Pembrolizumab for Marginal Zone Lymphoma

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Marginal Zone Lymphoma+2 MorePembrolizumab - Biological
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial studies pembrolizumab as a treatment for B-cell non-Hodgkin lymphoproliferative diseases.

Eligible Conditions
  • Indolent Non-Hodgkin Lymphoma
  • Marginal Zone Lymphoma
  • Follicular Lymphoma

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

2 Primary · 8 Secondary · Reporting Duration: Up to 5 years

Year 5
Progression-free Survival
Progression-free survival
Year 5
Duration of Response
Duration of response
Year 5
Time to Next Therapy
Time to next therapy
Day 30
Incidence of adverse events (AEs)
Up to 5 years
Overall response rate (complete response [CR] + partial response [PR] for follicular lymphoma and marginal zone lymphoma)
Up to 8 months.
Overall Response Rate (Complete Response [CR] + Partial Response [PR] for Follicular Lymphoma and Marginal Zone Lymphoma)
Year 1
Count of Participants Who Experience Adverse Events (AEs)

Trial Safety

Safety Progress

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

Side Effects for

Pembrolizumab Second Course
100%Parkinsonism
100%Urinary tract infection
100%Inappropriate antidiuretic hormone secretion
This histogram enumerates side effects from a completed 2021 Phase 3 trial (NCT03066778) in the Pembrolizumab Second Course ARM group. Side effects include: Parkinsonism with 100%, Urinary tract infection with 100%, Inappropriate antidiuretic hormone secretion with 100%.

Trial Design

1 Treatment Group

Treatment (pembrolizumab)
1 of 1

Experimental Treatment

9 Total Participants · 1 Treatment Group

Primary Treatment: Pembrolizumab · No Placebo Group · Phase 2

Treatment (pembrolizumab)Experimental Group · 2 Interventions: Pembrolizumab, Laboratory Biomarker Analysis · Intervention Types: Biological, Other
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to 5 years

Who is running the clinical trial?

Merck Sharp & Dohme LLCIndustry Sponsor
3,673 Previous Clinical Trials
4,958,895 Total Patients Enrolled
University of WashingtonLead Sponsor
1,595 Previous Clinical Trials
1,568,767 Total Patients Enrolled
Ajay K. GopalPrincipal InvestigatorFred Hutch/University of Washington Cancer Consortium
3 Previous Clinical Trials
93 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You are willing and able to provide written informed consent/assent for the trial.
You have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) performance scale.
Platelets > 25000/uL if not related to bone marrow involvement.
A lesion is considered to be large if it is greater than 1.5 cm in two dimensions.
You have an indication for treatment.
A participant must be at least 18 years of age and have a neutrophil count of at least 500/uL