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Monoclonal Antibodies

Pembrolizumab for Marginal Zone Lymphoma

Phase 2
Waitlist Available
Led By Wei Ding
Research Sponsored by Mayo Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Biopsy-proven small lymphocytic lymphoma or Peripheral blood B cell count of > 5 x 10^9/L consisting of small to moderate size lymphocytes
The predominant population of lymphocytes share both B-cell antigens (cluster of differentiation [CD]19, CD20 [typically dim expression] or CD23) as well as CD5 in the absence of other pan-T-cell markers (CD3, CD2, etc.)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years
Awards & highlights

Study Summary

This trial is testing pembrolizumab alone or with idelalisib or ibrutinib as a treatment for relapsed or refractory chronic lymphocytic leukemia or other low-grade B-cell non-Hodgkin lymphomas.

Eligible Conditions
  • Marginal Zone Lymphoma
  • Follicular Lymphoma
  • Lymphoplasmacytic Lymphoma
  • Lymphoma
  • Chronic Lymphocytic Leukemia
  • Non-Hodgkin's Lymphoma
  • Splenic Marginal Zone Lymphoma
  • Waldenstrom's Macroglobulinemia
  • MALT Lymphoma
  • Nodal Marginal Zone Lymphoma
  • Waldenstrom Macroglobulinemia
  • Richter Syndrome

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Proportion of Patients Who Achieve a Confirmed Response
Secondary outcome measures
Complete Response Rate
Confirmed All Response Rate of Patients Treated With Combination Therapy
Duration of Response
+8 more
Other outcome measures
Change in Immune Profiles
Change in Markers of Immune Modulation
PD-1 Levels
+2 more

Side effects data

From 2024 Phase 2 trial • 57 Patients • NCT03004183
21%
Fatigue
13%
Nausea
11%
Back pain
9%
Shortness of Breath
9%
Anemia
9%
Abdominal pain
9%
Diarrhea
7%
Kidney Injury and/or Infection
7%
Pneumonia
7%
Dyspnea
7%
Weight Loss
5%
Malnutrition, Hypercalcemia and Weakness
5%
Pneumothorax
5%
Activated partial thromboplastin time prolonged
5%
Intractable pain, back pain, hip pain
4%
Pleural effusion
4%
Atrial fibrillation with rapid ventricular response
2%
Skin rash
2%
Thrombocytopenia
2%
Respiratory failure
2%
colitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Single Arm

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment (pembrolizumab, idelalisib, or ibrutinib)Experimental Treatment4 Interventions
Patients receive pembrolizumab IV over 30 minutes on day 1. Treatment repeats every 21 days for up to 12 months in the absence of disease progression or unacceptable toxicity. Patients receiving benefit may continue to receive treatment for an additional 12 months at the discretion of the investigator. Patients with CLL or CLL with Richter's transformation experiencing stable disease without partial remission or progressive disease at 3 months of treatment with pembrolizumab proceed to the treatment continuation phase. CONTINUATION PHASE: Patients receive pembrolizumab IV over 30 minutes on day 1. Patients also receive idelalisib PO BID on days 1-21 OR ibrutinib PO QD on days 1-21. Treatment repeats every 21 days for up to 12 or 24 months in the absence of disease progression or unacceptable toxicity. Patients receiving benefit may continue to receive treatment for an additional 12 months at the discretion of the investigator.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ibrutinib
FDA approved
Idelalisib
FDA approved
Pembrolizumab
FDA approved

Find a Location

Who is running the clinical trial?

Mayo ClinicLead Sponsor
3,176 Previous Clinical Trials
3,757,986 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,609 Previous Clinical Trials
40,915,581 Total Patients Enrolled
Wei DingPrincipal InvestigatorMayo Clinic in Rochester
2 Previous Clinical Trials
48 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many people are part of this clinical research project?

"This particular trial is no longer recruiting patients. The listing for this clinical study was first posted on February 19th, 2015 and last updated on August 10th, 2021. There are many other active trials that may be of interest; 3889 studies are currently enrolling patients with waldenstrom macroglobulinemia and 1162 studies involve Pembrolizumab."

Answered by AI

What types of cancer does Pembrolizumab commonly target?

"Pembrolizumab is frequently used as a treatment for patients with unresectable melanoma. It can also be effective for those with high microsatellite instability, increased risk of disease recurrence, and other similar conditions."

Answered by AI

What other studies have been done on Pembrolizumab?

"There are 1162 total clinical trials being conducted that involve Pembrolizumab. Of these, 147 have reached Phase 3 and are still active. Although the majority of these studies originate in Houston, Texas, there are 43695 locations worldwide where research is ongoing."

Answered by AI

Can people sign up for this clinical trial right now?

"Unfortunately, this particular trial is not currently looking for new patients to enroll. The study was initially posted on February 19th, 2015 and the most recent edit was done on August 10th, 2021. For those still exploring their options, there are 3889 other trials actively recruiting patients with waldenstrom macroglobulinemia and 1162 clinical trials involving Pembrolizumab that have open enrollment at this time."

Answered by AI

Is Pembrolizumab known to have dangerous side effects?

"While there is some clinical data supporting the safety of Pembrolizumab, it received a score of 2 because there are no Phase 3 trials demonstrating its efficacy."

Answered by AI
~6 spots leftby Mar 2025