A Phase 2 interventional study of Laboratory Biomarker Analysis and Pembrolizumab in Recurrent Diffuse Large B-Cell Lymphoma, Recurrent Follicular Lymphoma and Refractory Diffuse Large B-Cell Lymphoma, sponsored by University of Washington. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-07-22.
Sponsored by University of Washington · Phase 2, Interventional, and Treatment
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Among 11 studies testing pembrolizumab in Lymphoma, Large B-Cell, Diffuse — 1 open to participants now, 4 under way, none of them phase 3. pembrolizumab · Lymphoma, Large B-Cell, Diffuse.
Among the 11 studies testing pembrolizumab in Lymphoma, Large B-Cell, Diffuse, this one is the 8th largest by enrollment, is one of 3 that started in 2018, is one of 8 in phase 2, and was the 6th registered.
1,870 studies on the registry are indexed under Lymphoma, Large B-Cell, Diffuse; 357 are open to participants now.
Browse Lymphoma, Large B-Cell, Diffuse studies →1 of the 11 studies testing pembrolizumab in Lymphoma, Large B-Cell, Diffuse is open now, in 1 country. Recruiting first, the newest first:
Jennifer Crombie, MD · Sites in United States
Ages 18+
By country, each count listing its studies:
pembrolizumab: first FDA approval 2014 (KEYTRUDA), first EMA approval 2015. What it is approved for, and how studies give it, is on its page →
Of the 266 Lymphoma, Large B-Cell, Diffuse studies recruiting now, 177 (67%) set no upper age limit and 51 (19%) stop at 75 or younger; 25 take children under 18; 7 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
On this site’s reading of the record, pembrolizumab is the treatment under test here. Read study by study →
11 studies; the count open now beside each. This study's row is marked.
First in 2013; this study’s year is marked. 3 started in 2018.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 18 is below the median of 45 across 1,499 interventional studies indexed under Lymphoma, Large B-Cell, Diffuse.
Median enrollment 35 across the 11 interventional studies. Of the 7 that completed or were terminated, 6 (86%) have results posted.
This tab as a report to print or save as PDF → With an account.
2 of 11 have an industry lead sponsor. The 9 most frequent:
University of Washington is the lead sponsor of 1,434 studies on the registry; 226 are open to participants now.
Of its 158 completed or terminated interventional studies of FDA-regulated products, 136 (86%) have results posted.
13 studies in Lymphoma, Large B-Cell, Diffuse by University of Washington: 2 open now, 5 under way, none of them phase 3. Of 8 finished, 6 (75%) have results posted.
Among the 13 studies in Lymphoma, Large B-Cell, Diffuse by University of Washington, this one is the 10th largest by enrollment, is the only one that started in 2018, is one of 6 in phase 2, and was the 5th registered.
University of Washington’s Lymphoma, Large B-Cell, Diffuse studies by the year they started, since 2007.
2 of the studies testing pembrolizumab in Lymphoma, Large B-Cell, Diffuse that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT03995147University of ChicagoPembrolizumab in Combination With Chemotherapy for Patients With Untreated B Cell Lymphoma | 2027-02-20 |
| NCT05934448Jennifer Crombie, MDPembro Plus CAR T-cell Therapy in R/R in PMBCL | 2027-06-06 |
Add all 2 to your calendar (.ics) → With an account.
Among the 11 studies testing pembrolizumab in Lymphoma, Large B-Cell, Diffuse, from their registry updates:
Nothing recorded among them since 2026-09-25.
Among University of Washington’s 13 in Lymphoma, Large B-Cell, Diffuse:
Nothing recorded among them since 2026-09-25.
This tab as a report to print or save as PDF → With an account.
This phase II trial studies how well pembrolizumab with rituximab or obinutuzumab work in treating patients with follicular lymphoma or diffuse large B cell lymphoma that has come back (recurrent) or does not respond to treatment (refractory). Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Rituximab and obinutuzumab are monoclonal antibodies. They bind to a protein called CD20, which is found on B cells (a type of white blood cell) and some types of cancer cells. This may help the immune system kill cancer cells. Giving pembrolizumab with rituximab or obinutuzumab may help kill more cancer cells in patients with follicular lymphoma or diffuse large B cell lymphoma.
