Adjuvant Treatment of Melanoma

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image 76k 238 hero icon safety

INDICATION OPDIVO® (nivolumab) is indicated for the adjuvant treatment of adult and pediatric patients 12 years and older with completely resected Stage IIB, Stage IIC, Stage III, or Stage IV melanoma.

CHECKMATE 76K: IN ADULT AND PEDIATRIC PATIENTS 12 YEARS AND OLDER WITH COMPLETELY RESECTED STAGE IIB/C MELANOMA

A familiar safety profile was observed for OPDIVO®1*

ADVERSE REACTIONS OCCURRING IN ≥10% OF PATIENTS TREATED WITH OPDIVO AT PRIMARY ANALYSIS
ADVERSE REACTIONS (%) OPDIVO (n=524) PLACEBO (n=264) OPDIVO (n=524) PLACEBO (n=264)
ALL GRADES (%) ALL GRADES (%) GRADES 3-4 (%) GRADES 3-4 (%)
General 
Fatigue

36

34

0.4

0.4
Musculoskeletal and connective tissue 
Musculoskeletal pain§

30

26

0.4

0.4
Skin and subcutaneous tissue 
Rash|| 
Pruritus

28
20

15
11

1.1
0.2

0.4 
0
Gastrointestinal 
Diarrhea 
Nausea

23
14

16
11

1.3
0

0
0
Endocrine 
Hypothyroidism**

14

2.3

0

0
Nervous system 
Headache††

12

14

0.2

0.8

*In the primary analysis at a median follow-up of ~15.8 months.2
As compared to safety profile of Checkmate 238 trial. Rates, severity, and specific reactions included under each type of adverse reaction vary across both trials. Please note the clinical trials were conducted under varying conditions, including different trial designs, patient populations, and dosing.1
Includes asthenia.
§Includes arthralgia, arthritis, back pain, bone pain, musculoskeletal chest pain, musculoskeletal discomfort, musculoskeletal stiffness, myalgia, neck pain, non-cardiac chest pain, spinal pain, pain in extremity.1
||
Includes dermatitis, dermatitis acneiform, dyshidrotic eczema, eczema, eczema asteatotic, eyelid rash, genital rash, pemphigoid, penile rash, rash erythematous, rash follicular, rash macular, rash maculo-papular, rash papular, rash pruritic, rash pustular, rash vesicular, skin exfoliation, toxic skin eruption.
Includes autoimmune colitis, colitis, diarrhea, enteritis, enterocolitis.
**Includes autoimmune hypothyroidism, blood thyroid stimulating hormone increased.
††Includes cluster headache, migraine.

 

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Treatment Modifications

See recommended dosing modifications for immune-mediated adverse reactions.

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Dosing Schedules

Find dosing information to get patients started on therapy. 

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More Melanoma Options

See selected safety profiles for other melanoma indications.

References:

  1. OPDIVO [package insert]. Princeton, NJ: Bristol-Myers Squibb Company.
  2. Kirkwood J, Del Vecchio M, Weber J, et al. Adjuvant nivolumab in resected stage IIB/C melanoma: primary results from the randomized, phase 3 CheckMate 76K trial. Nat Med. 2023;29:2835-2843.
  3. Weber J, Mandala M, Del Vecchio M, et al. Adjuvant nivolumab versus ipilimumab in resected stage III or IV melanoma. N Engl J Med. 2017;377(19):1824-1835.


466-US-2500040   04/25

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