18 and older, any sex, with Solid Tumors. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
The Number of Participants Experiencing Drug-Related Grade 3-4 Adverse Events (AEs)Primary· From first dose to 100 days after last dose (up to approximately 28 months)
A drug related adverse event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study drug that has a causal relationship with the treatment. AEs are graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (Version 4.03) (NCI CTCAE) guidelines where Grade 3= Severe and Grade 4= Life-threatening.
Group
Value
95% CI
Cohort A: Nivolumab 3 mg/kg Q2W
1
Cohort B: Nivolumab 240 mg Q2W
1
Cohort C: Nivolumab 360 mg Q3W
0
Cohort D: Nivolumab 480 mg Q4W
0
The Number of Participants Experiencing Drug-Related Grade 3-4 Serious Adverse Events (SAEs)Primary· From first dose to 100 days after last dose (up to approximately 28 months)
A drug related serious adverse event (SAE) is any untoward medical occurrence that at any dose: results in death; is life-threatening; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; or is an important medical event that has a casual relationship with the treatment. SAEs are graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (Version 4.03) (NCI CTCAE) guidelines where Grade 3= Severe and Grade 4= Life-threatening.
Group
Value
95% CI
Cohort A: Nivolumab 3 mg/kg Q2W
0
Cohort B: Nivolumab 240 mg Q2W
1
Cohort C: Nivolumab 360 mg Q3W
0
Cohort D: Nivolumab 480 mg Q4W
0
The Number of Participants Experiencing Abnormal Hepatic Laboratory Test ResultsPrimary· From first dose to 100 days after last dose (up to approximately 28 months)
The number of participants with the following laboratory abnormalities from the following on-treatment evaluations:
* ALT or AST \> 3 x ULN, \> 5 x ULN, \> 10 x ULN and \> 20 x ULN
* Total bilirubin \> 2 x ULN
* Concurrent (within 1 day) ALT or AST \> 3 x ULN and total bilirubin \> 2 x ULN
* Concurrent (within 30 days) ALT or AST \> 3 x ULN and total bilirubin \> 2 x ULN
ALT OR AST > 3XULN
Group
Value
95% CI
Cohort A: Nivolumab 3 mg/kg Q2W
0
Cohort B: Nivolumab 240 mg Q2W
3
Cohort C: Nivolumab 360 mg Q3W
0
Cohort D: Nivolumab 480 mg Q4W
1
ALT OR AST> 5XULN
Group
Value
95% CI
Cohort A: Nivolumab 3 mg/kg Q2W
0
Cohort B: Nivolumab 240 mg Q2W
2
Cohort C: Nivolumab 360 mg Q3W
0
Cohort D: Nivolumab 480 mg Q4W
0
ALT OR AST> 10XULN
Group
Value
95% CI
Cohort A: Nivolumab 3 mg/kg Q2W
0
Cohort B: Nivolumab 240 mg Q2W
1
Cohort C: Nivolumab 360 mg Q3W
0
Cohort D: Nivolumab 480 mg Q4W
0
ALT OR AST > 20XULN
Group
Value
95% CI
Cohort A: Nivolumab 3 mg/kg Q2W
0
Cohort B: Nivolumab 240 mg Q2W
0
Cohort C: Nivolumab 360 mg Q3W
0
Cohort D: Nivolumab 480 mg Q4W
0
TOTAL BILIRUBIN > 2XULN
Group
Value
95% CI
Cohort A: Nivolumab 3 mg/kg Q2W
0
Cohort B: Nivolumab 240 mg Q2W
3
Cohort C: Nivolumab 360 mg Q3W
1
Cohort D: Nivolumab 480 mg Q4W
0
ALT/AST ELEV>3XULN;TOTAL BILIRUBIN>2XULN IN 1 DAY
Group
Value
95% CI
Cohort A: Nivolumab 3 mg/kg Q2W
0
Cohort B: Nivolumab 240 mg Q2W
3
Cohort C: Nivolumab 360 mg Q3W
0
Cohort D: Nivolumab 480 mg Q4W
0
ALT/AST ELEV>3XULN;TOTAL BILIRUBIN>2XULN IN 30 DAYS
Group
Value
95% CI
Cohort A: Nivolumab 3 mg/kg Q2W
0
Cohort B: Nivolumab 240 mg Q2W
3
Cohort C: Nivolumab 360 mg Q3W
0
Cohort D: Nivolumab 480 mg Q4W
0
Best Overall Response (BOR)Secondary· From first dose up to approximately 28 months
Best overall response (BOR) was assessed by the investigator using Response Evaluation Criteria in Solid Tumor (RECIST v1.1). Complete Response (CR) is defined as a disappearance of all target lesions. Partial Response (PR) is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Stable Disease (SD) is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. Progressive Disease (PD) is defined as at least a 20% increa
