A Phase 2 interventional study of Pembrolizumab in Lymphoma, Histiocytic Sarcoma and Follicular Dendritic Cell Sarcoma, sponsored by Dana-Farber Cancer Institute. Suspended at 4 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-06.
Sponsored by Dana-Farber Cancer Institute · Phase 2, Interventional, and Treatment
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Among 11 studies testing pembrolizumab in Lymphoma — 3 open to participants now, 5 under way, none of them phase 3. pembrolizumab · Lymphoma.
Among the 11 studies testing pembrolizumab in Lymphoma, this one is the 5th largest by enrollment, is the only one that started in 2017, is one of 4 in phase 2, and was the 4th registered.
3,018 studies on the registry are indexed under Lymphoma; 433 are open to participants now.
Browse Lymphoma studies →3 of the 11 studies testing pembrolizumab in Lymphoma are open now, in 10 countries. Recruiting first, the newest first:
Merck Sharp & Dohme LLC · Sites in Japan
Ages 6 mo+
Dana-Farber Cancer Institute · Sites in United States
Ages 18+
Merck Sharp & Dohme LLC · Sites in United States, Brazil, France and 6 more countries
Ages 6 mo–17 yrs
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 346 Lymphoma studies recruiting now, 227 (66%) set no upper age limit and 78 (23%) stop at 75 or younger; 77 take children under 18; 20 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.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 7 · Phase 2 8
First in 2015; this study’s year is marked. 1 started in 2017.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 18 is below the median of 43 across 2,319 interventional studies indexed under Lymphoma.
Median enrollment 15 across the 11 interventional studies. Of the 3 that completed or were terminated, 2 (67%) have results posted.
This tab as a report to print or save as PDF → With an account.
3 of 11 have an industry lead sponsor. The 8 most frequent:
Dana-Farber Cancer Institute is the lead sponsor of 834 studies on the registry; 122 are open to participants now.
Of its 114 completed or terminated interventional studies of FDA-regulated products, 78 (68%) have results posted.
17 studies in Lymphoma by Dana-Farber Cancer Institute: 4 open now, 6 under way, none of them phase 3. Of 10 finished, 4 (40%) have results posted.
Among the 17 studies in Lymphoma by Dana-Farber Cancer Institute, this one is the 13th largest by enrollment of the 16 interventional ones that give a count, is the only one that started in 2017, is one of 5 in phase 2, and was the 8th registered.
Dana-Farber Cancer Institute’s Lymphoma studies by the year they started, since 2000.
2 of the studies testing pembrolizumab in Lymphoma that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06475235Dana-Farber Cancer InstitutePembrolizumab + Chemotherapy in Newly Diagnosed PCNSL | 2026-12-30 |
| NCT03995147University of ChicagoPembrolizumab in Combination With Chemotherapy for Patients With Untreated B Cell Lymphoma | 2027-02-20 |
Add all 2 to your calendar (.ics) → With an account.
Among the 11 studies testing pembrolizumab in Lymphoma, from their registry updates:
Nothing recorded among them since 2026-09-25.
Among Dana-Farber Cancer Institute’s 17 in Lymphoma:
Nothing recorded among them since 2026-09-25.
This tab as a report to print or save as PDF → With an account.
This research study is studying a drug called pembrolizumab as a possible treatment for aggressive lymphoma or a histiocyte or dendritic cell neoplasm.
The drug involved in this study is:
-Pembrolizumab
This research study is a Phase II clinical trial. Phase II clinical trials test the safety and effectiveness of an investigational drug to learn whether the drug works in treating a specific disease. "Investigational" means that the drug is being studied.
The FDA (the U.S. Food and Drug Administration) has not approved pembrolizumab for this specific disease but it has been approved for other uses.
The study drug is an antibody that targets a molecule called programmed cell death protein 1 (PD-1). PD-1 is used to turn down the immune system. In general, this is used by the body to prevent the immune system from being too active. However, several cancers appear to use this pathway to prevent the immune system from attacking them. The theory behind this study is that by blocking PD-1, we may be able to prevent the cancer from hiding from the immune system and allow the immune system to attack the cancer more effectively. There is evidence that the type of lymphoma the participant have may use PD-1 to escape the immune system.
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.
confirmed diagnosis of a histiocyte/dendritic cell neoplasm or aggressive lymphoma with at least one of the following features (with review required at a participating study center):
Participants must have normal organ and marrow function as defined below:
No prior allogeneic transplant unless all of the following apply:
Exclusion Criteria:
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.
