A Phase 4 interventional study of Nivolumab in Non-Small Cell Lung Cancer (NSCLC), Non-Small-Cell Lung Carcinoma and Nonsmall Cell Lung Cancer, sponsored by Bristol-Myers Squibb. Completed at 9 sites in India. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-12-04.
Sponsored by Bristol-Myers Squibb · Phase 4, Interventional, and Treatment
This is a study of nivolumab in participants with advanced Non-Small Cell Lung Cancer or Kidney Cancer in India.
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com
Inclusion Criteria:
Exclusion Criteria:
Other protocol defined inclusion/exclusion criteria could apply
administering nivolumab only
Drug: Nivolumab
specified dose on specified days
Also known as: Opdivo
Number of Participants With Treatment-related Adverse Events
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.
Time frame: 26 Weeks
Number of Participants With Treatment-related Select Adverse Events
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.
Time frame: 26 Weeks
Number of Participants With Treatment-related Serious Adverse Events
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.
Time frame: 26 Weeks
Number of Participants With Adverse Events Leading to Discontinuation
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.
Time frame: 26 Weeks
| Milestone | Nivolumab |
|---|---|
| Started | 100 |
| Completed | 34 |
| Not completed | 66 |
| Withdrew: Other reasons | 2 |
| Withdrew: Participant withdrew consent | 5 |
| Withdrew: Lost to follow-up | 2 |
| Withdrew: Death | 2 |
| Withdrew: Adverse event unrelated to study drug | 6 |
| Withdrew: Disease progression | 49 |
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.
| Count of participants | Nivolumab |
|---|---|
| Any Grade | 25 |
| Grade 3-4 | 4 |
| Grade 5 | 1 |
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.
| Count of participants | Nivolumab |
|---|---|
| Pulmonary (Grade 3) | 1 |
| Pulmonary (Grade 5) | 1 |
| Hepatic (Grade 1) | 1 |
| Skin (Grade 1) | 2 |
| Hypersensitivity/Infusion reaction (Grade 1) | 1 |
| Hypersensitivity/Infusion reaction (Grade 2) | 2 |
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.
| Count of participants | Nivolumab |
|---|---|
| Any Grade | 4 |
| Grade 3 - 4 | 3 |
| Grade 5 | 1 |
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.
| Count of participants | Nivolumab |
|---|---|
| Grade 1 | 7 |
| Grade 2 | 5 |
| Grade 3 | 9 |
| Grade 4 | 0 |
| Grade 5 | 1 |
Collected over 26 Weeks. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Nivolumab | 17/100 (17%) | 30/100 (30%) | 74/100 (74%) |
| Event | Nivolumab |
|---|---|
| Malignant neoplasm progressionNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 7/100 |
| AstheniaGeneral disorders | 3/100 |
| DyspnoeaRespiratory, thoracic and mediastinal disorders | 3/100 |
| Cardiac arrestCardiac disorders | 2/100 |
| HeadacheNervous system disorders | 2/100 |
| PneumonitisRespiratory, thoracic and mediastinal disorders | 2/100 |
| Respiratory failureRespiratory, thoracic and mediastinal disorders | 2/100 |
| Abdominal painGastrointestinal disorders | 1/100 |
| Intestinal obstructionGastrointestinal disorders | 1/100 |
| PyrexiaGeneral disorders | 1/100 |
| Event | Nivolumab |
|---|---|
| CoughRespiratory, thoracic and mediastinal disorders | 24/100 |
| PyrexiaGeneral disorders | 21/100 |
| VomitingGastrointestinal disorders | 17/100 |
| FatigueGeneral disorders | 16/100 |
| DyspnoeaRespiratory, thoracic and mediastinal disorders | 14/100 |
| Back painMusculoskeletal and connective tissue disorders | 13/100 |
| NauseaGastrointestinal disorders | 11/100 |
| Chest painGeneral disorders | 11/100 |
| Decreased appetiteMetabolism and nutrition disorders | 11/100 |
| HeadacheNervous system disorders | 11/100 |
| Age, Continuous(Years) | Nivolumab |
|---|---|
| Mean | 54.7 ± 10.79 |
| Sex: Female, Male(Participants) | Nivolumab |
|---|---|
| Female | 22 |
| Male | 78 |
| Ethnicity (NIH/OMB)(Participants) | Nivolumab |
|---|---|
| Hispanic or Latino | 0 |
| Not Hispanic or Latino | 0 |
| Unknown or Not Reported | 100 |
| Race (NIH/OMB)(Participants) | Nivolumab |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 100 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 0 |
| White | 0 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
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