Trial Outcomes & Findings for Nivolumab in Treating Patients With Stage IIB-IIC Melanoma That Can Be Removed by Surgery (NCT NCT03405155)
NCT ID: NCT03405155
Last Updated: 2026-07-16
Results Overview
Kaplan-Meier estimate of the percentage of participants who were recurrence-free at approximately 2 years after treatment initiation.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
26 participants
Primary outcome timeframe
Approximately 22 months (2 years)
Results posted on
2026-07-16
Participant Flow
Participant milestones
| Measure |
Treatment (Nivolumab)
Patients receive nivolumab IV over at least 30 minutes on day 1. Treatment repeats every 4 weeks for up to 12 courses in the absence of disease progression or unacceptable toxicity.
Nivolumab: Given IV
|
|---|---|
|
Overall Study
STARTED
|
26
|
|
Overall Study
COMPLETED
|
18
|
|
Overall Study
NOT COMPLETED
|
8
|
Reasons for withdrawal
| Measure |
Treatment (Nivolumab)
Patients receive nivolumab IV over at least 30 minutes on day 1. Treatment repeats every 4 weeks for up to 12 courses in the absence of disease progression or unacceptable toxicity.
Nivolumab: Given IV
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
7
|
|
Overall Study
Lost to Follow-up
|
1
|
Baseline Characteristics
Nivolumab in Treating Patients With Stage IIB-IIC Melanoma That Can Be Removed by Surgery
Baseline characteristics by cohort
| Measure |
Treatment (Nivolumab)
n=26 Participants
Patients receive nivolumab IV over at least 30 minutes on day 1. Treatment repeats every 4 weeks for up to 12 courses in the absence of disease progression or unacceptable toxicity.
Nivolumab: Given IV
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=9 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
19 Participants
n=9 Participants
|
|
Age, Categorical
>=65 years
|
7 Participants
n=9 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=9 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=9 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=9 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
26 Participants
n=9 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=9 Participants
|
|
Race (NIH/OMB)
White
|
25 Participants
n=9 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=9 Participants
|
|
Region of Enrollment
United States
|
26 participants
n=9 Participants
|
PRIMARY outcome
Timeframe: Approximately 22 months (2 years)Kaplan-Meier estimate of the percentage of participants who were recurrence-free at approximately 2 years after treatment initiation.
Outcome measures
| Measure |
Treatment (Nivolumab)
n=26 Participants
Patients receive nivolumab IV over at least 30 minutes on day 1. Treatment repeats every 4 weeks for up to 12 courses in the absence of disease progression or unacceptable toxicity.
Nivolumab: Given IV
|
|---|---|
|
Recurrence-free Survival
|
87.8 percentage of participants
Interval 64.2 to 96.3
|
SECONDARY outcome
Timeframe: Up to 24 monthsOverall Survival (OS) is defined as time from study entry until death from any cause. OS will be determined, as will the cumulative percentage of patients remaining progression-free/alive at selected time points after initial treatment at 24 months
Outcome measures
| Measure |
Treatment (Nivolumab)
n=26 Participants
Patients receive nivolumab IV over at least 30 minutes on day 1. Treatment repeats every 4 weeks for up to 12 courses in the absence of disease progression or unacceptable toxicity.
Nivolumab: Given IV
|
|---|---|
|
Overall Survival
|
26 Participants
|
SECONDARY outcome
Timeframe: Up to 24 monthsThe cumulative percentage of patients remaining distant metastases-free/alive at 1yr and 2yrs after initial treatment
Outcome measures
| Measure |
Treatment (Nivolumab)
n=26 Participants
Patients receive nivolumab IV over at least 30 minutes on day 1. Treatment repeats every 4 weeks for up to 12 courses in the absence of disease progression or unacceptable toxicity.
Nivolumab: Given IV
|
|---|---|
|
Cumulative Percentage of Patients Remaining Distant Metastases-Free/Alive at 1yr and 2yrs After Initial Treatment
At 1 year
|
96 Percentage of Participants
Interval 76.0 to 99.0
|
|
Cumulative Percentage of Patients Remaining Distant Metastases-Free/Alive at 1yr and 2yrs After Initial Treatment
At 2 years
|
92 Percentage of Participants
Interval 71.0 to 98.0
|
SECONDARY outcome
Timeframe: Up to 24 monthsAdverse events will be graded for severity according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0
Outcome measures
| Measure |
Treatment (Nivolumab)
n=26 Participants
Patients receive nivolumab IV over at least 30 minutes on day 1. Treatment repeats every 4 weeks for up to 12 courses in the absence of disease progression or unacceptable toxicity.
Nivolumab: Given IV
|
|---|---|
|
Number of Adverse Events
|
79 adverse events
|
Adverse Events
Treatment (Nivolumab)
Serious events: 2 serious events
Other events: 16 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Treatment (Nivolumab)
n=26 participants at risk
Patients receive nivolumab IV over at least 30 minutes on day 1. Treatment repeats every 4 weeks for up to 12 courses in the absence of disease progression or unacceptable toxicity.
