Kidney Cancer, Kidney Neoplasms, Nonsmall Cell Lung Cancer, Non-Small Cell Lung Cancer (NSCLC), Non-Small-Cell Lung Carcinoma, Renal Cancer, Renal Neoplasms
Conditions
Brief summary
This is a study of nivolumab in participants with advanced Non-Small Cell Lung Cancer or Kidney Cancer in India.
Interventions
DRUGNivolumab
specified dose on specified days
Sponsors
Bristol-Myers Squibb
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: * Locally advanced or metastatic non-small cell lung cancer (NSCLC) after prior chemotherapy OR advanced renal cell carcinoma (RCC) after prior therapy * Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1 * Prior radiotherapy or radiosurgery must have been completed at least 2 weeks prior to randomization
Exclusion criteria
* Participants with untreated, symptomatic central nervous system (CNS) metastases * Participants with carcinomatous meningitis * Participants with active, known or suspected autoimmune disease * Participants with a condition requiring systemic treatment with either corticosteroids or other immunosuppressive medications * Other active malignancy requiring concurrent intervention Other protocol defined inclusion/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Treatment-related Adverse Events | 26 Weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Treatment-related Select Adverse Events | 26 Weeks | 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. |
| Number of Participants With Treatment-related Serious Adverse Events | 26 Weeks | 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. |
| Number of Participants With Adverse Events Leading to Discontinuation | 26 Weeks | 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. |
Countries
India
Participant flow
Pre-assignment details
100 participants treated
Participants by arm
| Arm | Count |
|---|---|
| Nivolumab 3mg/kg IV q 2weeks | 100 |
| Total | 100 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event Unrelated to Study Drug | 6 |
| Overall Study | Death | 2 |
| Overall Study | Disease Progression | 49 |
| Overall Study | Lost to Follow-up | 2 |
| Overall Study | Other Reasons | 2 |
| Overall Study | Participant Withdrew Consent | 5 |
Baseline characteristics
| Characteristic | Nivolumab |
|---|---|
| Age, Continuous | 54.7 Years STANDARD_DEVIATION 10.79 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 100 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 100 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 0 Participants |
| Sex: Female, Male Female | 22 Participants |
| Sex: Female, Male Male | 78 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 17 / 100 |
| other Total, other adverse events | 74 / 100 |
| serious Total, serious adverse events | 30 / 100 |
Outcome results
Primary
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
Population: All treated participants
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Nivolumab | Number of Participants With Treatment-related Adverse Events | Any Grade | 25 Count of participants |
| Nivolumab | Number of Participants With Treatment-related Adverse Events | Grade 3-4 | 4 Count of participants |
| Nivolumab | Number of Participants With Treatment-related Adverse Events | Grade 5 | 1 Count of participants |
Secondary
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
Population: All treated participants
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Nivolumab | Number of Participants With Adverse Events Leading to Discontinuation | Grade 1 | 7 Count of participants |
| Nivolumab | Number of Participants With Adverse Events Leading to Discontinuation | Grade 2 | 5 Count of participants |
| Nivolumab | Number of Participants With Adverse Events Leading to Discontinuation | Grade 3 | 9 Count of participants |
| Nivolumab | Number of Participants With Adverse Events Leading to Discontinuation | Grade 4 | 0 Count of participants |
| Nivolumab | Number of Participants With Adverse Events Leading to Discontinuation | Grade 5 | 1 Count of participants |
Secondary
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
Population: All treated participants
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Nivolumab | Number of Participants With Treatment-related Select Adverse Events | Pulmonary (Grade 3) | 1 Count of participants |
| Nivolumab | Number of Participants With Treatment-related Select Adverse Events | Pulmonary (Grade 5) | 1 Count of participants |
| Nivolumab | Number of Participants With Treatment-related Select Adverse Events | Hepatic (Grade 1) | 1 Count of participants |
| Nivolumab | Number of Participants With Treatment-related Select Adverse Events | Skin (Grade 1) | 2 Count of participants |
| Nivolumab | Number of Participants With Treatment-related Select Adverse Events | Hypersensitivity/Infusion reaction (Grade 1) | 1 Count of participants |
| Nivolumab | Number of Participants With Treatment-related Select Adverse Events | Hypersensitivity/Infusion reaction (Grade 2) | 2 Count of participants |
Secondary
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
Population: All treated participants
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Nivolumab | Number of Participants With Treatment-related Serious Adverse Events | Any Grade | 4 Count of participants |
| Nivolumab | Number of Participants With Treatment-related Serious Adverse Events | Grade 3 - 4 | 3 Count of participants |
| Nivolumab | Number of Participants With Treatment-related Serious Adverse Events | Grade 5 | 1 Count of participants |