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 diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.
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.
A 0–100 scale of how well someone can carry out everyday activities. 100 is no complaints and no signs of illness; 70 is able to look after yourself but not to work or keep up normal activity; 50 is needing considerable help and frequent medical care.
Studies often ask for 60 or 70 and above. Your doctor gives the score.
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.
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.
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.
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.
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.
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.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
After a transplant from a donor, the donor’s immune cells attack the recipient’s body, often the skin, gut or liver.
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.
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.
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.
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.
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.
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.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
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.
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.
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.
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.
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.
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.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
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.
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.
Karnofsky performance status (KPS)
A 0–100 scale of how well someone can carry out everyday activities. 100 is no complaints and no signs of illness; 70 is able to look after yourself but not to work or keep up normal activity; 50 is needing considerable help and frequent medical care.
Studies often ask for 60 or 70 and above. Your doctor gives the score.
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.
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.
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.
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.
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.
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.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GVHD (graft-versus-host disease)
After a transplant from a donor, the donor’s immune cells attack the recipient’s body, often the skin, gut or liver.
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.
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.
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.
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.
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.
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.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
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.
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.
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.
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.
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.
Pembrolizumab will be administered intravenously every 3 weeks for 35 cycles
Drug: Pembrolizumab
The study drug is an antibody that targets a molecule called PD-1. Blocking PD-1 allow the immune system to attack the cancer more effectively.
Also known as: Keytruda
Overall Response Rate
The number of subjects with partial response (PR) or complete response (CR) by PET/CT scan Per Lugano criteria, CR is defined as positron emission tomography-computed tomography (PET-CT), score 1, 2, or 3 with or without a residual mass on 5 point scale (5PS) OR on CT, target nodes/nodal masses must regress to ≤1.5 cm in longest diameter (LDi). PR is defined as PET-CT score 4 or 5 with reduced uptake compared with baseline and residual mass(es) of any size. OR on CT ≥50% decrease in the sum of the products of the longest perpendicular diameters (SPD) of up to 6 target measurable nodes and extranodal sites.
Time frame: 2 years
Complete Response Rate
The number of patients with complete response (CR) Per Lugano criteria, CR is defined as PET-CT, score 1, 2, or 3 with or without a residual mass on 5PS OR on CT, target nodes/nodal masses must regress to ≤1.5 cm in LDi.
Time frame: 2 years
Number of Patients With Adverse Events of Any Grade
The number of patients with an adverse event of any grade that has definite, probable, or possible attribution to study treatment.
Time frame: Up to 35 cycles of treatment (approximately 2 years) plus up to an additional 24 months of follow-up after treatment
Duration of Response
