Trial Outcomes & Findings for Study of Nivolumab for Advanced Cancers in India (NCT NCT03444766)
NCT ID: NCT03444766
Last Updated: 2020-12-04
Results Overview
Number of participants with treatment-related Adverse Events based on worst ctc grade Includes events reported between first dose and 100 days after last dose of Nivolumab or for a total of 26 weeks from first on-study treatment with Nivolumab whichever is earliest.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
100 participants
Primary outcome timeframe
26 Weeks
Results posted on
2020-12-04
Participant Flow
100 participants treated
Participant milestones
| Measure |
Nivolumab
3mg/kg IV q 2weeks
|
|---|---|
|
Overall Study
STARTED
|
100
|
|
Overall Study
COMPLETED
|
34
|
|
Overall Study
NOT COMPLETED
|
66
|
Reasons for withdrawal
| Measure |
Nivolumab
3mg/kg IV q 2weeks
|
|---|---|
|
Overall Study
Other Reasons
|
2
|
|
Overall Study
Participant Withdrew Consent
|
5
|
|
Overall Study
Lost to Follow-up
|
2
|
|
Overall Study
Death
|
2
|
|
Overall Study
Adverse Event Unrelated to Study Drug
|
6
|
|
Overall Study
Disease Progression
|
49
|
Baseline Characteristics
Study of Nivolumab for Advanced Cancers in India
Baseline characteristics by cohort
| Measure |
Nivolumab
n=100 Participants
3mg/kg IV q 2weeks
|
|---|---|
|
Age, Continuous
|
54.7 Years
STANDARD_DEVIATION 10.79 • n=5 Participants
|
|
Sex: Female, Male
Female
|
22 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
78 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
100 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
100 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 26 WeeksPopulation: All treated participants
Number of participants with treatment-related Adverse Events based on worst ctc grade Includes events reported between first dose and 100 days after last dose of Nivolumab or for a total of 26 weeks from first on-study treatment with Nivolumab whichever is earliest.
Outcome measures
| Measure |
Nivolumab
n=100 Participants
3mg/kg IV q 2weeks
|
|---|---|
|
Number of Participants With Treatment-related Adverse Events
Grade 3-4
|
4 Count of participants
|
|
Number of Participants With Treatment-related Adverse Events
Any Grade
|
25 Count of participants
|
|
Number of Participants With Treatment-related Adverse Events
Grade 5
|
1 Count of participants
|
SECONDARY outcome
Timeframe: 26 WeeksPopulation: All treated participants
Number of participants with treatment-related Select Adverse Events based on worst ctc grade for the following categories: Pulmonary, Gastrointestinal, Endocrinopathies, Hepatic, Renal, Skin, Neurological and Hypersensitivity/Infusion reactions Includes events reported between first dose and 100 days after last dose of Nivolumab or for a total of 26 weeks from first on-study treatment with Nivolumab whichever is earliest.
Outcome measures
| Measure |
Nivolumab
n=100 Participants
3mg/kg IV q 2weeks
|
|---|---|
|
Number of Participants With Treatment-related Select Adverse Events
Pulmonary (Grade 3)
|
1 Count of participants
|
|
Number of Participants With Treatment-related Select Adverse Events
Pulmonary (Grade 5)
|
1 Count of participants
|
|
Number of Participants With Treatment-related Select Adverse Events
Hepatic (Grade 1)
|
1 Count of participants
|
|
Number of Participants With Treatment-related Select Adverse Events
Skin (Grade 1)
|
2 Count of participants
|
|
Number of Participants With Treatment-related Select Adverse Events
Hypersensitivity/Infusion reaction (Grade 1)
|
1 Count of participants
|
|
Number of Participants With Treatment-related Select Adverse Events
Hypersensitivity/Infusion reaction (Grade 2)
|
2 Count of participants
|
SECONDARY outcome
Timeframe: 26 WeeksPopulation: All treated participants
Number of participants with treatment-related Serious Adverse Events based on worst CTC grade Includes events reported between first dose and 100 days after last dose of Nivolumab or for a total of 26 weeks from first on-study treatment with Nivolumab whichever is earliest.
