Bladder Cancer
Conditions
Keywords
anti-PD-L1, PD-L1, MPDL3280A, PD-1, bladder cancer, atezolizumab, Tecentriq
Brief summary
This Phase II, single-arm study is designed to evaluate the effect of atezolizumab treatment in participants with locally advanced or metastatic urothelial bladder cancer. Participants will be enrolled into 1 of 2 cohorts. Cohort 1 (reported here) will consist of participants who are treatment-naïve and ineligible for cisplatin-containing chemotherapy. Cohort 2 will contain participants who have progressed during or following a prior platinum-based chemotherapy regimen. The results of the second cohort are reported separately (NCT02108652). Participants in both cohorts will be given a 1200 milligrams (mg) intravenous (IV) dose of atezolizumab on Day 1 of 21-day cycles. Treatment of participants in Cohort 1 will continue until disease progression per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) or unmanageable toxicity. Treatment of participants in Cohort 2 will continue until loss of clinical benefit or unmanageable toxicity.
Interventions
DRUGAtezolizumab
Atezolizumab 1200 mg will be given by IV infusion on Day 1 of 21-day cycles until disease progression per RECIST v1.1 criteria or unmanageable toxicity.
Sponsors
Hoffmann-La Roche
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
* Histologically or cytologically documented locally advanced or metastatic transitional cell carcinoma of the urothelium (including renal pelvis, ureters, urinary bladder, urethra) * Representative tumor specimens as specified by the protocol * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 * Life expectancy greater than or equal to (\>=) 12 weeks * Measurable disease, as defined by RECIST v1.1 * Adequate hematologic and end organ function Cohort 1-Specific Inclusion Criteria * No prior chemotherapy for inoperable locally advanced or metastatic or recurrent urothelial carcinoma * Ineligible for cisplatin-based chemotherapy due to one of the following: Impaired renal function, a hearing loss of 25 decibels (dB) at two contiguous frequencies, Grade 2 or greater peripheral neuropathy, or ECOG performance score of 2
Exclusion criteria
* Any approved anti-cancer therapy within 3 weeks prior to initiation of study treatment * Treatment with any other investigational agent or participation in another clinical trial with therapeutic intent within 28 days prior to enrollment * Active or untreated central nervous system (CNS) metastases as determined by computed tomography (CT) or magnetic resonance imaging (MRI) evaluation during screening and prior radiographic assessments * Leptomeningeal disease * Uncontrolled tumor-related pain * Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures (once monthly or more frequently) * Uncontrolled hypercalcemia (greater than \[\>\] 1.5 millimoles per liter \[mmol/L\] ionized calcium or Ca \> 12 milligrams per deciliter \[mg/dL\] or corrected serum calcium \> upper limits of normal \[ULN\]) or symptomatic hypercalcemia requiring continued use of bisphosphonate therapy or denosumab * Malignancies other than urothelial bladder cancer within 5 years prior to Cycle 1, Day 1, with the exception of those with a negligible risk of metastasis or death treated with expected curative outcome or incidental prostate cancer * Pregnant and lactating women * History of autoimmune disease * History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening chest CT scan * Serum albumin less than (\<) 2.5 grams per deciliter (g/dL) * Positive test for human immunodeficiency virus (HIV) and/or active hepatitis B or hepatitis C or tuberculosis * Severe infections within 4 weeks prior to Cycle 1, Day 1 * Significant cardiovascular disease * Major surgical procedure other than for diagnosis within 28 days prior to Cycle 1, Day 1 * Prior allogeneic stem cell or solid organ transplant * Administration of a live, attenuated vaccine within 4 weeks before Cycle 1, Day 1 * Any other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or render the patient at high risk from treatment complications * Prior treatment with CD137 agonists or immune checkpoint blockade therapies, including anti-cytotoxic T lymphocyte-associated antigen 4 (anti-CTLA-4), anti-programmed death-1 receptor (anti-PD-1), and anti-programmed death-ligand 1 (anti-PD-L1) therapeutic antibodies
