Metastatic Non-small Cell Lung Cancer
Conditions
Brief summary
This study is to assess the pharmacokinetics (PK) and safety of SC pembrolizumab (+) berahyaluronidase alfa vs intravenous (IV) pembrolizumab, administered with chemotherapy in first line treatment of adult Japanese participants with metastatic non-small cell lung cancer. The primary hypotheses of this study are pembrolizumab (+) berahyaluronidase alfa subcutaneous (SC) is noninferior to pembrolizumab IV with respect to PK parameters.
Detailed description
Japan extension study will require approximately six years which includes one additional year (beyond the global study's last participant last study related contact) from the time the first participant (or their legally acceptable representative) provides informed consent until the last participant's last study related contact to complete. The Japan extension study will include participants previously enrolled in Japan in the global study for MK-3475A-D77 (NCT05722015) plus the study will continue to enroll participants in Japan until the sample size for participants in Japan reaches approximately 39. As of Amendment 1 of the supplemental statistical analysis plan (effective date: 23 Aug 2024), patient reported outcomes will no longer be the secondary outcome measures of the study.
Interventions
BIOLOGICALPembrolizumab (+) Berahyaluronidase alfa
Pembrolizumab (+) Berahyaluronidase alfa SC will be administered for squamous and nonsquamous NSCLC as per the schedule specified in arm; participants may be eligible for second course.
DRUGPemetrexed
Pemetrexed 500 mg/m² by IV Infusion will be administered for nonsquamous NSCLC as per the schedule specified in arm.
DRUGCisplatin
Cisplatin 75 mg/m² by IV Infusion will be administered for nonsquamous and squamous NSCLC as per the schedule specified in arm.
DRUGCarboplatin
Carboplatin AUC 5 mg/mL/min in nonsquamous and AUC 6 mg/mL/min in squamous NSCLC will be administered as per the schedule specified in arm.
DRUGPaclitaxel
Paclitaxel 200 mg/m² by IV Infusion will be administered for squamous NSCLC as per the schedule specified in arm.
DRUGNab-paclitaxel
Nab-paclitaxel 100 mg/m² by IV Infusion will be administered for squamous NSCLC as per the schedule specified in arm.
BIOLOGICALPembrolizumab
Pembrolizumab by IV Infusion will be administered for squamous and nonsquamous NSCLC as per the schedule specified in arm; participants may be eligible for second course.
DRUGFilgrastim
Filgrastim will be administered as per the schedule specified for the arm.
Pegylated filgrastim will be administered as per the schedule specified for the arm.
Sponsors
Merck Sharp & Dohme LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
The key inclusion and
Exclusion criteria
include but are not limited to the following: Inclusion Criteria: * Has histologically or cytologically confirmed diagnosis of squamous or non-squamous Non-small Cell Lung Cancer (NSCLC) * Must provide archival tumor tissue sample or newly obtained core, incisional, or excisional biopsy of a tumor lesion not previously irradiated * Has a life expectancy of at least 3 months
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Objective Response Rate (ORR) | Up to ~ 16 months | ORR was defined as the percentage of participants who have a confirmed complete response (CR: disappearance of all target lesions) or partial response (PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters) per Response Evaluation Criteria In Solid Tumors 1.1 (RECIST 1.1) as assessed by blinded independent central review (BICR). The percentage of participants with CR or PR were reported. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cycle 3: Trough Serum Concentration (Ctrough) of Pembrolizumab at Steady State | Cycle 3: Arm 1: Day 1: Predose and Days 4, 10, and 42 postdose; Arm 2: Day 1: Predose and at the end of infusion, Days 4 and 42 postdose (cycle length = 42 days) | Ctrough is defined as the trough concentration at steady-state. Blood samples collected pre-dose and at multiple timepoints post-dose will be used to determine Ctrough. |
| Cycle 1: Maximum Serum Concentration (Cmax) of Pembrolizumab After the First Dose | Cycle 1: Arm 1: Day 1: Predose and Days 2, 3, 4, 5, 6, 7, 10, 15, 29, and 42 postdose; Arm 2: Day 1: Predose and at the end of infusion, Days 4, 15, 29, and 42 postdose (cycle length = 42 days) | Cmax was defined as the maximum serum concentration of pembrolizumab reached after first dose. Blood samples were collected at pre-specified timepoints for the determination of Cmax. Per protocol, geometric mean Cmax value of pembrolizumab after the first dose of pembrolizumab formulated with berahyaluronidase alfa in arm 1 and after first dose of pembrolizumab in arm 2 was presented. |
