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PD-1 Inhibitor

Pembrolizumab for Cancer Post-Stem Cell Transplant

Phase < 1
Recruiting
Led By Justin Kline, MD
Research Sponsored by University of Chicago
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Subjects must be ≥ 18 years of age.
Subjects must have an ECOG performance status of 0-1 (Appendix).
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from start date of therapy to the date of death from any cause, whichever may come first, assessed up to 100 months
Awards & highlights

Study Summary

This trial is designed to study the safety of giving the drug pembrolizumab to people who have had a stem cell transplant to treat their cancer. Pembrolizumab will be given at a fixed dose of 200 mg IV (into a vein) every 3 weeks. Up to 26 patients will be enrolled in this trial.

Who is the study for?
Adults with relapsed Myeloid Leukemia, B-Cell Lymphoma, Hodgkin's or Non-Hodgkin's Lymphoma after stem cell transplant can join. They must be in good health otherwise, not have severe graft-versus-host disease or active infections, and women of childbearing age need a negative pregnancy test and agree to use contraception.Check my eligibility
What is being tested?
The trial is testing Pembrolizumab for patients whose blood cancer returned after an allogeneic stem cell transplant. It involves getting the drug through IV every 3 weeks for up to 2 years unless there are serious side effects or the disease gets worse.See study design
What are the potential side effects?
Pembrolizumab may cause immune system-related side effects like inflammation in various organs, infusion reactions (like fever and chills), fatigue, skin rash, diarrhea, liver problems (hepatitis), hormonal gland issues (like thyroid dysfunction), and could worsen existing autoimmune diseases.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
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I can carry out all my usual activities without help.
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My cancer has returned after a stem cell transplant.
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My B cell lymphoma has a measurable tumor larger than 15mm long and 10mm wide.
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I haven't used any experimental treatments or devices in the last 4 weeks.
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My kidney function, measured by creatinine or GFR, is within the normal range.
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I had a stem cell transplant from a donor more than 90 days ago.
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I have never had Veno-Occlusive Disease (VOD).
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My organ functions are within normal ranges as required.
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I have taken a pregnancy test within the last 72 hours and it was negative.
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I am using or willing to use two forms of birth control or abstain from sex during the study.
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I agree to use or continue using birth control until 4 months after my last dose of the study medicine.
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I have AML, MDS, or B cell lymphomas that came back after a stem cell transplant from a matched donor.
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I haven't taken any immunosuppressive drugs for at least 2 weeks, except for low-dose steroids.
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I have signed the consent form for this study.
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My liver function tests are within the required range.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from start date of therapy to the date of death from any cause, whichever may come first, assessed up to 100 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and from start date of therapy to the date of death from any cause, whichever may come first, assessed up to 100 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of patients with adverse events
Secondary outcome measures
Time between first documentation of complete remission (CR) or partial remission (PR) (by IRC) to the first documentation of disease progression or death by any cause
Time between initial response and subsequent disease progression or relapse
Time between the start of therapy to death from any cause.
Other outcome measures
Compare PD-L1 expression on malignant cells at initial diagnosis and at disease relapse following alloSCT
Effect of pembrolizumab on the T cell receptor (TCR) repertoire in the peripheral blood, and where available, tumor environment, following alloSCT
Effect of pembrolizumab on the numbers and activations status of peripheral blood T cells
+1 more

Side effects data

From 2024 Phase 2 trial • 57 Patients • NCT03004183
21%
Fatigue
13%
Nausea
11%
Back pain
9%
Shortness of Breath
9%
Anemia
9%
Abdominal pain
9%
Diarrhea
7%
Kidney Injury and/or Infection
7%
Pneumonia
7%
Dyspnea
7%
Weight Loss
5%
Malnutrition, Hypercalcemia and Weakness
5%
Pneumothorax
5%
Activated partial thromboplastin time prolonged
5%
Intractable pain, back pain, hip pain
4%
Pleural effusion
4%
Atrial fibrillation with rapid ventricular response
2%
Skin rash
2%
Thrombocytopenia
2%
Respiratory failure
2%
colitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Single Arm

Trial Design

1Treatment groups
Experimental Treatment
Group I: PembrolizumabExperimental Treatment1 Intervention
Pembrolizumab will be administered at a fixed dose of 200 mg IV every 3 weeks. Treatment will be administered for up to 24 months, provided that neither disease progression, nor development of a dose-limiting toxicity (DLT), has occurred.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
FDA approved

Find a Location

Who is running the clinical trial?

University of ChicagoLead Sponsor
997 Previous Clinical Trials
817,672 Total Patients Enrolled
Justin Kline, MDPrincipal InvestigatorUniversity of Chicago
2 Previous Clinical Trials
64 Total Patients Enrolled

Media Library

Pembrolizumab (PD-1 Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT02981914 — Phase < 1
Myelodysplastic Syndrome Research Study Groups: Pembrolizumab
Myelodysplastic Syndrome Clinical Trial 2023: Pembrolizumab Highlights & Side Effects. Trial Name: NCT02981914 — Phase < 1
Pembrolizumab (PD-1 Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02981914 — Phase < 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many individuals are being treated as part of this experiment?

"Affirmative. Clinicaltrials.gov hosts data that confirms the recruitment of 26 patients from one medical centre for this trial, which was originally posted on March 7th 2017 and last updated June 29th 2021."

Answered by AI

What medical conditions has Pembrolizumab been proven to be effective in alleviating?

"Pembrolizumab is routinely administered as a treatment for malignant neoplasms. It has also been utilized to address cases of unresectable melanoma, microsatellite instability-high diseases, and situations where chemotherapy fails to stop disease progression."

Answered by AI

Are there any available openings in this medical research project?

"According to the public record on ClinicalTrials.gov, this clinical trial is actively recruiting participants. The listing was initially posted in March of 2017 with a final edit taking place at the end of June 2021."

Answered by AI

Could you provide information on other research pertaining to Pembrolizumab?

"At present, there are 962 trials utilising Pembrolizumab. Of these studies, 122 have moved into Phase 3 testing. The majority of research is based in Houston but the drug can be accessed at thirty-five thousand seven hundred and sixty five other locations worldwide."

Answered by AI
~3 spots leftby Mar 2025