Non-Small Cell Lung Cancer
Conditions
Brief summary
The purpose of the study is to determine the occurrence of high-grade (CTCAE v4.0 Grades 3-4), treatment-related, select adverse events in patients with advanced or metastatic Squamous Cell Non-Small Cell Lung Cancer (SqNSCLC) with progression of disease during or after at least 1 systemic therapy.
Interventions
DRUGNivolumab
Sponsors
PPD Development, LP
Bristol-Myers Squibb
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: * ECOG Status: PS 0-1 & PS 2 * Subjects with histologically or cytologically-documented SqNSCLC * Subjects must have experienced disease progression or recurrence during or after one prior platinum doublet-based chemotherapy regimen * Subjects must have evaluable disease by CT or MRI per RECIST 1.1 criteria * Subjects with treated or asymptomatic CNS metastases * Prior palliative radiotherapy must have been completed at least 14 days prior to study drug administration * Prior lines of antineoplastic therapy, including hemotherapy, hormonal therapy, immunotherapy, surgical resection of lesions, non-palliative radiation therapy, or standard or investigational agents for treatment of NSCLC, must be completed 28 days prior to the first dose of nivolumab * Males and Females, ages 18 or older
Exclusion criteria
* Subjects with untreated, symptomatic CNS metastases * Subjects with carcinomatous meningitis * Subjects with active, known or suspected autoimmune disease. * Subjects who received prior therapy with anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-CTLA-4 antibody (including ipilimumab or any other antibody or drug specifically targeting T-cell costimulation or checkpoint pathways) or who have previously taken part in a randomized BMS clinical trial for nivolumab or ipilimumab.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With High Grade (Grade 3, 4 and 5) Treatment Related Select Adverse Events | From first dose to time of analysis of primary endpoint (approximately up to 34 months) | The total number of participants with high grade treatment related select adverse events. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With High Grade Select Adverse Events | From first dose up to 100 days post last dose (up to 76 months) | The total number of participants with high grade select adverse events. High grade is defined as Common Terminology Criteria for Adverse Events (CTCAE) v4.0 Grades 3-4. An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation subject administered study drug and that does not necessarily have a causal relationship with this treatment. Select AEs include Pulmonary toxicity, Gastrointestinal toxicity (diarrhea or colitis, Endocrinopathies, Hepatotoxicity (including asymptomatic LFT elevations), Renal toxicity, Skin toxicity, and Neurological toxicity. |
| Median Time to Onset of Any Grade Select Adverse Events | From first dose up to 100 days post last dose (up to approximately 65 months) | Median Time to onset of any grade select adverse events reported up to 100 days after last dose. An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation subject administered study drug and that does not necessarily have a causal relationship with this treatment. Select AEs include Pulmonary toxicity, Gastrointestinal toxicity (diarrhea or colitis, Endocrinopathies, Hepatotoxicity (including asymptomatic LFT elevations), Renal toxicity, Skin toxicity, and Neurological toxicity. |
| Median Time to Resolution of Any Grade Select Adverse Events | From first dose to up to 100 days post last dose (up to approximately 45 months) | Median time to resolution of any grade select adverse events reported up to 100 days after last dose. An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation subject administered study drug and that does not necessarily have a causal relationship with this treatment. Select AEs include Pulmonary toxicity, Gastrointestinal toxicity (diarrhea or colitis, Endocrinopathies, Hepatotoxicity (including asymptomatic LFT elevations), Renal toxicity, Skin toxicity, and Neurological toxicity. |
| Overall Survival | From the first dosing up to the date of death (up to approximately 76 months) | Overall Survival (OS) is defined as the time from first dosing date to the date of death. A subject who has not died will be censored at last known date alive. OS will be followed continuously while subjects are on treatment and every 3 months via in-person or phone contact after subjects discontinue the study drug. |
| Objective Response Rate (ORR) | From first dose up to last dose (up to approximately 76 months) | ORR is defined as the percentage of subjects with a best overall response (BOR) of confirmed complete response (CR) or partial response (PR). CR is defined as the disappearance of all target lesions; PR is defined by at least a 30% decrease in the sum of the longest diameter of target lesions. ORR as assessed by the investigator will be reported. |
Countries
Austria, Denmark, Finland, Greece, Hungary, Ireland, Poland, Portugal, Romania, Russia, Spain, Sweden, United Kingdom
Participant flow
Pre-assignment details
1 participant was ECOG PS 3 and thus outside the scope of the protocol and excluded from analysis. There were 2 ECOG classification periods during the course of this study. The population from the first was used in the Primary Outcome Measure analysis. The population from the second was used in the Baseline Characteristics, Secondary Outcome Measures, and Adverse Event analysis. 1 participant was lost from the Primary Completion ECOG Classification that was accounted for at Study Completion.
