Comparing two treatments for a type of blood cancer called DLBCL
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)
This study is testing whether a new combination of treatments can help people with a specific type of blood cancer feel better compared to the standard treatment.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 594 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Merck Sharp & Dohme LLC Industry-sponsored |
| Drugs / interventions | zilovertamab, polatuzumab |
| Locations | 123 sites (Mobile, Alabama and 122 other locations) |
| Trial ID | NCT06890884 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness of zilovertamab vedotin combined with R-CHP against polatuzumab vedotin with R-CHP in patients diagnosed with germinal center B-cell-like diffuse large B-cell lymphoma (GCB DLBCL). The study will assess the response rate of these treatments in patients whose cancer is PET positive. Participants must have a confirmed diagnosis of GCB DLBCL and have not received prior treatment for their condition. The trial is designed to determine if the new combination therapy leads to better outcomes compared to the standard treatment.
Who should consider this trial
Good fit: Ideal candidates are individuals with newly diagnosed GCB DLBCL who have not undergone any prior treatment.
Not a fit: Patients with other subtypes of DLBCL or those who have received prior treatment for their condition may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a more effective treatment option for patients with GCB DLBCL.
How similar studies have performed: Other studies have shown promise in using targeted therapies for DLBCL, but this specific combination is being evaluated for the first time.
Eligibility criteria
Show full inclusion / exclusion criteria
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 controlled HIV on antiretroviral therapy (ART). * Participants who are hepatitis B surface antigen (HBsAg) positive are eligible if they have received hepatitis B virus (HBV) antiviral therapy and have undetectable HBV viral load prior to randomization. * Participants with history of hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable at screening. Exclusion Criteria: The main exclusion criteria include but are not limited to the following: * Has a history of transformation of indolent disease to DLBCL. * Has received a diagnosis of primary mediastinal B-cell lymphoma (PMBCL) or Grey zone lymphoma. * Has Ann Arbor Stage I DLBCL. * Has clinically significant (i.e., active) cardiovascular disease: cerebral vascular accident/stroke (\<6 months prior to enrollment), myocardial infarction (\<6 months prior to enrollment), unstable angina, congestive heart failure (New York Heart Association Classification Class ≥II), or serious cardiac arrhythmia requiring medication. * Has clinically significant pericardial or pleural effusion. * Has ongoing Grade \>1 peripheral neuropathy. * Has a demyelinating form of Charcot-Marie-Tooth disease. * HIV-infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease. * Has ongoing corticosteroid therapy. * Known additional malignancy that is progressing or has required active treatment within the past 2 years. * Known active central nervous system (CNS) lymphoma. * Has active autoimmune disease that has required systemic treatment in the past 2 years. * Has active infection requiring systemic therapy. * Has active HBV (defined as HBsAg positive and detectable HBV deoxyribonucleic acid (DNA)) and HCV (defined as anti-HCV antibody positive and detectable HCV ribonucleic acid (RNA)) infection. * Has history of stem cell/solid organ transplant.
Where this trial is running
Mobile, Alabama and 122 other locations
- Infirmary Cancer Care ( Site 0157) — Mobile, Alabama, United States (Recruiting)
- Ironwood Cancer & Research Centers ( Site 0204) — Chandler, Arizona, United States (Recruiting)
- Palo Verde Cancer Specialists ( Site 0105) — Glendale, Arizona, United States (Recruiting)
- Genesis Cancer and Blood Institute ( Site 0193) — Hot Springs, Arkansas, United States (Recruiting)
- Roy and Patricia Disney Family Cancer Center - Providence Saint Joseph Medical Center ( Site 0135) — Burbank, California, United States (Recruiting)
- City of Hope Comprehensive Cancer Center ( Site 0191) — Duarte, California, United States (Recruiting)
- Bass Medical Group ( Site 0123) — Walnut Creek, California, United States (Recruiting)
- Rocky Mountain Cancer Centers (RMCC) ( Site 8001) — Aurora, Colorado, United States (Recruiting)
