A Study of Zilovertamab Vedotin (MK-2140) as Monotherapy and in Combination in Participants With … (NCT05458297) | Clinical Trial Compass
Active — Not RecruitingPhase 2
A Study of Zilovertamab Vedotin (MK-2140) as Monotherapy and in Combination in Participants With Aggressive and Indolent B-cell Malignancies (MK-2140-006)
United States, Brazil, Canada189 participantsStarted 2022-07-21
Plain-language summary
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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
The main inclusion criteria include, but are not limited to the following:
Inclusion Criteria:
* For aggressive B-cell malignancies mantle cell lymphoma (MCL): Has histologically confirmed biopsy according to the 2016 World Health Organization (WHO) classification of neoplasms of the hematopoietic and lymphoid tissues and has relapsed or refractory disease after at least 2 prior systemic therapies including a Bruton's tyrosine kinase inhibition/inhibitor(s) (BTKi), and is post chimeric antigen receptor T (CAR-T) cell therapy or is ineligible for CAR-T cell therapy.
* For aggressive B-cell malignancies MCL Cohort C: Has histologically confirmed biopsy according to the 2016 World Health Organization (WHO) classification of neoplasms of the hematopoietic and lymphoid tissues and has relapsed or refractory disease after at least 1 prior systemic therapy and has no prior exposure to a non-covalent BTKi.
* For aggressive B-cell malignancies Richter transformation lymphoma (RTL): Has histologically confirmed biopsy according to the 2016 World Health Organization (WHO) classification of neoplasms of the hematopoietic and lymphoid tissues and has relapsed or refractory disease.
* For indolent B-cell malignancies follicular lymphoma (FL) and chronic lymphocytic leukemia (CLL): Has histologically confirmed biopsy and has relapsed or refractory disease after at least 2 prior systemic therapies and no other available therapy.
* Participants who are hepatitis B surface antigen (HBsAg) po…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is in Phase 2 and is no longer enrolling new participants — does that mean I've missed the window to join, or are there any related studies testing zilovertamab vedotin that I might still be eligible for?
2The trial is primarily measuring how many people experience adverse events and how many have to stop treatment because of side effects — what does that tell us about how well the safety profile of this drug is understood so far, and what kinds of side effects should I be prepared to discuss?
3My diagnosis is one of the conditions this trial covers — CLL, mantle cell lymphoma, follicular lymphoma, or Richter transformation — but the drug is being tested in different combinations and dosing approaches for each group, so which cohort would have applied to me, and how would that have affected what treatment I'd actually receive?
4Given that the trial measures response rates using specific criteria like Lugano or iwCLL depending on my diagnosis, how does the early response data from this study compare to what standard treatments are already achieving for my condition?
5Before considering a trial like this one, should I explore any standard-of-care treatments first, or is my situation one where a newer approach like an antibody-drug conjugate such as zilovertamab vedotin might be worth prioritizing based on what my doctor knows about my specific case?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Percentage of Participants with MCL (Cohort C), FL (Cohort D), and CLL (Cohort D) with ≥1 Adverse Event (AE)
Timeframe: Up to approximately 81 months
2
Percentage of Participants with MCL (Cohort C), FL (Cohort D), and CLL (Cohort D) who Discontinue from Study Therapy Due to AE
Timeframe: Up to approximately 81 months
3
Percentage of Participants with MCL (Cohort C) who Experience a Dose-Limiting Toxicity (DLT)
Timeframe: Up to approximately 81 months
4
Objective Response Rate (ORR) per Lugano Response Criteria as Assessed by Blinded Independent Central Review (BICR) in Participants with MCL (Cohort A), RT (Cohort B), and FL (Cohort D)
Timeframe: Up to approximately 81 months
5
ORR per Lugano Response Criteria as Assessed by Investigator in Participants with MCL (Cohort C)
Timeframe: Up to approximately 81 months
6
ORR per International Workshop on Chronic Lymphocytic Leukemia (iwCLL) Criteria as Assessed by Investigator in Participants with CLL (Cohort D)