Participants by arm
| Arm | Count |
|---|---|
| ECOG (PS0) ECOG Performance Status 0
Nivolumab 3 mg/kg as a 60- minute IV infusion every 2 weeks | 172 |
| ECOG (PS1) ECOG Performance Status 1
nivolumab 3 mg/kg as a 60- minute IV infusion every 2 weeks | 537 |
| ECOG Performance Status 2 Nivolumab 3 mg/kg as a 60-minute IV infusion every 2 weeks | 102 |
| ECOG (PS3) ECOG Performance Status 3
nivolumab 3 mg/kg as a 60- minute IV infusion every 2 weeks | 1 |
| Total | 812 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| ECOG Reclassification | Administrative reason by sponsor | 1 | 3 | 0 | 0 |
| ECOG Reclassification | Adverse event unrelated to study drug | 17 | 49 | 12 | 0 |
| ECOG Reclassification | Death | 1 | 5 | 0 | 0 |
| ECOG Reclassification | Disease Progression | 113 | 382 | 70 | 1 |
| ECOG Reclassification | Lost to Follow-up | 1 | 5 | 0 | 0 |
| ECOG Reclassification | Maximum clinical benefit | 6 | 5 | 0 | 0 |
| ECOG Reclassification | Other Reasons | 5 | 26 | 2 | 0 |
| ECOG Reclassification | Participant no longer meets study criteria | 3 | 8 | 3 | 0 |
| ECOG Reclassification | Participant request to discontinue study treatment | 6 | 6 | 2 | 0 |
| ECOG Reclassification | Participant withdrew consent | 2 | 3 | 4 | 0 |
| ECOG Reclassification | Poor/non-compliance | 0 | 3 | 2 | 0 |
| ECOG Reclassification | Study drug toxicity | 17 | 42 | 7 | 0 |
Baseline characteristics
| Characteristic | ECOG (PS0) | ECOG (PS1) | ECOG Performance Status 2 | ECOG (PS3) | Total |
|---|---|---|---|---|---|
| Age, Continuous | 63.6 Years STANDARD_DEVIATION 8.28 | 66.1 Years STANDARD_DEVIATION 8.27 | 67.9 Years STANDARD_DEVIATION 7.29 | 71 Years | 65.8 Years STANDARD_DEVIATION 8.24 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 13 Participants | 37 Participants | 11 Participants | 0 Participants | 61 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 159 Participants | 500 Participants | 91 Participants | 1 Participants | 751 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 2 Participants | 0 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 3 Participants | 0 Participants | 0 Participants | 3 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 7 Participants | 2 Participants | 0 Participants | 0 Participants | 9 Participants |
| Race (NIH/OMB) White | 165 Participants | 530 Participants | 102 Participants | 1 Participants | 798 Participants |
| Sex: Female, Male Female | 37 Participants | 111 Participants | 22 Participants | 1 Participants | 171 Participants |
| Sex: Female, Male Male | 135 Participants | 426 Participants | 80 Participants | 0 Participants | 641 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 131 / 172 | 446 / 537 | 90 / 102 | 1 / 1 |
| other Total, other adverse events | 149 / 172 | 472 / 537 | 86 / 102 | 1 / 1 |
| serious Total, serious adverse events | 115 / 172 | 375 / 537 | 84 / 102 | 1 / 1 |
Outcome results
Primary
Number of Participants With High Grade (Grade 3, 4 and 5) Treatment Related Select Adverse Events
The total number of participants with high grade treatment related select adverse events.
