Trial Outcomes & Findings for Testing Nivolumab to Prevent Disease From Coming Back After Treatment in Patients With Acute Myeloid Leukemia, REMAIN Trial (NCT NCT02275533)
NCT ID: NCT02275533
Last Updated: 2025-12-08
Results Overview
Time from randomization to disease relapse or death from any cause
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE2
Target enrollment
82 participants
Primary outcome timeframe
Assessed up to 5 years
Results posted on
2025-12-08
Participant Flow
Participant milestones
| Measure |
Arm I (Nivolumab)
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.
|
Arm II (Observation)
Patients undergo standard of care clinical observation for up to 2 years. Upon disease relapse, patients may cross-over to Arm I.
|
|---|---|---|
|
Overall Study
STARTED
|
41
|
41
|
|
Overall Study
COMPLETED
|
38
|
41
|
|
Overall Study
NOT COMPLETED
|
3
|
0
|
Reasons for withdrawal
| Measure |
Arm I (Nivolumab)
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.
|
Arm II (Observation)
Patients undergo standard of care clinical observation for up to 2 years. Upon disease relapse, patients may cross-over to Arm I.
|
|---|---|---|
|
Overall Study
Protocol Violation
|
2
|
0
|
|
Overall Study
Never received study treatment
|
1
|
0
|
Baseline Characteristics
Testing Nivolumab to Prevent Disease From Coming Back After Treatment in Patients With Acute Myeloid Leukemia, REMAIN Trial
Baseline characteristics by cohort
| Measure |
Arm I (Nivolumab)
n=38 Participants
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.
|
Arm II (Observation)
n=41 Participants
Patients undergo standard of care clinical observation for up to 2 years. Upon disease relapse, patients may cross-over to Arm I.
|
Total
n=79 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
63.2 years
n=37 Participants
|
65.5 years
n=37 Participants
|
64.4 years
n=74 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=37 Participants
|
19 Participants
n=37 Participants
|
37 Participants
n=74 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=37 Participants
|
22 Participants
n=37 Participants
|
42 Participants
n=74 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=37 Participants
|
0 Participants
n=37 Participants
|
0 Participants
n=74 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=37 Participants
|
0 Participants
n=37 Participants
|
2 Participants
n=74 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=37 Participants
|
0 Participants
n=37 Participants
|
0 Participants
n=74 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=37 Participants
|
5 Participants
n=37 Participants
|
7 Participants
n=74 Participants
|
|
Race (NIH/OMB)
White
|
32 Participants
n=37 Participants
|
32 Participants
n=37 Participants
|
64 Participants
n=74 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=37 Participants
|
0 Participants
n=37 Participants
|
0 Participants
n=74 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=37 Participants
|
4 Participants
n=37 Participants
|
6 Participants
n=74 Participants
|
|
Region of Enrollment
United States
|
38 participants
n=37 Participants
|
41 participants
n=37 Participants
|
79 participants
n=74 Participants
|
PRIMARY outcome
Timeframe: Assessed up to 5 yearsTime from randomization to disease relapse or death from any cause
Outcome measures
| Measure |
Arm I (Nivolumab)
n=38 Participants
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.
|
Arm II (Observation)
n=41 Participants
Patients undergo standard of care clinical observation for up to 2 years. Upon disease relapse, patients may cross-over to Arm I.
|
|---|---|---|
|
Progression Free Survival (PFS)
|
13.2 months
Interval 8.5 to 21.8
|
10.9 months
Interval 5.4 to 14.9
|
SECONDARY outcome
Timeframe: Assessed up to 5 yearsTime from randomization to the date of death from any cause
Outcome measures
| Measure |
Arm I (Nivolumab)
n=38 Participants
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.
|
Arm II (Observation)
n=41 Participants
Patients undergo standard of care clinical observation for up to 2 years. Upon disease relapse, patients may cross-over to Arm I.
|
|---|---|---|
|
Overall Survival (OS)
|
53.9 Months
Interval 23.4 to
NA = Upper confidence limit cannot be estimated due to insufficient number of participants with events
|
30.9 Months
Interval 14.4 to
NA = Upper confidence limit cannot be estimated due to insufficient number of participants with events
|
SECONDARY outcome
Timeframe: Assessed up to 5 yearsPatient death due to reasons other than relapse
Outcome measures
| Measure |
Arm I (Nivolumab)
n=38 Participants
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.
|
Arm II (Observation)
n=41 Participants
Patients undergo standard of care clinical observation for up to 2 years. Upon disease relapse, patients may cross-over to Arm I.
|
|---|---|---|
|
Non-relapse Mortality (NRM)
|
2 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Up to 5 yearsWill be assessed using National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. Grade 3 or higher regardless of attribution.
