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Anti-metabolite
Pembrolizumab + Azacitidine + Venetoclax for Acute Myeloid Leukemia
Phase 2
Waitlist Available
Led By Amer M Zeidan
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
ECOG performance status of 0-3
Newly diagnosed and pathologically-confirmed, previously untreated AML as defined by WHO criteria
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 years
Awards & highlights
Study Summary
This trial is testing a new combination of drugs to treat acute myeloid leukemia in older patients. The drugs work in different ways to stop the growth of cancer cells. The trial may help the body's immune system attack the cancer and reduce the chance of the leukemia coming back.
Who is the study for?
This trial is for patients aged 60 or older with newly diagnosed acute myeloid leukemia who are unfit for intensive chemotherapy. They should have an ECOG performance status of 0-3, specific risk profiles of AML, and adequate organ function. Pregnant women, those unwilling to use contraception, and individuals with certain medical conditions or prior treatments are excluded.Check my eligibility
What is being tested?
The study tests azacitidine and venetoclax combined with pembrolizumab (an immunotherapy drug) against the same chemotherapy drugs without pembrolizumab. The goal is to see if adding pembrolizumab improves treatment outcomes in these patients by helping the immune system fight cancer more effectively.See study design
What are the potential side effects?
Potential side effects include reactions related to the immune system attacking normal organs (autoimmune reactions), infusion-related reactions from receiving drugs through a vein, fatigue, liver issues reflected in blood tests, kidney function changes requiring monitoring, and increased risk of infections.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I can care for myself but may not be able to do heavy physical work.
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I have been newly diagnosed with AML without previous treatment.
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I cannot or do not want to undergo intensive chemotherapy.
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I am not pregnant.
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I can care for myself but may not be able to do heavy physical work.
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I am 60 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Percentage of patients with minimal residual disease negative complete remission (MRD-CR) or MRD-complete remission with incomplete count recovery (Cri) with azacitidine (AZA) + venetoclax (VEN) with MK-3475 (pembrolizumab)
Secondary outcome measures
Proportion of patients who develop severe toxicity
Other outcome measures
Biomarkers effects between treatment arms
Biomarkers or serial measurements of biomarkers associated with response outcomes
Biomarkers or serial measurements of biomarkers associated with survival outcomes
+5 moreSide 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
2Treatment groups
Experimental Treatment
Active Control
Group I: Arm II (AZA, VEN, pembrolizumab)Experimental Treatment5 Interventions
INDUCTION THERAPY PHASE: Patients receive pembrolizumab IV over 30 minutes on day 8 of cycle 1 and every 3 weeks in cycle 2-6, azacitidine IV over 10-40 minutes or SC on days 1-7 or days 1-5 in week 1 and 1-2 in week 2, and venetoclax PO on days 1-28 of cycle 1 and days 1-21 or 1-28 of subsequent cycles. Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity.
MAINTENANCE PHASE: Patients receive pembrolizumab IV over 30 minutes on day 8 of cycle 1 and every 3 weeks in cycle 2-6, azacitidine IV over 10-40 minutes or SC on days 1-7 or days 1-5 in week 1 and 1-2 in week 2, and venetoclax PO on days 1-28 of cycle 1 and days 1-21 or 1-28 of subsequent cycles. Treatment repeats every 28 days for up to 24 cycles in the absence of disease progression or unacceptable toxicity. After completion of 24 cycles, patients who respond to treatment or have SD may continue treatment with azacitidine and venetoclax per physician discretion.
Group II: Arm I (AZA, VEN)Active Control6 Interventions
INDUCTION THERAPY PHASE: Patients receive azacitidine IV over 10-40 minutes or SC on days 1-7 or days 1-5 in week 1 and 1-2 in week 2. Patients also receive venetoclax PO on days 1-28 of cycle 1 and days 1-21 or 1-28 of subsequent cycles. Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity.
MAINTENANCE THERAPY PHASE: Patients receive azacitidine IV over 10-40 minutes or SC on days 1-7 or days 1-5 in week 1 and 1-2 in week 2. Patients also receive venetoclax PO on days 1-28 of cycle 1 and days 1-21 or 1-28 of subsequent cycles. Cycles repeat every 28 days for up to 3 years in the absence of disease progression or unacceptable toxicity. After completion of 24 cycles, patients who respond to treatment or have SD may continue treatment per physician discretion.
