Diffuse Large B Cell LymphomaPhase 2NCT03990961
Pembrolizumab for Patients With PD-L1 Diffuse Large B Cell Lymphoma (DLBCL)
A Phase 2 study testing Pembrolizumab in people with Diffuse Large B Cell Lymphoma and Lymphoma, run by University of Chicago at 1 site in United States.
Trial summary
A non randomized, unblinded, open label phase 2 study to investigate the efficacy of pembrolizumab in patients with relapsed/refractory diffuse large B cell lymphoma (DLBCL) with PD-L1 genetic alterations Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diffuse Large B Cell Lymphoma, Lymphoma
- What is being tested?
- Pembrolizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Sep 2019to 1 Apr 2024
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male/female participants who are at least 18 years of age on the day of signing informed consent with a histologically confirmed diagnosis of DLBCL will be enrolled in this study.
- Note: Patients with high-grade B cell lymphomas not otherwised specified and those with MYC and BCL2 translocations (double hit lymphoma) are eligible, as are patients with transformed indolent lymphoma, so long as PD-L1 gene alterations are present.
- A male participant must agree to use a 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.
- A female participant is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies:
- Not a woman of childbearing potential (WOCBP)
- A WOCBP who agrees to follow the contraceptive guidance during the treatment period and for at least 120 days after the last dose of study treatment.
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- C.) patient must have negative pregnancy test within 72 hours of beginning treatment if WOCBP
- The participant (or legally acceptable representative if applicable) provides written informed consent for the trial.
- Have measurable disease, defined as at least one lesion that can be accurately measured in at least two dimensions by CT scan. Minimum measurement must be >15 mm in the longest diameter by >10 mm in the short axis. Lesions situated in a previously irradiated area are considered measurable if radiographic progression has been demonstrated in such lesions.
- Participants must have available archived biopsy material (ideally to be performed shortly before enrollment at the time of most recent relapse) for PD-L1 FISH and correlative studies.
- There is evidence of a PD-L1 gene alteration within lymphoma cells as assessed by FISH.
- Participants must have received ≥ 2 lines of prior systemic therapy, ≥ 1 line of prior systemic therapy (if ineligible for or refused autologous stem cell transplantation), or have received 1 line of prior therapy with primary-refractory disease or have relapsed within 12 months from the time of initial diagnosis.
- Note: patients having undergone prior CAR T cell therapy are eligible, as are patients having received a prior allogeneic transplantation, provided they do not meet any of the exclusionary GVHD criteria, and are at least 5 years removed from the date of their transplant.
- Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.
- Have adequate organ function within 10 days prior to the date of treatment allocation. Please see below for Adequate Organ Function Laboratory Values:
- Hematological
- Absolute neutrophil count (ANC) less than or equal to 1,000/microliters
- Platelets less than or equal to 50,000/microliters
- Hemoglobin less than or equal to 8.0 grams per decilitre
- Renal
- 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
- 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 5 x ULN for participants with liver metastases)
- Coagulation
- International normalized ratio (INR) OR prothrombin time (PT) and Activated partial thromboplastin time (aPTT) greater than or equal to 1.5 x ULN unless participant is receiving anticoagulant therapy as long as PT or aPTT is within therapeutic range of intended use of anticoagulants.
Who cannot join
- A WOCBP who has a positive urine pregnancy test within 72 hours prior to treatment allocation . If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
- Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (eg, CTLA-4, OX-40, CD137).
- Has received chemotherapy, monoclonal antibody therapy, or targeted small molecule therapy within 4 weeks prior to the first dose of study medication. Subjects must have recovered (≤ Grade 1) from adverse events related to a previously administered agent (patients with ≤ Grade 2 neuropathy are eligible). Subjects who have previously received CAR T cell therapy are eligible provided that relapse occurred > 90 days following the date of CAR T cell infusion.
- Note: If a participant received major surgery, he or she must have recovered adequately from complications from the intervention prior to starting study treatment.
- Has received prior radiotherapy within 1 week of start of study treatment. Participants must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis.
- Has a histologic diagnosis of primary mediastinal lymphoma or gray zone lymphoma.
