Trial Outcomes & Findings for Study of Nivolumab Plus Ipilimumab in Patients With Salivary Gland Cancer (NCT NCT03172624)
NCT ID: NCT03172624
Last Updated: 2025-12-18
Results Overview
using the new international criteria proposed by the revised Response Evaluation Criteria in Solid Tumors (RECIST) guideline (version 1.1)
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
64 participants
Primary outcome timeframe
2 years
Results posted on
2025-12-18
Participant Flow
Participant milestones
| Measure |
R/M Adenoid Cystic Carcinoma (ACC)
Enrolled patients will be treated with nivolumab 3 mg/kg every 2 weeks plus ipilimumab 1 mg/kg every 6 weeks (1 cycle= 6 weeks).
Nivolumab: nivolumab 3 mg/kg every 2 weeks
Ipilimumab: ipilimumab 1 mg/kg every 6 weeks (1 cycle= 6 weeks)
|
R/M SGC of Any Histology, Except ACC (Non ACC)
Enrolled patients will be treated with nivolumab 3 mg/kg every 2 weeks plus ipilimumab 1 mg/kg every 6 weeks (1 cycle= 6 weeks).
Nivolumab: nivolumab 3 mg/kg every 2 weeks
Ipilimumab: ipilimumab 1 mg/kg every 6 weeks (1 cycle= 6 weeks)
|
|---|---|---|
|
Overall Study
STARTED
|
32
|
32
|
|
Overall Study
COMPLETED
|
32
|
32
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study of Nivolumab Plus Ipilimumab in Patients With Salivary Gland Cancer
Baseline characteristics by cohort
| Measure |
R/M Adenoid Cystic Carcinoma (ACC)
n=32 Participants
Enrolled patients will be treated with nivolumab 3 mg/kg every 2 weeks plus ipilimumab 1 mg/kg every 6 weeks (1 cycle= 6 weeks).
Nivolumab: nivolumab 3 mg/kg every 2 weeks
Ipilimumab: ipilimumab 1 mg/kg every 6 weeks (1 cycle= 6 weeks)
|
R/M SGC of Any Histology, Except ACC (Non ACC)
n=32 Participants
Enrolled patients will be treated with nivolumab 3 mg/kg every 2 weeks plus ipilimumab 1 mg/kg every 6 weeks (1 cycle= 6 weeks).
Nivolumab: nivolumab 3 mg/kg every 2 weeks
Ipilimumab: ipilimumab 1 mg/kg every 6 weeks (1 cycle= 6 weeks)
|
Total
n=64 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
58 years
n=47 Participants
|
64 years
n=41 Participants
|
64 years
n=88 Participants
|
|
Sex: Female, Male
Female
|
19 Participants
n=47 Participants
|
12 Participants
n=41 Participants
|
31 Participants
n=88 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=47 Participants
|
20 Participants
n=41 Participants
|
33 Participants
n=88 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=47 Participants
|
0 Participants
n=41 Participants
|
2 Participants
n=88 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
30 Participants
n=47 Participants
|
29 Participants
n=41 Participants
|
59 Participants
n=88 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=47 Participants
|
3 Participants
n=41 Participants
|
3 Participants
n=88 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=47 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=88 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=47 Participants
|
1 Participants
n=41 Participants
|
4 Participants
n=88 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=47 Participants
|
1 Participants
n=41 Participants
|
1 Participants
n=88 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=47 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=88 Participants
|
|
Race (NIH/OMB)
White
|
28 Participants
n=47 Participants
|
26 Participants
n=41 Participants
|
54 Participants
n=88 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=47 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=88 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=47 Participants
|
4 Participants
n=41 Participants
|
5 Participants
n=88 Participants
|
|
Region of Enrollment
United States
|
32 Participants
n=47 Participants
|
32 Participants
n=41 Participants
|
64 Participants
n=88 Participants
|
PRIMARY outcome
Timeframe: 2 yearsusing the new international criteria proposed by the revised Response Evaluation Criteria in Solid Tumors (RECIST) guideline (version 1.1)
Outcome measures
| Measure |
R/M Adenoid Cystic Carcinoma (ACC)
n=32 Participants
Enrolled patients will be treated with nivolumab 3 mg/kg every 2 weeks plus ipilimumab 1 mg/kg every 6 weeks (1 cycle= 6 weeks).
Nivolumab: nivolumab 3 mg/kg every 2 weeks
Ipilimumab: ipilimumab 1 mg/kg every 6 weeks (1 cycle= 6 weeks)
|
R/M SGC of Any Histology, Except ACC (Non ACC)
n=32 Participants
Enrolled patients will be treated with nivolumab 3 mg/kg every 2 weeks plus ipilimumab 1 mg/kg every 6 weeks (1 cycle= 6 weeks).
