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PD-1 Inhibitor

Pembrolizumab for Gray Zone Lymphoma

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

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
  • Gray Zone Lymphoma
  • 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 2 trial • 57 Patients • NCT03004183
21%
Fatigue
13%
Nausea
11%
Back pain
9%
Diarrhea
9%
Anemia
9%
Shortness of Breath
9%
Abdominal pain
7%
Kidney Injury and/or Infection
7%
Pneumonia
7%
Weight Loss
7%
Dyspnea
5%
Malnutrition, Hypercalcemia and Weakness
5%
Pneumothorax
5%
Intractable pain, back pain, hip pain
5%
Activated partial thromboplastin time prolonged
4%
Atrial fibrillation with rapid ventricular response
4%
Pleural effusion
2%
colitis
2%
Thrombocytopenia
2%
Respiratory failure
2%
Skin rash
100%
80%
60%
40%
20%
0%
Study treatment Arm
Single Arm

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 2
~2070

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,842 Previous Clinical Trials
41,002,988 Total Patients Enrolled
1 Trials studying Gray Zone Lymphoma
348 Patients Enrolled for Gray Zone Lymphoma
Mark J Roschewski, M.D.Principal InvestigatorNational Cancer Institute (NCI)
18 Previous Clinical Trials
2,104 Total Patients Enrolled
1 Trials studying Gray Zone Lymphoma
348 Patients Enrolled for Gray Zone Lymphoma
~2 spots leftby Sep 2025
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