Time frame: From first dose to time of analysis of primary endpoint (approximately up to 34 months)
Population: All Treated participants
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| ECOG (PS0) | Number of Participants With High Grade (Grade 3, 4 and 5) Treatment Related Select Adverse Events | Endocrine | 4 Participants |
| ECOG (PS0) | Number of Participants With High Grade (Grade 3, 4 and 5) Treatment Related Select Adverse Events | Hypersensitivity/ Infusion reaction | 0 Participants |
| ECOG (PS0) | Number of Participants With High Grade (Grade 3, 4 and 5) Treatment Related Select Adverse Events | Pulmonary | 2 Participants |
| ECOG (PS0) | Number of Participants With High Grade (Grade 3, 4 and 5) Treatment Related Select Adverse Events | Hepatic | 3 Participants |
| ECOG (PS0) | Number of Participants With High Grade (Grade 3, 4 and 5) Treatment Related Select Adverse Events | Gastrointestinal | 1 Participants |
| ECOG (PS0) | Number of Participants With High Grade (Grade 3, 4 and 5) Treatment Related Select Adverse Events | Skin | 1 Participants |
| ECOG (PS0) | Number of Participants With High Grade (Grade 3, 4 and 5) Treatment Related Select Adverse Events | Renal | 0 Participants |
| ECOG (PS1) | Number of Participants With High Grade (Grade 3, 4 and 5) Treatment Related Select Adverse Events | Renal | 3 Participants |
| ECOG (PS1) | Number of Participants With High Grade (Grade 3, 4 and 5) Treatment Related Select Adverse Events | Skin | 7 Participants |
| ECOG (PS1) | Number of Participants With High Grade (Grade 3, 4 and 5) Treatment Related Select Adverse Events | Gastrointestinal | 10 Participants |
| ECOG (PS1) | Number of Participants With High Grade (Grade 3, 4 and 5) Treatment Related Select Adverse Events | Endocrine | 3 Participants |
| ECOG (PS1) | Number of Participants With High Grade (Grade 3, 4 and 5) Treatment Related Select Adverse Events | Hepatic | 11 Participants |
| ECOG (PS1) | Number of Participants With High Grade (Grade 3, 4 and 5) Treatment Related Select Adverse Events | Pulmonary | 5 Participants |
| ECOG (PS1) | Number of Participants With High Grade (Grade 3, 4 and 5) Treatment Related Select Adverse Events | Hypersensitivity/ Infusion reaction | 0 Participants |
| ECOG Performance Status 2 | Number of Participants With High Grade (Grade 3, 4 and 5) Treatment Related Select Adverse Events | Hypersensitivity/ Infusion reaction | 0 Participants |
| ECOG Performance Status 2 | Number of Participants With High Grade (Grade 3, 4 and 5) Treatment Related Select Adverse Events | Pulmonary | 0 Participants |
| ECOG Performance Status 2 | Number of Participants With High Grade (Grade 3, 4 and 5) Treatment Related Select Adverse Events | Gastrointestinal | 0 Participants |
| ECOG Performance Status 2 | Number of Participants With High Grade (Grade 3, 4 and 5) Treatment Related Select Adverse Events | Renal | 1 Participants |
| ECOG Performance Status 2 | Number of Participants With High Grade (Grade 3, 4 and 5) Treatment Related Select Adverse Events | Skin | 0 Participants |
| ECOG Performance Status 2 | Number of Participants With High Grade (Grade 3, 4 and 5) Treatment Related Select Adverse Events | Hepatic | 2 Participants |
| ECOG Performance Status 2 | Number of Participants With High Grade (Grade 3, 4 and 5) Treatment Related Select Adverse Events | Endocrine | 0 Participants |
Secondary
Median Time to Onset of Any Grade Select Adverse Events
Median Time to onset of any grade select adverse events reported up to 100 days after last dose. An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation subject administered study drug and that does not necessarily have a causal relationship with this treatment. Select AEs include Pulmonary toxicity, Gastrointestinal toxicity (diarrhea or colitis, Endocrinopathies, Hepatotoxicity (including asymptomatic LFT elevations), Renal toxicity, Skin toxicity, and Neurological toxicity.
