Trial Outcomes & Findings for Nivolumab in AML in Remission at High Risk for Relapse (NCT NCT02532231)
NCT ID: NCT02532231
Last Updated: 2024-10-24
Results Overview
Time from date of treatment start until the date of first objective documentation of disease-relapse.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
15 participants
Primary outcome timeframe
Up to 7 years 9 months
Results posted on
2024-10-24
Participant Flow
Participant milestones
| Measure |
Treatment (Nivolumab)
Patients receive nivolumab IV over 1 hour on days 1 and 15. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. After cycle 6, patients may receive nivolumab on day 1 only. After cycle 12, patients may receive nivolumab on day 1 of every 3 cycles. Patients experiencing disease progression may go back to receiving treatment on days 1 and 15 of each cycle.
Laboratory Biomarker Analysis: Correlative studies
Nivolumab: Given IV
|
|---|---|
|
Overall Study
STARTED
|
15
|
|
Overall Study
COMPLETED
|
15
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Nivolumab in AML in Remission at High Risk for Relapse
Baseline characteristics by cohort
| Measure |
Treatment (Nivolumab)
n=15 Participants
Patients receive nivolumab IV over 1 hour on days 1 and 15. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. After cycle 6, patients may receive nivolumab on day 1 only. After cycle 12, patients may receive nivolumab on day 1 of every 3 cycles. Patients experiencing disease progression may go back to receiving treatment on days 1 and 15 of each cycle.
Laboratory Biomarker Analysis: Correlative studies
Nivolumab: Given IV
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
12 Participants
n=93 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=93 Participants
|
|
Age, Continuous
|
56 years
n=93 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=93 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=93 Participants
|
|
Race (NIH/OMB)
White
|
10 Participants
n=93 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=93 Participants
|
|
Region of Enrollment
United States
|
15 participants
n=93 Participants
|
PRIMARY outcome
Timeframe: Up to 7 years 9 monthsTime from date of treatment start until the date of first objective documentation of disease-relapse.
Outcome measures
| Measure |
Treatment (Nivolumab)
n=15 Participants
Patients receive nivolumab IV over 1 hour on days 1 and 15. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. After cycle 6, patients may receive nivolumab on day 1 only. After cycle 12, patients may receive nivolumab on day 1 of every 3 cycles. Patients experiencing disease progression may go back to receiving treatment on days 1 and 15 of each cycle.
Laboratory Biomarker Analysis: Correlative studies
Nivolumab: Given IV
|
|---|---|
|
Recurrence-free Survival Rate
|
8.5 Months
Interval 1.0 to 47.0
|
SECONDARY outcome
Timeframe: Every 2 cycles (+/-1 cycle) for the first 6 cycles, then every 3 months while on study, then as clinically indicated till relapse; up to 7 years, 9 months.Participants with Immunologic responses to nivolumab among patients with acute myeloid leukemia (AML) in complete remission (CR) status post standard chemotherapy. CR is Neutrophil count \>/= 1.0 x 10\^9/L, with a platelet count of \>/+ x 10 \^ 9/L
Outcome measures
| Measure |
Treatment (Nivolumab)
n=15 Participants
Patients receive nivolumab IV over 1 hour on days 1 and 15. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. After cycle 6, patients may receive nivolumab on day 1 only. After cycle 12, patients may receive nivolumab on day 1 of every 3 cycles. Patients experiencing disease progression may go back to receiving treatment on days 1 and 15 of each cycle.
Laboratory Biomarker Analysis: Correlative studies
Nivolumab: Given IV
|
|---|---|
|
Number of Participants With Immunologic Responses to Nivolumab Among Patients With Acute Myeloid Leukemia (AML) in Complete Remission (CR) Status Post Standard Chemotherapy
|
6 Participants
|
SECONDARY outcome
Timeframe: Every 2 cycles (+/-1 cycle) for the first 6 cycles, then every 3 months while on study, then as clinically indicated till relapse; up to 7 years, 9 months.Population: There were 6 participants who were MRD negative and 9 who were MRD positive at the beginning of therapy with nivolumab. Therefor the number of participants analyzed for this outcome were 9 participants.
