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Checkpoint Inhibitor

Nivolumab for Acute Myeloid Leukemia

Phase 2

Waitlist Available

Led By Wendy Stock

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

Age >= 18 years

Eastern Cooperative Oncology Group (ECOG)/Karnofsky performance status of 0 or 1 (Karnofsky >= 70%)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up time from randomization to the date of death from any cause, assessed up to 2 years post-treatment

Awards & highlights

Study Summary

This trial looks at how well nivolumab works in patients with acute myeloid leukemia who had a decrease in or disappearance of cancer symptoms after chemotherapy.

Who is the study for?

Adults with acute myeloid leukemia in remission after chemotherapy, not eligible for stem cell transplant due to age or other factors, and who haven't used certain immune-targeting drugs before. Participants must have adequate organ function, agree to use contraception, and not be pregnant or breastfeeding.Check my eligibility

What is being tested?

The REMAIN trial is testing if Nivolumab can prevent cancer from returning in patients whose acute myeloid leukemia has responded well to chemotherapy. It involves monitoring health signs, collecting biological samples, bone marrow biopsies, and heart scans.See study design

What are the potential side effects?

Nivolumab may cause immune system-related side effects such as inflammation of organs (like the lungs or intestines), skin reactions, hormone gland problems (like thyroid dysfunction), infusion reactions during administration of the drug, fatigue and weakness.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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I am fully active or able to carry out light work.

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My kidney function, measured by creatinine or clearance, is within the required range.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ time from randomization to the date of death from any cause, assessed up to 2 years post-treatment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~time from randomization to the date of death from any cause, assessed up to 2 years post-treatment

This trial's timeline: 3 weeks for screening, Varies for treatment, and time from randomization to the date of death from any cause, assessed up to 2 years post-treatment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Progression free survival (PFS)

Secondary outcome measures

Incidence of adverse effects of nivolumab

Perinatal death

Overall survival (OS)

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%

Hypomagnesaemia

19%

Headache

18%

Arthralgia

16%

Asthenia

16%

Dizziness

16%

Neutrophil count decreased

15%

Thrombocytopenia

15%

Insomnia

14%

Rash

14%

Hyponatraemia

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%

Muscular weakness

10%

Alopecia

10%

Dry skin

10%

Hypoalbuminaemia

10%

Chest pain

10%

Dysgeusia

10%

Pneumonia

10%

Productive cough

Abdominal pain upper

Upper respiratory tract infection

Hypothyroidism

Mucosal inflammation

Peripheral sensory neuropathy

Lacrimation increased

Nasopharyngitis

Non-cardiac chest pain

Epistaxis

Haemoptysis

Stomatitis

Dysphonia

Bronchitis

Dehydration

Hyperkalaemia

Hyperglycaemia

Chills

Blood alkaline phosphatase increased

Hypertension

Lymphocyte count decreased

Anxiety

Leukopenia

Hypophosphataemia

Pleural effusion

Neuropathy peripheral

Pneumonitis

Oropharyngeal pain

Rash maculo-papular

Hypotension

Malaise

Pain

Musculoskeletal chest pain

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

Small intestinal haemorrhage

Femur fracture

Bone pain

Pericardial effusion malignant

Cancer pain

Confusional state

Pneumothorax

Neoplasm progression

Circulatory collapse

Atrial flutter

Bronchial obstruction

Hypercalcaemia

Superior vena cava syndrome

Syncope

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

2Treatment groups

Experimental Treatment

Active Control

Group I: Arm I (nivolumab)Experimental Treatment4 Interventions

Patients receive nivolumab IV over 60 minutes once every 2 weeks. Treatment repeats every 2 weeks for 46 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo bone marrow biopsy at screening, months 3, 6, and 12, as clinically indicated, and during off-study evaluation. Patients also undergo collection of blood samples at screening, weeks 9, 13, 25, and 53, and during off-study evaluation or at time of clinically suspected relapse. Patients may undergo ECHO as clinically indicated.

Group II: Arm II (observation)Active Control4 Interventions

Patients undergo standard of care clinical observation for up to 2 years. Upon disease relapse, patients may cross-over to Arm I. Patients also undergo bone marrow biopsy at screening, months 3, 6, and 12, as clinically indicated, and during off-study evaluation. Patients also undergo collection of blood samples at screening, weeks 9, 13, 25, and 53, and during off-study evaluation or at time of clinically suspected relapse. Patients may undergo ECHO as clinically indicated.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Bone Marrow Biopsy

2021

Completed Phase 2

~10

Echocardiography

2013

Completed Phase 4

~11670

Biospecimen Collection

2004

Completed Phase 2

~1730

Nivolumab

2014

Completed Phase 3

~4750

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor

13,654 Previous Clinical Trials

40,933,071 Total Patients Enrolled

Wendy StockPrincipal InvestigatorUniversity of Chicago Comprehensive Cancer Center EDDOP

2 Previous Clinical Trials

307 Total Patients Enrolled

Hongtao LiuPrincipal InvestigatorUniversity of Chicago Comprehensive Cancer Center EDDOP

5 Previous Clinical Trials

151 Total Patients Enrolled

Frequently Asked Questions

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

Has Nivolumab received the sanction of the US Food and Drug Administration?

"Nivolumab's safety rating was estimated to be a 2, as this is classified as Phase 2 trial. That indicates that there has been some evidence of its safety but no formal data backing its efficacy yet."

Answered by AI

Is the enrollment process still open for this clinical investigation?

"Unfortunately, the study listed on clinicaltrials.gov is not currently accepting new recruits. Initially posted in May of 2015 and last updated on September 1st 2022, this trial has yet to begin searching for participants. However, there are 2286 other trials actively recruiting patients at present."

Answered by AI

Is this experimental research a pioneering endeavor?

"A survey of clinicaltrials.gov has revealed that Nivolumab, which was first tested in 2012 by Ono Pharmaceutical Co. Ltd and involved 659 participants across 49 countries and 2354 cities, is currently being studied for 812 trials taking place worldwide."

Answered by AI

What is the current enrollment size for this research experiment?

"Unfortunately, the research team is no longer accepting applicants. Initially posted on May 27th 2015 and last updated September 1st 2022, this clinical trial has already reached its recruitment goals. For those seeking alternative studies to participate in, there are 1568 ongoing trials related to leukemia, myeloid acute diseases looking for patients as well as 718 Nivolumab-related medical experiments that currently need volunteers."

Answered by AI

What is the current scope of this trial with respect to medical facilities?

"At present, 47 clinics are enrolling patients for this medical trial. Participants will have the advantage of selecting a nearby location as La Jolla, Bronx and Tucson all provide access to potential enrolment in addition to 44 other sites distributed across the US."

Answered by AI

Has Nivolumab been trialed in any other research studies?

"Nivolumab was initially researched in 2012 at Local Institution, and to date there have been 812 completed studies. As of now, 718 trials are being conducted across the globe – a majority of which take place in La Jolla, California."

Answered by AI