Your session is about to expire
← Back to Search
Chemotherapy
Zilovertamab Vedotin + R-CHP for Diffuse Large B-Cell Lymphoma (waveLINE-007 Trial)
Phase 2
Waitlist Available
Research Sponsored by Merck Sharp & Dohme LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Has histologically confirmed diagnosis of DLBCL by prior biopsy
Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 assessed within 7 days prior to the start of study intervention
Must not have
Has received a diagnosis of primary mediastinal B-cell lymphoma (PMBCL)
Has received a strong inhibitor or inducer of CYP3A4 (including itraconazole, ketoconazole, posaconazole, or voriconazole) within 7 days prior to the start of study intervention or expected requirement for chronic use of a strong CYP3A4 inhibitor until <30 days after the last dose
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 60 months
Awards & highlights
No Placebo-Only Group
Summary
This trial tests a new drug called zilovertamab vedotin combined with standard chemotherapy in patients with DLBCL who haven't been treated before. The drug targets and kills cancer cells like a guided missile, while the chemotherapy helps to further attack the cancer.
Who is the study for?
This trial is for adults with a confirmed diagnosis of Diffuse Large B-Cell Lymphoma (DLBCL) who haven't been treated before. They should have PET-positive disease and be in good physical condition, meaning they can carry out daily activities with ease or with some limitation. People with certain heart conditions, other cancers within the last 2 years, recent radiotherapy, ongoing high-dose steroids, live vaccines taken recently, strong drug interactions or active infections are excluded.
What is being tested?
The study tests Zilovertamab Vedotin combined with R-CHP (Cyclophosphamide, Doxorubicin, Prednisone plus Rituximab or its biosimilar). It has two parts: first to find a safe dose and then to see how effective this combination is at that dose for treating people newly diagnosed with DLBCL.
What are the potential side effects?
Possible side effects include reactions related to infusion of the drugs like fever and chills; low blood cell counts leading to increased infection risk; nausea; fatigue; nerve damage causing numbness or tingling; hair loss due to chemotherapy agents used.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My diagnosis of DLBCL was confirmed through a biopsy.
Select...
I am fully active or restricted in physically strenuous activity but can do light work.
Select...
I have not received any treatment for DLBCL.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have been diagnosed with primary mediastinal B-cell lymphoma.
Select...
I haven't taken strong CYP3A4 inhibitors like itraconazole within the last week.
Select...
I am currently being treated for an infection.
Select...
I have an active hepatitis B infection.
Select...
I have an active lymphoma in my brain or spinal cord.
Select...
I am taking more than 30 mg of corticosteroids daily.
Select...
My slow-growing cancer has changed into aggressive large B-cell lymphoma.
Select...
I have ongoing nerve damage in my hands or feet that affects my daily activities.
Select...
I have an active hepatitis C infection.
Select...
I have had a serious heart condition or stroke in the last 6 months.
Select...
I have fluid around my heart or in my chest.
Select...
I have a type of Charcot-Marie-Tooth disease that affects the nerve covering.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to approximately 60 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 60 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Complete Response Rate (CRR) per Lugano Response Criteria
Number of Participants Who Discontinued Study Treatment Due to an AE
Number of Participants Who Experienced At Least One AE
+1 moreSecondary study objectives
Duration of Response (DOR) per Lugano Response Criteria
Objective Response Rate (ORR) per Lugano Response Criteria
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Group I: Zilovertamab Vedotin + R-CHP: Efficacy ExpansionExperimental Treatment7 Interventions
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).
Group II: Zilovertamab Vedotin + R-CHP: Dose Escalation/ConfirmationExperimental Treatment7 Interventions
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).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cyclophosphamide
2010
Completed Phase 4
~2310
Prednisone
2014
Completed Phase 4
~2500
Prednisolone
2005
Completed Phase 4
~3570
Rituximab
1999
Completed Phase 4
~2990
Doxorubicin
2012
Completed Phase 3
~8030
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Antibody-drug conjugates (ADCs) like Zilovertamab Vedotin target CD20 on B-cells, combining the specificity of monoclonal antibodies with the cytotoxic potency of chemotherapy. The antibody binds to CD20, is internalized by the cancer cell, and releases the cytotoxic drug to induce cell death.
This targeted approach minimizes damage to healthy cells, reducing side effects. Other treatments, such as Rituximab, also target CD20 but work by marking cancer cells for immune system destruction.
These mechanisms are crucial for Non-Hodgkin's Lymphoma patients as they offer precision, potential efficacy, and reduced toxicity compared to traditional chemotherapy.
Find a Location
Who is running the clinical trial?
Merck Sharp & Dohme LLCLead Sponsor
4,032 Previous Clinical Trials
5,189,741 Total Patients Enrolled
Medical DirectorStudy DirectorMerck Sharp & Dohme LLC
2,905 Previous Clinical Trials
8,091,409 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been diagnosed with primary mediastinal B-cell lymphoma.I had another cancer but have been cancer-free for 2 years, except for certain skin cancers or in situ cancers.I haven't taken strong CYP3A4 inhibitors like itraconazole within the last week.I had radiotherapy less than 28 days before starting the study treatment.I am currently being treated for an infection.I have an active hepatitis B infection.My diagnosis of DLBCL was confirmed through a biopsy.I have an active lymphoma in my brain or spinal cord.I am fully active or restricted in physically strenuous activity but can do light work.I am taking more than 30 mg of corticosteroids daily.I have not received any treatment for DLBCL.My slow-growing cancer has changed into aggressive large B-cell lymphoma.I have ongoing nerve damage in my hands or feet that affects my daily activities.I have an active hepatitis C infection.I have had a serious heart condition or stroke in the last 6 months.I have fluid around my heart or in my chest.I have a type of Charcot-Marie-Tooth disease that affects the nerve covering.I have not had a live vaccine in the last 30 days.
Research Study Groups:
This trial has the following groups:- Group 1: Zilovertamab Vedotin + R-CHP: Dose Escalation/Confirmation
- Group 2: Zilovertamab Vedotin + R-CHP: Efficacy Expansion
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.