← Back to Search

PD-1 Inhibitor

Pembrolizumab in Relapsed and Refractory Gray-Zone Lymphoma (GZL), Primary Central Nervous System Lymphoma (PCNSL), and Other Extranodal Diffuse Large B-cell Lymphomas

Phase 2
Waitlist Available
Led By Mark J Roschewski, M.D.
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up every 3-6 months, up to 2.5 years
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing pembrolizumab, a drug that helps the immune system fight cancer, in adults with rare, aggressive B-cell lymphomas that don't respond well to standard treatments. The drug works by blocking a protein that prevents the immune system from attacking cancer cells, allowing the immune system to destroy them.

Eligible Conditions
  • Lymphoma
  • Non-Hodgkin's Lymphoma
  • Central Nervous System Lymphoma

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~every 3-6 months, up to 2.5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and every 3-6 months, up to 2.5 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
Best Overall Response Rate of Pembrolizumab in Participants With Relapsed/Refractory Gray-zone Lymphomas (GZL) and Extra-nodal Diffuse Large B-cell Lymphomas (DLBCL)
Secondary study objectives
Best Overall Response Rate According to the 5-point Lugano Classification for Interpreting 18 F-fluorodeoxyglucose (FDG)-Positron Emission Tomography (PET) Scans
Duration of Response for Participants Who Respond to Pembrolizumab
Event-free Survival (EFS)
+3 more
Other study objectives
Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0).

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
9%
Neck pain
9%
Peripheral sensory neuropathy
8%
Gastrooesophageal reflux disease
8%
Hiccups
8%
Hyperglycaemia
8%
Hyperuricaemia
8%
Dizziness
8%
Hypophosphataemia
7%
Urinary tract infection
7%
Ear pain
7%
Localised oedema
7%
Hyperkalaemia
7%
Erythema
7%
Oral pain
6%
Abdominal pain upper
6%
Arthralgia
6%
Anxiety
6%
Febrile neutropenia
6%
Dyspepsia
6%
Saliva altered
5%
Back pain
5%
Oedema peripheral
5%
Hypertension
5%
Dyspnoea
4%
Nasopharyngitis
4%
Alopecia
4%
Dry skin
3%
Sepsis
3%
Pneumonia aspiration
3%
Trismus
3%
Pneumonitis
3%
Laryngeal oedema
2%
Malnutrition
2%
Pharyngeal haemorrhage
2%
Cellulitis
1%
Septic shock
1%
Systemic infection
1%
Clostridium difficile colitis
1%
Cardiac arrest
1%
Death
1%
Bronchitis
1%
Hepatitis
1%
Immune-mediated hepatitis
1%
Oesophagitis
1%
General physical health deterioration
1%
Hypophagia
1%
Tumour haemorrhage
1%
Cerebrovascular accident
1%
Syncope
1%
Acute respiratory failure
1%
Aspiration
1%
Colitis
1%
Mouth haemorrhage
1%
Hypersensitivity
1%
Acute myocardial infarction
1%
Abscess neck
1%
Device related infection
1%
Stoma site infection
1%
Vascular device infection
1%
Wound infection
1%
Hypercalcaemia
1%
Pulmonary embolism
1%
Respiratory failure
100%
80%
60%
40%
20%
0%
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: Participants with Gray-zone Lymphoma (GZL) or Extranodal Diffuse Large B-cell Lymphomas (DLBCL)Experimental Treatment1 Intervention
Participants with gray-zone lymphoma (GZL) or extranodal DLBCL relapsed from or refractory to prior therapy with an anthracycline-based regimen
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
2017
Completed Phase 3
~3150

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,938 Previous Clinical Trials
41,023,176 Total Patients Enrolled
1,408 Trials studying Lymphoma
383,462 Patients Enrolled for Lymphoma
Mark J Roschewski, M.D.Principal InvestigatorNational Cancer Institute (NCI)
18 Previous Clinical Trials
2,499 Total Patients Enrolled
14 Trials studying Lymphoma
2,199 Patients Enrolled for Lymphoma
~2 spots leftby Dec 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top