A Research Study, where the participant and healthcare providers are aware of the treatment being given, to evaluate safety and effectiveness of medication MK-2140 in patients with Diffuse Large B Cell Lymphoma who failed prior therapies.

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Merck Sharp & Dohme LLC

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Neoplasms [C04]

Trial duration

3 Feb 2022 → 22 Apr 2026

Decision date (initial)

2023-05-11

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

Merck Sharp & Dohme LLC

External identifiers

EU CT number

2022-501243-33-00

EudraCT number

2021-003397-32

WHO UTN

U1111-1279-9073

ClinicalTrials.gov

NCT05144841

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Pharmacokinetic, Therapy, Pharmacogenetic, Others, Safety, Efficacy, Pharmacogenomic

To evaluate zilovertamab vedotin with respect to objective response rate per Lugano Response Criteria as assessed by Blinded Independent Central Review (BICR)

Secondary objectives 2

1. To evaluate zilovertamab vedotin with respect to duration of response per Lugano Response Criteria as assessed by BICR
2. To evaluate the safety and tolerability of zilovertamab vedotin

Conditions and MedDRA coding

Diffuse Large B Cell Lymphoma (a type of non-Hodgkin’s lymphoma, in patients who failed prior therapies)

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 7

1. Has relapsed or refractory (rr) diffuse large B-cell lymphoma diffused large B-cell lymphoma (DLBCL); has progressed after at least 2 lines of prior therapy; and has progressed after auto- stem cell transplant (SCT) or are auto-SCT ineligible. Must have received prior multiagent regimen that includes an alkylating agent. anthracycline, and anti-CD20 (cluster of differentiation 20) monoclonal antibody.
2. Has histologically confirmed diagnosis of DLBCL.
3. Has radiographically measurable DLBCL per the Lugano Response Criteria
4. Should either be post- chimeric antigen receptor T cell therapy (CAR-T) failure or ineligible for CAR-T (for any reason)
5. Life expectancy of at least 3 months
6. Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 assessed within 7 days before time of enrollment
7. Has adequate organ function

Exclusion criteria 18

1. Has received a diagnosis of primary mediastinal B-cell lymphoma (PMBCL)
2. Has undergone solid organ transplant at any time
3. Has a history of any clinically significant cardiovascular conditions within 6 months of screening or serious cardiac arrhythmia requiring medication
4. Has known history of liver cirrhosis
5. Has pericardial effusion or clinically significant pleural effusion
6. Has ongoing Grade >1 peripheral neuropathy
7. Has a history of a second malignancy, unless potentially curative treatment has been completed with no evidence of malignancy for 2 years
8. Transformed DLBCL from indolent lymphoma
9. In participants with prior allo-SCT, acute graft versus host disease (GVHD) or ongoing evidence of chronic GVHD
10. Has received prior systemic anticancer therapy, including investigational agents within 4 weeks prior to the first dose of study intervention
11. Has received prior radiotherapy within 28 days of start of study intervention. Participants must have recovered from all radiation-related toxicities
12. Has ongoing corticosteroid therapy (exceeding 30 mg daily of prednisone equivalent)
13. Has received a live or live-attenuated vaccine within 30 days before the first dose of study intervention
14. Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks before the first dose of study intervention
15. Has known active central nervous system (CNS) lymphoma involvement or active CNS involvement by lymphoma
16. Has an active infection requiring systemic therapy
17. Has a known history of human immunodeficiency virus (HIV) infection
18. Has a known history of hepatitis B or known active hepatitis C virus (HCV)

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Objective Response Rate (ORR) per Lugano Response Criteria

Secondary endpoints 3

1. Duration of Response (DOR) per Lugano Response Criteria 1
2. Number of Participants Who Experience an Adverse Event (AE)
3. Number of Participants Who Discontinue Study Treatment Due to an AE

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 2

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Merck Sharp & Dohme LLC

Sponsor organisation

Merck Sharp & Dohme LLC

Address

126 East Lincoln Avenue

City

Rahway

Postcode

07065-4607

Country

United States

Scientific contact point

Organisation

Merck Sharp & Dohme LLC

Contact name

Nishitha Reddy

Public contact point

Organisation

Merck Sharp & Dohme LLC

Contact name

Nishitha Reddy

Third parties 11

Locations

9 EU/EEA countries · 24 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 53 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

7 submissions — initial application plus substantial / non-substantial modifications