Time frame: From first dose up to 100 days post last dose (up to approximately 65 months)
Population: All treated participants with ECOG PS Grade 0-2
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| ECOG (PS0) | Median Time to Onset of Any Grade Select Adverse Events | Gastrointestinal | 11.71 Weeks |
| ECOG (PS0) | Median Time to Onset of Any Grade Select Adverse Events | Renal | 28.86 Weeks |
| ECOG (PS0) | Median Time to Onset of Any Grade Select Adverse Events | Pulmonary | 33.43 Weeks |
| ECOG (PS0) | Median Time to Onset of Any Grade Select Adverse Events | Endrocrine | 12.79 Weeks |
| ECOG (PS0) | Median Time to Onset of Any Grade Select Adverse Events | Hypersensitivity/Infusion Reaction | 1.93 Weeks |
| ECOG (PS0) | Median Time to Onset of Any Grade Select Adverse Events | Skin | 12.14 Weeks |
| ECOG (PS0) | Median Time to Onset of Any Grade Select Adverse Events | Hepatic | 26.64 Weeks |
| ECOG (PS1) | Median Time to Onset of Any Grade Select Adverse Events | Pulmonary | 11.50 Weeks |
| ECOG (PS1) | Median Time to Onset of Any Grade Select Adverse Events | Endrocrine | 10.14 Weeks |
| ECOG (PS1) | Median Time to Onset of Any Grade Select Adverse Events | Gastrointestinal | 8.86 Weeks |
| ECOG (PS1) | Median Time to Onset of Any Grade Select Adverse Events | Hepatic | 11.43 Weeks |
| ECOG (PS1) | Median Time to Onset of Any Grade Select Adverse Events | Renal | 22.71 Weeks |
| ECOG (PS1) | Median Time to Onset of Any Grade Select Adverse Events | Skin | 7.86 Weeks |
| ECOG (PS1) | Median Time to Onset of Any Grade Select Adverse Events | Hypersensitivity/Infusion Reaction | 2.21 Weeks |
| ECOG Performance Status 2 | Median Time to Onset of Any Grade Select Adverse Events | Renal | 10.29 Weeks |
| ECOG Performance Status 2 | Median Time to Onset of Any Grade Select Adverse Events | Gastrointestinal | 6.00 Weeks |
| ECOG Performance Status 2 | Median Time to Onset of Any Grade Select Adverse Events | Hypersensitivity/Infusion Reaction | 2.14 Weeks |
| ECOG Performance Status 2 | Median Time to Onset of Any Grade Select Adverse Events | Skin | 14.71 Weeks |
| ECOG Performance Status 2 | Median Time to Onset of Any Grade Select Adverse Events | Pulmonary | 3.93 Weeks |
| ECOG Performance Status 2 | Median Time to Onset of Any Grade Select Adverse Events | Hepatic | 8.14 Weeks |
| ECOG Performance Status 2 | Median Time to Onset of Any Grade Select Adverse Events | Endrocrine | 19.86 Weeks |
Secondary
Median Time to Resolution of Any Grade Select Adverse Events
Median time to resolution of any grade select adverse events reported up to 100 days after last dose. An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation subject administered study drug and that does not necessarily have a causal relationship with this treatment. Select AEs include Pulmonary toxicity, Gastrointestinal toxicity (diarrhea or colitis, Endocrinopathies, Hepatotoxicity (including asymptomatic LFT elevations), Renal toxicity, Skin toxicity, and Neurological toxicity.
