Trial Outcomes & Findings for Adjuvant Nivolumab & Low Dose Ipilimumab for Stage III & Resected Stage IV Melanoma (NCT NCT02656706)
NCT ID: NCT02656706
Last Updated: 2026-01-16
Results Overview
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE2
Target enrollment
22 participants
Primary outcome timeframe
From day 1 of treatment through 30 days post the last dose of drug, for a total of about 7 months.
Results posted on
2026-01-16
Participant Flow
Participant milestones
| Measure |
Adjuvant Treatment
Ipilumumab:1mg/kg q6weeks (1 dose per cycle, 4 planned treatments over 6 months total) Nivolumab:3mg/kg q2weeks (3 doses per cycle, 12 planned treatments over 6 months total)
|
|---|---|
|
Overall Study
STARTED
|
22
|
|
Overall Study
COMPLETED
|
21
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
Adjuvant Treatment
Ipilumumab:1mg/kg q6weeks (1 dose per cycle, 4 planned treatments over 6 months total) Nivolumab:3mg/kg q2weeks (3 doses per cycle, 12 planned treatments over 6 months total)
|
|---|---|
|
Overall Study
Insurance Denial
|
1
|
Baseline Characteristics
Adjuvant Nivolumab & Low Dose Ipilimumab for Stage III & Resected Stage IV Melanoma
Baseline characteristics by cohort
| Measure |
Adjuvant Treatment
n=21 Participants
Ipilumumab:1mg/kg q6weeks (1 dose per cycle, 4 planned treatments over 6 months total) Nivolumab:3mg/kg q2weeks (3 doses per cycle, 12 planned treatments over 6 months total)
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=9 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
12 Participants
n=9 Participants
|
|
Age, Categorical
>=65 years
|
9 Participants
n=9 Participants
|
|
Age, Continuous
|
57 years
n=9 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=9 Participants
|
|
Sex: Female, Male
Male
|
13 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
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
White
|
21 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
|
21 participants
n=9 Participants
|
PRIMARY outcome
Timeframe: From day 1 of treatment through 30 days post the last dose of drug, for a total of about 7 months.Outcome measures
| Measure |
Adjuvant Treatment
n=21 Participants
Ipilumumab:1mg/kg q6weeks (1 dose per cycle, 4 planned treatments over 6 months total) Nivolumab:3mg/kg q2weeks (3 doses per cycle, 12 planned treatments over 6 months total)
|
|---|---|
|
Number of Participants With Treatment Related Toxicities
|
21 Participants
|
PRIMARY outcome
Timeframe: Post treatment for up to 5 yearsOutcome measures
| Measure |
Adjuvant Treatment
n=21 Participants
Ipilumumab:1mg/kg q6weeks (1 dose per cycle, 4 planned treatments over 6 months total) Nivolumab:3mg/kg q2weeks (3 doses per cycle, 12 planned treatments over 6 months total)
|
|---|---|
|
Number of Participants With Progression-free and Survival Overall
2-year progression free survival
|
18 Participants
|
|
Number of Participants With Progression-free and Survival Overall
2-year overall survall
|
19 Participants
|
Adverse Events
Adjuvant Treatment
Serious events: 11 serious events
Other events: 20 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Adjuvant Treatment
n=21 participants at risk
Ipilumumab:1mg/kg q6weeks (1 dose per cycle, 4 planned treatments over 6 months total) Nivolumab:3mg/kg q2weeks (3 doses per cycle, 12 planned treatments over 6 months total)
|
|---|---|
|
Cardiac disorders
Cardiac Disorders, other
|
4.8%
1/21 • Adverse events were collected from the time a signed and dated ICF is obtained until 30 days after the last dose of treatment, or until the subject withdrew consent from study participation, whichever occurs first. All cause mortality was assessed from the time a signed and dated ICF is obtained until up to 5 years post treatment (approximately 5.5 years).
|
|
Cardiac disorders
Pericardial effusion
|
4.8%
1/21 • Adverse events were collected from the time a signed and dated ICF is obtained until 30 days after the last dose of treatment, or until the subject withdrew consent from study participation, whichever occurs first. All cause mortality was assessed from the time a signed and dated ICF is obtained until up to 5 years post treatment (approximately 5.5 years).