Length of first complete (CR) or partial response (PR) until progression (PD) Per Lugano criteria, CR is defined as PET-CT, score 1, 2, or 3 with/without a residual mass on 5PS OR on CT, target nodes/nodal masses must regress to ≤1.5 cm in LDi. PR is defined as PET-CT score 4 or 5 with reduced uptake compared with baseline and residual mass(es) of any size. OR on CT ≥50% decrease in SPD of up to 6 target measurable nodes and extranodal sites. PD is defined as PET-CT score 4 or 5 with an increase in intensity of uptake from baseline and/or new fluoro-2-deoxy-D-glucose (FDG)-avid foci consistent with lymphoma at interim or end-of-treatment assessment. OR on CT, an individual node/lesion must be abnormal. OR new/clear progression of pre-existing nonmeasured lesions. OR regrowth of previously resolved lesions. OR new node \>1.5 cm in any axis or new extranodal site \>1.0 cm in any axis or be unequivocal and attributable to lymphoma. AND/OR new/recurrent involvement of the bone marrow
Time frame: Up to 35 cycles of treatment (approximately 2 years) plus up to an additional 24 months of follow-up after treatment
Progression-free Survival
Time from study registration until the earlier of first progression or death from any cause, censored for patients alive without progression or lost to follow-up without documented progression. Per Lugano criteria, progression is defined as PET-CT score 4 or 5 with an increase in intensity of uptake from baseline and/or new FDG-avid foci consistent with lymphoma at interim or end-of-treatment assessment. OR on CT, an individual node/lesion must be abnormal. OR new or clear progression of pre-existing nonmeasured lesions. OR regrowth of previously resolved lesions. OR a new node \>1.5 cm in any axis or a new extranodal site \>1.0 cm in any axis or be unequivocal and must be attributable to lymphoma. AND/OR new or recurrent involvement of the bone marrow
Time frame: Up to 35 cycles of treatment (approximately 2 years) plus up to an additional 24 months of follow-up after treatment
Duration of Complete Response
The length of first complete response (CR) until progression (PD) Per Lugano criteria, CR is defined as PET-CT, score 1, 2, or 3 with or without a residual mass on 5PS OR on CT, target nodes/nodal masses must regress to ≤1.5 cm in LDi. PD is defined as PET-CT score 4 or 5 with an increase in intensity of uptake from baseline and/or new FDG-avid foci consistent with lymphoma at interim or end-of-treatment assessment. OR on CT, an individual node/lesion must be abnormal. OR new or clear progression of pre-existing nonmeasured lesions. OR regrowth of previously resolved lesions. OR a new node \>1.5 cm in any axis or a new extranodal site \>1.0 cm in any axis or be unequivocal and must be attributable to lymphoma. AND/OR new or recurrent involvement of the bone marrow
Time frame: Up to 35 cycles of treatment (approximately 2 years) plus up to an additional 24 months of follow-up after treatment
Overall Survival
Time from study registration until death from any cause, censored for patients still alive or lost to follow-up
Time frame: Up to 35 cycles of treatment (approximately 2 years) plus up to an additional 24 months of follow-up after treatment
| Milestone | Pembrolizumab |
|---|---|
| Started | 18 |
| Completed | 18 |
| Not completed | 0 |
The number of subjects with partial response (PR) or complete response (CR) by PET/CT scan Per Lugano criteria, CR is defined as positron emission tomography-computed tomography (PET-CT), score 1, 2, or 3 with or without a residual mass on 5 point scale (5PS) OR on CT, target nodes/nodal masses must regress to ≤1.5 cm in longest diameter (LDi). PR is defined as PET-CT score 4 or 5 with reduced uptake compared with baseline and residual mass(es) of any size. OR on CT ≥50% decrease in the sum of the products of the longest perpendicular diameters (SPD) of up to 6 target measurable nodes and extranodal sites.
| Participants | Pembrolizumab |
|---|---|
| Overall Response Rate | 3 |
The number of patients with complete response (CR) Per Lugano criteria, CR is defined as PET-CT, score 1, 2, or 3 with or without a residual mass on 5PS OR on CT, target nodes/nodal masses must regress to ≤1.5 cm in LDi.
| Participants | Pembrolizumab |
|---|---|
| Complete Response Rate | 3 |
The number of patients with an adverse event of any grade that has definite, probable, or possible attribution to study treatment.
| Participants | Pembrolizumab |
|---|---|
| Number of Patients With Adverse Events of Any Grade | 18 |
Length of first complete (CR) or partial response (PR) until progression (PD) Per Lugano criteria, CR is defined as PET-CT, score 1, 2, or 3 with/without a residual mass on 5PS OR on CT, target nodes/nodal masses must regress to ≤1.5 cm in LDi. PR is defined as PET-CT score 4 or 5 with reduced uptake compared with baseline and residual mass(es) of any size. OR on CT ≥50% decrease in SPD of up to 6 target measurable nodes and extranodal sites. PD is defined as PET-CT score 4 or 5 with an increase in intensity of uptake from baseline and/or new fluoro-2-deoxy-D-glucose (FDG)-avid foci consistent with lymphoma at interim or end-of-treatment assessment. OR on CT, an individual node/lesion must be abnormal. OR new/clear progression of pre-existing nonmeasured lesions. OR regrowth of previously resolved lesions. OR new node \>1.5 cm in any axis or new extranodal site \>1.0 cm in any axis or be unequivocal and attributable to lymphoma. AND/OR new/recurrent involvement of the bone marrow
