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Checkpoint Inhibitor

Nivolumab + Ipilimumab for Acute Myeloid Leukemia or Myelodysplastic Syndrome

Phase 1
Waitlist Available
Led By Gheath Al-Atrash
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
Males must be surgically or biologically sterile or agree to use an adequate method of contraception during the study until 3 months after the last treatment
Patients must have received preparative regimens to include either busulfan- or melphalan-based regimens
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 1 year
Awards & highlights

Study Summary

This trialtests immunotherapy with monoclonal antibodies to treat high risk acute myeloid leukemia or myelodysplastic syndrome that has not responded to treatment.

Who is the study for?
This trial is for patients with high-risk, treatment-resistant or relapsed acute myeloid leukemia or myelodysplastic syndrome after a donor stem cell transplant. Participants must have stable vital organ functions, agree to contraception if of childbearing potential, and not have severe graft-versus-host disease, uncontrolled illnesses, known allergies to the study drugs, certain autoimmune diseases, active infections like HIV or hepatitis C.Check my eligibility
What is being tested?
The trial is testing the safety and optimal doses of two immunotherapy drugs—nivolumab and ipilimumab—administered post-stem cell transplant. These monoclonal antibodies are designed to boost the immune system's ability to fight cancer by targeting tumor cells' growth and spread mechanisms.See study design
What are the potential side effects?
Potential side effects include immune-related reactions that can affect organs (like inflammation), infusion-related symptoms (such as fever or chills), fatigue, skin rash, hormonal gland issues (like thyroid dysfunction), digestive problems (colitis), liver enzyme elevation which may indicate liver inflammation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am a male and will use birth control during and for 3 months after the study.
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I have been treated with busulfan or melphalan before my transplant.
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My white blood cell count has been stable for 3 days.
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I am not able to have children, am postmenopausal, or have a negative pregnancy test.
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My AML or MDS has returned or didn't respond after a stem cell transplant.
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I can take care of myself but might not be able to do heavy physical work.
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My kidney function is within the required range.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Optimal dose of nivolumab in combination with ipilimumab
Secondary outcome measures
Disease-free survival (DFS)
Duration of response (DOR)
Overall response rate (ORR)
+1 more
Other outcome measures
Immune cell phenotype
Immune checkpoint molecule expression
Immune phenotype in patients who experience aGVHD
+4 more