Assessed by flow cytometry as a predictor of response to immune therapy in treatment of AML. The number of participants who were MRD Positive at the start of therapy with nivolumab and changed to MRD Negative during treatment.
Outcome measures
| Measure |
Treatment (Nivolumab)
n=9 Participants
Patients receive nivolumab IV over 1 hour on days 1 and 15. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. After cycle 6, patients may receive nivolumab on day 1 only. After cycle 12, patients may receive nivolumab on day 1 of every 3 cycles. Patients experiencing disease progression may go back to receiving treatment on days 1 and 15 of each cycle.
Laboratory Biomarker Analysis: Correlative studies
Nivolumab: Given IV
|
|---|---|
|
Number of Participants Who Changed From MRD Postive to MRD Negative During Therapy With Nibolumab
|
2 Participants
|
SECONDARY outcome
Timeframe: Up to 7 years 9 monthsTime from date of treatment start until the date of first objective documentation of disease-relapse.
Outcome measures
| Measure |
Treatment (Nivolumab)
n=9 Participants
Patients receive nivolumab IV over 1 hour on days 1 and 15. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. After cycle 6, patients may receive nivolumab on day 1 only. After cycle 12, patients may receive nivolumab on day 1 of every 3 cycles. Patients experiencing disease progression may go back to receiving treatment on days 1 and 15 of each cycle.
Laboratory Biomarker Analysis: Correlative studies
Nivolumab: Given IV
|
|---|---|
|
Time to Relapse
|
2 Months
Interval 1.0 to 9.0
|
SECONDARY outcome
Timeframe: Up to 7 years 9 monthsTime from date of treatment start until date of death due to any cause or last Follow-up.
Outcome measures
| Measure |
Treatment (Nivolumab)
n=15 Participants
Patients receive nivolumab IV over 1 hour on days 1 and 15. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. After cycle 6, patients may receive nivolumab on day 1 only. After cycle 12, patients may receive nivolumab on day 1 of every 3 cycles. Patients experiencing disease progression may go back to receiving treatment on days 1 and 15 of each cycle.
Laboratory Biomarker Analysis: Correlative studies
Nivolumab: Given IV
|
|---|---|
|
Overall Survival
|
NA Months
Interval 2.0 to 47.0
At the time of study termination the median overall survival was not reached.
|
Adverse Events
Treatment (Nivolumab)
Serious events: 6 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Treatment (Nivolumab)
n=15 participants at risk
Patients receive nivolumab IV over 1 hour on days 1 and 15. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. After cycle 6, patients may receive nivolumab on day 1 only. After cycle 12, patients may receive nivolumab on day 1 of every 3 cycles. Patients experiencing disease progression may go back to receiving treatment on days 1 and 15 of each cycle.