Nivolumab: nivolumab 3 mg/kg every 2 weeks
Ipilimumab: ipilimumab 1 mg/kg every 6 weeks (1 cycle= 6 weeks)
|
|---|---|---|
|
Best Overall Response Rate
Partial Response
|
2 Participants
|
5 Participants
|
|
Best Overall Response Rate
Stable Disease
|
17 Participants
|
8 Participants
|
|
Best Overall Response Rate
Progressive Disease
|
13 Participants
|
18 Participants
|
|
Best Overall Response Rate
Not Evaluable
|
0 Participants
|
1 Participants
|
Adverse Events
R/M Adenoid Cystic Carcinoma (ACC)
Serious events: 18 serious events
Other events: 11 other events
Deaths: 6 deaths
R/M SGC of Any Histology, Except ACC (Non ACC)
Serious events: 9 serious events
Other events: 14 other events
Deaths: 7 deaths
Serious adverse events
| Measure |
R/M Adenoid Cystic Carcinoma (ACC)
n=32 participants at risk
Enrolled patients will be treated with nivolumab 3 mg/kg every 2 weeks plus ipilimumab 1 mg/kg every 6 weeks (1 cycle= 6 weeks).
Nivolumab: nivolumab 3 mg/kg every 2 weeks
Ipilimumab: ipilimumab 1 mg/kg every 6 weeks (1 cycle= 6 weeks)
|
R/M SGC of Any Histology, Except ACC (Non ACC)
n=32 participants at risk
Enrolled patients will be treated with nivolumab 3 mg/kg every 2 weeks plus ipilimumab 1 mg/kg every 6 weeks (1 cycle= 6 weeks).
Nivolumab: nivolumab 3 mg/kg every 2 weeks
Ipilimumab: ipilimumab 1 mg/kg every 6 weeks (1 cycle= 6 weeks)
|
|---|---|---|
|
Gastrointestinal disorders
Diarrhea
|
6.2%
2/32 • 2 years
|
3.1%
1/32 • 2 years
|
|
Gastrointestinal disorders
Dysphagia
|
3.1%
1/32 • 2 years
|
0.00%
0/32 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
18.8%
6/32 • 2 years
|
3.1%
1/32 • 2 years
|
|
Cardiac disorders
Ejection fraction decreased
|
0.00%
0/32 • 2 years
|
3.1%
1/32 • 2 years
|
|
Endocrine disorders
Endocrine disorders - Other, specify
|
3.1%
1/32 • 2 years
|
0.00%
0/32 • 2 years
|
|
General disorders
Fatigue
|
6.2%
2/32 • 2 years
|
3.1%
1/32 • 2 years
|
|
General disorders
Fever
|
3.1%
1/32 • 2 years
|
0.00%
0/32 • 2 years
|
|
Nervous system disorders
Headache
|
0.00%
0/32 • 2 years
|
3.1%
1/32 • 2 years
|
|
Injury, poisoning and procedural complications
Hip fracture
|
3.1%
1/32 • 2 years
|
0.00%
0/32 • 2 years
|
|
Vascular disorders
Hypertension
|
0.00%
0/32 • 2 years
|
3.1%
1/32 • 2 years
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
3.1%
1/32 • 2 years
|
0.00%
0/32 • 2 years
|
|
Metabolism and nutrition disorders
Hyponatremia
|
3.1%
1/32 • 2 years
|
3.1%
1/32 • 2 years
|
|
Vascular disorders
Hypotension
|
3.1%
1/32 • 2 years
|
0.00%
0/32 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
3.1%
1/32 • 2 years
|
3.1%
1/32 • 2 years
|
|
Infections and infestations
Infections and infestations - Other, specify
|
3.1%
1/32 • 2 years
|
0.00%
0/32 • 2 years
|
|
Nervous system disorders
Intracranial hemorrhage
|
3.1%
1/32 • 2 years
|
0.00%
0/32 • 2 years
|
|
Gastrointestinal disorders
Jejunal obstruction
|
3.1%
1/32 • 2 years
|
0.00%
0/32 • 2 years
|
|
Infections and infestations
Lung infection
|
3.1%
1/32 • 2 years
|
0.00%
0/32 • 2 years
|
|
General disorders
Malaise
|
3.1%
1/32 • 2 years
|
0.00%
0/32 • 2 years
|
|
Gastrointestinal disorders
Nausea
|
3.1%
1/32 • 2 years
|
0.00%
0/32 • 2 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms ben/mal/unk (inc cyst/polyp) Other, spec
|
9.4%
3/32 • 2 years
|
3.1%
1/32 • 2 years
|
|
Nervous system disorders
Nervous system disorders - Other, specify
|
0.00%
0/32 • 2 years
|
3.1%
1/32 • 2 years
|
|
General disorders
Non-cardiac chest pain
|
6.2%
2/32 • 2 years
|
0.00%
0/32 • 2 years
|
|
General disorders
Pain
|
6.2%
2/32 • 2 years
|
0.00%
0/32 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
3.1%
1/32 • 2 years
|
0.00%
0/32 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
3.1%