Outcome measures
| Measure |
Arm I (Nivolumab)
n=38 Participants
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.
|
Arm II (Observation)
n=41 Participants
Patients undergo standard of care clinical observation for up to 2 years. Upon disease relapse, patients may cross-over to Arm I.
|
|---|---|---|
|
Incidence of Adverse Effects of Nivolumab
|
27 Participants
|
5 Participants
|
Adverse Events
Arm I (Nivolumab)
Serious events: 8 serious events
Other events: 37 other events
Deaths: 16 deaths
Arm II (Observation)
Serious events: 3 serious events
Other events: 8 other events
Deaths: 20 deaths
Serious adverse events
| Measure |
Arm I (Nivolumab)
n=38 participants at risk
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.
|
Arm II (Observation)
n=41 participants at risk
Patients undergo standard of care clinical observation for up to 2 years. Upon disease relapse, patients may cross-over to Arm I.
|
|---|---|---|
|
Investigations
Alanine aminotransferase (ALT) increased
|
2.6%
1/38 • 5 years
|
0.00%
0/41 • 5 years
|
|
Investigations
Aspartate aminotransferase increase
|
2.6%
1/38 • 5 years
|
0.00%
0/41 • 5 years
|
|
Psychiatric disorders
Confusion
|
2.6%
1/38 • 5 years
|
0.00%
0/41 • 5 years
|
|
Infections and infestations
Lung infection
|
5.3%
2/38 • 5 years
|
0.00%
0/41 • 5 years
|
|
Gastrointestinal disorders
Diverticulitis
|
2.6%
1/38 • 5 years
|
0.00%
0/41 • 5 years
|
|
Investigations
Neutrophil count decreased
|
2.6%
1/38 • 5 years
|
2.4%
1/41 • 5 years
|
|
Investigations
Platelet count decreased
|
2.6%
1/38 • 5 years
|
0.00%
0/41 • 5 years
|
|
Cardiac disorders
Sinus tachycardia
|
2.6%
1/38 • 5 years
|
0.00%
0/41 • 5 years
|
|
Gastrointestinal disorders
Upper gastrointestinal hemorrhage
|
2.6%
1/38 • 5 years
|
0.00%
0/41 • 5 years
|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/38 • 5 years
|
2.4%
1/41 • 5 years
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/38 • 5 years
|
2.4%
1/41 • 5 years
|
|
General disorders
Fatigue
|
0.00%
0/38 • 5 years
|
2.4%
1/41 • 5 years
|
|
General disorders
Malaise
|
0.00%
0/38 • 5 years
|
2.4%
1/41 • 5 years
|
|
Infections and infestations
Sepsis
|
0.00%
0/38 • 5 years
|
2.4%
1/41 • 5 years
|
Other adverse events
| Measure |
Arm I (Nivolumab)
n=38 participants at risk
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.
|
Arm II (Observation)
n=41 participants at risk
Patients undergo standard of care clinical observation for up to 2 years. Upon disease relapse, patients may cross-over to Arm I.