Laboratory Biomarker Analysis: Correlative studies
Nivolumab: Given IV
|
|---|---|
|
Gastrointestinal disorders
Abdominal Pain
|
6.7%
1/15 • Number of events 1 • Up to 7 years 9 months
|
|
Cardiac disorders
Acute Coronary Syndrome
|
6.7%
1/15 • Number of events 1 • Up to 7 years 9 months
|
|
General disorders
Back Pain
|
6.7%
1/15 • Number of events 1 • Up to 7 years 9 months
|
|
Gastrointestinal disorders
Constipation
|
6.7%
1/15 • Number of events 1 • Up to 7 years 9 months
|
|
General disorders
Fever
|
13.3%
2/15 • Number of events 2 • Up to 7 years 9 months
|
|
Injury, poisoning and procedural complications
Fracture
|
6.7%
1/15 • Number of events 2 • Up to 7 years 9 months
|
|
Vascular disorders
Hypotension
|
6.7%
1/15 • Number of events 2 • Up to 7 years 9 months
|
|
Infections and infestations
Infection
|
6.7%
1/15 • Number of events 1 • Up to 7 years 9 months
|
|
Infections and infestations
Lung Infection
|
20.0%
3/15 • Number of events 5 • Up to 7 years 9 months
|
|
Gastrointestinal disorders
Nausea
|
6.7%
1/15 • Number of events 1 • Up to 7 years 9 months
|
|
Ear and labyrinth disorders
Otitis Externa
|
6.7%
1/15 • Number of events 1 • Up to 7 years 9 months
|
|
Skin and subcutaneous tissue disorders
Papulopustular Rash
|
6.7%
1/15 • Number of events 1 • Up to 7 years 9 months
|
|
Infections and infestations
Sepsis
|
6.7%
1/15 • Number of events 2 • Up to 7 years 9 months
|
|
Infections and infestations
Upper Respiratory Infection
|
6.7%
1/15 • Number of events 1 • Up to 7 years 9 months
|
Other adverse events
| Measure |
Treatment (Nivolumab)
n=15 participants at risk
Patients receive nivolumab IV over 1 hour on days 1 and 15. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. After cycle 6, patients may receive nivolumab on day 1 only. After cycle 12, patients may receive nivolumab on day 1 of every 3 cycles. Patients experiencing disease progression may go back to receiving treatment on days 1 and 15 of each cycle.
Laboratory Biomarker Analysis: Correlative studies
Nivolumab: Given IV
|
|---|---|
|
Skin and subcutaneous tissue disorders
Skin Lesions-Itchy
|
6.7%
1/15 • Number of events 1 • Up to 7 years 9 months
|
|
Gastrointestinal disorders
Diarrhea
|
20.0%
3/15 • Number of events 3 • Up to 7 years 9 months
|
|
Endocrine disorders
Thyroid function, low (hypothyroidism)
|
6.7%
1/15 • Number of events 1 • Up to 7 years 9 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
13.3%
2/15 • Number of events 2 • Up to 7 years 9 months
|
|
Gastrointestinal disorders
Vomiting
|
6.7%
1/15 • Number of events 1 • Up to 7 years 9 months
|
|
Investigations
AST, SGOT (serum glutamic oxaloacetic transaminase)
|
6.7%
1/15 • Number of events 1 • Up to 7 years 9 months
|
|
Investigations
ALT, SGPT (serum glutamic pyruvic transaminase)
|
6.7%
1/15 • Number of events 1 • Up to 7 years 9 months
|
|
Nervous system disorders
Dizziness
|
13.3%
2/15 • Number of events 2 • Up to 7 years 9 months
|
|
Skin and subcutaneous tissue disorders
Rash/desquamation
|
6.7%
1/15 • Number of events 1 • Up to 7 years 9 months
|
|
Skin and subcutaneous tissue disorders
Pruritus/itching
|
6.7%
1/15 • Number of events 1 • Up to 7 years 9 months
|
|
General disorders
Pain--Select
|
13.3%
2/15 • Number of events 3 • Up to 7 years 9 months
|
|
General disorders
Fatigue (asthenia, lethargy, malaise)
|
6.7%
1/15 • Number of events 1 • Up to 7 years 9 months
|
|
Gastrointestinal disorders
Distension/bloating, abdominal
|
6.7%
1/15 • Number of events 1 • Up to 7 years 9 months
|
|
Vascular disorders
Hypotension
|
6.7%
1/15 • Number of events 1 • Up to 7 years 9 months
|
|
Infections and infestations
Febrile neutropenia
|
6.7%
1/15 • Number of events 1 • Up to 7 years 9 months
|
|
Gastrointestinal disorders
Mucositis/stomatitis (clinical exam)
|
6.7%
1/15 • Number of events 1 • Up to 7 years 9 months
|
|
Gastrointestinal disorders
Nausea
|
6.7%
1/15 • Number of events 1 • Up to 7 years 9 months
|
Additional Information
Tapan Mahendra Kadia, MD/Professor
The University of Texas MD Anderson Cancer Center
Phone: 713-563-3534
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place