- Colorado West Healthcare System-Grand Valley Oncology ( Site 0165) — Grand Junction, Colorado, United States (Recruiting)
- Medical Oncology Hematology Consultants (MOHC) ( Site 8007) — Newark, Delaware, United States (Recruiting)
- Georgetown University Medical Center ( Site 0117) — Washington D.C., District of Columbia, United States (Recruiting)
- Boca Raton Regional Hospital-Lynn Cancer Institute ( Site 0130) — Boca Raton, Florida, United States (Recruiting)
- Baptist MD Anderson Cancer Center ( Site 0176) — Jacksonville, Florida, United States (Recruiting)
- Mount Sinai Cancer Center ( Site 0140) — Miami Beach, Florida, United States (Recruiting)
- Mid Florida Hematology and Oncology Center ( Site 0152) — Orange City, Florida, United States (Recruiting)
- Beacon Cancer Care ( Site 0142) — Post Falls, Idaho, United States (Recruiting)
- University of Chicago Medical Center ( Site 0126) — Chicago, Illinois, United States (Recruiting)
- Illinois Cancer Care ( Site 7005) — Peoria, Illinois, United States (Recruiting)
- University of Iowa-Holden Comprehensive Cancer Center ( Site 0139) — Iowa City, Iowa, United States (Recruiting)
- Mission Blood & Cancer Care ( Site 0114) — Waukee, Iowa, United States (Recruiting)
- Saint Elizabeth Medical Center Edgewood ( Site 0141) — Edgewood, Kentucky, United States (Recruiting)
- Baptist Health Hardin ( Site 0154) — Elizabethtown, Kentucky, United States (Recruiting)
- Baptist Health Lexington ( Site 0127) — Lexington, Kentucky, United States (Recruiting)
- Norton Women's and Children's Hospital-Norton Cancer Institute - St. Matthews ( Site 0185) — Louisville, Kentucky, United States (Recruiting)
- Our Lady of the Lake Physician Group-Medical Oncology ( Site 0180) — Baton Rouge, Louisiana, United States (Recruiting)
- Ochsner LSU Health - Monroe Medical Center, Family Medicine Clinic ( Site 0209) — Monroe, Louisiana, United States (Recruiting)
- Ochsner Clinic Foundation ( Site 0189) — New Orleans, Louisiana, United States (Recruiting)
- Louisiana State University Health Sciences Shreveport ( Site 0195) — Shreveport, Louisiana, United States (Recruiting)
- Dana Farber Cancer Institute ( Site 0111) — Boston, Massachusetts, United States (Recruiting)
- Minnesota Oncology Hematology (MNO) ( Site 8004) — Burnsville, Minnesota, United States (Recruiting)
- Bozeman Health Deaconess Hospital ( Site 0183) — Bozeman, Montana, United States (Recruiting)
- NHO Revive Research Institute, LLC ( Site 0121) — Lincoln, Nebraska, United States (Recruiting)
- University Of Nebraska Medical Center ( Site 0110) — Omaha, Nebraska, United States (Recruiting)
- Atlantic Health Morristown Medical Center ( Site 0163) — Morristown, New Jersey, United States (Recruiting)
- Valley Health Systems - Ridgewood Campus ( Site 0125) — Paramus, New Jersey, United States (Recruiting)
- Erie County Medical Center ( Site 0175) — Buffalo, New York, United States (Recruiting)
- Roswell Park Cancer Institute ( Site 0192) — Buffalo, New York, United States (Recruiting)
- Perlmutter Cancer Center at NYU Langone Hospital - Long Island ( Site 0208) — Mineola, New York, United States (Recruiting)
- Laura and Isaac Perlmutter Cancer Center at NYU Langone ( Site 0108) — New York, New York, United States (Recruiting)
- SUNY Upstate Cancer Center ( Site 0178) — Syracuse, New York, United States (Recruiting)
- Clinical Research Alliance ( Site 0122) — Westbury, New York, United States (Recruiting)
- University of North Carolina Medical Center ( Site 0136) — Chapel Hill, North Carolina, United States (Recruiting)
- Novant Health Presbyterian Medical Center ( Site 0177) — Charlotte, North Carolina, United States (Recruiting)
- Novant Health Forsyth Medical Center ( Site 0206) — Winston-Salem, North Carolina, United States (Recruiting)
- University of Cincinnati Medical Center ( Site 0156) — Cincinnati, Ohio, United States (Recruiting)
- University Hospitals of Cleveland ( Site 0155) — Cleveland, Ohio, United States (Recruiting)
- Fairview Hospital-Moll Cancer Center ( Site 0198) — Cleveland, Ohio, United States (Recruiting)
- Cleveland Clinic Main ( Site 0101) — Cleveland, Ohio, United States (Recruiting)
- Cleveland Clinic - Hillcrest Hospital-Hillcrest Hospital Cancer Center ( Site 0199) — Mayfield Heights, Ohio, United States (Recruiting)
- Providence Portland Medical Center ( Site 0120) — Portland, Oregon, United States (Recruiting)
+73 more sites — see ClinicalTrials.gov for the full list.
Study contacts
- Study coordinator: Toll Free Number
- Email: Trialsites@msd.com
- Phone: 1-888-577-8839
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.