|
|---|---|---|
|
Gastrointestinal disorders
Gastroesohpageal reflux
|
5.3%
2/38 • 5 years
|
2.4%
1/41 • 5 years
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
5.3%
2/38 • 5 years
|
2.4%
1/41 • 5 years
|
|
Nervous system disorders
Headache
|
21.1%
8/38 • 5 years
|
2.4%
1/41 • 5 years
|
|
Renal and urinary disorders
Hematuria
|
5.3%
2/38 • 5 years
|
0.00%
0/41 • 5 years
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
5.3%
2/38 • 5 years
|
0.00%
0/41 • 5 years
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
31.6%
12/38 • 5 years
|
2.4%
1/41 • 5 years
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
7.9%
3/38 • 5 years
|
2.4%
1/41 • 5 years
|
|
Vascular disorders
Hypertension
|
36.8%
14/38 • 5 years
|
0.00%
0/41 • 5 years
|
|
Endocrine disorders
Hyperthyroidism
|
5.3%
2/38 • 5 years
|
0.00%
0/41 • 5 years
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
5.3%
2/38 • 5 years
|
0.00%
0/41 • 5 years
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
13.2%
5/38 • 5 years
|
2.4%
1/41 • 5 years
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
10.5%
4/38 • 5 years
|
4.9%
2/41 • 5 years
|
|
Metabolism and nutrition disorders
Hypokalemia
|
5.3%
2/38 • 5 years
|
4.9%
2/41 • 5 years
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
10.5%
4/38 • 5 years
|
2.4%
1/41 • 5 years
|
|
Metabolism and nutrition disorders
Hyponatremia
|
7.9%
3/38 • 5 years
|
4.9%
2/41 • 5 years
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
18.4%
7/38 • 5 years
|
7.3%
3/41 • 5 years
|
|
Endocrine disorders
Hypothyroidism
|
18.4%
7/38 • 5 years
|
0.00%
0/41 • 5 years
|
|
General disorders
Infusion related reaction
|
5.3%
2/38 • 5 years
|
0.00%
0/41 • 5 years
|
|
Psychiatric disorders
Insomnia
|
7.9%
3/38 • 5 years
|
4.9%
2/41 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal inflammation
|
5.3%
2/38 • 5 years
|
0.00%
0/41 • 5 years
|
|
Investigations
Lipase increased
|
13.2%
5/38 • 5 years
|
0.00%
0/41 • 5 years
|
|
Investigations
Lymphocyte count decreased
|
21.1%
8/38 • 5 years
|
12.2%
5/41 • 5 years
|
|
Gastrointestinal disorders
Mucositis oral
|
10.5%
4/38 • 5 years
|
2.4%
1/41 • 5 years
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
5.3%
2/38 • 5 years
|
0.00%
0/41 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
13.2%
5/38 • 5 years
|
0.00%
0/41 • 5 years
|
|
Gastrointestinal disorders
Nausea
|
28.9%
11/38 • 5 years
|
0.00%
0/41 • 5 years
|
|
Investigations
Neutrophil count decreased
|
31.6%
12/38 • 5 years
|
9.8%
4/41 • 5 years
|
|
General disorders
Pain
|
13.2%
5/38 • 5 years
|
0.00%
0/41 • 5 years
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
10.5%
4/38 • 5 years
|
2.4%
1/41 • 5 years
|
|
Nervous system disorders
Paresthesia
|
5.3%
2/38 • 5 years
|
0.00%
0/41 • 5 years
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
7.9%
3/38 • 5 years
|
4.9%
2/41 • 5 years
|
|
Investigations
Platelet count decreased
|
36.8%
14/38 • 5 years
|
17.1%
7/41 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
13.2%
5/38 • 5 years
|
0.00%
0/41 • 5 years
|
|
Skin and subcutaneous tissue disorders
Pruritis
|
18.4%
7/38 • 5 years
|
4.9%
2/41 • 5 years
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
23.7%
9/38 • 5 years
|
4.9%
2/41 • 5 years
|
|
Investigations
Serum amylase increased
|
10.5%
4/38 • 5 years
|
0.00%
