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Nivolumab + Ipilimumab for Acute Myeloid Leukemia or Myelodysplastic Syndrome
Study Summary
This trialtests immunotherapy with monoclonal antibodies to treat high risk acute myeloid leukemia or myelodysplastic syndrome that has not responded to treatment.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2022 Phase 3 trial • 541 Patients • NCT02041533Trial Design
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Who is running the clinical trial?
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- I have had severe graft-versus-host disease after a transplant.I have been treated with busulfan or melphalan before my transplant.My white blood cell count has been stable for 3 days.My AML or MDS has returned or didn't respond after a stem cell transplant.I am not able to have children, am postmenopausal, or have a negative pregnancy test.It has been at least 6 weeks since my stem cell infusion.I am a male and will use birth control during and for 3 months after the study.I have severe lung issues that are not under control.I can take care of myself but might not be able to do heavy physical work.My kidney function is within the required range.I am allergic to nivolumab, ipilimumab, or their ingredients.
- Group 1: Arm A (nivolumab)
- Group 2: Arm B (ipilimumab)
- Group 3: Arm C (nivolumab and ipilimumab)
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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
What is the aggregate tally of individuals enrolled in this experiment?
"Affirmative. Information published on clinicaltrials.gov attests that this experiment, which was first listed on October 11th 2018, is actively recruiting participants. The team behind the study aims to recruit 55 people from a single centre."
What illnesses has Nivolumab been effectively utilized to manage?
"Nivolumab is commonly used to treat the effects of prior anti-angiogenic therapy, and has been successfully prescribed for ailments such as malignant neoplasms, unresectable melanoma, squamous cell carcinoma."
What adverse reactions have been reported with the use of Nivolumab?
"Due to limited clinical evidence, our team at Power gave Nivolumab a score of 1 on safety. This is because this Phase 1 trial has minimal data supporting both its efficacy and hazard profile."
Is the enrollment process for this research study still open?
"Affirmative. According to the information provided on clinicaltrials.gov, this research endeavor is actively recruiting patients and was first published on November 10th 2018. The latest alteration occurred 25 October 2022 with a goal of enrolling 55 participants at one site."
Could you provide a summary of the findings from prior research on Nivolumab?
"At present, 764 clinical studies are in progress regarding Nivolumab. Of those, 86 are currently in Phase 3. While the majority of these trials for Nivolumab are based in Pittsburgh, Pennsylvania, there is a total of 42752 facilities running experiments on this drug."
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