PD-1 Inhibition With Nivolumab for the Treatment of Patients With Acute Myeloid Leukemia in Remission at High Risk for Relapse
Phase: PHASE2
Conditions: Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome, Adult Acute Myeloid Leukemia in Remission, Blasts Under 10 Percent of Bone Marrow Nucleated Cells, Therapy-Related Myeloid Neoplasm
Sponsor: M.D. Anderson Cancer Center

2015-0213
June 9, 2015
1
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2015-0213 
June 9, 2015 
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PRODUCT INFORMATION TABLE: Please also see Drug Information Appendix A  
*Nivolumab may be  labeled as BMS-936558-01 Solution for Injection 
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Product Description:(Other names = MDX-1106, ONO-4538, anti-PD-1 
Product 
Description 
and Dosage 
Form 
Potency 
Primary 
Packaging 
(Volume)/ 
Label Type 
Secondary 
Packaging 
(Qty) /Label 
Type 
Appearance 
Storage Conditions 
(per label) 
Nivolumab 
(BMS-936558-
01)* Injection 
drug product is 
a sterile, non-
pyrogenic, 
single-use, 
isotonic 
aqueous 
solution 
formulated at 
10 mg/mL   
100 
mg/Vial (10 
mg/mL). 
Carton of 5 or 
10 vials 
10-cc Type 1 flint 
glass vials 
stoppered with 
butyl stoppers 
and sealed with 
aluminum seals. 
Clear to opalescent, 
colorless to pale 
yellow liquid.  May 
contain particles 
BMS-936558-01 
Injection must be 
stored at 2 to 8 
degrees C (36 to 46 
degrees F) and 
protected from light 
and  freezing  

2015-0213 
June 9, 2015 
16 
 
 
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The number of patients evaluated for 
toxicities 
10 -12 
13-15 
16-18 
19-20 
21-23 
24-26 
27-29 
Stop the trial if greater than or equal to 
this many of patients with toxicities 
6 
7 
8 
9 
10 
11 
12 
 
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2015-0213 
June 9, 2015 
30 
 
 
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True Toxicity Rate 
Early Stopping 
Probability 
Sample Size 
25th percentile 
Median 
75th percentile 
0.1 
0.0007 
30 
30 
30 
0.2 
0.0353 
30 
30 
30 
0.3 
0.2447 
29 
30 
30 
0.4 
0.635 
11 
18 
30 
0.5 
0.9134 
10 
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