0/41 • 5 years
|
|
Gastrointestinal disorders
Toothache
|
5.3%
2/38 • 5 years
|
0.00%
0/41 • 5 years
|
|
Infections and infestations
Upper respiratory infection
|
5.3%
2/38 • 5 years
|
0.00%
0/41 • 5 years
|
|
Gastrointestinal disorders
Vomiting
|
13.2%
5/38 • 5 years
|
0.00%
0/41 • 5 years
|
|
Investigations
Weight gain
|
13.2%
5/38 • 5 years
|
0.00%
0/41 • 5 years
|
|
Investigations
White blood cell decreased
|
31.6%
12/38 • 5 years
|
17.1%
7/41 • 5 years
|
|
Musculoskeletal and connective tissue disorders
Shoulder pain
|
5.3%
2/38 • 5 years
|
0.00%
0/41 • 5 years
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
10.5%
4/38 • 5 years
|
2.4%
1/41 • 5 years
|
|
Investigations
Aspartate aminotransferase increased
|
34.2%
13/38 • 5 years
|
2.4%
1/41 • 5 years
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
13.2%
5/38 • 5 years
|
0.00%
0/41 • 5 years
|
|
Investigations
Blood bilirubin increased
|
5.3%
2/38 • 5 years
|
4.9%
2/41 • 5 years
|
|
Injury, poisoning and procedural complications
Bruising
|
10.5%
4/38 • 5 years
|
2.4%
1/41 • 5 years
|
|
General disorders
Chills
|
7.9%
3/38 • 5 years
|
2.4%
1/41 • 5 years
|
|
Gastrointestinal disorders
Constipation
|
13.2%
5/38 • 5 years
|
2.4%
1/41 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
21.1%
8/38 • 5 years
|
4.9%
2/41 • 5 years
|
|
Investigations
Creatinine increased
|
13.2%
5/38 • 5 years
|
2.4%
1/41 • 5 years
|
|
Gastrointestinal disorders
Diarrhea
|
34.2%
13/38 • 5 years
|
4.9%
2/41 • 5 years
|
|
Nervous system disorders
Dizziness
|
13.2%
5/38 • 5 years
|
0.00%
0/41 • 5 years
|
|
Gastrointestinal disorders
Dry mouth
|
10.5%
4/38 • 5 years
|
2.4%
1/41 • 5 years
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
7.9%
3/38 • 5 years
|
0.00%
0/41 • 5 years
|
|
Gastrointestinal disorders
Dyspepsia
|
5.3%
2/38 • 5 years
|
2.4%
1/41 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
7.9%
3/38 • 5 years
|
7.3%
3/41 • 5 years
|
|
Ear and labyrinth disorders
Ear pain
|
5.3%
2/38 • 5 years
|
0.00%
0/41 • 5 years
|
|
General disorders
Edema limbs
|
13.2%
5/38 • 5 years
|
2.4%
1/41 • 5 years
|
|
Injury, poisoning and procedural complications
Fall
|
5.3%
2/38 • 5 years
|
0.00%
0/41 • 5 years
|
|
General disorders
Fatigue
|
42.1%
16/38 • 5 years
|
7.3%
3/41 • 5 years
|
|
General disorders
Fever
|
7.9%
3/38 • 5 years
|
2.4%
1/41 • 5 years
|
|
General disorders
Flu like symptoms
|
13.2%
5/38 • 5 years
|
0.00%
0/41 • 5 years
|
|
Vascular disorders
Flushing
|
7.9%
3/38 • 5 years
|
0.00%
0/41 • 5 years
|
|
Psychiatric disorders
Anxiety
|
7.9%
3/38 • 5 years
|
0.00%
0/41 • 5 years
|
|
Gastrointestinal disorders
Abdominal pain
|
13.2%
5/38 • 5 years
|
2.4%
1/41 • 5 years
|
|
Investigations
Activated partial thromboplastin time prolonged
|
5.3%
2/38 • 5 years
|
2.4%
1/41 • 5 years
|
|
Investigations
Alanine aminotransferase increased
|
28.9%
11/38 • 5 years
|
2.4%
1/41 • 5 years
|
|
Investigations
Alkaline phosphatase increased
|
13.2%
5/38 • 5 years
|
2.4%
1/41 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
5.3%
2/38 • 5 years
|
0.00%
0/41 • 5 years
|
|
Blood and lymphatic system disorders
Anemia
|
36.8%
14/38 • 5 years
|
9.8%
4/41 • 5 years
|
|
Metabolism and nutrition disorders
Anorexia
|
5.3%
2/38 • 5 years
|
4.9%
2/41 • 5 years
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60