A Study of Zilovertamab Vedotin (MK-2140) in Combination With Cyclophosphamide, Doxorubicin, and Prednisone Plus Rituximab or Rituximab Biosimilar (Truxima) (R-CHP) in Participants With Diffuse Large B-Cell Lymphoma (DLBCL) (MK-2140-007)

Sponsor
Merck Sharp & Dohme LLC
Study ID
NCT05406401
Phase
PHASE2
Status
Active Not Recruiting

Conditions

  • Lymphoma, Large B-Cell, Diffuse (DLBCL)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Zilovertamab Vedotin — BIOLOGICAL
    IV infusion
  • Cyclophosphamide — DRUG
    IV infusion
  • Doxorubicin — DRUG
    IV infusion
  • Rituximab — BIOLOGICAL
    IV infusion
  • Rituximab Biosimilar — BIOLOGICAL
    IV infusion
  • Prednisone — DRUG
    IV or oral administration (per local guidelines)
  • Prednisolone — DRUG
    IV or oral administration (per local guidelines)

Study Details

This study consists of a dose escalation/confirmation phase and an efficacy expansion phase. The dose escalation/confirmation phase is to determine the safety and tolerability and establish a preliminary recommended Phase 2 dose (RP2D) of zilovertamab vedotin when administered in combination with R-CHP in participants with DLBCL who have received no prior treatment for their disease. The efficacy expansion phase is to determine the efficacy of the RP2D of zilovertamab vedotin when administered in combination with R-CHP in participants with DLBCL who have received no prior treatment for their disease.

Key Dates

Start date
Jul 14, 2022
Status verified
Oct 2024
Primary completion
Apr 26, 2029
Completion
Apr 26, 2029

Study Design

Enrollment
60 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Zilovertamab Vedotin + R-CHP: Dose Escalation/Confirmation
    Participants in the dose escalation/confirmation phase receive a dose level of zilovertamab vedotin (from 1.5 mg/Kg up to 2.5 mg/Kg) plus 750 mg/m\^2 cyclophosphamide, 50 mg/m\^2 doxorubicin, and 375 mg/m\^2 rituximab or rituximab biosimilar (truxima) administered by intravenous (IV) infusion on Day 1 of each 21-day cycle (Q3W) for up to 8 cycles (up to approximately 5.5 months). Participants also receive 100 mg prednisone or prednisolone per day during Days 1-5 of each 21-day cycle for up to 8 cycles (up to approximately 5.5 months).
  • Experimental: Zilovertamab Vedotin + R-CHP: Efficacy Expansion
    Participants in the efficacy expansion phase receive the RP2D of zilovertamab vedotin plus 750 mg/m\^2 cyclophosphamide, 50 mg/m\^2 doxorubicin, and 375 mg/m\^2 rituximab or rituximab biosimilar (truxima) administered by intravenous (IV) infusion on Day 1 of each 21-day cycle (Q3W) for up to 8 cycles (up to approximately 5.5 months). Participants also receive 100 mg prednisone or prednisolone per day during Days 1-5 of each 21-day cycle for up to 8 cycles (up to approximately 5.5 months).

Primary Outcome Measure

Number of Participants Who Experienced Dose-limiting Toxicities (DLTs) in Cycle 1 [ Time Frame: Cycle 1 (up to 21 days) ]

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