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B Cell LymphomaPhase 2NCT03995147

Pembrolizumab in Combination With Chemotherapy for Patients With Untreated B Cell Lymphoma

A Phase 2 study testing Pembrolizumab and R-CHOP Protocol in people with B Cell Lymphoma and Lymphoma, run by University of Chicago at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

This study will research untreated non-germinal center diffuse large B cell lymphoma and what causes the disease and the way patients respond to pembrolizumab combined with R-CHOP chemotherapy regimen (rituximab, cyclophosphamide, doxorubicin, vincristine, prednisone) therapy. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
B Cell Lymphoma, Lymphoma, Lymphoma, B-Cell
What is being tested?
Pembrolizumab and R-CHOP Protocol
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
51 participants
Where
1 siteUnited States
Study dates
29 Aug 2019to 20 Feb 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

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 diffuse large B cell lymphoma or high-grade B cell lymphoma of a non-germinal center phenotype according to Hans criteria are eligible for enrollment in this study.
  • International Prognostic Index (IPI) score of ≥ 3, or an age-adjusted (aa) IPI score of ≥ 2.
  • A male participant must agree to use a contraception during the treatment period and for at least 120 days after the final dose of study treatment and 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) OR
  • 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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  • The participant (or legally acceptable representative if applicable) provides written informed consent for the trial.
  • 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).
  • Patients must be able to provide an archived tumor tissue sample or newly obtained core or excisional biopsy of a tumor lesion.
  • Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.
  • 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)

Who cannot join

  • Positive urine pregnancy test within 72 hours prior to the initiation of study treatment. 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 prior anti-lymphoma therapy, including radiation therapy, chemotherapy, targeted therapy, or immunotherapy.
  • Note: Prior corticosteroid treatment (<10 days in duration) to alleviate lymphoma-elated symptoms is permitted.
  • Note: If participant received major surgery, he or she must have recovered adequately from complications from the intervention prior to starting 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.
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  • 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, with the exception of short-term corticosteroid use to control lymphoma-related symptoms as outlined above) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug.
  • Has a known additional malignancy that is progressing or has required active treatment within the past 2 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. Other exceptions may be permitted after discussion with the principal investigator.
  • Has known active CNS involvement by lymphoma.
  • Has a diagnosis of high-grade B cell lymphoma with MYC and BCL2 and/or BCL6 gene rearrangements (double hit lymphoma), primary mediastinal lymphoma, gray zone lymphoma, composite lymphoma, or previously-untreated low-grade lymphoma with disease transformation to DLBCL.
  • 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, Hepatitis B core [HBc] antibody total reactive, or HBV virus detected) or known active Hepatitis C virus infection (defined as HCV RNA is detected). Note: All patients will be screened for prior Hepatitis B exposure prior to starting therapy. Hepatitis C testing is not required.
  • Has a known history of, or active infection with tuberculosis.
  • Has a history of solid organ transplantation.
  • Has a left ventricular ejection fraction < 45%, myocardial infarction within 6 months of initiating study treatment, New York Heart Assocation class III/IV heart failure, or any uncontrolled cardiovascular conditions.
  • 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

    Chicago, Illinois, 60637

Other trials in United States

About this study

Official title: Phase II Study of Pembrolizumab In Combination With R-CHOP for Patients With Untreated, High-Risk, Non-Germinal Center-Derived DLBCL

This study will research untreated non-germinal center diffuse large B cell lymphoma and what causes the disease and the way patients respond to pembrolizumab combined with R-CHOP chemotherapy regimen (rituximab, cyclophosphamide, doxorubicin, vincristine, prednisone) therapy.

Being tested
Pembrolizumab, R-CHOP Protocol
Medical subject headings
Lymphoma, B-Cell, Lymphoma, Lymphoma, Large B-Cell, Diffuse

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PembrolizumabDrug

    Pembrolizumab will be administered at a fixed dose of 200mg intravenously every 3 weeks in combination with R-CHOP for 6 cycles.

    Participants that respond to the combination regiment will continue to receive pembrolizumab 200 mg IV every 3 weeks for additional 35 cycles (2 years).

  • R-CHOP ProtocolDrug

    Also called Rituximab, Cyclophosphamide, doxorubicin, vincristine, prednisone

    R-CHOP chemo-immunotherapy will be administered in combination with Pembrolizumab

Study groups in NCT03995147
Study groupRoleWhat they receive
Treatment ArmExperimentalNot described
Receives: Drug: Pembrolizumab; Drug: R-CHOP Protocol

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression free survival (PFS) rate when combining pembrolizumab with R-CHOP

    Measured: 24 months

Secondary outcomes (4)

  1. Complete response (CR) rate after 6 cycles of pembrolizumab in combination with R-CHOP

    Measured: 18 weeks

  2. Event free survival (EFS) rate after 6 cycles of pembrolizumab in combination with R-CHOP

    Measured: 18 weeks

  3. Overall survival (OS) rate after 6 cycles of pembrolizumab in combination with R-CHOP

    Measured: 18 weeks

  4. Number of participants with treatment related adverse events as assessed by CTCAE v 4.0

    Safety and tolerability of pembrolizumab in combination with R-CHOP followed by Pembrolizumab.

    Measured: 29 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Jun 2019
  2. Study start29 Aug 2019
  3. Primary completion20 Feb 2027 (estimated)
  4. Study completion20 Feb 2027 (estimated)

Resources

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
51 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03995147
Sponsor's protocol ID
IRB19-0072
Status last verified
Jun 2025
First submitted
17 Jun 2019
Last updated
8 Jun 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Pembrolizumab and R-CHOP Protocol in people with 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 20 inclusion and 23 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: under way, not looking for participants, as of the sponsor's last update on 8 Jun 2025. 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?

This study is still under way. Results are not available in the source record yet.

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?

Progression free survival (PFS) rate when combining pembrolizumab with R-CHOP (time frame: 24 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03995147.

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 8 Jun 2025.

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