|
|
Endocrine disorders
Adrenal insufficiency
|
4.8%
1/21 • Adverse events were collected from the time a signed and dated ICF is obtained until 30 days after the last dose of treatment, or until the subject withdrew consent from study participation, whichever occurs first. All cause mortality was assessed from the time a signed and dated ICF is obtained until up to 5 years post treatment (approximately 5.5 years).
|
|
Endocrine disorders
Endocrine disorders, other
|
4.8%
1/21 • Adverse events were collected from the time a signed and dated ICF is obtained until 30 days after the last dose of treatment, or until the subject withdrew consent from study participation, whichever occurs first. All cause mortality was assessed from the time a signed and dated ICF is obtained until up to 5 years post treatment (approximately 5.5 years).
|
|
Gastrointestinal disorders
Colitis
|
9.5%
2/21 • Adverse events were collected from the time a signed and dated ICF is obtained until 30 days after the last dose of treatment, or until the subject withdrew consent from study participation, whichever occurs first. All cause mortality was assessed from the time a signed and dated ICF is obtained until up to 5 years post treatment (approximately 5.5 years).
|
|
Gastrointestinal disorders
Diarrhea
|
4.8%
1/21 • Adverse events were collected from the time a signed and dated ICF is obtained until 30 days after the last dose of treatment, or until the subject withdrew consent from study participation, whichever occurs first. All cause mortality was assessed from the time a signed and dated ICF is obtained until up to 5 years post treatment (approximately 5.5 years).
|
|
Gastrointestinal disorders
Nausea
|
4.8%
1/21 • Adverse events were collected from the time a signed and dated ICF is obtained until 30 days after the last dose of treatment, or until the subject withdrew consent from study participation, whichever occurs first. All cause mortality was assessed from the time a signed and dated ICF is obtained until up to 5 years post treatment (approximately 5.5 years).
|
|
Gastrointestinal disorders
Vomitting
|
4.8%
1/21 • Adverse events were collected from the time a signed and dated ICF is obtained until 30 days after the last dose of treatment, or until the subject withdrew consent from study participation, whichever occurs first. All cause mortality was assessed from the time a signed and dated ICF is obtained until up to 5 years post treatment (approximately 5.5 years).
|
|
General disorders
Pain
|
9.5%
2/21 • Adverse events were collected from the time a signed and dated ICF is obtained until 30 days after the last dose of treatment, or until the subject withdrew consent from study participation, whichever occurs first. All cause mortality was assessed from the time a signed and dated ICF is obtained until up to 5 years post treatment (approximately 5.5 years).
|
|
Immune system disorders
Immune system disorders, other
|
14.3%
3/21 • Adverse events were collected from the time a signed and dated ICF is obtained until 30 days after the last dose of treatment, or until the subject withdrew consent from study participation, whichever occurs first. All cause mortality was assessed from the time a signed and dated ICF is obtained until up to 5 years post treatment (approximately 5.5 years).
|
|
Infections and infestations
Infection
|
4.8%
1/21 • Adverse events were collected from the time a signed and dated ICF is obtained until 30 days after the last dose of treatment, or until the subject withdrew consent from study participation, whichever occurs first. All cause mortality was assessed from the time a signed and dated ICF is obtained until up to 5 years post treatment (approximately 5.5 years).
|
|
Investigations
Alanine aminotransferase increased
|
4.8%
1/21 • Adverse events were collected from the time a signed and dated ICF is obtained until 30 days after the last dose of treatment, or until the subject withdrew consent from study participation, whichever occurs first. All cause mortality was assessed from the time a signed and dated ICF is obtained until up to 5 years post treatment (approximately 5.5 years).
|
|
Investigations
Creatinine increased
|
9.5%
2/21 • Adverse events were collected from the time a signed and dated ICF is obtained until 30 days after the last dose of treatment, or until the subject withdrew consent from study participation, whichever occurs first. All cause mortality was assessed from the time a signed and dated ICF is obtained until up to 5 years post treatment (approximately 5.5 years).
|
|
Metabolism and nutrition disorders
Dehydration
|
14.3%
3/21 • Adverse events were collected from the time a signed and dated ICF is obtained until 30 days after the last dose of treatment, or until the subject withdrew consent from study participation, whichever occurs first. All cause mortality was assessed from the time a signed and dated ICF is obtained until up to 5 years post treatment (approximately 5.5 years).
