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PD-1 Inhibitor

Pembrolizumab for Lymphoma

Phase 2
Waitlist Available
Research Sponsored by Merck Sharp & Dohme Corp.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Has radiographically measurable cHL or PMBCL disease as per Lugano classification with at least 1 nodal lesion (which has not been previously radiated) that is >15 mm in long axis, regardless of the length of the short axis, and/or extranodal lesion of >10 mm in long and short axis.
- For participants who are ineligible for auto-SCT, have received at least ≥2 lines of prior therapy and have failed to respond to or relapsed after their last line of treatment. At least 1 of the prior lines of therapy must contain a rituximab-based regimen.
Must not have
Has received prior chimeric antigen receptor T-cell (CAR-T) therapy
Has received prior therapy with an anti-programmed cell death 1 protein (PD-1), anti-programmed cell death ligand 1 (PD-L1), or anti-programmed cell death ligand 2 (PD-L2) agent or with an agent directed to another stimulatory or coinhibitory T-cell receptor (e.g., CTLA-4, OX-40, CD137)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 40 months
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing whether the drug pembrolizumab can help treat people with Hodgkin lymphoma or primary mediastinal large B-cell lymphoma.

Who is the study for?
This trial is for adults with specific types of lymphoma (cHL or PMBCL) that have come back or didn't respond to treatment. They should be fairly healthy, able to perform daily activities with ease or only limited help, and not pregnant or breastfeeding. Participants need measurable disease, may have had certain prior treatments but not others like CAR-T therapy, and must not have serious heart issues or active infections.
What is being tested?
The study tests Pembrolizumab given every six weeks to see how well it works against two kinds of lymphoma. The main goal is to check the percentage of patients whose cancer shrinks or disappears after treatment as judged by a set standard called Lugano classification criteria.
What are the potential side effects?
Pembrolizumab can cause immune system-related side effects such as inflammation in various organs including lungs (pneumonitis), liver, intestines, hormone glands and skin. It might also lead to infusion reactions during drug administration.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My cancer can be measured on scans and has a large enough lesion that hasn't been treated with radiation.
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I've had 2+ treatments for my condition and didn't respond well to the last one, including a treatment with rituximab.
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My Hodgkin's lymphoma returned after my last treatment.
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I've had at least one treatment for Hodgkin lymphoma and it didn't work or the cancer came back.
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My PMBCL cancer has returned or is not responding to treatment.
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My diagnosis is cHL or PMBCL, as confirmed by a lab test.
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I am fully active or restricted in physically strenuous activity but can do light work.
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My Hodgkin lymphoma has returned or is not responding to treatment.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have received CAR-T cell therapy before.
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I have been treated with specific immune therapy drugs before.
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I haven't had monoclonal antibody treatment in the last 4 weeks or have recovered from its side effects.
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My lymphoma has spread to my brain or spinal cord.
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I am currently being treated for an infection.
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I have or had lung inflammation that needed steroids.
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I have a history of Hepatitis B or active Hepatitis C.
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I haven't had radiotherapy in the last 2 weeks and have no lung damage from past treatments.
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I have an immune system disorder or have been on high-dose steroids or other immune-weakening medicines recently.
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I haven't had cancer treatment or major surgery in the last 4 weeks.
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I have had a solid organ transplant or a bone marrow transplant in the last 5 years.
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I have fluid around my heart or in my lungs.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 40 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 40 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Objective Response Rate (ORR) per Lugano Classification as Assessed by Investigator
Secondary study objectives
Antidrug Antibody Levels (ADA) for Pembrolizumab
Area Under the Curve (AUC) of Pembrolizumab
Duration of Response (DOR) per Lugano Classification as Assessed by BICR
+6 more

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%
Clostridium difficile colitis
1%
Systemic infection
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: Arm 1Experimental Treatment1 Intervention
Pembrolizumab (MK-3475), 400 mg, Q6W, intravenous (IV) infusion, Day 1 then Q6W up to 18 doses.
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?

Merck Sharp & Dohme Corp.Lead Sponsor
2,286 Previous Clinical Trials
4,582,156 Total Patients Enrolled
Merck Sharp & Dohme LLCLead Sponsor
4,012 Previous Clinical Trials
5,185,236 Total Patients Enrolled
Medical DirectorStudy DirectorMerck Sharp & Dohme LLC
2,887 Previous Clinical Trials
8,088,778 Total Patients Enrolled

Media Library

Pembrolizumab (PD-1 Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04875195 — Phase 2
Hodgkin's Lymphoma Research Study Groups: Arm 1
Hodgkin's Lymphoma Clinical Trial 2023: Pembrolizumab Highlights & Side Effects. Trial Name: NCT04875195 — Phase 2
Pembrolizumab (PD-1 Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04875195 — Phase 2
~15 spots leftby Nov 2025
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