A Study to Evaluate Zilovertamab Vedotin (MK-2140) Combination With Rituximab Plus Cyclophosphamide, Doxorubicin, and Prednisone (R-CHP) Versus Rituximab Plus Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (R-CHOP) in Participants With Previously Untreated DLBCL (MK-2140-010)

Conditions

• Diffuse Large B-Cell Lymphoma

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Zilovertamab vedotin — BIOLOGICAL
  IV infusion
• Rituximab — BIOLOGICAL
  IV infusion
• Cyclophosphamide — DRUG
  IV infusion
• Doxorubicin — DRUG
  IV infusion
• Rituximab Biosimilar — BIOLOGICAL
  IV infusion
• Prednisone — DRUG
  Per Approved Product Label
• Prednisolone — DRUG
  Oral administration
• Vincristine — DRUG
  IV infusion
• Rescue medication — DRUG
  Participants receive rescue medication per approved product label. The rescue medication is granulocyte colony-stimulating factor (G-CSF).
• Methylprednisolone — DRUG
  Per Approved Product Label

Study Details

The purpose of this study is to evaluate if zilovertamab vedotin with standard treatment can help people live longer without the cancer growing or spreading than people who receive standard treatment alone.

Key Dates

Start date

Jan 27, 2025

Status verified

Jun 2026

Primary completion

Jul 2, 2029

Completion

Mar 29, 2032

Study Design

Enrollment

1,046 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Zilovertamab vedotin + Rituximab + Cyclophosphamide, Doxorubicin, Prednisone (R-CHP)
  Participants receive a dose of zilovertamab vedotin (1.75 mg/kg) plus 750 mg/m\^2 cyclophosphamide, 50 mg/m\^2 doxorubicin, and 375 mg/m\^2 rituximab or rituximab biosimilar administered by intravenous (IV) infusion on Day 1 of each 21-day cycle (Q3W) for up to 6 cycles (up to approximately 4 months) plus 2 cycles of rituximab or biosimilar for participants with high risk DLBCL. Participants also receive 100 mg prednisone, prednisolone, or methylprednisolone via oral tablet per day during Days 1-5 of each 21-day cycle for up to 6 cycles (up to approximately 4 months).
• Active Comparator: Rituximab + Cyclophosphamide, Doxorubicin, Vincristine, Prednisone (R-CHOP)
  Participants receive 750 mg/m\^2 cyclophosphamide, 50 mg/m\^2 doxorubicin, and 375 mg/m\^2 rituximab or rituximab biosimilar, 1.4 mg/m\^2 vincristine administered by intravenous (IV) infusion on Day 1 of each 21-day cycle (Q3W) for up to 6 cycles (up to approximately 4 months) plus 2 cycles of rituximab or biosimilar for participants with high risk DLBCL. Participants also receive 100 mg prednisone, prednisolone, or methylprednisolone via oral tablet per day during Days 1-5 of each 21-day cycle for up to 6 cycles (up to approximately 4 months).

Primary Outcome Measure

Progression-free survival (PFS) [ Time Frame: Up to ~ 50 months ]

Central Contacts

• Toll Free Number
  1-888-577-8839
  [email protected]

Locations (42)

Find similar trials in Gilbert, AZ

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