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Monoclonal Antibodies
Zilovertamab Vedotin for 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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 57 months
Awards & highlights
Study Summary
This trial is testing the safety and effectiveness of a new drug, zilovertamab vedotin, for people with certain types of lymphoma who have not responded well to other treatments.
Who is the study for?
This trial is for adults with certain B-cell lymphomas (like MCL, RTL, FL, CLL) that have come back or didn't respond after previous treatments. They should be able to perform daily activities with minimal help and not have severe ongoing health issues like infections or heart disease. People who've had recent vaccines, live with HIV/HBV/HCV, or received cancer treatment too close to the study start are excluded.Check my eligibility
What is being tested?
The trial tests Zilovertamab vedotin alone and combined with Nemtabrutinib in patients divided into groups based on their specific type of lymphoma and prior treatments. The main goal is to see how well these therapies shrink the cancer as judged by independent reviewers using established criteria.See study design
What are the potential side effects?
While not all side effects are listed here, participants may experience symptoms related to nerve damage (like numbness), reactions at the infusion site, fatigue, digestive problems such as nausea or diarrhea, blood disorders including low counts leading to increased infection risk.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to approximately 57 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 57 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
ORR per International Workshop on Chronic Lymphocytic Leukemia (iwCLL) Criteria as Assessed by Investigator
ORR per Lugano Response Criteria as Assessed by Investigator (cohort C)
Objective Response Rate (ORR) per Lugano Response Criteria as Assessed by Blinded Independent Central Review (BICR) [cohorts A, B, E and FL participants in D]
+3 moreSecondary outcome measures
DOR per Lugano Response Criteria as Assessed by Investigator (cohort C)
DOR per iwCLL Criteria as Assessed by Investigator (cohorts D [CLL] and F)
Duration of Response (DOR) per Lugano Response Criteria as Assessed by BICR (cohorts A, B, D (FL), and E)
+2 moreTrial Design
6Treatment groups
Experimental Treatment
Group I: Cohort FExperimental Treatment1 Intervention
Participants will receive either zilovertamab vedotin 2.5 mg/kg every 3 weeks (Q3W) or 2.0 mg/kg with infusions on Days 1 and 8 of each 3 week cycle (Q2/3W) until disease progression or discontinuation.
Group II: Cohort EExperimental Treatment1 Intervention
Participants will receive either zilovertamab vedotin 2.5 mg/kg every 3 weeks (Q3W) or 2.0 mg/kg with infusions on Days 1 and 8 of each 3 week cycle (Q2/3W) until disease progression or discontinuation.
Group III: Cohort DExperimental Treatment1 Intervention
Participants will receive either zilovertamab vedotin 2.5 mg/kg every 3 weeks (Q3W) or 2.0 mg/kg with infusions on Days 1 and 8 of each 3 week cycle (Q2/3W) until disease progression or discontinuation.
Group IV: Cohort CExperimental Treatment2 Interventions
Participants will receive zilovertamab vedotin every 3 weeks (Q3W) combined with nemtabrutinib daily until disease progression or discontinuation.
Group V: Cohort BExperimental Treatment1 Intervention
Participants will receive zilovertamab vedotin 2.5 mg/kg every 3 weeks (Q3W) until disease progression or discontinuation.
Group VI: Cohort AExperimental Treatment1 Intervention
Participants will receive zilovertamab vedotin 2.5 mg/kg every 3 weeks (Q3W) until disease progression or discontinuation.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Zilovertamab vedotin
2019
Completed Phase 2
~200
Find a Location
Who is running the clinical trial?
Merck Sharp & Dohme LLCLead Sponsor
3,892 Previous Clinical Trials
5,060,871 Total Patients Enrolled
91 Trials studying Lymphoma
8,330 Patients Enrolled for Lymphoma
Medical DirectorStudy DirectorMerck Sharp & Dohme LLC
2,777 Previous Clinical Trials
8,063,944 Total Patients Enrolled
40 Trials studying Lymphoma
11,365 Patients Enrolled for Lymphoma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My follicular lymphoma has changed into a more aggressive form.My lymphoma has spread to my brain or spinal cord.I had another cancer but was treated successfully and have been cancer-free for 2 years.I have a relapsed or unresponsive aggressive B-cell cancer as confirmed by a biopsy.I have not had a live vaccine in the last 30 days.I haven't had cancer treatment within the specified time before starting the study.I had radiotherapy within the last 28 days and have recovered from its side effects.I am currently being treated for an infection.I am HBsAg positive but have been on HBV therapy for 4+ weeks with an undetectable viral load.I have fluid around my heart or in my lungs.I am taking more than 30 mg of corticosteroids daily.I have had a serious heart condition or stroke in the last 6 months.I have stomach or intestine problems that could affect how my body absorbs medication.I have a type of Charcot-Marie-Tooth disease that affects the nerve covering.I have persistent nerve pain or tingling in my hands or feet.My B-cell cancer has returned or didn't respond after 2 treatments and no other options are available.My aggressive B-cell cancer has returned or didn't respond after 2 treatments including a BTK inhibitor, and I've had or can't have CAR-T cell therapy.I have an aggressive B-cell cancer that has returned or didn't respond to treatment, and I haven't used a specific type of therapy.My physical ability was assessed as able to care for myself up to being up and about more than half of waking hours, within the last week.
Research Study Groups:
This trial has the following groups:- Group 1: Cohort B
- Group 2: Cohort D
- Group 3: Cohort E
- Group 4: Cohort A
- Group 5: Cohort F
- Group 6: Cohort C
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.
What potential perils could arise from ingesting Zilovertamab vedotin?
"Assessment of the safety profile for Zilovertamab vedotin scored a 2 on our team's scale due to being in Phase 2, where there is some evidence backing its security but none attesting to efficacy."
Answered by AI
How many volunteers are currently engaged in this research study?
"Affirmative, clinicaltrials.gov verifies that this medical trial is currently recruiting patients. Initially posted on July 21st 2022 and most recently edited on November 24th 2022, 275 participants are needed from 4 different sites."
Answered by AI
How many locations have been approved to conduct this experiment?
"At this time, 4 clinics in Decatur, Saint Matthews, Spokane and other cities are enrolling patients for the trial. To reduce travel burdens associated with participation it is important to pick a clinic that is most proximal to you."
Answered by AI
What is the ultimate aim of this research endeavor?
"This clinical trial will assess efficacy over almost 5 years and the primary endpoint is Percentage of Participants Discontinuing from Study Therapy Due to Adverse Events (cohort C and D). Additionally, Duration of Response per Lugano Response Criteria as Assessed by BICR (cohorts A, B, D (FL), and E) as well as Duration of Response per iwCLL Criteria as Assessed by Investigator (cohorts D [CLL] and F) will be evaluated. Finally, a measure for Percentage of Participants Discontinuing from Study Therapy Due to AE's in cohorts A-"
Answered by AI
Is there an opportunity to join this experiment currently?
"Affirmative. Clinicaltrials.gov indicates that, as of November 24th 2022, this research is actively seeking participants; with an initial posting date of July 21st 2022 and a goal to recruit 275 patients across 4 sites."
Answered by AI
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