Pembrolizumab in Untreated B-Cell Non-Hodgkin Lymphoproliferative Diseases

NCT03498612 | Terminated Phase 2 Results DMC FDA Drug

• 3 other identifiers: 9647NCI-2018-00432RG1716072
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Follicular Lymphoma; Indolent B-Cell Non-Hodgkin Lymphoma; Marginal Zone Lymphoma

Keywords

Non-Hodgkin Lymphoma

Outcome Measures

Primary Outcomes (1)

• Overall Response Rate (Complete Response [CR] + Partial Response [PR] for Follicular Lymphoma and Marginal Zone Lymphoma)

  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.

  Up to 8 months.

Secondary Outcomes (4)

• Duration of Response

  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

• Progression-free Survival

  From the first study drug administration to the first occurrence of lymphoma progression or death from any cause, assessed up to 5 years

• Time to Next Therapy

  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

• Count of Participants Who Experience Adverse Events (AEs)

  Up to 90 days after last dose, up to 1 year.

Study Arms (1)

Treatment (pembrolizumab)

EXPERIMENTAL

Patients receive pembrolizumab IV over 30 minutes on day 1. Treatment repeats every 3 weeks for up to 18 cycles in the absence of disease progression or unacceptable toxicity.

Other: Laboratory Biomarker Analysis; Biological: Pembrolizumab

Interventions

Laboratory Biomarker Analysis OTHER

Correlative studies

Treatment (pembrolizumab)

Pembrolizumab BIOLOGICAL

Given IV

Also known as: Keytruda, Lambrolizumab, MK-3475, SCH 900475

Treatment (pembrolizumab)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Be willing and able to provide written informed consent/assent for the trial
• Must have measurable disease defined by at least one of the following criteria:
• \* Lesions greater than 1.5 cm that can be accurately measured in two dimensions by computed tomography (CT) (preferred), or magnetic resonance imaging (MRI)
• Must have indication for treatment (adapted from National Comprehensive Cancer Network \[NCCN\] 2015 guidelines)
• \* Any of the following constitute an indication for treatment:
• Significant symptoms due to any iBCL: Which may include pain/discomfort, limitation of function, fatigue/malaise/constitutional symptoms, B-symptoms (fever, weight loss, night sweats), pruritus
• Threatened end-organ function due to any iBCL
• Progressive cytopenia secondary to any iBCL
• Steady progression of follicular lymphoma (FL) and marginal zone lymphoma (MZL)
• Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) performance scale
• Absolute neutrophil count (ANC) \>= 500/uL Note: Growth factor and/or transfusion support is permissible to stabilize participant prior to study treatment if needed. No lower limit if cytopenia is related to bone marrow involvement.
• Platelets \>= 25000/uL Note: Growth factor and/or transfusion support is permissible to stabilize participant prior to study treatment if needed. No lower limit if cytopenia is related to bone marrow involvement.
• Hemoglobin \>= 8 g/dL Note: Growth factor and/or transfusion support is permissible to stabilize participant prior to study treatment if needed. No lower limit if cytopenia is related to bone marrow involvement.
• Serum creatinine =\< 1.5 x upper limit of normal (ULN) OR measured or calculated creatinine clearance (glomerular filtration rate \[GFR\] can also be used in place of creatinine or creatinine clearance \[CrCl\]) \>= 30 mL/min for participant with creatinine levels \> 1.5 x institutional ULN (GFR can also be used in place of creatinine or CrCl)
• \* Creatinine clearance should be calculated per institutional standard

You may not qualify if:

• Is currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks of the first dose of treatment
• Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment
• Has a known history of active TB (Bacillus tuberculosis)
• Hypersensitivity to pembrolizumab or any of its excipients
• Has had prior chemotherapy, radiation therapy, or immunotherapy for the diagnosis of iBCL
• Has a known additional malignancy that is progressing or requires active treatment; exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer
• Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis
• 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 (e.g. thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment
• Has known history of, or any evidence of active, non-infectious pneumonitis
• Has an active infection requiring systemic therapy
• Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, 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 trial, starting with the pre-screening or screening visit through 120 days after the last dose of trial treatment
• Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent
• Has a known history of human immunodeficiency virus (HIV) (HIV 1/2 antibodies)

Sponsors & Collaborators

• University of Washington: lead
• Merck Sharp & Dohme LLC: collaborator

Study Sites (1)

Fred Hutch/University of Washington Cancer Consortium

Seattle, Washington, 98109, United States

Location

MeSH Terms

Conditions

Lymphoma, Follicular; Lymphoma, B-Cell, Marginal Zone; Lymphoma, Non-Hodgkin

Interventions

pembrolizumab

Condition Hierarchy (Ancestors)

Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Lymphoma, B-Cell

Results Point of Contact

• Title: Ajay Gopal, MD
• Organization: University of Washington

agopal@uw.edu

206-606-2037

Study Officials

• Ajay K. Gopal

  Fred Hutch/University of Washington Cancer Consortium

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Division of Medical Oncology

Study Record Dates

• First Submitted: March 27, 2018
• First Posted: April 13, 2018
• Study Start: July 9, 2018
• Primary Completion: June 9, 2021
• Study Completion: August 29, 2024
• Last Updated: November 12, 2025
• Results First Posted: December 30, 2022

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)