Zilovertamab vedotin for Lymphoma

Tufts Medical Center ( Site 0024), Boston, MA
Lymphoma+3 More ConditionsZilovertamab vedotin - Biological
Eligibility
18+
All Sexes

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.

Eligible Conditions
  • Richter Transformation Lymphoma
  • Chronic Lymphocytic Leukemia
  • Mantle Cell Lymphoma
  • Follicular Lymphoma

Treatment Effectiveness

Phase-Based Effectiveness

1 of 3
Phase 2

Study Objectives

10 Primary · 9 Secondary · Reporting Duration: Up to approximately 57 months

Month 57
DOR per Lugano Response Criteria as Assessed by Investigator (cohort C)
DOR per iwCLL Criteria as Assessed by Investigator
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
Duration of Response (DOR) per Lugano Response Criteria as Assessed by BICR (cohorts A, B, D (FL), and E)
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)
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]
Percentage of Participants Discontinuing from Study Therapy Due to AE (MCL, FL, and CLL)
Percentage of Participants Discontinuing from Study Therapy Due to AE (MCL, RTL, FL, and CLL)
Dilatation and Curettage
Percentage of Participants Discontinuing from Study Therapy Due to AE (cohorts A, B, E, and F)
Percentage of Participants with Dose-Limiting Toxicity (DLT)
Percentage of Participants with Dose-Limiting Toxicity (DLT) [cohort C]
Percentage of Participants with ≥1 AE (MCL, RTL, FL, and CLL)
Percentage of Participants with ≥1 AE (cohorts A, B, E, and F)
Percentage of Participants with ≥1 Adverse Event (AE) [MCL, FL, and CLL]
Percentage of Participants with ≥1 Adverse Event (AE) [cohort C and D]

Trial Safety

Phase-Based Safety

2 of 3
This is further along than 68% of similar trials

Awards & Highlights

No Placebo Group
All patients enrolled in this trial will receive the new treatment.

Trial Design

8 Treatment Groups

Zilovertamab vedotin 2.5 mg/kg
1 of 8
Zilovertamab vedotin 2.0 mg/kg
1 of 8
Cohort A
1 of 8
Cohort B
1 of 8
Cohort C
1 of 8
Cohort D
1 of 8
Cohort E
1 of 8
Cohort F
1 of 8

Experimental Treatment

275 Total Participants · 8 Treatment Groups

Primary Treatment: Zilovertamab vedotin · No Placebo Group · Phase 2

Zilovertamab vedotin 2.5 mg/kgExperimental Group · 2 Interventions: Zilovertamab vedotin, Nemtabrutinib · Intervention Types: Biological, Drug
Zilovertamab vedotin 2.0 mg/kg
Biological
Experimental Group · 1 Intervention: Zilovertamab vedotin · Intervention Types: Biological
Cohort A
Biological
Experimental Group · 1 Intervention: Zilovertamab vedotin · Intervention Types: Biological
Cohort B
Biological
Experimental Group · 1 Intervention: Zilovertamab vedotin · Intervention Types: Biological
Cohort CExperimental Group · 2 Interventions: Zilovertamab vedotin, Nemtabrutinib · Intervention Types: Biological, Drug
Cohort D
Biological
Experimental Group · 1 Intervention: Zilovertamab vedotin · Intervention Types: Biological
Cohort E
Biological
Experimental Group · 1 Intervention: Zilovertamab vedotin · Intervention Types: Biological
Cohort F
Biological
Experimental Group · 1 Intervention: Zilovertamab vedotin · Intervention Types: Biological

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to approximately 57 months

Who is running the clinical trial?

Merck Sharp & Dohme LLCLead Sponsor
3,737 Previous Clinical Trials
4,973,555 Total Patients Enrolled
84 Trials studying Lymphoma
6,773 Patients Enrolled for Lymphoma
Medical DirectorStudy DirectorMerck Sharp & Dohme LLC
2,670 Previous Clinical Trials
7,958,937 Total Patients Enrolled
38 Trials studying Lymphoma
9,976 Patients Enrolled for Lymphoma

Eligibility Criteria

Age 18+ · All Participants · 0 Total Inclusion Criteria

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Frequently Asked Questions

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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-" - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.