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With a Confirmed Objective Response of Complete Response (CR) or Partial Response (PR) as Assessed by the Independent Review Facility (IRF) According to RECIST v1.1 | Baseline until confirmed disease progression or death, whichever occurred first (assessed at every 9 weeks for the first 12 months, thereafter every 12 weeks until data cutoff date 04 July 2016, up to maximum length of follow-up of 23.52 months) | Tumor response was assessed by the IRF according to RECIST v1.1. CR was defined as disappearance of all target and non-target lesions and (if applicable) normalization of tumor marker levels. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (\<) 10 millimeters (mm). PR was defined as greater than or equal to (≥) 30 percent (%) decrease in sum of longest diameter (LD) of target lesions in reference to Baseline sum LD. Response was to be confirmed ≥4 weeks after the initial assessment of CR or PR. The percentage of participants with a confirmed objective response of CR or PR was reported. The exact 95% confidence interval (CI) was calculated using the Clopper-Pearson method. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| DOR as Assessed by the Investigator According to RECIST v1.1 | Baseline until confirmed disease progression or death, whichever occurred first (assessed at every 9 weeks for the first 12 months, thereafter every 12 weeks until data cutoff date 04 July 2016, up to maximum length of follow-up of 23.52 months) | DOR was defined as the time from the initial occurrence of documented CR or PR (whichever occurred first) until documented disease progression or death due to any cause on study, whichever occurred first. Tumor response was assessed by the investigator according to RECIST v1.1. CR was defined as disappearance of all target and non-target lesions and no new measurable or unmeasurable lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. PR was defined as ≥30% decrease in sum of LD of target lesions in reference to Baseline sum LD. |
| Minimum Serum Concentration (Cmin) of Atezolizumab | Pre-dose (0 hours) on Day 1 of Cycles 1, 2, 3, 4, 8 (Cycle length = 21 days) | — |
| Percentage of Participants With Death or Disease Progression as Assessed by the IRF According to RECIST v1.1 | Baseline until confirmed disease progression or death, whichever occurred first (assessed at every 9 weeks for the first 12 months, thereafter every 12 weeks until data cutoff date 04 July 2016, up to maximum length of follow-up of 23.52 months) | Tumor response was assessed by the IRF according to RECIST v1.1. Disease progression or PD was defined as ≥20% increase in sum LD in reference to the smallest on-study sum LD, or the appearance of new lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. |
| Progression-Free Survival (PFS) as Assessed by the IRF According to RECIST v1.1 | Baseline until confirmed disease progression or death, whichever occurred first (assessed at every 9 weeks for the first 12 months, thereafter every 12 weeks until data cutoff date 04 July 2016, up to maximum length of follow-up of 23.52 months) | PFS was defined as the time from start of treatment to the first event of death or PD. Tumor response was assessed by the IRF according to RECIST v1.1. Disease progression or PD was defined as ≥20% increase in sum LD in reference to the smallest on-study sum LD, or the appearance of new lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. |
| Percentage of Participants With Death or Disease Progression as Assessed by the Investigator According to RECIST v1.1 | Baseline until confirmed disease progression or death, whichever occurred first (assessed at every 9 weeks for the first 12 months, thereafter every 12 weeks until data cutoff date 04 July 2016, up to maximum length of follow-up of 23.52 months) | Tumor response was assessed by the investigator according to RECIST v1.1. Disease progression or PD was defined as ≥20% increase in sum LD in reference to the smallest on-study sum LD, or the appearance of new lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The percentage of participants who died or experienced PD was reported. |
| PFS as Assessed by the Investigator According to RECIST v1.1 | Baseline until confirmed disease progression or death, whichever occurred first (assessed at every 9 weeks for the first 12 months, thereafter every 12 weeks until data cutoff date 04 July 2016, up to maximum length of follow-up of 23.52 months) | PFS was defined as the time from start of treatment to the first event of death or PD. Tumor response was assessed by the investigator according to RECIST v1.1. Disease progression or PD was defined as ≥20% increase in sum LD in reference to the smallest on-study sum LD, or the appearance of new lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. |