OUTLINE: Patients are assigned to 1 of 3 arms.
ARM I:
INDUCTION: Patients diagnosed with R/R FL receive pembrolizumab intravenously (IV) over 30 minutes on day 1. Treatment repeats every 3 weeks for 4 cycles in the absence of disease progression or unacceptable toxicity. Patients also receive rituximab IV on days 1, 8, and 15 of cycle 1, and on day 1 of cycle 2.
EXTENDED THERAPY: Patients with at least a partial response receive pembrolizumab IV over 30 minutes on day 1. Cycles repeat every 3 weeks for up to 2 years (35 cycles) in the absence of disease progression or unacceptable toxicity.
ARM II:
INDUCTION: Patients diagnosed with R/R DLBCL receive pembrolizumab intravenously (IV) over 30 minutes on day 1. Treatment repeats every 3 weeks for 4 cycles in the absence of disease progression or unacceptable toxicity. Patients also receive rituximab IV on days 1, 8, and 15 of cycle 1, and on day 1 of cycle 2.
EXTENDED THERAPY: Patients with at least a partial response receive pembrolizumab IV over 30 minutes on day 1. Cycles repeat every 3 weeks for up to 2 years (35 cycles) in the absence of disease progression or unacceptable toxicity.
Arm III:
INDUCTION: Patients diagnosed with R/R FL receive pembrolizumab IV over 30 minutes on day 1. Treatment repeats every 3 weeks for 4 cycles in the absence of disease progression or unacceptable toxicity. Patients also receive obinutuzumab IV on days 1, 8, and 15 of cycle 1, and on day 1 of cycle 2.
EXTENDED THERAPY: Patients with at least a partial response receive pembrolizumab IV over 30 minutes on day 1. Cycles repeat every 3 weeks for up to 2 years (35 cycles) in the absence of disease progression or unacceptable toxicity. Patients with stable disease or better, who are experiencing clinical benefit in the judgment of the investigator, may receive obinutuzumab IV on day 1 of cycles 5, 9, 13, 17, 21, and 25.
After completion of study treatment, patients are followed up for 90 days.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Have DLBCL or relapsed/refractory FL
For FL Arm C (obinutuzumab + pembrolizumab), patients must have relapsed/refractory disease after rituximab-containing therapy including:
(ANC) >= 500/uL (within 28 days of cycle 1 day 1)
>= 25,000/uL (within 28 days of cycle 1 day 1)
>= 8 g/dL (within 28 days of cycle 1 day 1)
Serum creatinine =\< 1.5 X (ULN) OR measured or calculated ( [GFR] can also be used in place of creatinine or creatinine clearance [CrCl]) >= 30 mL/min for subject with creatinine levels > 1.5 X institutional ULN (within 28 days of cycle 1 day 1)
**Creatinine clearance (CrCl) should be calculated per institutional standard
Female subjects of childbearing potential must be willing to use an adequate method of ; contraception, for the course of the study until at least 12 months after the last dose of study medication
**Note: Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject
Male subjects of childbearing potential must agree to use an adequate method of contraception starting with the first dose of study therapy until at least 12 months after the last dose of study therapy
Exclusion Criteria:
Has had prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to study day 1 or who has not recovered (i.e., =\< grade 1 or at baseline) from adverse events due to a previously administered agent
* Note: Subjects with =\< grade 2 neuropathy are an exception to this criterion and may qualify for the study
* Note: If subject received major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting therapy
Has received a within 30 days of planned start of study therapy. Administration of killed vaccines is allowed
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).
Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
PD-1, PD-L1 and CTLA-4 are proteins that act as brakes on the immune system. Checkpoint inhibitors, such as pembrolizumab or nivolumab, block them so the immune system can attack a cancer.