Group
Value
95% CI
Cohort A: Nivolumab 3 mg/kg Q2W
0
Cohort B: Nivolumab 240 mg Q2W
0
Cohort C: Nivolumab 360 mg Q3W
0
Cohort D: Nivolumab 480 mg Q4W
0
Cohort A: Nivolumab 3 mg/kg Q2W
3
Cohort B: Nivolumab 240 mg Q2W
2
Cohort C: Nivolumab 360 mg Q3W
1
Cohort D: Nivolumab 480 mg Q4W
2
Cohort A: Nivolumab 3 mg/kg Q2W
2
Cohort B: Nivolumab 240 mg Q2W
12
Cohort C: Nivolumab 360 mg Q3W
6
Cohort D: Nivolumab 480 mg Q4W
6
Cohort A: Nivolumab 3 mg/kg Q2W
9
Cohort B: Nivolumab 240 mg Q2W
5
Cohort C: Nivolumab 360 mg Q3W
4
Cohort D: Nivolumab 480 mg Q4W
4
Duration of Response (DOR)Secondary· From the date of first response (CR or PR) to the date of the first documented tumor progression or death due to any cause, whichever occurs first. (Up to approximately 28 months)
Duration of response is defined as the time from the date of first response (CR or PR) to the date of the first documented tumor progression as determined using RECIST 1.1 or death due to any cause, whichever occurs first. Participants who remain alive and have not progressed will be censored on the date of their last tumor assessment. Participants who started subsequent therapy without a prior reported progression will be censored at the last tumor assessment prior to initiation of the subsequent anticancer therapy. Complete response (CR) is defined as a disappearance of all target lesions an
Hepatocellular carcinoma
Group
Value
95% CI
Cohort D: Nivolumab 480 mg Q4W
NA
95.3 – 95.3
Non-small cell lung carcinoma (NSCLC)
Group
Value
95% CI
Cohort A: Nivolumab 3 mg/kg Q2W
NA
8.3 – 8.3
Cohort C: Nivolumab 360 mg Q3W
6.1
6.1 – 6.1
Nasopharyngeal carcinoma
Group
Value
95% CI
Cohort A: Nivolumab 3 mg/kg Q2W
NA
48.7 – 75.7
Cohort B: Nivolumab 240 mg Q2W
NA
34.1 – 81.1
Cohort D: Nivolumab 480 mg Q4W
NA
83.3 – 83.3
Objective Response Rate (ORR)Secondary· From first dose up to approximately 28 months
Objective response rate (ORR) is defined as the percentage of all treated participants whose best overall response (BOR) is either a complete response (CR) or partial response (PR) by investigator using Response Evaluation Criteria in Solid Tumor (RECIST v1.1). Complete response (CR) is defined as a disappearance of all target lesions and partial response (PR) is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Other tumor types include: gastric, melanoma, neuroblastoma, colorectal cancer, cervical cancer, duodenal pa
Hepatocellular carcinoma
Group
Value
95% CI
Cohort B: Nivolumab 240 mg Q2W
0
NA – NA
Cohort D: Nivolumab 480 mg Q4W
100
NA – NA
Non-small cell lung carcinoma (NSCLC)
Group
Value
95% CI
Cohort A: Nivolumab 3 mg/kg Q2W
11.1
NA – NA
Cohort B: Nivolumab 240 mg Q2W
0
NA – NA
Cohort C: Nivolumab 360 mg Q3W
100
NA – NA
Cohort D: Nivolumab 480 mg Q4W
0
NA – NA
Nasopharyngeal carcinoma
Group
Value
95% CI
Cohort A: Nivolumab 3 mg/kg Q2W
33.3
NA – NA
Cohort B: Nivolumab 240 mg Q2W
11.8
1.5 – 36.4
Cohort C: Nivolumab 360 mg Q3W
0
0.0 – 30.8
Cohort D: Nivolumab 480 mg Q4W
100
NA – NA
Other tumor types
Group
Value
95% CI
Cohort D: Nivolumab 480 mg Q4W
0
NA – NA
Response Rate at 24 WeeksSecondary· Week 24
Response rate at 24 weeks is defined as the percentage of all treated participants who have CR or PR by 24 weeks. Complete response (CR) is defined as a disappearance of all target lesions and partial response (PR) is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Other tumor types include: gastric, melanoma, neuroblastoma, colorectal cancer, cervical cancer, duodenal papillary carcinoma, and gallbladder carcinoma.