| Duration of Response (DOR) as Assessed by the IRF According to RECIST v1.1 | Baseline until confirmed disease progression or death, whichever occurred first (assessed at every 9 weeks for the first 12 months, thereafter every 12 weeks until data cutoff date 04 July 2016, up to maximum length of follow-up of 23.52 months) | DOR was defined as the time from the initial occurrence of documented CR or PR (whichever occurred first) until documented disease progression or death due to any cause on study, whichever occurred first. Tumor response was assessed by the IRF according to RECIST v1.1. CR was defined as disappearance of all target and non-target lesions and (if applicable) normalization of tumor marker levels. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. PR was defined as ≥30% decrease in sum of LD of target lesions in reference to Baseline sum LD. Response was to be confirmed ≥4 weeks after the initial assessment of CR or PR. |
| Percentage of Participants Who Died | Baseline until death (data cutoff date 04 July 2016, up to maximum length of follow-up of 23.52 months) | The percentage of participants who died from any cause was reported. |
| Overall Survival (OS) | Baseline until death (data cutoff date 04 July 2016, up to maximum length of follow-up of 23.52 months) | OS was defined as the time from start of treatment to the time of death from any cause on study. |
| Percentage of Participants Alive at 1-year | 1-year | — |
| Maximum Serum Concentration (Cmax) of Atezolizumab | Pre-dose (0 hours) and 30 minutes post-dose on Day 1 of Cycle 1 (Cycle length = 21 days) | — |
| Percentage of Participants Positive for Anti-therapeutic Antibodies (ATA) to Atezolizumab | Day 1 of all cycles (Cycle length = 21 days) and at treatment discontinuation (data cutoff date 04 July 2016, up to maximum length of follow-up of 23.52 months) | — |
| Percentage of Participants With a Confirmed Objective Response of CR or PR as Assessed by the Investigator According RECIST v1.1 | Baseline until confirmed disease progression or death, whichever occurred first (assessed at every 9 weeks for the first 12 months, thereafter every 12 weeks until data cutoff date 04 July 2016, up to maximum length of follow-up of 23.52 months) | Tumor response was assessed by the investigator according to RECIST v1.1. CR was defined as disappearance of all target and non-target lesions and (if applicable) normalization of tumor marker levels. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. PR was defined as ≥30% decrease in sum of LD of target lesions in reference to Baseline sum LD. Response was to be confirmed ≥4 weeks after the initial assessment of CR or PR. The percentage of participants with a confirmed objective response of CR or PR was reported. The exact 95% CI was calculated using the Clopper-Pearson method. |
Countries
Canada, France, Germany, Italy, Netherlands, Spain, United Kingdom, United States
Participant flow
Recruitment details
The study is considered Completed because the planned study activities and analyses have been performed.
Pre-assignment details
The analysis included data up to cutoff date 28 February 2023.
Participants by arm
| Arm | Count |
|---|---|
| Cohort 1: Treatment-naive Cisplatin Ineligible Participants Participants with advanced disease who were treatment-naive for advanced urothelial carcinoma and cisplatin ineligible received atezolizumab 1200 mg via IV infusion on Day 1 of 21-day cycles until disease progression per RECIST v1.1 criteria or unmanageable toxicity. | 119 |
| Total | 119 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 96 |
| Overall Study | Lost to Follow-up | 2 |
| Overall Study | Physician Decision | 1 |
| Overall Study | Study Terminated By Sponsor | 9 |
| Overall Study | Withdrawal by Subject | 11 |
Baseline characteristics
| Characteristic | Cohort 1: Treatment-naive Cisplatin Ineligible Participants |
|---|---|
| Age, Continuous | 71.8 years STANDARD_DEVIATION 8.9 |
| Sex: Female, Male Female | 23 Participants |
| Sex: Female, Male Male | 96 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 96 / 119 |
| other Total, other adverse events | 110 / 119 |
| serious Total, serious adverse events | 49 / 119 |
Outcome results
Primary
Percentage of Participants With a Confirmed Objective Response of Complete Response (CR) or Partial Response (PR) as Assessed by the Independent Review Facility (IRF) According to RECIST v1.1
Tumor response was assessed by the IRF according to RECIST v1.1. CR was defined as disappearance of all target and non-target lesions and (if applicable) normalization of tumor marker levels. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (\<) 10 millimeters (mm). PR was defined as greater than or equal to (≥) 30 percent (%) decrease in sum of longest diameter (LD) of target lesions in reference to Baseline sum LD. Response was to be confirmed ≥4 weeks after the initial assessment of CR or PR. The percentage of participants with a confirmed objective response of CR or PR was reported. The exact 95% confidence interval (CI) was calculated using the Clopper-Pearson method.