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
4.8%
1/21 • Adverse events were collected from the time a signed and dated ICF is obtained until 30 days after the last dose of treatment, or until the subject withdrew consent from study participation, whichever occurs first. All cause mortality was assessed from the time a signed and dated ICF is obtained until up to 5 years post treatment (approximately 5.5 years).
|
|
Metabolism and nutrition disorders
Hyponatremia
|
4.8%
1/21 • Adverse events were collected from the time a signed and dated ICF is obtained until 30 days after the last dose of treatment, or until the subject withdrew consent from study participation, whichever occurs first. All cause mortality was assessed from the time a signed and dated ICF is obtained until up to 5 years post treatment (approximately 5.5 years).
|
|
Nervous system disorders
Meningismus
|
4.8%
1/21 • Adverse events were collected from the time a signed and dated ICF is obtained until 30 days after the last dose of treatment, or until the subject withdrew consent from study participation, whichever occurs first. All cause mortality was assessed from the time a signed and dated ICF is obtained until up to 5 years post treatment (approximately 5.5 years).
|
|
Nervous system disorders
Stroke
|
4.8%
1/21 • Adverse events were collected from the time a signed and dated ICF is obtained until 30 days after the last dose of treatment, or until the subject withdrew consent from study participation, whichever occurs first. All cause mortality was assessed from the time a signed and dated ICF is obtained until up to 5 years post treatment (approximately 5.5 years).
|
|
Nervous system disorders
Syncope
|
4.8%
1/21 • Adverse events were collected from the time a signed and dated ICF is obtained until 30 days after the last dose of treatment, or until the subject withdrew consent from study participation, whichever occurs first. All cause mortality was assessed from the time a signed and dated ICF is obtained until up to 5 years post treatment (approximately 5.5 years).
|
|
Psychiatric disorders
Confusion
|
4.8%
1/21 • Adverse events were collected from the time a signed and dated ICF is obtained until 30 days after the last dose of treatment, or until the subject withdrew consent from study participation, whichever occurs first. All cause mortality was assessed from the time a signed and dated ICF is obtained until up to 5 years post treatment (approximately 5.5 years).
|
|
Respiratory, thoracic and mediastinal disorders
Chylothorax
|
4.8%
1/21 • Adverse events were collected from the time a signed and dated ICF is obtained until 30 days after the last dose of treatment, or until the subject withdrew consent from study participation, whichever occurs first. All cause mortality was assessed from the time a signed and dated ICF is obtained until up to 5 years post treatment (approximately 5.5 years).
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
4.8%
1/21 • Adverse events were collected from the time a signed and dated ICF is obtained until 30 days after the last dose of treatment, or until the subject withdrew consent from study participation, whichever occurs first. All cause mortality was assessed from the time a signed and dated ICF is obtained until up to 5 years post treatment (approximately 5.5 years).
|
|
Skin and subcutaneous tissue disorders
Rash
|
4.8%
1/21 • Adverse events were collected from the time a signed and dated ICF is obtained until 30 days after the last dose of treatment, or until the subject withdrew consent from study participation, whichever occurs first. All cause mortality was assessed from the time a signed and dated ICF is obtained until up to 5 years post treatment (approximately 5.5 years).
|
Other adverse events
| Measure |
Adjuvant Treatment
n=21 participants at risk
Ipilumumab:1mg/kg q6weeks (1 dose per cycle, 4 planned treatments over 6 months total) Nivolumab:3mg/kg q2weeks (3 doses per cycle, 12 planned treatments over 6 months total)
|
|---|---|
|
Eye disorders
Blurred vision
|
23.8%
5/21 • Adverse events were collected from the time a signed and dated ICF is obtained until 30 days after the last dose of treatment, or until the subject withdrew consent from study participation, whichever occurs first. All cause mortality was assessed from the time a signed and dated ICF is obtained until up to 5 years post treatment (approximately 5.5 years).
|
|
Blood and lymphatic system disorders
Anemia
|
47.6%
10/21 • Adverse events were collected from the time a signed and dated ICF is obtained until 30 days after the last dose of treatment, or until the subject withdrew consent from study participation, whichever occurs first. All cause mortality was assessed from the time a signed and dated ICF is obtained until up to 5 years post treatment (approximately 5.5 years).
