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Checkpoint Inhibitor

Pembrolizumab for Non-Hodgkin's Lymphoma

Phase 2

Waitlist Available

Led By Ajay K. Gopal

Research Sponsored by University of Washington

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Steady progression of follicular lymphoma (FL) and marginal zone lymphoma (MZL)

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)

Must not have

Has a known history of human immunodeficiency virus (HIV) (HIV 1/2 antibodies)

Be in urgent need of therapy for lymphoma related complications (such as hyperviscosity syndrome) and those with bulky disease

Timeline

Screening 3 weeks

Treatment Varies

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

Awards & highlights

No Placebo-Only Group

Summary

This trial studies pembrolizumab as a treatment for B-cell non-Hodgkin lymphoproliferative diseases.

Who is the study for?

This trial is for adults with untreated B-cell non-Hodgkin lymphoproliferative diseases who need treatment and have measurable disease. Participants must be in good physical condition (ECOG 0 or 1), not pregnant, willing to use birth control, and without serious health issues like active TB, HIV, certain cancers, CNS metastases, or severe autoimmune diseases.

What is being tested?

The study tests pembrolizumab's effectiveness on patients with specific types of lymphoma. Pembrolizumab is an immunotherapy drug that may help the immune system fight cancer by blocking a pathway tumors use to hide from it.

What are the potential side effects?

Pembrolizumab can cause side effects such as fatigue, skin reactions, diarrhea, lung inflammation (pneumonitis), hormonal gland problems (like thyroid dysfunction), and can worsen pre-existing autoimmune diseases.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My lymphoma is getting worse over time.

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I have symptoms or conditions that require treatment according to NCCN guidelines.

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I have a tumor larger than 1.5 cm that can be measured by CT or MRI.

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My organ function is at risk due to my cancer.

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I am fully active or restricted in physically strenuous activity but can do light work.

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My blood cell counts are dropping due to my lymphoma.

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My kidney function is within the required range for the study.

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I have a tumor larger than 1.5 cm that can be measured by CT or MRI.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have been diagnosed with HIV.

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I need urgent treatment for my lymphoma complications.

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I have been treated with drugs targeting PD-1, PD-L1, or PD-L2.

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I have received treatment for iBCL before.

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I haven't needed systemic treatment for an autoimmune disease in the last 2 years.

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I have a history of or currently have non-infectious lung inflammation.

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I am currently being treated for an infection.

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I have only received the flu shot, not the nasal spray vaccine.

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I have an active tuberculosis infection.

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I have not received a live vaccine in the last 30 days.

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I have cancer that has spread to my brain or spinal cord.

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I have an immune system disorder or have been on steroids or other immune-weakening medicines in the last week.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

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

Screening ~ 3 weeks

Treatment ~ Varies

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and from the first study drug administration to the first occurrence of lymphoma progression or death from any cause, assessed up to 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

Secondary study objectives

Count of Participants Who Experience Adverse Events (AEs)

Duration of Response

Progression-free Survival

Side effects data

From 2024 Phase 3 trial • 804 Patients • NCT03040999

64%

Radiation skin injury

63%

Stomatitis

58%

Anaemia

56%

Nausea

48%

Dry mouth

45%

Constipation

45%

Weight decreased

44%

Dysphagia

42%

Neutrophil count decreased

33%

Dysgeusia

33%

Vomiting

32%

Fatigue

31%

White blood cell count decreased

28%

Hypomagnesaemia

26%

Decreased appetite

25%

Hypothyroidism

25%

Hypokalaemia

24%

Lymphocyte count decreased

24%

Platelet count decreased

23%

Oropharyngeal pain

23%

Blood creatinine increased

22%

Diarrhoea

22%

Odynophagia

20%

Hypoacusis

20%

Alanine aminotransferase increased

20%

Hyponatraemia

19%

Tinnitus

19%

Oral candidiasis

19%

Asthenia

16%

Pyrexia

16%

Cough

15%

Aspartate aminotransferase increased

15%

Rash

14%

Insomnia

13%

Acute kidney injury

13%

Pharyngeal inflammation

13%

Pruritus

12%

Dysphonia

12%

Gamma-glutamyltransferase increased

11%

Pneumonia

11%

Dehydration

10%

Hyperthyroidism

10%

Hypoalbuminaemia

10%

Hypocalcaemia

10%

Headache

10%

Productive cough

Neck pain

Peripheral sensory neuropathy

Gastrooesophageal reflux disease

Hiccups

Hyperglycaemia

Hyperuricaemia

Dizziness

Hypophosphataemia

Urinary tract infection

Ear pain

Localised oedema

Hyperkalaemia

Erythema

Oral pain

Abdominal pain upper

Arthralgia

Anxiety

Febrile neutropenia

Dyspepsia

Saliva altered

Back pain

Oedema peripheral

Hypertension

Dyspnoea

Nasopharyngitis

Alopecia

Dry skin

Sepsis

Pneumonia aspiration

Trismus

Pneumonitis

Laryngeal oedema

Malnutrition

Pharyngeal haemorrhage

Cellulitis

Septic shock

Clostridium difficile colitis

Systemic infection

Cardiac arrest

Death

Bronchitis

Hepatitis

Immune-mediated hepatitis

Oesophagitis

General physical health deterioration

Hypophagia

Tumour haemorrhage

Cerebrovascular accident

Syncope

Acute respiratory failure

Aspiration

Colitis

Mouth haemorrhage

Hypersensitivity

Acute myocardial infarction

Abscess neck

Device related infection

Stoma site infection

Vascular device infection

Wound infection

Hypercalcaemia

Pulmonary embolism

Respiratory failure

100%

80%

60%

40%

20%

Study treatment Arm

Pembrolizumab + CRT Followed by Pembrolizumab

Placebo + CRT Followed by Placebo

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (pembrolizumab)Experimental Treatment2 Interventions

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Pembrolizumab

2017

Completed Phase 3

~3150

0 / 20Eligibility criteria met