OncoMatch/Clinical Trials/NCT05139017
A Study of Zilovertamab Vedotin (MK-2140) in Combination With Standard of Care in Participants With Relapsed or Refractory Diffuse Large B-Cell Lymphoma (rrDLBCL) (MK-2140-003)
Is NCT05139017 recruiting? Yes, currently enrolling (May 2026). This Phase 2/3 trial studies multiple treatments for dlbcl.
Treatment: Zilovertamab vedotin · Rituximab · Gemcitabine · Oxaliplatin · Bendamustine · Granulocyte Colony-Stimulating Factor (G-CSF) — The purpose of this Phase 2/3, randomized, multisite, open-label, dose confirmation, and expansion study is to evaluate the safety, and efficacy of zilovertamab vedotin (ZV) in combination with standard of care options for the treatment of rrDLBCL. This study will be divided into 2 parts: Dose Confirmation (Part 1) and Efficacy Expansion (Part 2) and will enroll participants who are at least 18 years of age with rrDLBCL. The hypotheses are: ZV in combination with rituximab, gemcitabine, and oxaliplatin (R-GemOx) is superior to R-GemOx with respect to progression-free survival (PFS) per Lugano response criteria by blinded independent review committee (BICR); and that ZV in combination with bendamustine rituximab (BR) is superior to BR with respect to PFS per Lugano response criteria by BICR. With protocol amendment 4 (effective: 04-April-2024), enrollment in Cohort B (study arms Bendamustine Rituximab \[BR\] and ZV + BR) is discontinued. No efficacy outcome analysis and hypothesis testing will be conducted for Cohort B.
Check if I qualifyExtracted eligibility criteria
Cancer type
Diffuse Large B-Cell Lymphoma
Non-Hodgkin Lymphoma
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: systemic anticancer therapy — relapsed or refractory
Has relapsed or refractory DLBCL and is ineligible for or have failed autologous stem-cell transplant (ASCT) and have failed at least 1 line of prior therapy.
Cannot have received: solid organ transplant
Has received solid organ transplant at any time.
Cannot have received: systemic anticancer therapy
Exception: within 4 weeks prior to the first dose of study intervention
Has received prior systemic anticancer therapy, including investigational agents within 4 weeks prior to the first dose of study intervention.
Cannot have received: radiotherapy
Exception: within 4 weeks of start of study intervention
Has received prior radiotherapy within 4 weeks of start of study intervention.
Lab requirements
Blood counts
Kidney function
Liver function
Has adequate organ function.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Palo Verde Hematology/ Oncology Center, Ltd. ( Site 0175) · Glendale, Arizona
- Beverly Hills Cancer Center ( Site 0184) · Beverly Hills, California
- Bass Medical Group ( Site 0166) · Walnut Creek, California
- Innovative Clinical Research Institute ( Site 0122) · Whittier, California
- Boca Raton Regional Hospital- Lynn Cancer Institute ( Site 0163) · Boca Raton, Florida
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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