PD-L1 can also be measured in a tumour sample. Some scores count stained tumour cells only (TPS); others also count certain immune cells (CPS). The study names the score and the minimum it uses.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
Relapsed and refractory
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Allogeneic and autologous transplant
Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Line of therapy
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Measurable disease
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Absolute neutrophil count (ANC)
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Creatinine clearance (CrCl)
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
INR, PT and aPTT (clotting tests)
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Brain metastases
Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).
Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
PD-1, PD-L1 and checkpoint inhibitors
PD-1, PD-L1 and CTLA-4 are proteins that act as brakes on the immune system. Checkpoint inhibitors, such as pembrolizumab or nivolumab, block them so the immune system can attack a cancer.
PD-L1 can also be measured in a tumour sample. Some scores count stained tumour cells only (TPS); others also count certain immune cells (CPS). The study names the score and the minimum it uses.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Live vaccines
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
INDUCTION: Patients diagnosed with R/R FL receive pembrolizumab IV over 30 minutes on day 1. Treatment repeats every 3 weeks for 4 cycles in the absence of disease progression or unacceptable toxicity. Patients also receive rituximab IV on days 1, 8, and 15 of cycle 1, and on day 1 of cycle 2. EXTENDED THERAPY: Patients with at least a partial response receive pembrolizumab IV over 30 minutes on day 1. Cycles repeat every 3 weeks for up to 2 years (35 cycles) in the absence of disease progression or unacceptable toxicity.
Other: Laboratory Biomarker Analysis · Biological: Pembrolizumab · Biological: Rituximab
INDUCTION: Patients diagnosed with R/R DLBCL receive pembrolizumab IV over 30 minutes on day 1. Treatment repeats every 3 weeks for 4 cycles in the absence of disease progression or unacceptable toxicity. Patients also receive rituximab IV on days 1, 8, and 15 of cycle 1, and on day 1 of cycle 2. EXTENDED THERAPY: Patients with at least a partial response receive pembrolizumab IV over 30 minutes on day 1. Cycles repeat every 3 weeks for up to 2 years (35 cycles) in the absence of disease progression or unacceptable toxicity.
Other: Laboratory Biomarker Analysis · Biological: Pembrolizumab · Biological: Rituximab
INDUCTION: Patients diagnosed with R/R FL receive pembrolizumab IV over 30 minutes on day 1. Treatment repeats every 3 weeks for 4 cycles in the absence of disease progression or unacceptable toxicity. Patients also receive obinutuzumab IV on days 1, 8, and 15 of cycle 1, and on day 1 of cycle 2. EXTENDED THERAPY: Patients with at least a partial response receive pembrolizumab IV over 30 minutes on day 1. Cycles repeat every 3 weeks for up to 2 years (35 cycles) in the absence of disease progression or unacceptable toxicity.
Other: Laboratory Biomarker Analysis · Biological: Pembrolizumab · Biological: Obinutuzumab
Correlative studies
Given IV
Also known as: Keytruda, Lambrolizumab, MK-3475, SCH 900475
Given IV
Also known as: ABP 798, BI 695500, C2B8 Monoclonal Antibody, Chimeric Anti-CD20 Antibody, CT-P10, IDEC-102, IDEC-C2B8, IDEC-C2B8 Monoclonal Antibody, MabThera, Monoclonal Antibody IDEC-C2B8, PF-05280586, Rituxan, Rituximab Biosimilar ABP 798, Rituximab Biosimilar BI 695500, Rituximab Biosimilar CT-P10, Rituximab Biosimilar GB241, Rituximab Biosimilar IBI301, Rituximab Biosimilar PF-05280586, Rituximab Biosimilar RTXM83, Rituximab Biosimilar SAIT101, RTXM83, rituximab biosimilar TQB2303, rituximab-abbs, Truxima, Rituximab Biosimilar SIBP-02
Given IV
Also known as: Anti-CD20 Monoclonal Antibody R7159, GA-101, GA101, Gazyva, huMAB(CD20), R7159, RO 5072759, RO-5072759, RO5072759
Overall Response Rate
Will be defined as the rate of complete + partial responses using computed tomography (CT) criteria (Lugano 2014).
Time frame: Up to 90 days after the last dose of pembrolizumab
Incidence of Serious or Drug-related Adverse Events
Evaluated by the NCI Common Terminology for Adverse Events (CTCAE), version 4.0.
