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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 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.

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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)).

Conditions Studied

Chronic Lymphocytic Leukemia Mantle Cell Lymphoma Follicular Lymphoma Richter Transformation Lymphoma

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

FieldValue
Enrollment Target 223 participants
Start Date 2022-07-21
Est. Completion 2029-05-17
Phase Phase 2

Sponsor

Merck Sharp & Dohme

558 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05458297

The ClinicalTrials.gov registry entry for NCT05458297 describes a study currently listed as active not recruiting, categorized as Phase 2. The registered enrollment target is 223 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 181-participant average among 187 other Chronic Lymphocytic Leukemia trials with a reported enrollment target (23% higher). The listed sponsor is Merck Sharp & Dohme, which has 558 total studies on file at ClinicalTrials.gov.

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 reports 20 study locations spanning 15 distinct geographic areas - top geographies include 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.

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