Time frame: Baseline until confirmed disease progression or death, whichever occurred first (assessed at every 9 weeks for the first 12 months, thereafter every 12 weeks until data cutoff date 04 July 2016, up to maximum length of follow-up of 23.52 months)
Population: Cohort 1 objective response-evaluable population included intent-to-treat (ITT) participants who had measurable disease per RECIST v1.1 at baseline. Cohort 1 ITT population included all participants from Cohort 1 who received any amount of study drug.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cohort 1: Treatment-naive Cisplatin Ineligible Participants | Percentage of Participants With a Confirmed Objective Response of Complete Response (CR) or Partial Response (PR) as Assessed by the Independent Review Facility (IRF) According to RECIST v1.1 | 22.7 percentage of participants |
Secondary
DOR as Assessed by the Investigator According to RECIST v1.1
DOR was defined as the time from the initial occurrence of documented CR or PR (whichever occurred first) until documented disease progression or death due to any cause on study, whichever occurred first. Tumor response was assessed by the investigator according to RECIST v1.1. CR was defined as disappearance of all target and non-target lesions and no new measurable or unmeasurable lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. PR was defined as ≥30% decrease in sum of LD of target lesions in reference to Baseline sum LD.
Time frame: Baseline until confirmed disease progression or death, whichever occurred first (assessed at every 9 weeks for the first 12 months, thereafter every 12 weeks until data cutoff date 04 July 2016, up to maximum length of follow-up of 23.52 months)
Population: Cohort 1 objective response-evaluable population. Here, number of participants analyzed = participants who were evaluable for this outcome.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Cohort 1: Treatment-naive Cisplatin Ineligible Participants | DOR as Assessed by the Investigator According to RECIST v1.1 | NA months |
Secondary
Duration of Response (DOR) as Assessed by the IRF According to RECIST v1.1
DOR was defined as the time from the initial occurrence of documented CR or PR (whichever occurred first) until documented disease progression or death due to any cause on study, whichever occurred first. Tumor response was assessed by the IRF according to RECIST v1.1. CR was defined as disappearance of all target and non-target lesions and (if applicable) normalization of tumor marker levels. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. PR was defined as ≥30% decrease in sum of LD of target lesions in reference to Baseline sum LD. Response was to be confirmed ≥4 weeks after the initial assessment of CR or PR.
