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PD-L1 Inhibitor

Pembrolizumab for Diffuse Large B-Cell Lymphoma

Phase 2
Recruiting
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
A male participant must agree to use contraception during the treatment period and for at least 120 days after the last dose of study treatment. Participants must refrain from donating sperm during this period.
Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years
Awards & highlights

Study 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.Check my eligibility
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.See study design
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 agree to use contraception and not donate sperm for 120 days after my last treatment dose.
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I am fully active or restricted in physically strenuous activity but can do light work.
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My lymphoma is high-grade or has specific gene changes.
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I have had at least two treatments for my condition, or refused a specific transplant.
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My kidney function, measured by creatinine or GFR, is within the required range.
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My kidney function is normal.
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My blood clotting tests are within safe limits, even if I'm on blood thinners.
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My recent tests show my organs are functioning well.
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My lymphoma has a PD-L1 gene change.
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I had CAR T cell therapy or a transplant over 5 years ago without severe side effects.
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I have a biopsy sample available from my most recent cancer relapse.
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I am not pregnant, not breastfeeding, and meet one of the specific conditions.
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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.
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My liver is functioning properly.

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
Overall response rate (ORR) to pembrolizumab treatment compared to historical controls.
Secondary outcome measures
Duration of response (DOR) to pembrolizumab treatment
Overall survival (OS)
Progression-free survival (PFS)

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: Pembrolizumab TreatmentExperimental Treatment1 Intervention
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?

University of ChicagoLead Sponsor
997 Previous Clinical Trials
817,685 Total Patients Enrolled
Merck Sharp & Dohme LLCIndustry Sponsor
3,868 Previous Clinical Trials
5,051,840 Total Patients Enrolled
Justin Kline, MDPrincipal InvestigatorUniversity of Chicago
2 Previous Clinical Trials
77 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

Frequently Asked Questions

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

What other avenues of research have been explored with Pembrolizumab?

"Currently, there are 1000 trials running that study Pembrolizumab. 122 of those studies are in the third and final stage of clinical trials. The majority of these trials take place in Houston, Texas; however, there are 36034 locations across the world where these trials are taking place."

Answered by AI

Can patients currently enroll in this research study?

"The most recent information available on clinicaltrials.gov suggests that this study is still recruiting patients. The posting date was September 4th, 2019 and the last edit was made on January 5th, 2021. Up to 29 people from a single location can participate in the trial."

Answered by AI

What is the maximum capacity for participants in this experiment?

"The latest information available on clinicaltrials.gov verifies that this study is still seeking enrolment from potential participants. The listing for the trial was first published on September 4th, 2019 and updated as recently as January 5th, 2021. Currently, 29 people are needed to fill the vacant spots at a single location."

Answered by AI

Has Pembrolizumab been federally recognized as a safe treatment?

"Pembrolizumab has received a score of 2 for safety. This is due to the fact that it is only in Phase 2, meaning while there have been studies conducted observing its safety, none have yet looked at whether or not it is effective."

Answered by AI

What are the conditions that Pembrolizumab is indicated to treat?

"Pembrolizumab is approved to treat malignant neoplasms, but it has also shown promise in treating conditions such as unresectable melanoma, microsatellite instability high, and disease progression after chemotherapy."

Answered by AI
~8 spots leftby Apr 2025