Side effects data

From 2022 Phase 3 trial • 541 Patients • NCT02041533
57%
Nausea
54%
Anaemia
51%
Fatigue
39%
Decreased appetite
36%
Malignant neoplasm progression
32%
Constipation
31%
Diarrhoea
30%
Cough
29%
Vomiting
29%
Dyspnoea
25%
Oedema peripheral
24%
Back pain
21%
Pyrexia
21%
Neutropenia
19%
Headache
19%
Hypomagnesaemia
18%
Arthralgia
16%
Asthenia
16%
Dizziness
16%
Neutrophil count decreased
15%
Thrombocytopenia
15%
Insomnia
14%
Hyponatraemia
14%
Rash
14%
Weight decreased
14%
Platelet count decreased
13%
Blood creatinine increased
13%
White blood cell count decreased
12%
Hypokalaemia
12%
Pruritus
12%
Abdominal pain
12%
Pain in extremity
11%
Myalgia
11%
Alanine aminotransferase increased
11%
Aspartate aminotransferase increased
10%
Alopecia
10%
Dry skin
10%
Hypoalbuminaemia
10%
Muscular weakness
10%
Chest pain
10%
Dysgeusia
10%
Pneumonia
10%
Productive cough
9%
Abdominal pain upper
9%
Upper respiratory tract infection
9%
Hypothyroidism
9%
Mucosal inflammation
9%
Peripheral sensory neuropathy
8%
Lacrimation increased
8%
Nasopharyngitis
8%
Non-cardiac chest pain
8%
Epistaxis
8%
Haemoptysis
8%
Stomatitis
8%
Dysphonia
7%
Bronchitis
7%
Blood alkaline phosphatase increased
7%
Chills
7%
Hypertension
7%
Dehydration
7%
Hyperkalaemia
7%
Hyperglycaemia
7%
Lymphocyte count decreased
7%
Anxiety
6%
Leukopenia
6%
Hypophosphataemia
6%
Pleural effusion
6%
Neuropathy peripheral
6%
Pneumonitis
6%
Oropharyngeal pain
5%
Rash maculo-papular
5%
Hypotension
5%
Musculoskeletal chest pain
5%
Malaise
5%
Pain
5%
Dry mouth
5%
Urinary tract infection
5%
Dyspepsia
5%
Gamma-glutamyltransferase increased
5%
Depression
5%
Muscle spasms
4%
Fall
4%
Pulmonary embolism
3%
Metastases to central nervous system
3%
Myocardial infarction
3%
Febrile neutropenia
3%
Musculoskeletal pain
3%
Chronic obstructive pulmonary disease
2%
Sepsis
2%
Malignant pleural effusion
2%
General physical health deterioration
2%
Adrenal insufficiency
2%
Atrial fibrillation
2%
Cardiac failure
2%
Embolism
1%
Hypercalcaemia
1%
Neoplasm progression
1%
Small intestinal haemorrhage
1%
Femur fracture
1%
Pericardial effusion malignant
1%
Cancer pain
1%
Confusional state
1%
Pneumothorax
1%
Circulatory collapse
1%
Bone pain
1%
Atrial flutter
1%
Bronchial obstruction
1%
Superior vena cava syndrome
1%
Syncope
1%
Performance status decreased
1%
Pancytopenia
1%
Colitis
1%
Pericardial effusion
1%
Gastrointestinal haemorrhage
1%
Ileus
1%
Small intestinal obstruction
1%
Lung cancer metastatic
1%
Respiratory tract infection
1%
Respiratory failure
1%
Tumour pain
1%
Appendicitis
1%
Skin infection
1%
Ataxia
1%
Seizure
100%
80%
60%
40%
20%
0%
Study treatment Arm
Investigator Choice of Chemotherapy
Post Chemotherapy Optional Nivolumab
Nivolumab

Trial Design

3Treatment groups
Experimental Treatment
Group I: Arm C (nivolumab and ipilimumab)Experimental Treatment2 Interventions
Beginning at least 6 weeks post-stem cell transplant, patients receive nivolumab IV over 60 minutes on days 1, 14, and 28, and ipilimumab IV over 90 minutes on day 1. Treatment repeats every 6 weeks for up to 6 cycles in the absence of disease progression or unacceptable toxicity.
Group II: Arm B (ipilimumab)Experimental Treatment1 Intervention
Beginning at least 6 weeks post-stem cell transplant, patients receive ipilimumab IV over 90 minutes on day 1. Treatment repeats every 21 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity.
Group III: Arm A (nivolumab)Experimental Treatment1 Intervention
Beginning at least 6 weeks post-stem cell transplant, patients receive nivolumab IV over 60 minutes on days 1 and 15. Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ipilimumab
FDA approved
Nivolumab
FDA approved

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor
2,966 Previous Clinical Trials
1,804,752 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,654 Previous Clinical Trials
40,933,124 Total Patients Enrolled
Gheath Al-AtrashPrincipal InvestigatorM.D. Anderson Cancer Center
2 Previous Clinical Trials
26 Total Patients Enrolled

Media Library

Ipilimumab (Checkpoint Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03600155 — Phase 1
Acute Myelogenous Leukemia Research Study Groups: Arm A (nivolumab), Arm B (ipilimumab), Arm C (nivolumab and ipilimumab)
Acute Myelogenous Leukemia Clinical Trial 2023: Ipilimumab Highlights & Side Effects. Trial Name: NCT03600155 — Phase 1
Ipilimumab (Checkpoint Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03600155 — Phase 1

Frequently Asked Questions

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

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Nivolumab and Ipilimumab After Donor Stem Cell Transplant in Treating Patients With High Risk Refractory or Relapsed Acute Myeloid Leukemia or Myelodysplastic Syndrome
2018. "Nivolumab and Ipilimumab After Donor Stem Cell Transplant in Treating Patients With High Risk Refractory or Relapsed Acute Myeloid Leukemia or Myelodysplastic Syndrome". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03600155.
~4 spots leftby Apr 2025
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