Time frame: Up to 90 days after the last dose of pembrolizumab
Progression-free Survival (PFS)
The Kaplan-Meier method will be used to estimate median PFS.
Time frame: Up to 90 days after the last dose of pembrolizumab
Overall Survival (OS)
The Kaplan-Meier method will be used to estimate median OS.
Time frame: Up to 90 days after the last dose of pembrolizumab
| Milestone | Arm I Follicular Lymphoma (Pembrolizumab, Rituximab) | Arm II DLBCL (Pembrolizumab, Rituximab) | Arm III Follicular Lymphoma (Pembrolizumab, Obinutuzumab) |
|---|---|---|---|
| Started | 7 | 8 | 3 |
| Completed | 7 | 8 | 3 |
| Not completed | 0 | 0 | 0 |
Will be defined as the rate of complete + partial responses using computed tomography (CT) criteria (Lugano 2014).
| percentage of participants | Arm I Follicular Lymphoma (Pembrolizumab, Rituximab) | Arm II DLBCL (Pembrolizumab, Rituximab) | Arm III Follicular Lymphoma (Pembrolizumab, Obinutuzumab) |
|---|---|---|---|
| Overall Response Rate | 29 | 0 | 0 |
Evaluated by the NCI Common Terminology for Adverse Events (CTCAE), version 4.0.
| percentage of participants | Arm I Follicular Lymphoma (Pembrolizumab, Rituximab) | Arm II DLBCL (Pembrolizumab, Rituximab) | Arm III Follicular Lymphoma (Pembrolizumab, Obinutuzumab) |
|---|---|---|---|
| Incidence of Serious or Drug-related Adverse Events | 100 | 63 | 67 |
The Kaplan-Meier method will be used to estimate median PFS.
| years | Arm I Follicular Lymphoma (Pembrolizumab, Rituximab) | Arm II DLBCL (Pembrolizumab, Obinutuzumab) | Arm III Follicular Lymphoma (Pembrolizumab, Obinutuzumab) |
|---|---|---|---|
| Progression-free Survival (PFS) | 0.23 (0.18 to NA) | 0.21 (0.11 to NA) | 0.50 (0.38 to NA) |
The Kaplan-Meier method will be used to estimate median OS.
| years | Arm I Follicular Lymphoma (Pembrolizumab, Rituximab) | Arm II DLBCL (Pembrolizumab, Obinutuzumab) | Arm III Follicular Lymphoma (Pembrolizumab, Obinutuzumab) |
|---|---|---|---|
| Overall Survival (OS) | NA (3.1 to NA) | 1.5 (0.65 to NA) | NA (1.1 to NA) |
Collected over Adverse events were recorded from the time of informed consent and for 90 days after the last dose of pembrolizumab.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Arm I Follicular Lymphoma (Pembrolizumab, Rituximab) | 2/7 (28.6%) | 2/7 (28.6%) | 7/7 (100%) |
| Arm II DLBCL (Pembrolizumab, Rituximab) | 5/8 (62.5%) | 5/8 (62.5%) | 8/8 (100%) |
| Arm III Follicular Lymphoma (Pembrolizumab, Obinutuzumab) | 1/3 (33.3%) | 0/3 (0%) | 3/3 (100%) |
| Event | Arm I Follicular Lymphoma (Pembrolizumab, Rituximab) | Arm II DLBCL (Pembrolizumab, Rituximab) | Arm III Follicular Lymphoma (Pembrolizumab, Obinutuzumab) |
|---|---|---|---|
| Heart FailureCardiac disorders | 1/7 | 0/8 | 0/3 |
| Pleural EffusionRespiratory, thoracic and mediastinal disorders | 1/7 | 0/8 | 0/3 |
| PneumoniaInfections and infestations | 1/7 | 0/8 | 0/3 |
| DiarrheaGastrointestinal disorders | 0/7 | 1/8 | 0/3 |
| HypokalemiaMetabolism and nutrition disorders | 0/7 | 1/8 | 0/3 |