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- Has known active CNS lymphoma and/or lymphomatous meningitis. Participants with previously treated brain metastases may participate provided they are radiologically stable, i.e. without evidence of progression for at least 4 weeks by repeat imaging (note that the repeat imaging should be performed during study screening), clinically stable and without requirement of steroid treatment for at least 14 days prior to first dose of study treatment.
- Has received a live vaccine within 30 days prior to the first dose of study drug. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella/zoster (chicken pox), yellow fever, rabies, Bacillus Calmette-Guérin (BCG), and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (eg, FluMist®) are live attenuated vaccines and are not allowed.
- Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study treatment.
- Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug. Short courses of corticosteroids will be allowed for palliation of symptoms related to lymphoma, but must be discontinued within 7 days prior to the first dose of study drug.
- Subjects having received prior allogeneic stem cell transplant, must be at least 5 years removed from the date of their transplant. The also must have no history of severe (grade 3-4) acute GVHD, and/or current > grade 1 acute GHVD. Subjects must not have active chronic GVHD that requires active immune suppression or more than 10 mg of prednisone/day or equivalent.
- Has a history of a solid organ transplant.
- Has a known additional malignancy that is progressing or has required active treatment within the past 3 years.
- Note: Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ (e.g. breast carcinoma, cervical cancer in situ) that have undergone potentially curative therapy are not excluded
- Has severe hypersensitivity (≥Grade 3) to pembrolizumab and/or any of its excipients.
- Has active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (eg., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.
- Has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis.
- Has an active infection requiring systemic therapy.
- Has a known history of Human Immunodeficiency Virus (HIV) infection.
- Has a known history of Hepatitis B (defined as Hepatitis B surface antigen [HBsAg] reactive) or known active Hepatitis C virus (defined as detection of HCV RNA) infection.
- Has a known history of active TB (Bacillus Tuberculosis).
- Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the subject's participation for the full duration of the study, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.
- Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
- Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the study, starting with the screening visit through 120 days after the last dose of trial treatment.
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of Chicago Medicine
Chicago, Illinois, 60637
About this study
Official title: Phase II Study of Pembrolizumab for PD-L1 Gene-Altered, Relapsed/Refractory DLBCL
A non randomized, unblinded, open label phase 2 study to investigate the efficacy of pembrolizumab in patients with relapsed/refractory diffuse large B cell lymphoma (DLBCL) with PD-L1 genetic alterations
- Conditions
- Diffuse Large B Cell Lymphoma, Lymphoma
- Being tested
- Pembrolizumab
- Medical subject headings
- Lymphoma, Large B-Cell, Diffuse, Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PembrolizumabDrug
Also called Keytruda
Subjects will receive pembrolizumab treatment at a dose of 200mg IV every 3 weeks for a duration of 2 years (35 cycles).
| Study group | Role | What they receive |
|---|---|---|
| Pembrolizumab Treatment | Experimental | Not described Receives: Drug: Pembrolizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Response Rate (ORR) to Pembrolizumab Treatment Compared to Historical Controls.
The overall response rate (ORR) summarizes the best overall response (BOR) rate of the individual patients whose BOR is complete response (CR) or partial response (PR). The ORR is expressed as a percentage of all treated participants with 95% confidence intervals obtained using the exact binomial distribution.
Measured: 4.5 years
Secondary outcomes (3)
Duration of Response (DOR) to Pembrolizumab Treatment
Duration of response (DOR) is defined as the time when complete response (CR) or partial response (PR) is first observed to the time of progressed disease (PD) or death for the subjects whose best overall response is complete response (CR) or partial response (PR).
Measured: 4.5 years
Progression-free Survival (PFS)
Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of the target lesions, a measurable increase in a non-target lesion, or the appearance of new lesions. Progression-free survival (PFS) is defined as the time from the first date of first treatment in the study until the progressive disease is confirmed or upon patient death.
Measured: 4.5 years
Overall Survival (OS)
Overall Survival (OS) is defined as the time between the first date of first treatment in the study and the date of death from any cause or the last known date the patient was alive.