Hepatocellular carcinoma
Group
Value
95% CI
Cohort B: Nivolumab 240 mg Q2W
0
NA – NA
Cohort D: Nivolumab 480 mg Q4W
100
NA – NA
Non-small cell lung carcinoma (NSCLC)
Group
Value
95% CI
Cohort A: Nivolumab 3 mg/kg Q2W
11.1
NA – NA
Cohort B: Nivolumab 240 mg Q2W
0
NA – NA
Cohort C: Nivolumab 360 mg Q3W
100
NA – NA
Cohort D: Nivolumab 480 mg Q4W
0
NA – NA
Nasopharyngeal carcinoma
Group
Value
95% CI
Cohort A: Nivolumab 3 mg/kg Q2W
33.3
NA – NA
Cohort B: Nivolumab 240 mg Q2W
5.9
0.1 – 28.7
Cohort C: Nivolumab 360 mg Q3W
0
0.0 – 30.8
Cohort D: Nivolumab 480 mg Q4W
100
NA – NA
Other tumor types
Group
Value
95% CI
Cohort D: Nivolumab 480 mg Q4W
0
NA – NA
Disease Control Rate (DCR) at 24 WeeksSecondary· Week 24
Disease control rate (DCR) at 24 weeks is defined as the percentage of all treated participants who have CR, PR or SD by 24 weeks. Complete Response (CR) is defined as a disappearance of all target lesions. Partial Response (PR) is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Stable Disease (SD) is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. Other tumor types include: gastric, melanoma, neuroblas
Colorectal Cancer
Group
Value
95% CI
Cohort D: Nivolumab 480 mg Q4W
100
NA – NA
Hepatocellular carcinoma
Group
Value
95% CI
Cohort B: Nivolumab 240 mg Q2W
0
NA – NA
Cohort D: Nivolumab 480 mg Q4W
100
NA – NA
Non-small cell lung carcinoma (NSCLC)
Group
Value
95% CI
Cohort A: Nivolumab 3 mg/kg Q2W
11.1
NA – NA
Cohort B: Nivolumab 240 mg Q2W
0
NA – NA
Cohort C: Nivolumab 360 mg Q3W
100
NA – NA
Cohort D: Nivolumab 480 mg Q4W
66.7
NA – NA
Nasopharyngeal carcinoma
Group
Value
95% CI
Cohort A: Nivolumab 3 mg/kg Q2W
33.3
NA – NA
Cohort B: Nivolumab 240 mg Q2W
23.5
6.8 – 49.9
Cohort C: Nivolumab 360 mg Q3W
20.0
2.5 – 55.6
Cohort D: Nivolumab 480 mg Q4W
100
NA – NA
Other tumor types
Group
Value
95% CI
Cohort D: Nivolumab 480 mg Q4W
0
NA – NA
The Number of Participants With Positive Anti Drug Antibody (ADA) Assessments at Baseline and Positive or Negative ADA Samples After TreatmentSecondary· From pre-dose on day 1 Cycle 1 up to participants end of study (up to approximately 28 months)
The number of participants with the following anti-drug responses:
1. Baseline ADA positive: all participants with baseline ADA positive samples.
2. ADA Positive: participants that have at least one ADA positive sample relative to baseline at any time after initiation of treatment.
3. ADA negative: participants that have no ADA positive samples after the initiation of treatment.
ADA positive sample at baseline
Group
Value
95% CI
Cohort A: Nivolumab 3 mg/kg Q2W
1
Cohort B: Nivolumab 240 mg Q2W
4
Cohort C: Nivolumab 360 mg Q3W
0
Cohort D: Nivolumab 480 mg Q4W
0
ADA positive sample after initiation of treatment
Group
Value
95% CI
Cohort A: Nivolumab 3 mg/kg Q2W
1
Cohort B: Nivolumab 240 mg Q2W
0
Cohort C: Nivolumab 360 mg Q3W
0
Cohort D: Nivolumab 480 mg Q4W
2
ADA Negative sample after initiation of treatment
Group
Value
95% CI
Cohort A: Nivolumab 3 mg/kg Q2W
12
Cohort B: Nivolumab 240 mg Q2W
19
Cohort C: Nivolumab 360 mg Q3W
10
Cohort D: Nivolumab 480 mg Q4W
10
Cmax - Maximum Observed Serum ConcentrationSecondary· Day 1 Cycle 1, 3, 5, 6 (pre-dose, 0.5, 4, 8, 24, 48, 96, 168, hours post dose. Cohort C-D includes also 336 hours post dose)
Nivolumab pharmacokinetic parameters are derived from serum concentration versus time data. Cmax is the maximum observed serum concentration over time.
