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Monoclonal Antibodies

Pembrolizumab + Chemotherapy for B-Cell Lymphoma

Phase 2
Waitlist Available
Led By Justin Kline, MD
Research Sponsored by University of Chicago
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Have measurable disease with one or more measurable lymphoma lesions (>1.5 cm in the long axis and >1.0 cm in the short axis).
Have adequate organ function. See below for adequate organ function laboratory values: Hematological: Absolute neutrophil count (ANC) less or equal to 1000/microliter, Platelets less or equal to 100,000/microliters, Hemoglobin less or equal to 8.0/grams per decilitre; Renal: Creatinine or Measured/calculated creatinine clearance (CrCl) greater or equal to 1.5xULN or less than or equal to 30 mililiter per minute for participants with creatinine levels less than 1.5xULN; Hepatic: Total bilirubin greater than or equal to 1.5 x ULN or direct bilirubin greater than or equal to ULN for participants with total bilirubin levels less than 1.5 x ULN, AST (SGOT) and ALT (SGPT) greater than or equal to 2.5 x ULN (greater than or equal to 2.5 x ULN for participants with liver involvement)
Must not have
Has received prior anti-lymphoma therapy, including radiation therapy, chemotherapy, targeted therapy, or immunotherapy.
Has an active infection requiring systemic therapy.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 29 months
Awards & highlights
All Individual Drugs Already Approved
Approved for 30 Other Conditions
No Placebo-Only Group

Summary

This trial will research a new chemotherapy treatment for lymphoma and what causes the disease.

Who is the study for?
Adults with untreated non-germinal center diffuse large B cell lymphoma or high-grade B cell lymphoma, not pregnant or breastfeeding, willing to use contraception. Must have measurable disease and adequate organ function. Cannot have had prior anti-lymphoma therapy or certain other treatments, no active infections like HIV or hepatitis, and no history of severe hypersensitivity to trial drugs.
What is being tested?
The study is testing the effectiveness of pembrolizumab combined with R-CHOP chemotherapy (rituximab, cyclophosphamide, doxorubicin, vincristine, prednisone) in treating patients with specific types of B cell lymphoma that haven't been treated before.
What are the potential side effects?
Possible side effects include reactions related to immune system activation such as inflammation in various organs including lungs (pneumonitis), infusion-related reactions from the drug administration process itself; fatigue; blood disorders; increased risk for infections due to immune suppression.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have a lymphoma lesion larger than 1.5 cm long and 1.0 cm wide.
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My blood, kidney, and liver tests meet the required levels.
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I am 18 or older with a confirmed diagnosis of a specific type of lymphoma.
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I have a lymphoma lesion larger than 1.5 cm long and 1.0 cm wide.
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My cancer's risk score is high based on the IPI or aaIPI.
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I can provide a sample of my tumor for testing.
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My organ functions are within normal ranges.
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I am fully active or restricted in physically strenuous activity but can do light work.
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My kidney function, measured by creatinine clearance, is within the required range.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have previously undergone treatment for lymphoma.
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I am currently being treated for an infection.
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I have been treated with specific immune therapy drugs before.
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I have a history of Hepatitis B or an active Hepatitis C infection.
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I have a heart condition with an ejection fraction below 45%, recent heart attack, severe heart failure, or uncontrolled heart issues.
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I have a specific type of lymphoma diagnosed as high-grade, primary mediastinal, gray zone, composite, or transformed low-grade to DLBCL.
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I have been diagnosed with HIV.
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I have not received a live vaccine in the last 30 days.
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I have had an organ transplant.
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I have or had tuberculosis.
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My lymphoma has spread to my brain or spinal cord.
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I have had or currently have lung inflammation treated with steroids.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~29 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 29 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Secondary study objectives
Number of participants with treatment related adverse events as assessed by CTCAE v 4.0

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 30 Other Conditions
This treatment demonstrated efficacy for 30 other conditions.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment ArmExperimental Treatment2 Interventions
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
FDA approved

Find a Location

Who is running the clinical trial?

Merck Sharp & Dohme LLCIndustry Sponsor
4,019 Previous Clinical Trials
5,186,456 Total Patients Enrolled
University of ChicagoLead Sponsor
1,056 Previous Clinical Trials
760,732 Total Patients Enrolled
Justin Kline, MDPrincipal InvestigatorUniversity of Chicago Medicine
2 Previous Clinical Trials
17 Total Patients Enrolled

Media Library

Pembrolizumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT03995147 — Phase 2
Non-Hodgkin's Lymphoma Research Study Groups: Treatment Arm
Non-Hodgkin's Lymphoma Clinical Trial 2023: Pembrolizumab Highlights & Side Effects. Trial Name: NCT03995147 — Phase 2
Pembrolizumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03995147 — Phase 2
~2 spots leftby Feb 2025
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