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)
Condition(s) studied
Investigational drug(s) / intervention(s)
Zilovertamab vedotin: IV infusion
Rituximab: IV infusion
Cyclophosphamide: IV infusion
Doxorubicin: IV infusion
Rituximab Biosimilar: IV infusion
Prednisone: Oral administration or IV infusion
Prednisolone: Oral administration or IV infusion
Polatuzumab vedotin: IV infusion
Rescue Medication: Participants receive rescue medication at the investigators discretion, per approved product label. Recommended rescue medication is Granulocyte Colony-Stimulating Factor (G-CSF).
Study 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
Primary outcome measure(s)
- Complete Response Rate (CRR) at End of Treatment (EOT) per Lugano Response Criteria — Up to approximately 31 months
CRR at EOT is defined as the percentage of participants who experience complete response (CR) per Lugano response criteria as assessed by blinded independent central review (BICR) at end of treatment. CR is complete metabolic (no/minimal FDG uptake) and radiologic response (target lesions regress to ≤1.5 cm in longest transverse diameter of a lesion) and no new lesions. Participants with missing data or who discontinue treatment or study prior to reaching EOT will be considered non-responders and included in the total number of participants.
Trial sites (146)
| Facility | City | Region | Status |
|---|---|---|---|
| Infirmary Cancer Care ( Site 0157) | Mobile | Alabama | Recruiting |
| Ironwood Cancer & Research Centers ( Site 0204) | Chandler | Arizona | Recruiting |
| Palo Verde Cancer Specialists ( Site 0105) | Glendale | Arizona | Recruiting |
| City of Hope - Phoenix ( Site 0202) | Goodyear | Arizona | Recruiting |
| Genesis Cancer and Blood Institute ( Site 0193) | Hot Springs | Arkansas | Recruiting |
| Roy and Patricia Disney Family Cancer Center - Providence Saint Joseph Medical Center ( Site 0135) | Burbank | California | Recruiting |
| City of Hope Comprehensive Cancer Center ( Site 0191) | Duarte | California | Recruiting |
| Bass Medical Group ( Site 0123) | Walnut Creek | California | Recruiting |
| Rocky Mountain Cancer Centers (RMCC) ( Site 8001) | Aurora | Colorado | Recruiting |
| Colorado West Healthcare System-Grand Valley Oncology ( Site 0165) | Grand Junction | Colorado | Recruiting |
| Medical Oncology Hematology Consultants (MOHC) ( Site 8007) | Newark | Delaware | Recruiting |
| Georgetown University Medical Center ( Site 0117) | Washington D.C. | District of Columbia | Recruiting |
| Boca Raton Regional Hospital-Lynn Cancer Institute ( Site 0130) | Boca Raton | Florida | Recruiting |
| Baptist MD Anderson Cancer Center ( Site 0176) | Jacksonville | Florida | Recruiting |
| Mount Sinai Braman Comprehensive Cancer Center ( Site 0140) | Miami Beach | Florida | Recruiting |
| Mid Florida Hematology and Oncology Center ( Site 0152) | Orange City | Florida | Recruiting |
| Beacon Cancer Care ( Site 0142) | Post Falls | Idaho | Recruiting |
| University of Chicago Medical Center ( Site 0126) | Chicago | Illinois | Recruiting |
| Illinois Cancer Care ( Site 7005) | Peoria | Illinois | Recruiting |
| University of Iowa-Holden Comprehensive Cancer Center ( Site 0139) | Iowa City | Iowa | Recruiting |
| Mission Blood & Cancer Care ( Site 0114) | Waukee | Iowa | Recruiting |
| Saint Elizabeth Medical Center Edgewood ( Site 0141) | Edgewood | Kentucky | Recruiting |
| Baptist Health Hardin ( Site 0154) | Elizabethtown | Kentucky | Recruiting |
| Baptist Health Lexington ( Site 0127) | Lexington | Kentucky | Recruiting |
| Norton Women's and Children's Hospital-Norton Cancer Institute - St. Matthews ( Site 0185) | Louisville | Kentucky | Recruiting |
| Our Lady of the Lake Physician Group-Medical Oncology ( Site 0180) | Baton Rouge | Louisiana | Recruiting |
| Ochsner LSU Health - Monroe Medical Center, Family Medicine Clinic ( Site 0209) | Monroe | Louisiana | Recruiting |
| Ochsner Clinic Foundation ( Site 0189) | New Orleans | Louisiana | Recruiting |
| Louisiana State University Health Sciences Shreveport ( Site 0195) | Shreveport | Louisiana | Recruiting |
| Beth Israel Deaconess Medical Center ( Site 0161) | Boston | Massachusetts | Recruiting |
| Dana Farber Cancer Institute ( Site 0111) | Boston | Massachusetts | Recruiting |
| Minnesota Oncology Hematology (MNO) ( Site 8004) | Burnsville | Minnesota | Recruiting |
| Bozeman Health Deaconess Hospital ( Site 0183) | Bozeman | Montana | Recruiting |
| NHO Revive Research Institute, LLC ( Site 0121) | Lincoln | Nebraska | Recruiting |
| University Of Nebraska Medical Center ( Site 0110) | Omaha | Nebraska | Recruiting |
| Atlantic Health Morristown Medical Center ( Site 0163) | Morristown | New Jersey | Recruiting |
| Valley Health Systems - Ridgewood Campus ( Site 0125) | Paramus | New Jersey | Recruiting |
| Erie County Medical Center ( Site 0175) | Buffalo | New York | Completed |
| Roswell Park Cancer Institute ( Site 0192) | Buffalo | New York | Recruiting |
| Perlmutter Cancer Center at NYU Langone Hospital - Long Island ( Site 0208) | Mineola | New York | Recruiting |
+ 106 more sites — see the full list on the official registry below.
More Merck Sharp & Dohme LLC trials in Italy
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06890884 on ClinicalTrials.gov ↗ ← All trials in Italy