Outcome measures
| Measure |
Nivolumab
n=100 Participants
3mg/kg IV q 2weeks
|
|---|---|
|
Number of Participants With Treatment-related Serious Adverse Events
Any Grade
|
4 Count of participants
|
|
Number of Participants With Treatment-related Serious Adverse Events
Grade 3 - 4
|
3 Count of participants
|
|
Number of Participants With Treatment-related Serious Adverse Events
Grade 5
|
1 Count of participants
|
SECONDARY outcome
Timeframe: 26 WeeksPopulation: All treated participants
Number of participants with Adverse events leading to discontinuation of treatment based on worst CTC grade Includes events reported between first dose and 100 days after last dose of Nivolumab or for a total of 26 weeks from first on-study treatment with Nivolumab whichever is earliest.
Outcome measures
| Measure |
Nivolumab
n=100 Participants
3mg/kg IV q 2weeks
|
|---|---|
|
Number of Participants With Adverse Events Leading to Discontinuation
Grade 1
|
7 Count of participants
|
|
Number of Participants With Adverse Events Leading to Discontinuation
Grade 2
|
5 Count of participants
|
|
Number of Participants With Adverse Events Leading to Discontinuation
Grade 3
|
9 Count of participants
|
|
Number of Participants With Adverse Events Leading to Discontinuation
Grade 4
|
0 Count of participants
|
|
Number of Participants With Adverse Events Leading to Discontinuation
Grade 5
|
1 Count of participants
|
Adverse Events
Nivolumab
Serious events: 30 serious events
Other events: 74 other events
Deaths: 17 deaths
Serious adverse events
| Measure |
Nivolumab
n=100 participants at risk
3mg/kg IV q 2weeks
|
|---|---|
|
Cardiac disorders
Cardiac arrest
|
2.0%
2/100 • 26 Weeks
Includes events reported between first dose and 100 days after last dose of Nivolumab or for a total of 26 weeks from first on-study treatment with Nivolumab whichever is earliest.
|
|
Gastrointestinal disorders
Abdominal pain
|
1.0%
1/100 • 26 Weeks
Includes events reported between first dose and 100 days after last dose of Nivolumab or for a total of 26 weeks from first on-study treatment with Nivolumab whichever is earliest.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
1.0%
1/100 • 26 Weeks
Includes events reported between first dose and 100 days after last dose of Nivolumab or for a total of 26 weeks from first on-study treatment with Nivolumab whichever is earliest.
|
|
General disorders
Asthenia
|
3.0%
3/100 • 26 Weeks
Includes events reported between first dose and 100 days after last dose of Nivolumab or for a total of 26 weeks from first on-study treatment with Nivolumab whichever is earliest.
|
|
General disorders
Pyrexia
|
1.0%
1/100 • 26 Weeks
Includes events reported between first dose and 100 days after last dose of Nivolumab or for a total of 26 weeks from first on-study treatment with Nivolumab whichever is earliest.
|
|
Immune system disorders
Haemophagocytic lymphohistiocytosis
|
1.0%
1/100 • 26 Weeks
Includes events reported between first dose and 100 days after last dose of Nivolumab or for a total of 26 weeks from first on-study treatment with Nivolumab whichever is earliest.
|
|
Infections and infestations
Lower respiratory tract infection
|
1.0%
1/100 • 26 Weeks
Includes events reported between first dose and 100 days after last dose of Nivolumab or for a total of 26 weeks from first on-study treatment with Nivolumab whichever is earliest.
|
|
Infections and infestations
Malaria
|
1.0%
1/100 • 26 Weeks
Includes events reported between first dose and 100 days after last dose of Nivolumab or for a total of 26 weeks from first on-study treatment with Nivolumab whichever is earliest.
|
|
Infections and infestations
Respiratory tract infection viral
|
1.0%
1/100 • 26 Weeks
Includes events reported between first dose and 100 days after last dose of Nivolumab or for a total of 26 weeks from first on-study treatment with Nivolumab whichever is earliest.