|
|
Endocrine disorders
Adrenal insufficiency
|
9.5%
2/21 • Adverse events were collected from the time a signed and dated ICF is obtained until 30 days after the last dose of treatment, or until the subject withdrew consent from study participation, whichever occurs first. All cause mortality was assessed from the time a signed and dated ICF is obtained until up to 5 years post treatment (approximately 5.5 years).
|
|
Endocrine disorders
Hyperthyroidism
|
33.3%
7/21 • Adverse events were collected from the time a signed and dated ICF is obtained until 30 days after the last dose of treatment, or until the subject withdrew consent from study participation, whichever occurs first. All cause mortality was assessed from the time a signed and dated ICF is obtained until up to 5 years post treatment (approximately 5.5 years).
|
|
Endocrine disorders
Hypothyroidism
|
9.5%
2/21 • Adverse events were collected from the time a signed and dated ICF is obtained until 30 days after the last dose of treatment, or until the subject withdrew consent from study participation, whichever occurs first. All cause mortality was assessed from the time a signed and dated ICF is obtained until up to 5 years post treatment (approximately 5.5 years).
|
|
Gastrointestinal disorders
Colitis
|
9.5%
2/21 • Adverse events were collected from the time a signed and dated ICF is obtained until 30 days after the last dose of treatment, or until the subject withdrew consent from study participation, whichever occurs first. All cause mortality was assessed from the time a signed and dated ICF is obtained until up to 5 years post treatment (approximately 5.5 years).
|
|
Gastrointestinal disorders
Constipation
|
9.5%
2/21 • Adverse events were collected from the time a signed and dated ICF is obtained until 30 days after the last dose of treatment, or until the subject withdrew consent from study participation, whichever occurs first. All cause mortality was assessed from the time a signed and dated ICF is obtained until up to 5 years post treatment (approximately 5.5 years).
|
|
Gastrointestinal disorders
Diarrhea
|
38.1%
8/21 • Adverse events were collected from the time a signed and dated ICF is obtained until 30 days after the last dose of treatment, or until the subject withdrew consent from study participation, whichever occurs first. All cause mortality was assessed from the time a signed and dated ICF is obtained until up to 5 years post treatment (approximately 5.5 years).
|
|
Gastrointestinal disorders
Dry mouth
|
19.0%
4/21 • Adverse events were collected from the time a signed and dated ICF is obtained until 30 days after the last dose of treatment, or until the subject withdrew consent from study participation, whichever occurs first. All cause mortality was assessed from the time a signed and dated ICF is obtained until up to 5 years post treatment (approximately 5.5 years).
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
14.3%
3/21 • Adverse events were collected from the time a signed and dated ICF is obtained until 30 days after the last dose of treatment, or until the subject withdrew consent from study participation, whichever occurs first. All cause mortality was assessed from the time a signed and dated ICF is obtained until up to 5 years post treatment (approximately 5.5 years).
|
|
Gastrointestinal disorders
Nausea
|
52.4%
11/21 • Adverse events were collected from the time a signed and dated ICF is obtained until 30 days after the last dose of treatment, or until the subject withdrew consent from study participation, whichever occurs first. All cause mortality was assessed from the time a signed and dated ICF is obtained until up to 5 years post treatment (approximately 5.5 years).
|
|
Gastrointestinal disorders
Vomiting
|
19.0%
4/21 • Adverse events were collected from the time a signed and dated ICF is obtained until 30 days after the last dose of treatment, or until the subject withdrew consent from study participation, whichever occurs first. All cause mortality was assessed from the time a signed and dated ICF is obtained until up to 5 years post treatment (approximately 5.5 years).
|
|
General disorders
Edema
|
28.6%
6/21 • Adverse events were collected from the time a signed and dated ICF is obtained until 30 days after the last dose of treatment, or until the subject withdrew consent from study participation, whichever occurs first. All cause mortality was assessed from the time a signed and dated ICF is obtained until up to 5 years post treatment (approximately 5.5 years).
|
|
General disorders
Fatigue
|
61.9%
13/21 • Adverse events were collected from the time a signed and dated ICF is obtained until 30 days after the last dose of treatment, or until the subject withdrew consent from study participation, whichever occurs first. All cause mortality was assessed from the time a signed and dated ICF is obtained until up to 5 years post treatment (approximately 5.5 years).
