial Phase 2
In Phase 2 trials, researchers try to find out if a treatment works in about 100 to 500 participantsResearch participantIn clinical research, a person who qualifies and agrees to participate in a study. Also called volunteer, trial participant. – usually people who have the health condition the treatment is intended to treat. In vaccine trials, the participants are usually healthy. Phase 2 trials may happen in a doctor’s office, a clinic, or a hospital.
Trial Locations
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