Time frame: From first dose to up to 100 days post last dose (up to approximately 45 months)
Population: All treated participants with ECOG PS Grade 0-2
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| ECOG (PS0) | Median Time to Resolution of Any Grade Select Adverse Events | Hepatic | 4.57 Weeks |
| ECOG (PS0) | Median Time to Resolution of Any Grade Select Adverse Events | Hypersensitivity/Infusion Reaction | 1.14 Weeks |
| ECOG (PS0) | Median Time to Resolution of Any Grade Select Adverse Events | Renal | 10.14 Weeks |
| ECOG (PS0) | Median Time to Resolution of Any Grade Select Adverse Events | Pulmonary | 3.00 Weeks |
| ECOG (PS0) | Median Time to Resolution of Any Grade Select Adverse Events | Gastrointestinal | 2.86 Weeks |
| ECOG (PS0) | Median Time to Resolution of Any Grade Select Adverse Events | Endrocrine | NA Weeks |
| ECOG (PS0) | Median Time to Resolution of Any Grade Select Adverse Events | Skin | NA Weeks |
| ECOG (PS1) | Median Time to Resolution of Any Grade Select Adverse Events | Hypersensitivity/Infusion Reaction | 0.14 Weeks |
| ECOG (PS1) | Median Time to Resolution of Any Grade Select Adverse Events | Endrocrine | 169.43 Weeks |
| ECOG (PS1) | Median Time to Resolution of Any Grade Select Adverse Events | Gastrointestinal | 2.00 Weeks |
| ECOG (PS1) | Median Time to Resolution of Any Grade Select Adverse Events | Hepatic | 7.71 Weeks |
| ECOG (PS1) | Median Time to Resolution of Any Grade Select Adverse Events | Pulmonary | 4.29 Weeks |
| ECOG (PS1) | Median Time to Resolution of Any Grade Select Adverse Events | Renal | 6.14 Weeks |
| ECOG (PS1) | Median Time to Resolution of Any Grade Select Adverse Events | Skin | 15.43 Weeks |
| ECOG Performance Status 2 | Median Time to Resolution of Any Grade Select Adverse Events | Endrocrine | NA Weeks |
| ECOG Performance Status 2 | Median Time to Resolution of Any Grade Select Adverse Events | Renal | 59.14 Weeks |
| ECOG Performance Status 2 | Median Time to Resolution of Any Grade Select Adverse Events | Gastrointestinal | 2.00 Weeks |
| ECOG Performance Status 2 | Median Time to Resolution of Any Grade Select Adverse Events | Hypersensitivity/Infusion Reaction | 0.14 Weeks |
| ECOG Performance Status 2 | Median Time to Resolution of Any Grade Select Adverse Events | Skin | 5.71 Weeks |
| ECOG Performance Status 2 | Median Time to Resolution of Any Grade Select Adverse Events | Pulmonary | 2.29 Weeks |
| ECOG Performance Status 2 | Median Time to Resolution of Any Grade Select Adverse Events | Hepatic | 3.57 Weeks |
Secondary
Number of Participants With High Grade Select Adverse Events
The total number of participants with high grade select adverse events. High grade is defined as Common Terminology Criteria for Adverse Events (CTCAE) v4.0 Grades 3-4. An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation subject administered study drug and that does not necessarily have a causal relationship with this treatment. Select AEs include Pulmonary toxicity, Gastrointestinal toxicity (diarrhea or colitis, Endocrinopathies, Hepatotoxicity (including asymptomatic LFT elevations), Renal toxicity, Skin toxicity, and Neurological toxicity.
