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NCT03498612

Pembrolizumab in Untreated B-Cell Non-Hodgkin Lymphoproliferative Diseases

Terminated Phase 2 Results posted Last updated 12 November 2025
What this trial tests

Phase 2 trial testing Laboratory Biomarker Analysis in Follicular Lymphoma in 9 participants. Terminated before completion.

Timeline
9 July 2018
Primary endpoint
9 June 2021
29 August 2024

Quick facts

Lead sponsorUniversity of Washington
PhasePhase 2
StatusTerminated
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment9
Start date9 July 2018
Primary completion9 June 2021
Estimated completion29 August 2024
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

University of Washington

Who can join

18 and older, any sex, with Follicular Lymphoma or Indolent B-Cell Non-Hodgkin Lymphoma. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Overall Response Rate (Complete Response [CR] + Partial Response [PR] for Follicular Lymphoma and Marginal Zone Lymphoma) Primary · Up to 8 months.

Measured by Lugano Criteria evaluated by positron emission tomography (PET)/computed tomography (CT) or CT or white blood cell count for chronic lymphocytic leukemia (CLL). The corresponding 95% two-sided confidence interval will be derived.

GroupValue95% CI
Treatment (pembrolizumab)3
Duration of Response Secondary · From the time by which the measurement criteria are met for CR or PR, whichever is recorded first, until death or the first date by which recurrent or progressive disease is objectively documented, assessed up to 5 years

Kaplan Meier methodology will be used to estimate event-free curves.

GroupValue95% CI
Treatment (pembrolizumab)414 – 60
Progression-free Survival Secondary · From the first study drug administration to the first occurrence of lymphoma progression or death from any cause, assessed up to 5 years

Data for subjects without disease progression or death will be censored at the date of the last tumor assessment. Kaplan-Meier methodology will be used to estimate the event-free curves.

GroupValue95% CI
Treatment (pembrolizumab)6.33.77 – NA
Time to Next Therapy Secondary · From the time of first study drug administration until the date of the first subsequent therapy given to treat the indolent B-cell non-Hodgkin lymphoproliferative diseases, assessed up to 5 years
GroupValue95% CI
Treatment (pembrolizumab)5.44.73 – NA
Count of Participants Who Experience Adverse Events (AEs) Secondary · Up to 90 days after last dose, up to 1 year.

Safety summaries will include tabulations in the form of tables. The frequency of treatment-emergent AE's will be summarized. Additional AE summaries will include AE frequency by AE severity and relationship to the study drug.

GroupValue95% CI
Treatment (pembrolizumab)9

Adverse events — posted to ClinicalTrials.gov

Time frame: From the time of informed consent through 90 days following the last dose of pembrolizumab, up to 1 year.. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Treatment (pembrolizumab)
Serious: 2/9 (22%)
Deaths: 0/9

Serious adverse events (2 terms)

ReactionSystemTreatment (pembrolizumab)
Rituximab Desensitization ProtocolGeneral disorders
Retroperitoneal Venous HemorrhageInjury, poisoning and procedural complications
Other adverse events (33 terms — click to expand)

ReactionSystemTreatment (pembrolizumab)
FatigueGeneral disorders
Alanine aminotransferase increasedInvestigations
Alkaline phosphatase increasedInvestigations
Aspartate aminotransferase increasedInvestigations
Blood bilirubin increasedInvestigations
DiarrheaGastrointestinal disorders
Edema limbsGeneral disorders
NauseaGastrointestinal disorders
Abdominal PainGastrointestinal disorders
ACTH decreasedEndocrine disorders
ArthralgiaMusculoskeletal and connective tissue disorders
Back PainMusculoskeletal and connective tissue disorders
ChillsGeneral disorders
ConstipationGastrointestinal disorders
Dry EyeEye disorders
Dry SkinSkin and subcutaneous tissue disorders
Dry MouthGastrointestinal disorders
DyspneaRespiratory, thoracic and mediastinal disorders
Elevated TSHEndocrine disorders
FeverGeneral disorders
Elevated T3Endocrine disorders
Elevated T4Endocrine disorders
HyperglycemiaMetabolism and nutrition disorders
HyperthyroidismEndocrine disorders
HyponatremiaMetabolism and nutrition disorders
Left shoulder painMusculoskeletal and connective tissue disorders
PneumonitisRespiratory, thoracic and mediastinal disorders
PruritisSkin and subcutaneous tissue disorders
Right forehead pink papuleSkin and subcutaneous tissue disorders
Right lower rib painGeneral disorders
Scrotal edemaReproductive system and breast disorders
Left foot fungal infectionInfections and infestations
Testosterone decreasedEndocrine disorders

Most-reported serious reactions: Rituximab Desensitization Protocol, Retroperitoneal Venous Hemorrhage.

Data from ClinicalTrials.gov NCT03498612 adverse events section.

Sponsor's own description

This phase II trial studies how well pembrolizumab works in treating patients with B-cell non-Hodgkin lymphoproliferative diseases that have not been treated. 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.

Publications & conference data

7 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Advances in targeted therapy for malignant lymphoma.
    Wang L, Qin W, Huo YJ, Li X, et al · · 2020 · cited 88× · PMID 32296035 · DOI 10.1038/s41392-020-0113-2
  2. Early Evaluation of Immunotherapy Response in Lymphoma Patients by 18F-FDG PET/CT: A Literature Overview.
    Ferrari C, Maggialetti N, Masi T, Nappi AG, et al · · 2021 · cited 15× · PMID 33803667 · DOI 10.3390/jpm11030217
  3. Current Immunotherapy Approaches in Non-Hodgkin Lymphomas.
    Pytlik R, Polgarova K, Karolova J, Klener P. · · 2020 · cited 14× · PMID 33260966 · DOI 10.3390/vaccines8040708
  4. Management of Extranodal Marginal Zone Lymphoma: Present and Upcoming Perspectives.
    Kaddu-Mulindwa D, Thurner L, Christofyllakis K, Bewarder M, et al · · 2022 · cited 11× · PMID 35740684 · DOI 10.3390/cancers14123019
  5. Novel treatment approaches and future perspectives in follicular lymphoma.
    Sutamtewagul G, Link BK. · · 2019 · cited 7× · PMID 30719267 · DOI 10.1177/2040620718820510
  6. Successful PD-1 inhibitor treatment in a patient with refractory transformed follicular lymphoma who failed to respond to CAR-T cell therapy: a case report and literature review.
    Zheng W, Xue Q, Sha X, Wang Y, et al · · 2021 · cited 3× · PMID 34570671 · DOI 10.1080/15384047.2021.1967083
  7. A phase 2 study of frontline pembrolizumab in follicular lymphoma.
    Ho C, Zhu S, Gooley T, Gujral TS, et al · · 2024 · PMID 39691260 · DOI 10.1002/jha2.1029

Verify or expand the search:

Other trials of Laboratory Biomarker Analysis

Trials testing the same drug.

Other recruiting trials for Follicular Lymphoma

Currently open trials in the same condition.

Other University of Washington trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03498612.

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