Time frame: Baseline until confirmed disease progression or death, whichever occurred first (assessed at every 9 weeks for the first 12 months, thereafter every 12 weeks until data cutoff date 04 July 2016, up to maximum length of follow-up of 23.52 months)
Population: Cohort 1 objective response-evaluable population. Here, number of participants analyzed = participants who were evaluable for this outcome.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Cohort 1: Treatment-naive Cisplatin Ineligible Participants | Duration of Response (DOR) as Assessed by the IRF According to RECIST v1.1 | NA months |
Secondary
Maximum Serum Concentration (Cmax) of Atezolizumab
Time frame: Pre-dose (0 hours) and 30 minutes post-dose on Day 1 of Cycle 1 (Cycle length = 21 days)
Population: Cohort 1 pharmacokinetic (PK) evaluable population was defined as participants who received any dose of atezolizumab treatment and had PK data at timepoints that were sufficient to determine PK parameters. Here, number of participants analyzed = participants who were evaluable for this outcome.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cohort 1: Treatment-naive Cisplatin Ineligible Participants | Maximum Serum Concentration (Cmax) of Atezolizumab | 386 microgram(s)/milliliter (mcg/mL) | Standard Deviation 118 |
Secondary
Minimum Serum Concentration (Cmin) of Atezolizumab
Time frame: Pre-dose (0 hours) on Day 1 of Cycles 1, 2, 3, 4, 8 (Cycle length = 21 days)
Population: Cohort 1 PK evaluable population. Here, number of participants analyzed = participants who were evaluable for this outcome. n = participants who were evaluable at specified timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1: Treatment-naive Cisplatin Ineligible Participants | Minimum Serum Concentration (Cmin) of Atezolizumab | Pre-dose Cycle 1 (n=117) | 0 mcg/mL | Standard Deviation 0 |
| Cohort 1: Treatment-naive Cisplatin Ineligible Participants | Minimum Serum Concentration (Cmin) of Atezolizumab | Pre-dose Cycle 2 (n=106) | 77.7 mcg/mL | Standard Deviation 35.3 |
| Cohort 1: Treatment-naive Cisplatin Ineligible Participants | Minimum Serum Concentration (Cmin) of Atezolizumab | Pre-dose Cycle 4 (n=66) | 159 mcg/mL | Standard Deviation 68.4 |
| Cohort 1: Treatment-naive Cisplatin Ineligible Participants | Minimum Serum Concentration (Cmin) of Atezolizumab | Pre-dose Cycle 8 (n=47) | 169 mcg/mL | Standard Deviation 110 |
| Cohort 1: Treatment-naive Cisplatin Ineligible Participants | Minimum Serum Concentration (Cmin) of Atezolizumab | Pre-dose Cycle 3 (n=57) | 117 mcg/mL | Standard Deviation 48.8 |
Secondary
Overall Survival (OS)
OS was defined as the time from start of treatment to the time of death from any cause on study.
Time frame: Baseline until death (data cutoff date 04 July 2016, up to maximum length of follow-up of 23.52 months)
Population: Cohort 1 ITT population.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Cohort 1: Treatment-naive Cisplatin Ineligible Participants | Overall Survival (OS) | 15.9 months |
Secondary
Percentage of Participants Alive at 1-year
Time frame: 1-year
Population: Cohort 1 ITT population.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cohort 1: Treatment-naive Cisplatin Ineligible Participants | Percentage of Participants Alive at 1-year | 57.2 percentage of participants |
Secondary
Percentage of Participants Positive for Anti-therapeutic Antibodies (ATA) to Atezolizumab
Time frame: Day 1 of all cycles (Cycle length = 21 days) and at treatment discontinuation (data cutoff date 04 July 2016, up to maximum length of follow-up of 23.52 months)
Population: Cohort 1 Safety Evaluable Population. Here, number of participants analyzed = participants for whom ATA samples were available.
| Arm | Measure | Value (NUMBER) | Dispersion |
|---|---|---|---|
| Cohort 1: Treatment-naive Cisplatin Ineligible Participants | Percentage of Participants Positive for Anti-therapeutic Antibodies (ATA) to Atezolizumab | 47.7 percentage of participants | 0 |
Secondary
Percentage of Participants Who Died
The percentage of participants who died from any cause was reported.
Time frame: Baseline until death (data cutoff date 04 July 2016, up to maximum length of follow-up of 23.52 months)
Population: Cohort 1 ITT population.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cohort 1: Treatment-naive Cisplatin Ineligible Participants | Percentage of Participants Who Died | 49.6 percentage of participants |
Secondary
Percentage of Participants With a Confirmed Objective Response of CR or PR as Assessed by the Investigator According RECIST v1.1
Tumor response was assessed by the investigator according to RECIST v1.1. CR was defined as disappearance of all target and non-target lesions and (if applicable) normalization of tumor marker levels. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. PR was defined as ≥30% decrease in sum of LD of target lesions in reference to Baseline sum LD. Response was to be confirmed ≥4 weeks after the initial assessment of CR or PR. The percentage of participants with a confirmed objective response of CR or PR was reported. The exact 95% CI was calculated using the Clopper-Pearson method.