Time frame: From first dose up to 100 days post last dose (up to 76 months)
Population: All treated participants with ECOG PS Grade 0-2
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| ECOG (PS0) | Number of Participants With High Grade Select Adverse Events | Gastrointestinal | 1 Participants |
| ECOG (PS0) | Number of Participants With High Grade Select Adverse Events | Pulmonary | 3 Participants |
| ECOG (PS0) | Number of Participants With High Grade Select Adverse Events | Hepatic | 6 Participants |
| ECOG (PS0) | Number of Participants With High Grade Select Adverse Events | Skin | 2 Participants |
| ECOG (PS0) | Number of Participants With High Grade Select Adverse Events | Hypersensitivity/ Infusion reaction | 0 Participants |
| ECOG (PS0) | Number of Participants With High Grade Select Adverse Events | Renal | 0 Participants |
| ECOG (PS0) | Number of Participants With High Grade Select Adverse Events | Endocrine | 5 Participants |
| ECOG (PS1) | Number of Participants With High Grade Select Adverse Events | Hepatic | 19 Participants |
| ECOG (PS1) | Number of Participants With High Grade Select Adverse Events | Skin | 7 Participants |
| ECOG (PS1) | Number of Participants With High Grade Select Adverse Events | Gastrointestinal | 11 Participants |
| ECOG (PS1) | Number of Participants With High Grade Select Adverse Events | Endocrine | 4 Participants |
| ECOG (PS1) | Number of Participants With High Grade Select Adverse Events | Pulmonary | 9 Participants |
| ECOG (PS1) | Number of Participants With High Grade Select Adverse Events | Renal | 7 Participants |
| ECOG (PS1) | Number of Participants With High Grade Select Adverse Events | Hypersensitivity/ Infusion reaction | 0 Participants |
| ECOG Performance Status 2 | Number of Participants With High Grade Select Adverse Events | Pulmonary | 1 Participants |
| ECOG Performance Status 2 | Number of Participants With High Grade Select Adverse Events | Gastrointestinal | 0 Participants |
| ECOG Performance Status 2 | Number of Participants With High Grade Select Adverse Events | Hypersensitivity/ Infusion reaction | 1 Participants |
| ECOG Performance Status 2 | Number of Participants With High Grade Select Adverse Events | Renal | 1 Participants |
| ECOG Performance Status 2 | Number of Participants With High Grade Select Adverse Events | Hepatic | 3 Participants |
| ECOG Performance Status 2 | Number of Participants With High Grade Select Adverse Events | Endocrine | 0 Participants |
| ECOG Performance Status 2 | Number of Participants With High Grade Select Adverse Events | Skin | 0 Participants |
Secondary
Objective Response Rate (ORR)
ORR is defined as the percentage of subjects with a best overall response (BOR) of confirmed complete response (CR) or partial response (PR). CR is defined as the disappearance of all target lesions; PR is defined by at least a 30% decrease in the sum of the longest diameter of target lesions. ORR as assessed by the investigator will be reported.
Time frame: From first dose up to last dose (up to approximately 76 months)
Population: All response evaluable participants
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| ECOG (PS0) | Objective Response Rate (ORR) | 8.0 Percentage |
| ECOG (PS1) | Objective Response Rate (ORR) | 11.0 Percentage |
| ECOG Performance Status 2 | Objective Response Rate (ORR) | 1.6 Percentage |
Secondary
Overall Survival
Overall Survival (OS) is defined as the time from first dosing date to the date of death. A subject who has not died will be censored at last known date alive. OS will be followed continuously while subjects are on treatment and every 3 months via in-person or phone contact after subjects discontinue the study drug.
Time frame: From the first dosing up to the date of death (up to approximately 76 months)
Population: All treated participants with ECOG PS Grade 0-2
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| ECOG (PS0) | Overall Survival | 12.1 Months |
| ECOG (PS1) | Overall Survival | 10.3 Months |
| ECOG Performance Status 2 | Overall Survival | 5.2 Months |
Post Hoc
Number of Participants With High Grade (Grade 3, 4 and 5) Treatment Related Select Adverse Events - Extended Collection
The total number of participants with high grade treatment related select adverse events. High grade is defined as Common Terminology Criteria for Adverse Events (CTCAE) v4.0 Grades 3-4 or 5. An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation subject administered study drug and that does not necessarily have a causal relationship with this treatment. Select AEs include Pulmonary toxicity, Gastrointestinal toxicity (diarrhea or colitis, Endocrinopathies, Hepatotoxicity (including asymptomatic LFT elevations), Renal toxicity, Skin toxicity, and Neurological toxicity. Note: This outcome measure represents an updated version of the primary endpoint to include additional data collection that has occurred after the primary completion date.