|
|
General disorders
Non cardiac chest pain
|
14.3%
3/21 • Adverse events were collected from the time a signed and dated ICF is obtained until 30 days after the last dose of treatment, or until the subject withdrew consent from study participation, whichever occurs first. All cause mortality was assessed from the time a signed and dated ICF is obtained until up to 5 years post treatment (approximately 5.5 years).
|
|
General disorders
Pain
|
42.9%
9/21 • Adverse events were collected from the time a signed and dated ICF is obtained until 30 days after the last dose of treatment, or until the subject withdrew consent from study participation, whichever occurs first. All cause mortality was assessed from the time a signed and dated ICF is obtained until up to 5 years post treatment (approximately 5.5 years).
|
|
Immune system disorders
Immune system disorders, other
|
9.5%
2/21 • Adverse events were collected from the time a signed and dated ICF is obtained until 30 days after the last dose of treatment, or until the subject withdrew consent from study participation, whichever occurs first. All cause mortality was assessed from the time a signed and dated ICF is obtained until up to 5 years post treatment (approximately 5.5 years).
|
|
Infections and infestations
Infection
|
28.6%
6/21 • Adverse events were collected from the time a signed and dated ICF is obtained until 30 days after the last dose of treatment, or until the subject withdrew consent from study participation, whichever occurs first. All cause mortality was assessed from the time a signed and dated ICF is obtained until up to 5 years post treatment (approximately 5.5 years).
|
|
Investigations
Alanine aminotransferase increased
|
38.1%
8/21 • Adverse events were collected from the time a signed and dated ICF is obtained until 30 days after the last dose of treatment, or until the subject withdrew consent from study participation, whichever occurs first. All cause mortality was assessed from the time a signed and dated ICF is obtained until up to 5 years post treatment (approximately 5.5 years).
|
|
Investigations
Aspartate aminotransferase increased
|
28.6%
6/21 • Adverse events were collected from the time a signed and dated ICF is obtained until 30 days after the last dose of treatment, or until the subject withdrew consent from study participation, whichever occurs first. All cause mortality was assessed from the time a signed and dated ICF is obtained until up to 5 years post treatment (approximately 5.5 years).
|
|
Investigations
Blood bilirubin increased
|
14.3%
3/21 • Adverse events were collected from the time a signed and dated ICF is obtained until 30 days after the last dose of treatment, or until the subject withdrew consent from study participation, whichever occurs first. All cause mortality was assessed from the time a signed and dated ICF is obtained until up to 5 years post treatment (approximately 5.5 years).
|
|
Investigations
Creatinine increased
|
19.0%
4/21 • Adverse events were collected from the time a signed and dated ICF is obtained until 30 days after the last dose of treatment, or until the subject withdrew consent from study participation, whichever occurs first. All cause mortality was assessed from the time a signed and dated ICF is obtained until up to 5 years post treatment (approximately 5.5 years).
|
|
Investigations
Hemoglobin increased
|
23.8%
5/21 • Adverse events were collected from the time a signed and dated ICF is obtained until 30 days after the last dose of treatment, or until the subject withdrew consent from study participation, whichever occurs first. All cause mortality was assessed from the time a signed and dated ICF is obtained until up to 5 years post treatment (approximately 5.5 years).
|
|
Investigations
Lymphocyte count decreased
|
42.9%
9/21 • Adverse events were collected from the time a signed and dated ICF is obtained until 30 days after the last dose of treatment, or until the subject withdrew consent from study participation, whichever occurs first. All cause mortality was assessed from the time a signed and dated ICF is obtained until up to 5 years post treatment (approximately 5.5 years).
|
|
Investigations
Platelet count decreased
|
23.8%
5/21 • Adverse events were collected from the time a signed and dated ICF is obtained until 30 days after the last dose of treatment, or until the subject withdrew consent from study participation, whichever occurs first. All cause mortality was assessed from the time a signed and dated ICF is obtained until up to 5 years post treatment (approximately 5.5 years).