Patients also undergo bone marrow biopsy and/or aspiration and collection of blood samples throughout the trial and undergo a skin biopsy at baseline.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Biospecimen Collection
2004
Completed Phase 2
~1730
Venetoclax
2019
Completed Phase 3
~1990
Biopsy
2014
Completed Phase 4
~850
Pembrolizumab
2017
Completed Phase 2
~2010
Azacitidine
2012
Completed Phase 3
~1440
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
13,654 Previous Clinical Trials
40,933,077 Total Patients Enrolled
Amer M ZeidanPrincipal InvestigatorYale University Cancer Center LAO
2 Previous Clinical Trials
152 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I don't have any health issues that could affect the trial's results or my participation.My AML is not considered low risk, except for a good-risk cytogenetic profile.You have a mental illness or social situation that might make it difficult for you to follow the study guidelines.I have or had lung inflammation treated with steroids.I can care for myself but may not be able to do heavy physical work.Your kidney function will be checked according to the hospital's guidelines.I am currently taking steroids or drugs that weaken my immune system.I am using treatments like hydroxyurea for high white blood cell count.I have a specific type of acute myeloid leukemia (AML).I have been newly diagnosed with AML without previous treatment.I can use specific treatments for high white blood cell count before starting the study.You have a type of leukemia called AML that is considered intermediate or poor risk, except for a specific type called "good-risk" AML. Your eligibility will be determined based on genetic testing from a blood or marrow sample taken up to 3 weeks before signing consent. Your kidney function must also meet certain requirements.My AML developed from a previous blood disorder.My kidney function tests are within normal limits.I am HIV positive with undetectable viral load and cured of HCV.I have been treated with drugs targeting PD-1, PD-L1, or PD-L2.I am being treated for anemia that causes my red blood cells to break down.I still have side effects from cancer treatment, except for mild neuropathy or hair loss.I currently have an infection that isn't under control.I have an immune system disorder or have been on high-dose steroids or immunosuppressants recently.I cannot or do not want to undergo intensive chemotherapy.I have not received a live vaccine in the last 30 days.I haven't had cancer treatment with antibodies in the last 4 weeks or still have side effects from them.I do not have any unmanaged ongoing illnesses.I have received a transplant from another person.You have had an allergic reaction to pembrolizumab or any other drugs being used in this study.I have active brain or spinal cord cancer.I have not needed treatment for an autoimmune disease in the last 2 years.I do not have another cancer that needs treatment or shortens my life expectancy to 2 years or less.I cannot or do not want to undergo intensive chemotherapy.Your bilirubin levels need to be within a certain range.I am not pregnant.I can care for myself but may not be able to do heavy physical work.I have newly diagnosed AML without prior treatment, according to WHO criteria.I haven't had chemotherapy, targeted therapy, or radiotherapy in the last 4 to 6 weeks.I have AML and haven't been treated with hypomethylating agents for it. I may have used them for MDS or MPN but not more than one cycle.My cancer has not spread to my bone marrow.I have an active tuberculosis infection.I have used lenalidomide or other treatments for my previous MDS condition.You are currently pregnant or breastfeeding.I am 60 years old or older.I have completed at least one full cycle of HMA therapy for my MDS or AML.I have recovered from any major surgery complications.My kidney function, measured by GFR, is within the required range.
Research Study Groups:
This trial has the following groups:- Group 1: Arm I (AZA, VEN)
- Group 2: Arm II (AZA, VEN, 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.
Are we still looking for candidates to participate in this clinical trial?
"The listing on clinicaltrials.gov verifies that this study is still inviting patients to participate. This trial was originally posted on August 3rd, 2020 and was last updated November 10th, 2020. They are looking for a total of 76 individuals at 24 different locations."
Answered by AI
What is the projected participant size for this clinical trial?
"That is correct. The trial, which was initially posted on August 3rd 2020, is recruiting patients at the moment. They are looking for a total of 76 individuals from 24 different sites."
Answered by AI
Yes, the clinical trial is being conducted in multiple hospitals across Canada.
"There are 24 recruiting patients for this clinical trial including Siteman Cancer Center-South County in Saint Louis, University of Kansas Cancer Center in Kansas City, and Johns Hopkins University/Sidney Kimmel Cancer Center in Baltimore. There are also other sites located in 24 different locations."
Answered by AI
Are there other ongoing studies that include Pembrolizumab?
"Pembrolizumab was first studied in 2006 at Chinese University of Hong Kong-Prince of Wales Hospital and, to date, 495 clinical trials have been completed. There are 1,344 active studies currently underway; many of these taking place in Saint Louis, Missouri."
Answered by AI
For what purpose is Pembrolizumab most often prescribed?
"Pembrolizumab is often given to patients who have relapsed or developed a resistance to other treatments for mediastinal large b-cell lymphoma. Additionally, this drug can be used in the treatment of conditions like complete blood count and induction chemotherapy."
Answered by AI
Have there been any reports of severe side effects from Pembrolizumab?
"Pembrolizumab falls into the Phase 2 category, so there is some data affirming its safety. However, since there are no studies supporting its efficacy, it gets a score of 2."
Answered by AI
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