Time frame: From first dose to up to 100 days post last dose (up to approximately 76 months)
Population: All treated participants with ECOG PS Grade 0-2
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| ECOG (PS0) | Number of Participants With High Grade (Grade 3, 4 and 5) Treatment Related Select Adverse Events - Extended Collection | Renal | 0 Participants |
| ECOG (PS0) | Number of Participants With High Grade (Grade 3, 4 and 5) Treatment Related Select Adverse Events - Extended Collection | Gastrointestinal | 1 Participants |
| ECOG (PS0) | Number of Participants With High Grade (Grade 3, 4 and 5) Treatment Related Select Adverse Events - Extended Collection | Endocrine | 4 Participants |
| ECOG (PS0) | Number of Participants With High Grade (Grade 3, 4 and 5) Treatment Related Select Adverse Events - Extended Collection | Hypersensitivity/ Infusion reaction | 0 Participants |
| ECOG (PS0) | Number of Participants With High Grade (Grade 3, 4 and 5) Treatment Related Select Adverse Events - Extended Collection | Hepatic | 4 Participants |
| ECOG (PS0) | Number of Participants With High Grade (Grade 3, 4 and 5) Treatment Related Select Adverse Events - Extended Collection | Pulmonary | 2 Participants |
| ECOG (PS0) | Number of Participants With High Grade (Grade 3, 4 and 5) Treatment Related Select Adverse Events - Extended Collection | Skin | 2 Participants |
| ECOG (PS1) | Number of Participants With High Grade (Grade 3, 4 and 5) Treatment Related Select Adverse Events - Extended Collection | Renal | 3 Participants |
| ECOG (PS1) | Number of Participants With High Grade (Grade 3, 4 and 5) Treatment Related Select Adverse Events - Extended Collection | Pulmonary | 6 Participants |
| ECOG (PS1) | Number of Participants With High Grade (Grade 3, 4 and 5) Treatment Related Select Adverse Events - Extended Collection | Hypersensitivity/ Infusion reaction | 0 Participants |
| ECOG (PS1) | Number of Participants With High Grade (Grade 3, 4 and 5) Treatment Related Select Adverse Events - Extended Collection | Gastrointestinal | 10 Participants |
| ECOG (PS1) | Number of Participants With High Grade (Grade 3, 4 and 5) Treatment Related Select Adverse Events - Extended Collection | Hepatic | 12 Participants |
| ECOG (PS1) | Number of Participants With High Grade (Grade 3, 4 and 5) Treatment Related Select Adverse Events - Extended Collection | Endocrine | 3 Participants |
| ECOG (PS1) | Number of Participants With High Grade (Grade 3, 4 and 5) Treatment Related Select Adverse Events - Extended Collection | Skin | 7 Participants |
| ECOG Performance Status 2 | Number of Participants With High Grade (Grade 3, 4 and 5) Treatment Related Select Adverse Events - Extended Collection | Endocrine | 0 Participants |
| ECOG Performance Status 2 | Number of Participants With High Grade (Grade 3, 4 and 5) Treatment Related Select Adverse Events - Extended Collection | Skin | 0 Participants |
| ECOG Performance Status 2 | Number of Participants With High Grade (Grade 3, 4 and 5) Treatment Related Select Adverse Events - Extended Collection | Gastrointestinal | 0 Participants |
| ECOG Performance Status 2 | Number of Participants With High Grade (Grade 3, 4 and 5) Treatment Related Select Adverse Events - Extended Collection | Hepatic | 2 Participants |
| ECOG Performance Status 2 | Number of Participants With High Grade (Grade 3, 4 and 5) Treatment Related Select Adverse Events - Extended Collection | Pulmonary | 0 Participants |
| ECOG Performance Status 2 | Number of Participants With High Grade (Grade 3, 4 and 5) Treatment Related Select Adverse Events - Extended Collection | Renal | 1 Participants |
| ECOG Performance Status 2 | Number of Participants With High Grade (Grade 3, 4 and 5) Treatment Related Select Adverse Events - Extended Collection | Hypersensitivity/ Infusion reaction | 0 Participants |