|
|
Investigations
Weight gain
|
14.3%
3/21 • Adverse events were collected from the time a signed and dated ICF is obtained until 30 days after the last dose of treatment, or until the subject withdrew consent from study participation, whichever occurs first. All cause mortality was assessed from the time a signed and dated ICF is obtained until up to 5 years post treatment (approximately 5.5 years).
|
|
Investigations
Weight loss
|
28.6%
6/21 • Adverse events were collected from the time a signed and dated ICF is obtained until 30 days after the last dose of treatment, or until the subject withdrew consent from study participation, whichever occurs first. All cause mortality was assessed from the time a signed and dated ICF is obtained until up to 5 years post treatment (approximately 5.5 years).
|
|
Metabolism and nutrition disorders
Anorexia
|
14.3%
3/21 • Adverse events were collected from the time a signed and dated ICF is obtained until 30 days after the last dose of treatment, or until the subject withdrew consent from study participation, whichever occurs first. All cause mortality was assessed from the time a signed and dated ICF is obtained until up to 5 years post treatment (approximately 5.5 years).
|
|
Metabolism and nutrition disorders
Dehydration
|
19.0%
4/21 • Adverse events were collected from the time a signed and dated ICF is obtained until 30 days after the last dose of treatment, or until the subject withdrew consent from study participation, whichever occurs first. All cause mortality was assessed from the time a signed and dated ICF is obtained until up to 5 years post treatment (approximately 5.5 years).
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
9.5%
2/21 • Adverse events were collected from the time a signed and dated ICF is obtained until 30 days after the last dose of treatment, or until the subject withdrew consent from study participation, whichever occurs first. All cause mortality was assessed from the time a signed and dated ICF is obtained until up to 5 years post treatment (approximately 5.5 years).
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
19.0%
4/21 • Adverse events were collected from the time a signed and dated ICF is obtained until 30 days after the last dose of treatment, or until the subject withdrew consent from study participation, whichever occurs first. All cause mortality was assessed from the time a signed and dated ICF is obtained until up to 5 years post treatment (approximately 5.5 years).
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
19.0%
4/21 • Adverse events were collected from the time a signed and dated ICF is obtained until 30 days after the last dose of treatment, or until the subject withdrew consent from study participation, whichever occurs first. All cause mortality was assessed from the time a signed and dated ICF is obtained until up to 5 years post treatment (approximately 5.5 years).
|
|
Metabolism and nutrition disorders
Hypokalemia
|
61.9%
13/21 • Adverse events were collected from the time a signed and dated ICF is obtained until 30 days after the last dose of treatment, or until the subject withdrew consent from study participation, whichever occurs first. All cause mortality was assessed from the time a signed and dated ICF is obtained until up to 5 years post treatment (approximately 5.5 years).
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
42.9%
9/21 • Adverse events were collected from the time a signed and dated ICF is obtained until 30 days after the last dose of treatment, or until the subject withdrew consent from study participation, whichever occurs first. All cause mortality was assessed from the time a signed and dated ICF is obtained until up to 5 years post treatment (approximately 5.5 years).
|
|
Metabolism and nutrition disorders
Hyponatremia
|
57.1%
12/21 • Adverse events were collected from the time a signed and dated ICF is obtained until 30 days after the last dose of treatment, or until the subject withdrew consent from study participation, whichever occurs first. All cause mortality was assessed from the time a signed and dated ICF is obtained until up to 5 years post treatment (approximately 5.5 years).
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
9.5%
2/21 • Adverse events were collected from the time a signed and dated ICF is obtained until 30 days after the last dose of treatment, or until the subject withdrew consent from study participation, whichever occurs first. All cause mortality was assessed from the time a signed and dated ICF is obtained until up to 5 years post treatment (approximately 5.5 years).