|
|
Investigations
Blood electrolytes abnormal
|
1.0%
1/100 • 26 Weeks
Includes events reported between first dose and 100 days after last dose of Nivolumab or for a total of 26 weeks from first on-study treatment with Nivolumab whichever is earliest.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
1.0%
1/100 • 26 Weeks
Includes events reported between first dose and 100 days after last dose of Nivolumab or for a total of 26 weeks from first on-study treatment with Nivolumab whichever is earliest.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
1.0%
1/100 • 26 Weeks
Includes events reported between first dose and 100 days after last dose of Nivolumab or for a total of 26 weeks from first on-study treatment with Nivolumab whichever is earliest.
|
|
Metabolism and nutrition disorders
Pseudohyperkalaemia
|
1.0%
1/100 • 26 Weeks
Includes events reported between first dose and 100 days after last dose of Nivolumab or for a total of 26 weeks from first on-study treatment with Nivolumab whichever is earliest.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
1.0%
1/100 • 26 Weeks
Includes events reported between first dose and 100 days after last dose of Nivolumab or for a total of 26 weeks from first on-study treatment with Nivolumab whichever is earliest.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm progression
|
7.0%
7/100 • 26 Weeks
Includes events reported between first dose and 100 days after last dose of Nivolumab or for a total of 26 weeks from first on-study treatment with Nivolumab whichever is earliest.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to central nervous system
|
1.0%
1/100 • 26 Weeks
Includes events reported between first dose and 100 days after last dose of Nivolumab or for a total of 26 weeks from first on-study treatment with Nivolumab whichever is earliest.
|
|
Nervous system disorders
Headache
|
2.0%
2/100 • 26 Weeks
Includes events reported between first dose and 100 days after last dose of Nivolumab or for a total of 26 weeks from first on-study treatment with Nivolumab whichever is earliest.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
1.0%
1/100 • 26 Weeks
Includes events reported between first dose and 100 days after last dose of Nivolumab or for a total of 26 weeks from first on-study treatment with Nivolumab whichever is earliest.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
1.0%
1/100 • 26 Weeks
Includes events reported between first dose and 100 days after last dose of Nivolumab or for a total of 26 weeks from first on-study treatment with Nivolumab whichever is earliest.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
1.0%
1/100 • 26 Weeks
Includes events reported between first dose and 100 days after last dose of Nivolumab or for a total of 26 weeks from first on-study treatment with Nivolumab whichever is earliest.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
3.0%
3/100 • 26 Weeks
Includes events reported between first dose and 100 days after last dose of Nivolumab or for a total of 26 weeks from first on-study treatment with Nivolumab whichever is earliest.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
1.0%
1/100 • 26 Weeks
Includes events reported between first dose and 100 days after last dose of Nivolumab or for a total of 26 weeks from first on-study treatment with Nivolumab whichever is earliest.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
1.0%
1/100 • 26 Weeks
Includes events reported between first dose and 100 days after last dose of Nivolumab or for a total of 26 weeks from first on-study treatment with Nivolumab whichever is earliest.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
2.0%
2/100 • 26 Weeks
Includes events reported between first dose and 100 days after last dose of Nivolumab or for a total of 26 weeks from first on-study treatment with Nivolumab whichever is earliest.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
1.0%
1/100 • 26 Weeks
Includes events reported between first dose and 100 days after last dose of Nivolumab or for a total of 26 weeks from first on-study treatment with Nivolumab whichever is earliest.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
2.0%
2/100 • 26 Weeks
Includes events reported between first dose and 100 days after last dose of Nivolumab or for a total of 26 weeks from first on-study treatment with Nivolumab whichever is earliest.
|
Other adverse events
| Measure |
Nivolumab
n=100 participants at risk
3mg/kg IV q 2weeks
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
8.0%
8/100 • 26 Weeks
Includes events reported between first dose and 100 days after last dose of Nivolumab or for a total of 26 weeks from first on-study treatment with Nivolumab whichever is earliest.
|
|
Endocrine disorders
Hypothyroidism
|
6.0%
6/100 • 26 Weeks
Includes events reported between first dose and 100 days after last dose of Nivolumab or for a total of 26 weeks from first on-study treatment with Nivolumab whichever is earliest.