| months | Pembrolizumab |
|---|---|
| Duration of Response | 15 (4 to 26) |
Time from study registration until the earlier of first progression or death from any cause, censored for patients alive without progression or lost to follow-up without documented progression. Per Lugano criteria, progression is defined as PET-CT score 4 or 5 with an increase in intensity of uptake from baseline and/or new FDG-avid foci consistent with lymphoma at interim or end-of-treatment assessment. OR on CT, an individual node/lesion must be abnormal. OR new or clear progression of pre-existing nonmeasured lesions. OR regrowth of previously resolved lesions. OR a new node \>1.5 cm in any axis or a new extranodal site \>1.0 cm in any axis or be unequivocal and must be attributable to lymphoma. AND/OR new or recurrent involvement of the bone marrow
| months | Pembrolizumab |
|---|---|
| Progression-free Survival | 1.5 (0.5 to 28) |
The length of first complete response (CR) until progression (PD) Per Lugano criteria, CR is defined as PET-CT, score 1, 2, or 3 with or without a residual mass on 5PS OR on CT, target nodes/nodal masses must regress to ≤1.5 cm in LDi. PD is defined as PET-CT score 4 or 5 with an increase in intensity of uptake from baseline and/or new FDG-avid foci consistent with lymphoma at interim or end-of-treatment assessment. OR on CT, an individual node/lesion must be abnormal. OR new or clear progression of pre-existing nonmeasured lesions. OR regrowth of previously resolved lesions. OR a new node \>1.5 cm in any axis or a new extranodal site \>1.0 cm in any axis or be unequivocal and must be attributable to lymphoma. AND/OR new or recurrent involvement of the bone marrow
| months | Pembrolizumab |
|---|---|
| Duration of Complete Response | 12 (0 to 24) |
Time from study registration until death from any cause, censored for patients still alive or lost to follow-up
| months | Pembrolizumab |
|---|---|
| Overall Survival | 24 (1 to 35) |
Collected over Adverse events were collected for all patients who received any amount of study treatment from initiation of treatment for up to 35 cycles (approximately 2 years) plus up to an additional 24 months of follow-up after treatment. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Pembrolizumab | 10/18 (55.6%) | 8/18 (44.4%) | 18/18 (100%) |
| Event | Pembrolizumab |
|---|---|
| Aspartate aminotransferase increasedInvestigations | 1/18 |
| Death NOSGeneral disorders | 1/18 |
| DysarthriaNervous system disorders | 1/18 |
| DysphagiaGastrointestinal disorders | 1/18 |
| DyspneaRespiratory, thoracic and mediastinal disorders | 1/18 |
| Eye disorders - Other, specifyEye disorders | 1/18 |
| HypertensionVascular disorders | 1/18 |
| HypoxiaRespiratory, thoracic and mediastinal disorders | 1/18 |
| Lymphocyte count decreasedInvestigations | 1/18 |
| Mucositis oralGastrointestinal disorders | 1/18 |
| Event | Pembrolizumab |
|---|---|
| AnemiaBlood and lymphatic system disorders | 10/18 |
| FatigueGeneral disorders | 10/18 |
| Alkaline phosphatase increasedInvestigations | 9/18 |
| HyperglycemiaMetabolism and nutrition disorders | 7/18 |
| Platelet count decreasedInvestigations | 7/18 |
| NauseaGastrointestinal disorders | 7/18 |
| White blood cell decreasedInvestigations | 6/18 |
| Aspartate aminotransferase increasedInvestigations | 6/18 |
| Alanine aminotransferase increasedInvestigations | 6/18 |
| DiarrheaGastrointestinal disorders | 6/18 |
| Age, Categorical(Participants) | Pembrolizumab |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 8 |
| >=65 years | 10 |
| Age, Continuous(years) | Pembrolizumab |
|---|---|
| Median | 66 (33 to 81) |
| Sex: Female, Male(Participants) | Pembrolizumab |
|---|---|
| Female | 6 |
| Male | 12 |
| Ethnicity (NIH/OMB)(Participants) | Pembrolizumab |
|---|---|
| Hispanic or Latino | 1 |
| Not Hispanic or Latino | 17 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | Pembrolizumab |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 1 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 1 |
| White | 15 |
| More than one race | 1 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(Participants) | Pembrolizumab |
|---|---|
| United States | 18 |
| Eastern Cooperative Oncology Group (ECOG) Performance Status (PS)(Participants) | Pembrolizumab |
|---|---|
| 00 - Fully active, able to carry on all pre-disease performance without restriction | 6 |
| 01 - Restricted in physically strenuous activity but ambulatory and able to carry out light work | 12 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Dec 2017 to primary completion in Aug 2022, 56 months.
Results were first posted in Nov 2023, 1 year 3 months after primary completion.
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Studies of the drug tested here: Pembrolizumab
Dana-Farber Cancer Institute →