Measured: 4.5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2019
- Study start4 Sep 2019
- Primary completion1 Apr 2024
- Study completion1 Apr 2024
Why it stopped: Study was closed early due to slow enrollment.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Diffuse Large B Cell LymphomaStudies of the same condition, open and under way.
- More trials run by University of ChicagoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Sponsor
- Investigators
- Justin Kline, MD, Principal investigator, University of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03990961
- Sponsor's protocol ID
- IRB19-0076
- Status last verified
- Feb 2026
- First submitted
- 17 Jun 2019
- Last updated
- 20 Feb 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of Pembrolizumab for PD-L1 Gene-Altered, Relapsed/Refractory DLBCL
- ClinicalTrials.gov ID
- NCT03990961
- Acronym / sponsor ID
- IRB19-0076
- Conditions
- Diffuse Large B Cell Lymphoma, Lymphoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study was closed early due to slow enrollment.
- Enrolment
- 5 participants (actual)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- 4 Sep 2019 (actual)
- Primary completion
- 1 Apr 2024 (actual)
- Study completion
- 1 Apr 2024 (actual)
- First posted
- 19 Jun 2019 (actual)
- Results
- Posted 20 Feb 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A non randomized, unblinded, open label phase 2 study to investigate the efficacy of pembrolizumab in patients with relapsed/refractory diffuse large B cell lymphoma (DLBCL) with PD-L1 genetic alterations
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pembrolizumab Treatment | Experimental | Drug: Pembrolizumab |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (26 listed)
- Male/female participants who are at least 18 years of age on the day of signing informed consent with a histologically confirmed diagnosis of DLBCL will be enrolled in this study.
- Note: Patients with high-grade B cell lymphomas not otherwised specified and those with MYC and BCL2 translocations (double hit lymphoma) are eligible, as are patients with transformed indolent lymphoma, so long as PD-L1 gene alterations are present.
- A male participant must agree to use a 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.
- A female participant is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies:
- C.) patient must have negative pregnancy test within 72 hours of beginning treatment if WOCBP
Key exclusion criteria (24 listed)
- A WOCBP who has a positive urine pregnancy test within 72 hours prior to treatment allocation . If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
- Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (eg, CTLA-4, OX-40, CD137).
- Has received chemotherapy, monoclonal antibody therapy, or targeted small molecule therapy within 4 weeks prior to the first dose of study medication. Subjects must have recovered (≤ Grade 1) from adverse events related to a previously administered agent (patients with ≤ Grade 2 neuropathy are eligible). Subjects who have previously received CAR T cell therapy are eligible provided that relapse occurred > 90 days following the date of CAR T cell infusion.
- Note: If a participant received major surgery, he or she must have recovered adequately from complications from the intervention prior to starting study treatment.
- Has received prior radiotherapy within 1 week of start of study treatment. Participants must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PembrolizumabAlso: KeytrudaSubjects will receive pembrolizumab treatment at a dose of 200mg IV every 3 weeks for a duration of 2 years (35 cycles). | Drug | Pembrolizumab Treatment |
Primary outcome
Overall Response Rate (ORR) to Pembrolizumab Treatment Compared to Historical Controls.
Time frame: 4.5 years
The overall response rate (ORR) summarizes the best overall response (BOR) rate of the individual patients whose BOR is complete response (CR) or partial response (PR). The ORR is expressed as a percentage of all treated participants with 95% confidence intervals obtained using the exact binomial distribution.
3 secondary outcomes
Duration of Response (DOR) to Pembrolizumab Treatment
Time frame: 4.5 years
Progression-free Survival (PFS)
Time frame: 4.5 years
Overall Survival (OS)
Time frame: 4.5 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Justin Kline, MD principal investigator
University of Chicago
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Pembrolizumab in people with Diffuse Large B Cell Lymphoma and Lymphoma, run by University of Chicago at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 26 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 20 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Feb 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Response Rate (ORR) to Pembrolizumab Treatment Compared to Historical Controls. (time frame: 4.5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2026; AzTrials last refreshed its copy on 29 Oct 2026.