Cycle 1 Day 1
Group
Value
95% CI
Cohort A: Nivolumab 3 mg/kg Q2W
57.025
± NA
Cohort B: Nivolumab 240 mg Q2W
77.674
± NA
Cohort C: Nivolumab 360 mg Q3W
108.455
± NA
Cohort D: Nivolumab 480 mg Q4W
206.630
± NA
Cycle 3 Day 1
Group
Value
95% CI
Cohort A: Nivolumab 3 mg/kg Q2W
132.222
± NA
Cohort B: Nivolumab 240 mg Q2W
171.604
± NA
Cycle 5 Day 1
Group
Value
95% CI
Cohort D: Nivolumab 480 mg Q4W
265.550
± NA
Cycle 6 Day 1
Group
Value
95% CI
Cohort C: Nivolumab 360 mg Q3W
165.369
± NA
Tmax - Time of Maximum Observed Serum ConcentrationSecondary· Day 1 Cycle 1, 3, 5, 6 (pre-dose, 0.5, 4, 8, 24, 48, 96, 168, hours post dose. Cohort C-D includes also 336 hours post dose)
Nivolumab pharmacokinetic parameters are derived from serum concentration versus time data. Tmax is the time of maximum observed serum concentration.
Cycle 1 Day 1
Group
Value
95% CI
Cohort A: Nivolumab 3 mg/kg Q2W
4.00
0.5 – 4.0
Cohort B: Nivolumab 240 mg Q2W
4.00
0.5 – 8.0
Cohort C: Nivolumab 360 mg Q3W
4.0
4.0 – 8.0
Cohort D: Nivolumab 480 mg Q4W
4.01
0.5 – 8.0
Cycle 3 Day 1
Group
Value
95% CI
Cohort A: Nivolumab 3 mg/kg Q2W
8.00
4.0 – 48.2
Cohort B: Nivolumab 240 mg Q2W
8.00
4.0 – 48.0
Cycle 5 Day 1
Group
Value
95% CI
Cohort D: Nivolumab 480 mg Q4W
2.26
0.5 – 8.0
Cycle 6 Day 1
Group
Value
95% CI
Cohort C: Nivolumab 360 mg Q3W
8.00
0.5 – 24.1
AUC (0-T)-Area Under the Plasma Concentration-Time CurveSecondary· Day 1 Cycle 1, 3, 5, 6 (pre-dose, 0.5, 4, 8, 24, 48, 96, 168, hours post dose. Cohort C-D includes also 336 hours post dose)
Nivolumab pharmacokinetic parameters are derived from serum concentration versus time data. AUC (0-T) is the area under the plasma concentration-time curve from time zero to the last time of the last quantifiable concentration.
Cycle 1 Day 1
Group
Value
95% CI
Cohort A: Nivolumab 3 mg/kg Q2W
8353.429
± NA
Cohort B: Nivolumab 240 mg Q2W
11646.854
± NA
Cohort C: Nivolumab 360 mg Q3W
23567.315
± NA
Cohort D: Nivolumab 480 mg Q4W
49115.208
± NA
Cycle 3 Day 1
Group
Value
95% CI
Cohort A: Nivolumab 3 mg/kg Q2W
28442.153
± NA
Cohort B: Nivolumab 240 mg Q2W
35649.049
± NA
Cycle 5 Day 1
Group
Value
95% CI
Cohort D: Nivolumab 480 mg Q4W
91967.438
± NA
Cycle 6 Day 1
Group
Value
95% CI
Cohort C: Nivolumab 360 mg Q3W
51087.588
± NA
Adverse events — posted to ClinicalTrials.gov
Time frame: All-cause mortality was assessed from participants first dose to their study completion (up to approximately 28 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to an approximately 14 months, maximum of 28 months).