Nivolumab: Given IV
|
|---|---|
|
General disorders
Death
|
7.7%
2/26 • Number of events 2 • Adverse event reporting will begin after study treatment, unless AE/SAE is caused by a study specific screening procedure, and continue until30 days after the last dose of study treatment. Approximately, 4 years.
|
Other adverse events
| Measure |
Treatment (Nivolumab)
n=26 participants at risk
Patients receive nivolumab IV over at least 30 minutes on day 1. Treatment repeats every 4 weeks for up to 12 courses in the absence of disease progression or unacceptable toxicity.
Nivolumab: Given IV
|
|---|---|
|
Blood and lymphatic system disorders
Neutrophil count decreased
|
3.8%
1/26 • Number of events 1 • Adverse event reporting will begin after study treatment, unless AE/SAE is caused by a study specific screening procedure, and continue until30 days after the last dose of study treatment. Approximately, 4 years.
|
|
Endocrine disorders
Hyperthyroidism
|
3.8%
1/26 • Number of events 1 • Adverse event reporting will begin after study treatment, unless AE/SAE is caused by a study specific screening procedure, and continue until30 days after the last dose of study treatment. Approximately, 4 years.
|
|
Endocrine disorders
Hypothyroidism
|
11.5%
3/26 • Number of events 3 • Adverse event reporting will begin after study treatment, unless AE/SAE is caused by a study specific screening procedure, and continue until30 days after the last dose of study treatment. Approximately, 4 years.
|
|
Endocrine disorders
Hot flash
|
3.8%
1/26 • Number of events 1 • Adverse event reporting will begin after study treatment, unless AE/SAE is caused by a study specific screening procedure, and continue until30 days after the last dose of study treatment. Approximately, 4 years.
|
|
Blood and lymphatic system disorders
Autoimmune disorder (Thyroiditis; Thyroid changes/disease)
|
3.8%
1/26 • Number of events 1 • Adverse event reporting will begin after study treatment, unless AE/SAE is caused by a study specific screening procedure, and continue until30 days after the last dose of study treatment. Approximately, 4 years.
|
|
Blood and lymphatic system disorders
TSH increased
|
3.8%
1/26 • Number of events 1 • Adverse event reporting will begin after study treatment, unless AE/SAE is caused by a study specific screening procedure, and continue until30 days after the last dose of study treatment. Approximately, 4 years.
|
|
Eye disorders
Conjunctivitis infective
|
3.8%
1/26 • Number of events 1 • Adverse event reporting will begin after study treatment, unless AE/SAE is caused by a study specific screening procedure, and continue until30 days after the last dose of study treatment. Approximately, 4 years.
|
|
General disorders
Fatigue
|
50.0%
13/26 • Number of events 13 • Adverse event reporting will begin after study treatment, unless AE/SAE is caused by a study specific screening procedure, and continue until30 days after the last dose of study treatment. Approximately, 4 years.
|
|
General disorders
Flu-like symptoms
|
3.8%
1/26 • Number of events 1 • Adverse event reporting will begin after study treatment, unless AE/SAE is caused by a study specific screening procedure, and continue until30 days after the last dose of study treatment. Approximately, 4 years.
|
|
General disorders
Pain in extremity
|
3.8%
1/26 • Number of events 1 • Adverse event reporting will begin after study treatment, unless AE/SAE is caused by a study specific screening procedure, and continue until30 days after the last dose of study treatment. Approximately, 4 years.
|
|
General disorders
Peripheral edema
|
3.8%
1/26 • Number of events 1 • Adverse event reporting will begin after study treatment, unless AE/SAE is caused by a study specific screening procedure, and continue until30 days after the last dose of study treatment. Approximately, 4 years.
|
|
General disorders
Dry mouth
|
3.8%
1/26 • Number of events 1 • Adverse event reporting will begin after study treatment, unless AE/SAE is caused by a study specific screening procedure, and continue until30 days after the last dose of study treatment. Approximately, 4 years.
|
|
Gastrointestinal disorders
Abdominal pain
|
3.8%
1/26 • Number of events 1 • Adverse event reporting will begin after study treatment, unless AE/SAE is caused by a study specific screening procedure, and continue until30 days after the last dose of study treatment. Approximately, 4 years.
|
|
Gastrointestinal disorders
Constipation
|
11.5%
3/26 • Number of events 3 • Adverse event reporting will begin after study treatment, unless AE/SAE is caused by a study specific screening procedure, and continue until30 days after the last dose of study treatment. Approximately, 4 years.
|
|
Gastrointestinal disorders
Diarrhea
|
26.9%
7/26 • Number of events 7 • Adverse event reporting will begin after study treatment, unless AE/SAE is caused by a study specific screening procedure, and continue until30 days after the last dose of study treatment. Approximately, 4 years.
|
|
Gastrointestinal disorders
Nausea
|
3.8%
1/26 • Number of events 1 • Adverse event reporting will begin after study treatment, unless AE/SAE is caused by a study specific screening procedure, and continue until30 days after the last dose of study treatment. Approximately, 4 years.
