A Clinical Study of Zilovertamab Vedotin (MK-2140) Plus Rituximab Plus Cyclophosphamide, Doxorubicin, and Prednisone (R-CHP) Versus Polatuzumab Vedotin Plus R-CHP in People With Diffuse Large B-cell Lymphoma (DLBCL) (MK-2140-011/waveLINE-011)

Conditions

• Lymphoma, Large B-Cell, Diffuse

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
  Oral administration or IV infusion
• Prednisolone — DRUG
  Oral administration or IV infusion
• Polatuzumab vedotin — BIOLOGICAL
  IV infusion
• Rescue Medication — DRUG
  Participants receive rescue medication at the investigators discretion, per approved product label. Recommended rescue medication is Granulocyte Colony-Stimulating Factor (G-CSF).

Study Details

Researchers are looking for ways to treat germinal center B-cell-like diffuse large B-cell lymphoma (GCB DLBCL). DLBCL is a fast-growing blood cancer that affects B-cells. GCB is a type of DLBCL that affects young B-cells that are still maturing. The goal of this study is to learn if more people who receive zilovertamab vedotin (MK-2140) and R-CHP have the cancer respond (go away) than those who receive polatuzumab vedotin and R-CHP.

Key Dates

First listed

Mar 24, 2025

Start date

Apr 11, 2025

Status verified

Jul 2026

Primary completion

Dec 13, 2027

Completion

Dec 16, 2032

Study Design

Enrollment

594 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Zilovertamab vedotin + Rituximab + Cyclophosphamide, Doxorubicin, Prednisone (R-CHP)
  Participants will 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 3-week cycle for up to 6 cycles (up to approximately 4 months) plus 2 additional cycles of rituximab or biosimilar for participants with high risk DLBCL. Participants will also receive 100 mg prednisone or prednisolone via oral tablet per day during Days 1-5 of each 3-week cycle for up to 6 cycles (up to approximately 4 months).
• Active Comparator: Polatuzumab vedotin + R-CHP
  Participants will receive a dose of polatuzumab vedotin (1.8 mg/kg) plus 750 mg/m\^2 cyclophosphamide, 50 mg/m\^2 doxorubicin, and 375 mg/m\^2 rituximab or rituximab biosimilar administered by IV infusion on Day 1 of each 3-week cycle for up to 6 cycles (up to approximately 4 months) plus 2 additional cycles of rituximab or biosimilar for participants with high risk DLBCL. Participants will also receive 100 mg prednisone or prednisolone via oral tablet per day during Days 1-5 of each 3-week cycle for up to 6 cycles (up to approximately 4 months).

Primary Outcome Measure

Complete Response Rate (CRR) at End of Treatment (EOT) per Lugano Response Criteria [ Time Frame: Up to approximately 31 months ]

Central Contacts

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

Locations (72)

Find similar trials in Mobile, AL

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