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
9.5%
2/21 • Adverse events were collected from the time a signed and dated ICF is obtained until 30 days after the last dose of treatment, or until the subject withdrew consent from study participation, whichever occurs first. All cause mortality was assessed from the time a signed and dated ICF is obtained until up to 5 years post treatment (approximately 5.5 years).
|
|
Nervous system disorders
Paresthesia
|
9.5%
2/21 • Adverse events were collected from the time a signed and dated ICF is obtained until 30 days after the last dose of treatment, or until the subject withdrew consent from study participation, whichever occurs first. All cause mortality was assessed from the time a signed and dated ICF is obtained until up to 5 years post treatment (approximately 5.5 years).
|
|
Psychiatric disorders
Anxiety
|
19.0%
4/21 • Adverse events were collected from the time a signed and dated ICF is obtained until 30 days after the last dose of treatment, or until the subject withdrew consent from study participation, whichever occurs first. All cause mortality was assessed from the time a signed and dated ICF is obtained until up to 5 years post treatment (approximately 5.5 years).
|
|
Psychiatric disorders
Insomnia
|
28.6%
6/21 • Adverse events were collected from the time a signed and dated ICF is obtained until 30 days after the last dose of treatment, or until the subject withdrew consent from study participation, whichever occurs first. All cause mortality was assessed from the time a signed and dated ICF is obtained until up to 5 years post treatment (approximately 5.5 years).
|
|
Renal and urinary disorders
Acute kidney injury
|
9.5%
2/21 • Adverse events were collected from the time a signed and dated ICF is obtained until 30 days after the last dose of treatment, or until the subject withdrew consent from study participation, whichever occurs first. All cause mortality was assessed from the time a signed and dated ICF is obtained until up to 5 years post treatment (approximately 5.5 years).
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
14.3%
3/21 • Adverse events were collected from the time a signed and dated ICF is obtained until 30 days after the last dose of treatment, or until the subject withdrew consent from study participation, whichever occurs first. All cause mortality was assessed from the time a signed and dated ICF is obtained until up to 5 years post treatment (approximately 5.5 years).
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
9.5%
2/21 • Adverse events were collected from the time a signed and dated ICF is obtained until 30 days after the last dose of treatment, or until the subject withdrew consent from study participation, whichever occurs first. All cause mortality was assessed from the time a signed and dated ICF is obtained until up to 5 years post treatment (approximately 5.5 years).
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
14.3%
3/21 • Adverse events were collected from the time a signed and dated ICF is obtained until 30 days after the last dose of treatment, or until the subject withdrew consent from study participation, whichever occurs first. All cause mortality was assessed from the time a signed and dated ICF is obtained until up to 5 years post treatment (approximately 5.5 years).
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
9.5%
2/21 • Adverse events were collected from the time a signed and dated ICF is obtained until 30 days after the last dose of treatment, or until the subject withdrew consent from study participation, whichever occurs first. All cause mortality was assessed from the time a signed and dated ICF is obtained until up to 5 years post treatment (approximately 5.5 years).
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
9.5%
2/21 • Adverse events were collected from the time a signed and dated ICF is obtained until 30 days after the last dose of treatment, or until the subject withdrew consent from study participation, whichever occurs first. All cause mortality was assessed from the time a signed and dated ICF is obtained until up to 5 years post treatment (approximately 5.5 years).
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
38.1%
8/21 • Adverse events were collected from the time a signed and dated ICF is obtained until 30 days after the last dose of treatment, or until the subject withdrew consent from study participation, whichever occurs first. All cause mortality was assessed from the time a signed and dated ICF is obtained until up to 5 years post treatment (approximately 5.5 years).
|
|
Skin and subcutaneous tissue disorders
Rash
|
47.6%
10/21 • Adverse events were collected from the time a signed and dated ICF is obtained until 30 days after the last dose of treatment, or until the subject withdrew consent from study participation, whichever occurs first. All cause mortality was assessed from the time a signed and dated ICF is obtained until up to 5 years post treatment (approximately 5.5 years).
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders, other
|
9.5%
2/21 • Adverse events were collected from the time a signed and dated ICF is obtained until 30 days after the last dose of treatment, or until the subject withdrew consent from study participation, whichever occurs first. All cause mortality was assessed from the time a signed and dated ICF is obtained until up to 5 years post treatment (approximately 5.5 years).
|
|
Skin and subcutaneous tissue disorders
Skin hypopigmentation
|
9.5%
2/21 • Adverse events were collected from the time a signed and dated ICF is obtained until 30 days after the last dose of treatment, or until the subject withdrew consent from study participation, whichever occurs first. All cause mortality was assessed from the time a signed and dated ICF is obtained until up to 5 years post treatment (approximately 5.5 years).
|
Additional Information
Maria Constantinou, MD
Brown University Oncology Research Group
Phone: 401-863-300
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place