A Randomized, Open-label, Multicenter, Phase 2 Study Evaluating the Efficacy and Safety of Zilovertamab Vedotin (MK-2140) Plus R-CHP Versus Polatuzumab Vedotin Plus R-CHP in Treatment-naïve Participants With GCB Subtype of Diffuse Large B-cell Lymphoma (DLBCL)
Merck Sharp & Dohme LLC
Summary
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.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: The main inclusion criteria include but are not limited to the following: * Has histologically confirmed diagnosis of germinal center B-cell (GCB) subtype of diffuse large B-cell lymphoma (DLBCL), by prior biopsy, according to the World Health Organization (WHO) classification of neoplasms of the hematopoietic and lymphoid tissues. * Has positron emission tomography (PET) positive disease at screening, defined as 4 to 5 on the Lugano 5-point scale. * Has received no prior treatment for their DLBCL. * Human immunodeficiency virus (HIV) infected participants must have well…
Interventions
- BiologicalZilovertamab vedotin
IV infusion
- BiologicalRituximab
IV infusion
- DrugCyclophosphamide
IV infusion
- DrugDoxorubicin
IV infusion
- BiologicalRituximab Biosimilar
IV infusion
- DrugPrednisone
Oral administration or IV infusion
- DrugPrednisolone
Oral administration or IV infusion
Locations (123)
- Infirmary Cancer Care ( Site 0157)Mobile, Alabama
- Ironwood Cancer & Research Centers ( Site 0204)Chandler, Arizona
- Palo Verde Cancer Specialists ( Site 0105)Glendale, Arizona
- Genesis Cancer and Blood Institute ( Site 0193)Hot Springs, Arkansas
- Roy and Patricia Disney Family Cancer Center - Providence Saint Joseph Medical Center ( Site 0135)Burbank, California
- City of Hope Comprehensive Cancer Center ( Site 0191)Duarte, California