| Cycle 1: Trough Serum Concentration (Ctrough) of Pembrolizumab After the First Dose | At designated time points (Up to ~28 months) | Ctrough was defined as the lowest serum concentration of pembrolizumab reached after first dose. Blood samples were collected at pre-specified timepoints for the determination of Ctrough. Per protocol, geometric mean Ctrough value of pembrolizumab after the first dose of pembrolizumab formulated with berahyaluronidase alfa in arm 1 and after first dose of pembrolizumab in arm 2 was presented. |
| Cycle 3: Area Under the Curve From Time 0 to 6 Weeks (AUC0-6 Weeks) of Pembrolizumab at Steady State | At designated time points (Up to ~28 months) | AUC0-6 weeks was defined as a measure of pembrolizumab exposure that was calculated as the product of serum drug concentration and time from zero to 6 weeks. Blood samples were collected at pre-specified timepoints to determine AUC0-6 weeks. Per protocol, geometric mean AUC0-6 weeks value of pembrolizumab at steady state of pembrolizumab formulated with berahyaluronidase alfa in arm 1 and pembrolizumab in arm 2 was presented. |
| Cycle 3: Maximum Serum Concentration (Cmax) of Pembrolizumab at Steady State | Cycle 3: Arm 1: Day 1: Predose and Days 4, 10, and 42 postdose; Arm 2: Day 1: Predose and at the end of infusion, Days 4 and 42 postdose (cycle length = 42 days) | Cmax was defined as the maximum serum concentration of pembrolizumab reached at steady state. Blood samples were collected at pre-specified timepoints to determine Cmax. Per protocol, geometric mean Cmax value of pembrolizumab at steady state of pembrolizumab formulated with berahyaluronidase alfa in arm 1 and pembrolizumab in arm 2 was presented. |
| Cycle 1: Area Under the Curve From Time 0 to 6 Weeks (AUC0-6 Weeks) of Pembrolizumab After the First Dose | Cycle 1: Arm 1: Day 1: Predose and Days 2, 3, 4, 5, 6, 7, 10, 15, 29, and 42 postdose; Arm 2: Day 1: Predose and at the end of infusion, Days4, 15, 29, and 42 postdose (cycle length = 42 days) | AUC0-6 weeks was defined as a measure of pembrolizumab exposure that was calculated as the product of serum drug concentration and time from zero to 6 weeks. Blood samples were collected at pre-specified timepoints to determine AUC0-6 weeks. Per protocol, geometric mean AUC0-6 weeks value of pembrolizumab after the first dose of pembrolizumab formulated with berahyaluronidase alfa in arm 1 and after first dose of pembrolizumab in arm 2 was presented. |
| Number of Participants Who Test Positive for Anti-Drug Antibodies (ADAs) for Pembrolizumab | At designated time points (Up to ~28 months) | Blood samples are to be collected at designated time points for the determination of the presence or absence of anti-pembrolizumab antibodies. The percentage of participants who develop anti pembrolizumab antibodies will be reported. |
| Progression-free Survival (PFS) Per Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST 1.1) | Up to ~59 months | PFS is defined as the time from randomization to the first documented disease progression per RECIST 1.1 by BICR or death due to any cause, whichever occurs first. |
| Duration of Response (DOR) Per Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST 1.1) | Up to ~59 months | For participants who show confirmed CR or PR, DOR is defined as the time from the first documented evidence of CR or PR until disease progression or death due to any cause, whichever occurs first. |
| Number of Participants Who Experienced at Least One Adverse Event (AE) | Up to~28 months | An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants with an AE will be reported for Arms 1 and 2. |
| Number of Participants Who Discontinued Study Treatment Due to an Adverse Event (AE) | Up to~25 months | An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who discontinue study treatment due to an AE will be reported for Arms 1 and 2. |
| Overall Survival (OS) | Up to ~59 months | OS is defined as the time from randomization to death due to any cause. |
Countries
Japan
Participant flow
Pre-assignment details
39 Japanese participants were randomized and received treatment (global study \[NCT05722015; n=23\] or to the extension portion \[n=16\]).