|
|
Gastrointestinal disorders
Abdominal pain
|
6.0%
6/100 • 26 Weeks
Includes events reported between first dose and 100 days after last dose of Nivolumab or for a total of 26 weeks from first on-study treatment with Nivolumab whichever is earliest.
|
|
Gastrointestinal disorders
Constipation
|
10.0%
10/100 • 26 Weeks
Includes events reported between first dose and 100 days after last dose of Nivolumab or for a total of 26 weeks from first on-study treatment with Nivolumab whichever is earliest.
|
|
Gastrointestinal disorders
Diarrhoea
|
6.0%
6/100 • 26 Weeks
Includes events reported between first dose and 100 days after last dose of Nivolumab or for a total of 26 weeks from first on-study treatment with Nivolumab whichever is earliest.
|
|
Gastrointestinal disorders
Nausea
|
11.0%
11/100 • 26 Weeks
Includes events reported between first dose and 100 days after last dose of Nivolumab or for a total of 26 weeks from first on-study treatment with Nivolumab whichever is earliest.
|
|
Gastrointestinal disorders
Vomiting
|
17.0%
17/100 • 26 Weeks
Includes events reported between first dose and 100 days after last dose of Nivolumab or for a total of 26 weeks from first on-study treatment with Nivolumab whichever is earliest.
|
|
General disorders
Asthenia
|
6.0%
6/100 • 26 Weeks
Includes events reported between first dose and 100 days after last dose of Nivolumab or for a total of 26 weeks from first on-study treatment with Nivolumab whichever is earliest.
|
|
General disorders
Chest pain
|
11.0%
11/100 • 26 Weeks
Includes events reported between first dose and 100 days after last dose of Nivolumab or for a total of 26 weeks from first on-study treatment with Nivolumab whichever is earliest.
|
|
General disorders
Fatigue
|
16.0%
16/100 • 26 Weeks
Includes events reported between first dose and 100 days after last dose of Nivolumab or for a total of 26 weeks from first on-study treatment with Nivolumab whichever is earliest.
|
|
General disorders
Pyrexia
|
21.0%
21/100 • 26 Weeks
Includes events reported between first dose and 100 days after last dose of Nivolumab or for a total of 26 weeks from first on-study treatment with Nivolumab whichever is earliest.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
11.0%
11/100 • 26 Weeks
Includes events reported between first dose and 100 days after last dose of Nivolumab or for a total of 26 weeks from first on-study treatment with Nivolumab whichever is earliest.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
6.0%
6/100 • 26 Weeks
Includes events reported between first dose and 100 days after last dose of Nivolumab or for a total of 26 weeks from first on-study treatment with Nivolumab whichever is earliest.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
7.0%
7/100 • 26 Weeks
Includes events reported between first dose and 100 days after last dose of Nivolumab or for a total of 26 weeks from first on-study treatment with Nivolumab whichever is earliest.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
13.0%
13/100 • 26 Weeks
Includes events reported between first dose and 100 days after last dose of Nivolumab or for a total of 26 weeks from first on-study treatment with Nivolumab whichever is earliest.
|
|
Nervous system disorders
Headache
|
11.0%
11/100 • 26 Weeks
Includes events reported between first dose and 100 days after last dose of Nivolumab or for a total of 26 weeks from first on-study treatment with Nivolumab whichever is earliest.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
24.0%
24/100 • 26 Weeks
Includes events reported between first dose and 100 days after last dose of Nivolumab or for a total of 26 weeks from first on-study treatment with Nivolumab whichever is earliest.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
14.0%
14/100 • 26 Weeks
Includes events reported between first dose and 100 days after last dose of Nivolumab or for a total of 26 weeks from first on-study treatment with Nivolumab whichever is earliest.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
6.0%
6/100 • 26 Weeks
Includes events reported between first dose and 100 days after last dose of Nivolumab or for a total of 26 weeks from first on-study treatment with Nivolumab whichever is earliest.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
10.0%
10/100 • 26 Weeks
Includes events reported between first dose and 100 days after last dose of Nivolumab or for a total of 26 weeks from first on-study treatment with Nivolumab whichever is earliest.
|
Additional Information
Bristol-Myers Squibb Study Director
Bristol-Myers Squibb
Phone: Please Email
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60