Time frame: Baseline until confirmed disease progression or death, whichever occurred first (assessed at every 9 weeks for the first 12 months, thereafter every 12 weeks until data cutoff date 04 July 2016, up to maximum length of follow-up of 23.52 months)
Population: Cohort 1 objective response-evaluable population.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cohort 1: Treatment-naive Cisplatin Ineligible Participants | Percentage of Participants With a Confirmed Objective Response of CR or PR as Assessed by the Investigator According RECIST v1.1 | 25.2 percentage of participants |
Secondary
Percentage of Participants With Death or Disease Progression as Assessed by the Investigator According to RECIST v1.1
Tumor response was assessed by the investigator according to RECIST v1.1. Disease progression or PD was defined as ≥20% increase in sum LD in reference to the smallest on-study sum LD, or the appearance of new lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The percentage of participants who died or experienced PD was reported.
Time frame: Baseline until confirmed disease progression or death, whichever occurred first (assessed at every 9 weeks for the first 12 months, thereafter every 12 weeks until data cutoff date 04 July 2016, up to maximum length of follow-up of 23.52 months)
Population: Cohort 1 ITT population.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cohort 1: Treatment-naive Cisplatin Ineligible Participants | Percentage of Participants With Death or Disease Progression as Assessed by the Investigator According to RECIST v1.1 | 71.4 percentage of participants |
Secondary
Percentage of Participants With Death or Disease Progression as Assessed by the IRF According to RECIST v1.1
Tumor response was assessed by the IRF according to RECIST v1.1. Disease progression or PD was defined as ≥20% increase in sum LD in reference to the smallest on-study sum LD, or the appearance of new lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.
Time frame: Baseline until confirmed disease progression or death, whichever occurred first (assessed at every 9 weeks for the first 12 months, thereafter every 12 weeks until data cutoff date 04 July 2016, up to maximum length of follow-up of 23.52 months)
Population: Cohort 1 ITT population.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cohort 1: Treatment-naive Cisplatin Ineligible Participants | Percentage of Participants With Death or Disease Progression as Assessed by the IRF According to RECIST v1.1 | 73.9 percentage of participants |
Secondary
PFS as Assessed by the Investigator According to RECIST v1.1
PFS was defined as the time from start of treatment to the first event of death or PD. Tumor response was assessed by the investigator according to RECIST v1.1. Disease progression or PD was defined as ≥20% increase in sum LD in reference to the smallest on-study sum LD, or the appearance of new lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.
Time frame: Baseline until confirmed disease progression or death, whichever occurred first (assessed at every 9 weeks for the first 12 months, thereafter every 12 weeks until data cutoff date 04 July 2016, up to maximum length of follow-up of 23.52 months)
Population: Cohort 1 ITT population.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Cohort 1: Treatment-naive Cisplatin Ineligible Participants | PFS as Assessed by the Investigator According to RECIST v1.1 | 4.17 months |
Secondary
Progression-Free Survival (PFS) as Assessed by the IRF According to RECIST v1.1
PFS was defined as the time from start of treatment to the first event of death or PD. Tumor response was assessed by the IRF according to RECIST v1.1. Disease progression or PD was defined as ≥20% increase in sum LD in reference to the smallest on-study sum LD, or the appearance of new lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.
Time frame: Baseline until confirmed disease progression or death, whichever occurred first (assessed at every 9 weeks for the first 12 months, thereafter every 12 weeks until data cutoff date 04 July 2016, up to maximum length of follow-up of 23.52 months)
Population: Cohort 1 ITT population.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Cohort 1: Treatment-naive Cisplatin Ineligible Participants | Progression-Free Survival (PFS) as Assessed by the IRF According to RECIST v1.1 | 2.69 months |