Participants by arm
| Arm | Count |
|---|---|
| Arm 1: Pembrolizumab Formulated With Berahyaluronidase Alfa + Platinum Doublet Chemotherapy Japanese participants with treatment-naïve metastatic NSCLC receive 790 mg of Pembrolizumab Formulated With Berahyaluronidase Alfa via subcutaneous (SC) injection on Day 1 of each 6-week cycle for 18 cycles (up to approximately 108 weeks) in combination with platinum doublet chemotherapy. | 28 |
| Arm 2: Pembrolizumab + Platinum Doublet Chemotherapy Japanese participants with treatment-naïve metastatic NSCLC receive 400 mg pembrolizumab intravenous (IV) infusion on Day 1 of each 6-week cycle for 18 cycles (up to approximately 108 weeks) in combination with platinum doublet chemotherapy. | 11 |
| Total | 39 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 5 | 3 |
| Overall Study | Participants ongoing | 23 | 8 |
Baseline characteristics
| Characteristic | Arm 1: Pembrolizumab Formulated With Berahyaluronidase Alfa + Platinum Doublet Chemotherapy | Arm 2: Pembrolizumab + Platinum Doublet Chemotherapy | Total |
|---|---|---|---|
| Age, Continuous | 68.3 Years STANDARD_DEVIATION 9 | 70.7 Years STANDARD_DEVIATION 8.2 | 69.0 Years STANDARD_DEVIATION 8.8 |
| Eastern Cooperative Oncology Group (ECOG) Performance Status ECOG = 0 | 18 Participants | 6 Participants | 24 Participants |
| Eastern Cooperative Oncology Group (ECOG) Performance Status ECOG = 1 | 10 Participants | 5 Participants | 15 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 28 Participants | 11 Participants | 39 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Histology (squamous vs. nonsquamous) Non-squamous | 14 Participants | 9 Participants | 23 Participants |
| Histology (squamous vs. nonsquamous) Squamous | 14 Participants | 2 Participants | 16 Participants |
| Programmed Cell Death Ligand 1 (PD-L1) Status TPS <1% | 12 Participants | 6 Participants | 18 Participants |
| Programmed Cell Death Ligand 1 (PD-L1) Status TPS 1-49% | 11 Participants | 4 Participants | 15 Participants |
| Programmed Cell Death Ligand 1 (PD-L1) Status TPS ≥50% | 2 Participants | 1 Participants | 3 Participants |
| Programmed Cell Death Ligand 1 (PD-L1) Status Unknown | 3 Participants | 0 Participants | 3 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 28 Participants | 11 Participants | 39 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Female | 4 Participants | 3 Participants | 7 Participants |
| Sex: Female, Male Male | 24 Participants | 8 Participants | 32 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 5 / 28 | 3 / 11 |
| other Total, other adverse events | 28 / 28 | 11 / 11 |
| serious Total, serious adverse events | 12 / 28 | 3 / 11 |
Outcome results
Primary
Objective Response Rate (ORR)
ORR was defined as the percentage of participants who have a confirmed complete response (CR: disappearance of all target lesions) or partial response (PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters) per Response Evaluation Criteria In Solid Tumors 1.1 (RECIST 1.1) as assessed by blinded independent central review (BICR). The percentage of participants with CR or PR were reported.
Time frame: Up to ~ 16 months
Population: All Japanese participants who were randomized to the global study (NCT05722015) or to the extension portion.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Arm 1: Pembrolizumab Formulated With Berahyaluronidase Alfa + Platinum Doublet Chemotherapy | Objective Response Rate (ORR) | 64.3 Percentage of participants |
| Arm 2: Pembrolizumab + Platinum Doublet Chemotherapy | Objective Response Rate (ORR) | 18.2 Percentage of participants |
Secondary
Cycle 1: Area Under the Curve From Time 0 to 6 Weeks (AUC0-6 Weeks) of Pembrolizumab After the First Dose
AUC0-6 weeks was defined as a measure of pembrolizumab exposure that was calculated as the product of serum drug concentration and time from zero to 6 weeks. Blood samples were collected at pre-specified timepoints to determine AUC0-6 weeks. Per protocol, geometric mean AUC0-6 weeks value of pembrolizumab after the first dose of pembrolizumab formulated with berahyaluronidase alfa in arm 1 and after first dose of pembrolizumab in arm 2 was presented.
Time frame: Cycle 1: Arm 1: Day 1: Predose and Days 2, 3, 4, 5, 6, 7, 10, 15, 29, and 42 postdose; Arm 2: Day 1: Predose and at the end of infusion, Days4, 15, 29, and 42 postdose (cycle length = 42 days)
Population: All Japanese participants who were randomized to the global study (NCT05722015) or to the extension portion who received a dose in Cycle 1 with at least 1 valid postdose pharmacokinetic (PK) sample available in Cycle1 and for whom a model-based assessment of AUC0-6 weeks could be made.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Arm 1: Pembrolizumab Formulated With Berahyaluronidase Alfa + Platinum Doublet Chemotherapy | Cycle 1: Area Under the Curve From Time 0 to 6 Weeks (AUC0-6 Weeks) of Pembrolizumab After the First Dose | 1864.76 µg·day/mL | Geometric Coefficient of Variation 22.18 |
| Arm 2: Pembrolizumab + Platinum Doublet Chemotherapy | Cycle 1: Area Under the Curve From Time 0 to 6 Weeks (AUC0-6 Weeks) of Pembrolizumab After the First Dose | 1697.98 µg·day/mL | Geometric Coefficient of Variation 18.5 |
95% CI: [0.95, 1.27]
Secondary
Cycle 1: Maximum Serum Concentration (Cmax) of Pembrolizumab After the First Dose
Cmax was defined as the maximum serum concentration of pembrolizumab reached after first dose. Blood samples were collected at pre-specified timepoints for the determination of Cmax. Per protocol, geometric mean Cmax value of pembrolizumab after the first dose of pembrolizumab formulated with berahyaluronidase alfa in arm 1 and after first dose of pembrolizumab in arm 2 was presented.
Time frame: Cycle 1: Arm 1: Day 1: Predose and Days 2, 3, 4, 5, 6, 7, 10, 15, 29, and 42 postdose; Arm 2: Day 1: Predose and at the end of infusion, Days 4, 15, 29, and 42 postdose (cycle length = 42 days)
Population: All Japanese participants who were randomized to the global study (NCT05722015) or to the extension portion who received who received a dose in Cycle 1 with at least 1 valid postdose PK sample available in Cycle 1 and for whom a model-based assessment of Cmax could be made.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Arm 1: Pembrolizumab Formulated With Berahyaluronidase Alfa + Platinum Doublet Chemotherapy | Cycle 1: Maximum Serum Concentration (Cmax) of Pembrolizumab After the First Dose | 71.54 µg/ml | Geometric Coefficient of Variation 23.7 |
| Arm 2: Pembrolizumab + Platinum Doublet Chemotherapy | