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. 2016 Jun 30;5(7):e1192740. doi: 10.1080/2162402X.2016.1192740

Table 1.

Clinical trials of anti-CD137 mAb as monotherapy or in combination with rituximab.

        Adverse events (AEs) (Total n)
   
Therapeutic agent
Trial (Status)*
Patient population
Response
AE
N(%)
DLTs, Discontinued treatment N(%)
Reference
Urelumab (BMS-663513) Monotherapy
  NCT00309023 (Terminated) Metastatic or locally advanced solid tumors 3 PRs (18C mo, 3C mo, 1.5C mo) Integrated for the three trials  
      4 SD (10 mo, 6 mo, 6 mo, 4+ mo) 0.1 mg/kg (n = 61)
        Any grade ≤ 4 AE (most common)  
        Fatigue 10(16) 7(11)
        Nausea 8(13) discontinued due to a treatment-related AE
        Increased AST 5(8)  
        Decreased Appetite 5(8)  
        Asthenia 5(8)  
        Any grade ≤ 4 SAE  
        Increased ALT 1(2)  
 
 
 
 
Erysipelas
]1(2)
 
 
  NCT00612664 (Completed) Melanoma Terminated in Dec 2008 following two hepatotoxicity-related deaths (≥1 mg/kg) 0.3 mg/kg (n = 56)  
        Any grade ≤ 4 AE (most common)    
        Increased AST 8(14) 5(9)  
        Fatigue 8(14) discontinued due to a treatment-related AE 42-44
        Increased ALT 6(11)  
        Rash 4(7)  
        Pruritus 3(5)  
        Any grade ≤ 4 SAE  
        Increased ALT 2(4)  
        Increased AST 2(4)  
        Abnormal LFT 1(2)  
        Acute hepatitis 1(2)  
 
 
 
 
Enteritis
1(2)
 
  NCT01471210 (Ongoing, not recruiting) Advanced solid tumors or r/r B-cell NHL No updates yet ≥ 1 mg/kg (n=229)  
        Any grade ≤ 4 AE (most common)    
        Increased AST 62(27) 37(16)  
        Increased ALT 61(27) discontinued due to a treatment-related AE  
        Fatigue 55(24)    
        Rash 45(20)    
        Nausea 31(14)    
        Any grade ≤ 4 SAE (most common)    
        Increased AST 12(5)    
        Increased ALT 11(5)    
        Neutropenia 7(3)    
        Thrombocytopenia 5(2)    
        Febrile neutropenia 4(2)    
 
Combination therapy with rituximab
 
 
 
 
 
 
 
NCT01775631(Ongoing, not recruiting)
r/r B-cell NHL
 
No updates yet
 
 
45
PF-05082566 NCT01307267 (Recruiting) Monotherapy
    Solid tumors or B-cell NHL   (n = 34) No DLTs 46
        Grade 1    
      24/34 evaluable for response: Rash 3(9)    
      1 MR (0.06 mg/kg) Fever 2(6)    
      1 PR (0.6 mg/kg) Nausea/vomiting 2(6)    
      7 SD (across multiple doses) Weight loss 1(13)    
        Headache 1(13)    
        Fatigue 1(13)    
        Thrombocytopenia 1(13)    
 
 
 
 
No Grade 2 or higher
 
 
    Combination therapy with rituximab          
        (n=38) No DLTs 47
        All grades    
    CD20-positive NHL Up to 2.4 mg/kg:[]ORR = 21% (6/28) Fatigue 9(24) No patient discontinued due to treatment-related AEs  
      Rituximab-refractory**: Rash 4(11)    
      ORR = 29% (4/14) 2 CR (0.03 and 0.12 mg/kg), Headache 3(8)    
      DR>2 years 2 PR Lymphopenia 3(8)    
        Thrombocytopenia 2(5)    
        Neutropenia 1(3)    
        Grade 3    
        Lymphopenia 1(3)    
        Thrombocytopenia 1(3)    
        Neutropenia 1(3)    
               

*Trial status update as of January 2016.

**Rituximab-refractory is defined as no response (PD or SD) to the prior therapy or PD during or within 6 mo of the last dose of rituximab.