|
|
Gastrointestinal disorders
Mucositis oral
|
3.8%
1/26 • Number of events 1 • Adverse event reporting will begin after study treatment, unless AE/SAE is caused by a study specific screening procedure, and continue until30 days after the last dose of study treatment. Approximately, 4 years.
|
|
Gastrointestinal disorders
Flatulence
|
3.8%
1/26 • Number of events 1 • Adverse event reporting will begin after study treatment, unless AE/SAE is caused by a study specific screening procedure, and continue until30 days after the last dose of study treatment. Approximately, 4 years.
|
|
Gastrointestinal disorders
Colitis
|
3.8%
1/26 • Number of events 1 • Adverse event reporting will begin after study treatment, unless AE/SAE is caused by a study specific screening procedure, and continue until30 days after the last dose of study treatment. Approximately, 4 years.
|
|
Gastrointestinal disorders
Gastrointestinal disorders, Other
|
3.8%
1/26 • Number of events 1 • Adverse event reporting will begin after study treatment, unless AE/SAE is caused by a study specific screening procedure, and continue until30 days after the last dose of study treatment. Approximately, 4 years.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
3.8%
1/26 • Number of events 1 • Adverse event reporting will begin after study treatment, unless AE/SAE is caused by a study specific screening procedure, and continue until30 days after the last dose of study treatment. Approximately, 4 years.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Joint Pain, Left knee
|
3.8%
1/26 • Number of events 1 • Adverse event reporting will begin after study treatment, unless AE/SAE is caused by a study specific screening procedure, and continue until30 days after the last dose of study treatment. Approximately, 4 years.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorders, other
|
3.8%
1/26 • Number of events 1 • Adverse event reporting will begin after study treatment, unless AE/SAE is caused by a study specific screening procedure, and continue until30 days after the last dose of study treatment. Approximately, 4 years.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder - Other, specify
|
3.8%
1/26 • Number of events 1 • Adverse event reporting will begin after study treatment, unless AE/SAE is caused by a study specific screening procedure, and continue until30 days after the last dose of study treatment. Approximately, 4 years.
|
|
Metabolism and nutrition disorders
Anorexia
|
3.8%
1/26 • Number of events 1 • Adverse event reporting will begin after study treatment, unless AE/SAE is caused by a study specific screening procedure, and continue until30 days after the last dose of study treatment. Approximately, 4 years.
|
|
Nervous system disorders
Peripheral Neuropathy
|
3.8%
1/26 • Number of events 1 • Adverse event reporting will begin after study treatment, unless AE/SAE is caused by a study specific screening procedure, and continue until30 days after the last dose of study treatment. Approximately, 4 years.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
3.8%
1/26 • Number of events 1 • Adverse event reporting will begin after study treatment, unless AE/SAE is caused by a study specific screening procedure, and continue until30 days after the last dose of study treatment. Approximately, 4 years.
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
3.8%
1/26 • Number of events 1 • Adverse event reporting will begin after study treatment, unless AE/SAE is caused by a study specific screening procedure, and continue until30 days after the last dose of study treatment. Approximately, 4 years.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhea
|
3.8%
1/26 • Number of events 1 • Adverse event reporting will begin after study treatment, unless AE/SAE is caused by a study specific screening procedure, and continue until30 days after the last dose of study treatment. Approximately, 4 years.
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
3.8%
1/26 • Number of events 1 • Adverse event reporting will begin after study treatment, unless AE/SAE is caused by a study specific screening procedure, and continue until30 days after the last dose of study treatment. Approximately, 4 years.
|
|
Respiratory, thoracic and mediastinal disorders
Sore Throat
|
3.8%
1/26 • Number of events 1 • Adverse event reporting will begin after study treatment, unless AE/SAE is caused by a study specific screening procedure, and continue until30 days after the last dose of study treatment. Approximately, 4 years.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
23.1%
6/26 • Number of events 6 • Adverse event reporting will begin after study treatment, unless AE/SAE is caused by a study specific screening procedure, and continue until30 days after the last dose of study treatment. Approximately, 4 years.
|
|
Skin and subcutaneous tissue disorders
Rash
|
42.3%
11/26 • Number of events 11 • Adverse event reporting will begin after study treatment, unless AE/SAE is caused by a study specific screening procedure, and continue until30 days after the last dose of study treatment. Approximately, 4 years.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
3.8%
1/26 • Number of events 1 • Adverse event reporting will begin after study treatment, unless AE/SAE is caused by a study specific screening procedure, and continue until30 days after the last dose of study treatment. Approximately, 4 years.
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
3.8%
1/26 • Number of events 1 • Adverse event reporting will begin after study treatment, unless AE/SAE is caused by a study specific screening procedure, and continue until30 days after the last dose of study treatment. Approximately, 4 years.
|
|
Skin and subcutaneous tissue disorders
Papulopustular rash
|
3.8%
1/26 • Number of events 1 • Adverse event reporting will begin after study treatment, unless AE/SAE is caused by a study specific screening procedure, and continue until30 days after the last dose of study treatment. Approximately, 4 years.
|
Additional Information
Takami Sato, MD, PhD
Sidney Kimmel Comprehensive Cancer Center
Phone: (215) 503-5088
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place