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Anti-metabolites
Pembrolizumab for Myelodysplastic Syndrome
Phase 2
Waitlist Available
Led By Guillermo Garcia-Manero
Research Sponsored by M.D. Anderson Cancer Center
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 up to 4 years
Awards & highlights
Study Summary
This trial is studying the side effects and effectiveness of two drugs, azacitidine and pembrolizumab, in treating patients with myelodysplastic syndrome.
Eligible Conditions
- Myelodysplastic Syndrome
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 4 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 4 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Event Free Survival
Overall Response Rate (ORR) Defined as Complete Response + Partial Response + Hematological Improvement
Overall Survival
Other outcome measures
Immunological and molecular changes
Side effects data
From 2024 Phase 2 trial • 57 Patients • NCT0300418321%
Fatigue
13%
Nausea
11%
Back pain
9%
Shortness of Breath
9%
Anemia
9%
Abdominal pain
9%
Diarrhea
7%
Pneumonia
7%
Kidney Injury and/or Infection
7%
Dyspnea
7%
Weight Loss
5%
Malnutrition, Hypercalcemia and Weakness
5%
Pneumothorax
5%
Intractable pain, back pain, hip pain
5%
Activated partial thromboplastin time prolonged
4%
Pleural effusion
4%
Atrial fibrillation with rapid ventricular response
2%
Thrombocytopenia
2%
Respiratory failure
2%
Skin rash
2%
colitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Single Arm
Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (azacitidine, pembrolizumab)Experimental Treatment2 Interventions
Patients receive azacitidine Intravenous (IV) over 10-40 minutes or Subcutaneous (SC) on days 1-7, and pembrolizumab IV over 30 minutes every 3 weeks. Cycles repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Azacitidine
2012
Completed Phase 3
~1440
Pembrolizumab
2017
Completed Phase 2
~2010
Find a Location
Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
2,967 Previous Clinical Trials
1,804,762 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,657 Previous Clinical Trials
40,933,627 Total Patients Enrolled
Guillermo Garcia-ManeroPrincipal InvestigatorM.D. Anderson Cancer Center
9 Previous Clinical Trials
1,518 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You received a stem cell transplant in the past.You are currently receiving or have received an experimental treatment within four weeks of starting this study.You have a mental health condition or struggle with drug or alcohol addiction that could make it difficult for you to follow the trial requirements.You have had lung inflammation in the past, or currently have lung inflammation that is not caused by an infection.You are allergic to 5-azacitidine or MK3475 or any substances used to make them.You may or may not have received treatment with a medication called a hypomethylating agent. If you have received this treatment, you must have taken it for at least 6 cycles and not had a positive response or your condition has worsened.You have another cancer that is getting worse or needs immediate treatment, except for certain types of skin or cervical cancers that have been treated before.You have taken experimental drugs or received chemotherapy, immunotherapy or radiation therapy within the last month before the start of this clinical trial.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (azacitidine, pembrolizumab)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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