| ArthralgiaMusculoskeletal and connective tissue disorders | 0/7 | 1/8 | 0/3 |
| Altered mental statusPsychiatric disorders | 0/7 | 1/8 | 0/3 |
| FeverGeneral disorders | 0/7 | 1/8 | 0/3 |
| Streptococcus salivariusInfections and infestations | 0/7 | 1/8 | 0/3 |
| HypercalcemiaInvestigations | 0/7 | 1/8 | 0/3 |
| Event | Arm I Follicular Lymphoma (Pembrolizumab, Rituximab) | Arm II DLBCL (Pembrolizumab, Rituximab) | Arm III Follicular Lymphoma (Pembrolizumab, Obinutuzumab) |
|---|---|---|---|
| FatigueGastrointestinal disorders | 5/7 | 4/8 | 3/3 |
| Upper respiratory infectionInfections and infestations | 4/7 | 0/8 | 0/3 |
| DiarrheaGastrointestinal disorders | 3/7 | 1/8 | 1/3 |
| Infusion related reactionGeneral disorders | 3/7 | 0/8 | 0/3 |
| AnorexiaMetabolism and nutrition disorders | 1/7 | 2/8 | 1/3 |
| DyspneaRespiratory, thoracic and mediastinal disorders | 1/7 | 0/8 | 1/3 |
| HeadacheNervous system disorders | 1/7 | 1/8 | 1/3 |
| DizzinessNervous system disorders | 0/7 | 0/8 | 1/3 |
| Night sweatsGastrointestinal disorders | 0/7 | 0/8 | 1/3 |
| HyperuricemiaMetabolism and nutrition disorders | 0/7 | 0/8 | 1/3 |
| Age, Categorical(Participants) | Arm I Follicular Lymphoma (Pembrolizumab, Rituximab) | Arm II DLBCL (Pembrolizumab, Obinutuzumab) | Arm III Follicular Lymphoma (Pembrolizumab, Obinutuzumab) | Total |
|---|---|---|---|---|
| <=18 years | 0 | 0 | 0 | 0 |
| Between 18 and 65 years | 6 | 1 | 2 | 9 |
| >=65 years | 1 | 7 | 1 | 9 |
| Sex: Female, Male(Participants) | Arm I Follicular Lymphoma (Pembrolizumab, Rituximab) | Arm II DLBCL (Pembrolizumab, Obinutuzumab) | Arm III Follicular Lymphoma (Pembrolizumab, Obinutuzumab) | Total |
|---|---|---|---|---|
| Female | 3 | 2 | 0 | 5 |
| Male | 4 | 6 | 3 | 13 |
| Ethnicity (NIH/OMB)(Participants) | Arm I Follicular Lymphoma (Pembrolizumab, Rituximab) | Arm II DLBCL (Pembrolizumab, Obinutuzumab) | Arm III Follicular Lymphoma (Pembrolizumab, Obinutuzumab) | Total |
|---|---|---|---|---|
| Hispanic or Latino | 1 | 0 | 1 | 2 |
| Not Hispanic or Latino | 6 | 8 | 2 | 16 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Arm I Follicular Lymphoma (Pembrolizumab, Rituximab) | Arm II DLBCL (Pembrolizumab, Obinutuzumab) | Arm III Follicular Lymphoma (Pembrolizumab, Obinutuzumab) | Total |
|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 | 0 |
| White | 7 | 8 | 3 | 18 |
| More than one race | 0 | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 |
| Region of Enrollment(participants) | Arm I Follicular Lymphoma (Pembrolizumab, Rituximab) | Arm II DLBCL (Pembrolizumab, Obinutuzumab) | Arm III Follicular Lymphoma (Pembrolizumab, Obinutuzumab) | Total |
|---|---|---|---|---|
| United States | 7 | 8 | 3 | 18 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Mar 2018 to primary completion in Dec 2023, 68 months.
Results were first posted in Apr 2025, 1 year 3 months after primary completion.
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Studies of the drugs tested here: Pembrolizumab · Rituximab · Obinutuzumab
Lymphoma, Large B-Cell, Diffuse →