1/32 • 2 years
|
0.00%
0/32 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
3.1%
1/32 • 2 years
|
3.1%
1/32 • 2 years
|
|
Infections and infestations
Sepsis
|
3.1%
1/32 • 2 years
|
0.00%
0/32 • 2 years
|
|
Cardiac disorders
Sinus tachycardia
|
3.1%
1/32 • 2 years
|
3.1%
1/32 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Stridor
|
3.1%
1/32 • 2 years
|
0.00%
0/32 • 2 years
|
|
Nervous system disorders
Stroke
|
0.00%
0/32 • 2 years
|
3.1%
1/32 • 2 years
|
|
Nervous system disorders
Syncope
|
3.1%
1/32 • 2 years
|
0.00%
0/32 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Trismus
|
3.1%
1/32 • 2 years
|
0.00%
0/32 • 2 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumor pain
|
6.2%
2/32 • 2 years
|
0.00%
0/32 • 2 years
|
|
Renal and urinary disorders
Urinary retention
|
3.1%
1/32 • 2 years
|
0.00%
0/32 • 2 years
|
|
Investigations
Weight loss
|
3.1%
1/32 • 2 years
|
0.00%
0/32 • 2 years
|
|
Investigations
Alanine aminotransferase increased
|
3.1%
1/32 • 2 years
|
0.00%
0/32 • 2 years
|
|
Blood and lymphatic system disorders
Anemia
|
3.1%
1/32 • 2 years
|
3.1%
1/32 • 2 years
|
|
Investigations
Aspartate aminotransferase increased
|
6.2%
2/32 • 2 years
|
3.1%
1/32 • 2 years
|
|
Endocrine disorders
Adrenal insufficiency
|
3.1%
1/32 • 2 years
|
0.00%
0/32 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
3.1%
1/32 • 2 years
|
0.00%
0/32 • 2 years
|
|
Eye disorders
Blurred vision
|
3.1%
1/32 • 2 years
|
0.00%
0/32 • 2 years
|
|
Blood and lymphatic system disorders
Bone marrow hypocellular
|
0.00%
0/32 • 2 years
|
3.1%
1/32 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Bronchopulmonary hemorrhage
|
3.1%
1/32 • 2 years
|
0.00%
0/32 • 2 years
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/32 • 2 years
|
3.1%
1/32 • 2 years
|
|
Cardiac disorders
Cardiac disorders - Other, specify
|
0.00%
0/32 • 2 years
|
3.1%
1/32 • 2 years
|
|
Psychiatric disorders
Confusion
|
0.00%
0/32 • 2 years
|
3.1%
1/32 • 2 years
|
|
General disorders
Death NOS
|
0.00%
0/32 • 2 years
|
3.1%
1/32 • 2 years
|
Other adverse events
| Measure |
R/M Adenoid Cystic Carcinoma (ACC)
n=32 participants at risk
Enrolled patients will be treated with nivolumab 3 mg/kg every 2 weeks plus ipilimumab 1 mg/kg every 6 weeks (1 cycle= 6 weeks).
Nivolumab: nivolumab 3 mg/kg every 2 weeks
Ipilimumab: ipilimumab 1 mg/kg every 6 weeks (1 cycle= 6 weeks)
|
R/M SGC of Any Histology, Except ACC (Non ACC)
n=32 participants at risk
Enrolled patients will be treated with nivolumab 3 mg/kg every 2 weeks plus ipilimumab 1 mg/kg every 6 weeks (1 cycle= 6 weeks).
Nivolumab: nivolumab 3 mg/kg every 2 weeks
Ipilimumab: ipilimumab 1 mg/kg every 6 weeks (1 cycle= 6 weeks)
|
|---|---|---|
|
Investigations
White blood cell decreased
|
3.1%
1/32 • 2 years
|
9.4%
3/32 • 2 years
|
|
Investigations
Alanine aminotransferase increased
|
6.2%
2/32 • 2 years
|
0.00%
0/32 • 2 years
|
|
Blood and lymphatic system disorders
Anemia
|
12.5%
4/32 • 2 years
|
3.1%
1/32 • 2 years
|
|
Investigations
Aspartate aminotransferase increased
|
12.5%
4/32 • 2 years
|
6.2%
2/32 • 2 years
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
0.00%
0/32 • 2 years
|
12.5%
4/32 • 2 years
|
|
Metabolism and nutrition disorders
Hyponatremia
|
12.5%
4/32 • 2 years
|
15.6%
5/32 • 2 years
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
6.2%
2/32 • 2 years
|
6.2%
2/32 • 2 years
|
|
Investigations
Lymphocyte count decreased
|
34.4%
11/32 • 2 years
|
43.8%
14/32 • 2 years
|
|
Investigations
Neutrophil count decreased
|
6.2%
2/32 • 2 years
|
9.4%
3/32 • 2 years
|
Additional Information
Dr. Alan Ho, MD, PhD
Memorial Sloan Kettering Cancer Center
Phone: 646-888-4235
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place