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Cohort A: Nivolumab 3 mg/kg Q2W
Serious: 6/15 (40%)
Deaths: 4/15
Cohort B: Nivolumab 240 mg Q2W
Serious: 8/20 (40%)
Deaths: 7/20
Cohort C: Nivolumab 360 mg Q3W
Serious: 2/11 (18%)
Deaths: 0/11
Cohort D: Nivolumab 480 mg Q4W
Serious: 7/12 (58%)
Deaths: 1/12
Serious adverse events (23 terms)
Reaction
System
Cohort A: Nivolumab 3 mg/k…
Cohort B: Nivolumab 240 mg…
Cohort C: Nivolumab 360 mg…
Cohort D: Nivolumab 480 mg…
Malignant neoplasm progression
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
—
—
—
—
Pneumonia
Infections and infestations
—
—
—
—
Pericardial effusion
Cardiac disorders
—
—
—
—
Hypothalamo-pituitary disorder
Endocrine disorders
—
—
—
—
Optic neuropathy
Eye disorders
—
—
—
—
Dysphagia
Gastrointestinal disorders
—
—
—
—
Intestinal obstruction
Gastrointestinal disorders
—
—
—
—
Pancreatitis
Gastrointestinal disorders
—
—
—
—
Asthenia
General disorders
—
—
—
—
Jaundice cholestatic
Hepatobiliary disorders
—
—
—
—
Appendicitis
Infections and infestations
—
—
—
—
Septic shock
Infections and infestations
—
—
—
—
Tracheal haemorrhage
Injury, poisoning and procedural complications
—
—
—
—
Platelet count decreased
Investigations
—
—
—
—
Decreased appetite
Metabolism and nutrition disorders
—
—
—
—
Hyponatraemia
Metabolism and nutrition disorders
—
—
—
—
Muscular weakness
Musculoskeletal and connective tissue disorders
—
—
—
—
Brain oedema
Nervous system disorders
—
—
—
—
Cerebellar haemorrhage
Nervous system disorders
—
—
—
—
Paraplegia
Nervous system disorders
—
—
—
—
Urinary tract obstruction
Renal and urinary disorders
—
—
—
—
Asphyxia
Respiratory, thoracic and mediastinal disorders
—
—
—
—
Respiratory failure
Respiratory, thoracic and mediastinal disorders
—
—
—
—
Other adverse events (131 terms — click to expand)
Reaction
System
Cohort A: Nivolumab 3 mg/k…
Cohort B: Nivolumab 240 mg…
Cohort C: Nivolumab 360 mg…
Cohort D: Nivolumab 480 mg…
Hypothyroidism
Endocrine disorders
—
—
—
—
Malaise
General disorders
—
—
—
—
Upper respiratory tract infection
Infections and infestations
—
—
—
—
Alanine aminotransferase increased
Investigations
—
—
—
—
Aspartate aminotransferase increased
Investigations
—
—
—
—
Decreased appetite
Metabolism and nutrition disorders
—
—
—
—
Hyponatraemia
Metabolism and nutrition disorders
—
—
—
—
Dizziness
Nervous system disorders
—
—
—
—
Proteinuria
Renal and urinary disorders
—
—
—
—
Rash
Skin and subcutaneous tissue disorders
—
—
—
—
Anaemia
Blood and lymphatic system disorders
—
—
—
—
Vomiting
Gastrointestinal disorders
—
—
—
—
Pyrexia
General disorders
—
—
—
—
Pneumonia
Infections and infestations
—
—
—
—
C-reactive protein increased
Investigations
—
—
—
—
Granulocytosis
Blood and lymphatic system disorders
—
—
—
—
Leukocytosis
Blood and lymphatic system disorders
—
—
—
—
Thrombocytosis
Blood and lymphatic system disorders
—
—
—
—
Constipation
Gastrointestinal disorders
—
—
—
—
Diarrhoea
Gastrointestinal disorders
—
—
—
—
Asthenia
General disorders
—
—
—
—
Fatigue
General disorders
—
—
—
—
Blood bilirubin increased
Investigations
—
—
—
—
Haemoglobin decreased
Investigations
—
—
—
—
Weight decreased
Investigations
—
—
—
—
Hypochloraemia
Metabolism and nutrition disorders
—
—
—
—
Cancer pain
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
The purpose of this study is to determine whether nivolumab is safe and effective in the treatment of advanced or recurrent solid tumors in Chinese subjects.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
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· Phase 3
· not yet recruiting
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· Phase 2
· not yet recruiting
NCT07510334 — VSV-IFNβ-NIS With Ipilimumab and Nivolumab for the Treatment of Advanced or Metastatic Clear Cell Renal Cell Carcinoma
· Phase 2
· not yet recruiting
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Trials by the same sponsor.
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Bristol-Myers Squibb
Last refreshed: 24 October 2022
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02593786.