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Chemotherapy
Zilovertamab Vedotin + R-CHP for Diffuse Large B-Cell Lymphoma
Phase 2
Recruiting
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 5.5 months
Awards & highlights
Study Summary
This trialtests a new drug to treat DLBCL. It tests safety, tolerability and effectiveness in people who have not had prior treatment.
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.Check my eligibility
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.See study design
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to approximately 5.5 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 5.5 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Complete Response Rate (CRR) per Lugano Response Criteria
Number of Participants Who Discontinued Study Treatment Due to an Adverse Event (AE)
Number of Participants Who Experienced At Least One Adverse Event (AE)
+1 moreSecondary outcome measures
Duration of Response (DOR) per Lugano Response Criteria
Objective Response Rate (ORR) per Lugano Response Criteria
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
1995
Completed Phase 3
~3770
Doxorubicin
2012
Completed Phase 3
~7940
Rituximab
1999
Completed Phase 4
~1880
Prednisone
2014
Completed Phase 4
~2370
Prednisolone
2005
Completed Phase 4
~2720
Find a Location
Who is running the clinical trial?
Merck Sharp & Dohme LLCLead Sponsor
3,892 Previous Clinical Trials
5,061,086 Total Patients Enrolled
Medical DirectorStudy DirectorMerck Sharp & Dohme LLC
2,777 Previous Clinical Trials
8,064,159 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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many participants are being enrolled in this research project?
"That is correct, the clinical trial was posted on 7/14/2022 and is currently looking for 60 patients at 1 site."
Answered by AI
Are new patients being accepted into this experiment right now?
"Yes, this trial is still recruiting patients according to the latest update on clinicaltrials.gov from November 18th, 2022. This information was first made available on July 14th, 2020."
Answered by AI
Does the FDA currently approve of Zilovertamab Vedotin + R-CHP: Dose Escalation/Confirmation?
"Zilovertamab Vedotin + R-CHP: Dose Escalation/Confirmation has only been studied for safety in Phase 2 trials, so it received a score of 2."
Answered by AI
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