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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 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 1 year

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%

Hypoalbuminaemia

10%

Muscular weakness

10%

Dry skin

10%

Chest pain

10%

Dysgeusia

10%

Pneumonia

10%

Productive cough

Abdominal pain upper

Upper respiratory tract infection

Hypothyroidism

Mucosal inflammation

Peripheral sensory neuropathy

Nasopharyngitis

Lacrimation increased

Non-cardiac chest pain

Epistaxis

Haemoptysis

Stomatitis

Dysphonia

Chills

Hyperkalaemia

Hypertension

Bronchitis

Dehydration

Blood alkaline phosphatase increased

Hyperglycaemia

Lymphocyte count decreased

Anxiety

Hypophosphataemia

Leukopenia

Pleural effusion

Neuropathy peripheral

Pneumonitis

Oropharyngeal pain

Hypotension

Pain

Malaise

Musculoskeletal chest pain

Rash maculo-papular

Dry mouth

Urinary tract infection

Dyspepsia

Gamma-glutamyltransferase increased

Depression

Muscle spasms

Fall

Pulmonary embolism

Metastases to central nervous system

Myocardial infarction

Febrile neutropenia

Musculoskeletal pain

Chronic obstructive pulmonary disease

Sepsis

Malignant pleural effusion

General physical health deterioration

Adrenal insufficiency

Atrial fibrillation

Cardiac failure

Embolism

Pericardial effusion malignant

Pneumothorax

Atrial flutter

Bone pain

Small intestinal haemorrhage

Bronchial obstruction

Femur fracture

Syncope

Hypercalcaemia

Confusional state

Cancer pain

Neoplasm progression

Circulatory collapse

Superior vena cava syndrome

Performance status decreased

Pancytopenia

Colitis

Pericardial effusion

Gastrointestinal haemorrhage

Ileus

Small intestinal obstruction

Lung cancer metastatic

Respiratory tract infection

Respiratory failure

Tumour pain

Appendicitis

Skin infection

Ataxia

Seizure

100%

80%

60%

40%

20%

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

0 / 7Eligibility criteria met