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PD-L1 Inhibitor

Pembrolizumab for Diffuse Large 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 an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.

- Creatinine OR measured or calculated clearance (GFR can also be used in place of creatinine or CrCl) greater than or equal to 1.5XULN OR less than or equal to 30mL/min for participant with creatinine levels less than 1.5 X institutional ULN

Must not have

Has an active infection requiring systemic therapy.

Has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

Summary

This trial is testing a new immunotherapy drug for people with a certain type of lymphoma that has come back or didn't respond to other treatment.

Who is the study for?

Adults with a confirmed diagnosis of Diffuse Large B-Cell Lymphoma (DLBCL) and PD-L1 gene alterations, who have tried at least two systemic therapies or are ineligible for stem cell transplantation. Participants must not be pregnant or breastfeeding and agree to use contraception. They should have measurable disease, adequate organ function, an ECOG performance status of 0-1, and no severe allergies to pembrolizumab.

What is being tested?

The trial is testing the effectiveness of Pembrolizumab in patients with DLBCL that has relapsed or hasn't responded to previous treatments. It's an open-label phase 2 study focusing on those with PD-L1 genetic changes.

What are the potential side effects?

Pembrolizumab may cause immune-related side effects such as inflammation in various organs, skin reactions, hormone gland problems (like thyroid disorders), infusion reactions, fatigue, appetite changes, diarrhea or constipation.

Eligibility Criteria

Inclusion Criteria

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

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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 or GFR, is within the required range.

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My lymphoma has a PD-L1 gene change.

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I am 18 or older with a confirmed diagnosis of DLBCL.

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I have a tumor that can be measured by CT scan, larger than 15mm by 10mm.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am currently being treated for an infection.

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I have had or currently have lung inflammation treated with steroids.

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I have a history of Hepatitis B or active Hepatitis C.

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I have an active tuberculosis infection.

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I had radiotherapy over a week ago and have no side effects needing steroids.

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I have an autoimmune disease but haven't needed strong medication for it in the last 2 years.

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I have been diagnosed with HIV.

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I have been diagnosed with primary mediastinal or gray zone lymphoma.

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I have not received a live vaccine in the last 30 days.

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I had a stem cell transplant over 5 years ago, with no severe GVHD or current treatment for chronic GVHD.

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I have been treated with specific immune therapy drugs before.

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I have another cancer that is getting worse or was treated in the last 3 years.

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I have had a solid organ transplant.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Side effects data

From 2024 Phase 2 trial • 57 Patients • NCT03004183

21%

Fatigue

13%

Nausea

11%

Back pain

Diarrhea

Anemia

Shortness of Breath

Abdominal pain

Kidney Injury and/or Infection

Pneumonia

Weight Loss

Dyspnea

Malnutrition, Hypercalcemia and Weakness

Pneumothorax

Intractable pain, back pain, hip pain

Activated partial thromboplastin time prolonged

Atrial fibrillation with rapid ventricular response

Pleural effusion

colitis

Thrombocytopenia

Respiratory failure

Skin rash

100%

80%

60%

40%

20%

Study treatment Arm

Single Arm

Trial Design

1Treatment groups

Experimental Treatment

Group I: Pembrolizumab TreatmentExperimental Treatment1 Intervention

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Pembrolizumab

FDA approved

0 / 18Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of ChicagoLead Sponsor

1,034 Previous Clinical Trials

753,689 Total Patients Enrolled

Merck Sharp & Dohme LLCIndustry Sponsor

3,950 Previous Clinical Trials

5,174,978 Total Patients Enrolled

Justin Kline, MDPrincipal InvestigatorUniversity of Chicago

2 Previous Clinical Trials

63 Total Patients Enrolled

Media Library

Pembrolizumab (PD-L1 Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03990961 — Phase 2

Non-Hodgkin's Lymphoma Research Study Groups: Pembrolizumab Treatment

Non-Hodgkin's Lymphoma Clinical Trial 2023: Pembrolizumab Highlights & Side Effects. Trial Name: NCT03990961 — Phase 2

Pembrolizumab (PD-L1 Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03990961 — Phase 2

~1 spots leftby Apr 2025

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