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NCT05458297 · ClinicalTrials.gov registry record · Phase 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)
A Phase 2 study of Chronic Lymphocytic Leukemia and Mantle Cell Lymphoma, sponsored by Merck Sharp & Dohme.
- Active
- Registry status
- Phase 2
- Development phase
- 223
- Enrollment target
- 20
- Study locations
NCT05458297: Active Phase 2 study of Chronic Lymphocytic Leukemia and Mantle Cell Lymphoma, sponsored by Merck Sharp & Dohme.
NCT05458297 is a Phase 2 study of Chronic Lymphocytic Leukemia and Mantle Cell Lymphoma that is active but no longer recruiting, run by Merck Sharp & Dohme. The registered enrollment target is 223 participants, above the 181-participant average among 187 other Chronic Lymphocytic Leukemia trials with a reported enrollment target (23% higher). The trial reports 20 study locations across 15 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05458297, a Phase 2 study of Chronic Lymphocytic Leukemia and Mantle Cell Lymphoma, is active but no longer recruiting, sponsored by Merck Sharp & Dohme.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 223 participants
- Enrollment target
- 20
- Study locations
Study 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)).
Primary Outcome
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The percentage of participants with MCL (Cohort C), FL (Cohort D), and CLL (Cohort D) who experienced a
Conditions Studied
Interventions
- DRUG Nemtabrutinib
- BIOLOGICAL Zilovertamab vedotin
Study Locations (20)
Massachusetts
- Tufts Medical Center ( Site 0024) - Boston
- Massachusetts General Hospital ( Site 0018) - Boston
- Dana-Farber Cancer Institute-Lymphoma ( Site 0026) - Boston
Arizona
- Banner MD Anderson Cancer Center ( Site 0040) - Gilbert
- Banner MD Anderson Cancer Center - University Medical Center Phoenix-Medical Oncology ( Site 0036) - Phoenix
Michigan
- University of Michigan ( Site 0009) - Ann Arbor
- Henry Ford Hospital ( Site 0035) - Detroit
Wisconsin
- University of Wisconsin Hospitals and Clinics-Carbone Cancer Center ( Site 0030) - Madison
- Medical College of Wisconsin ( Site 0021) - Milwaukee
Alaska
- Alaska Oncology and Hematology ( Site 0037) - Anchorage
Colorado
- University of Colorado Anschutz Medical Campus-The Center for Cancer and Blood Disorders ( Site 0008) - Aurora
Illinois
- Cancer Care Specialists of Illinois ( Site 0031) - Decatur
Kansas
- University of Kansas Medical Center-Division of Hematologic Malignancies and Cellular Therapeutics ( Site 0038) - Fairway
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 223 participants |
| Start Date | 2022-07-21 |
| Est. Completion | 2029-05-17 |
| Phase | Phase 2 |
What the registry record for NCT05458297 still lists
NCT05458297 is an interventional study that assigns participants to a tested intervention. The registered 223 participants enrollment target is mid-sized for trials with a published cap, above the 181-participant average among 187 other Chronic Lymphocytic Leukemia trials with a reported enrollment target (23% higher).
The record links to 4 conditions, with Chronic Lymphocytic Leukemia appearing as the primary indexed condition, and to 2 interventions - of which Nemtabrutinib is the first listed.
NCT05458297 names 20 study sites across 15 states, led by Massachusetts, Arizona, Michigan.
Frequently Asked Questions
What is clinical trial NCT05458297 about?
NCT05458297 is a clinical study titled "A Study of Zilovertamab Vedotin (MK-2140) as Monotherapy and in Combination in Participants With Aggressive and Indolent B-cell Malignancies (MK-2140-006)". 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 l...
What is the current status of trial NCT05458297?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 223 participants. The study started on 2022-07-21. Estimated completion is 2029-05-17.
What conditions does trial NCT05458297 study?
This clinical trial studies the following conditions: Chronic Lymphocytic Leukemia, Mantle Cell Lymphoma, Follicular Lymphoma, Richter Transformation Lymphoma.
What interventions are being tested in trial NCT05458297?
The interventions under investigation include: Nemtabrutinib (DRUG), Zilovertamab vedotin (BIOLOGICAL).
Who is sponsoring clinical trial NCT05458297?
This trial is sponsored by Merck Sharp & Dohme, which has 558 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05458297 being conducted?
This trial has 20 study locations across Alaska, Arizona, Colorado, Illinois, Kansas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05458297's enrollment target sits among peer trials
223 38th of 187 higher than 150 of 187 other Chronic Lymphocytic Leukemia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Chronic Lymphocytic Leukemia trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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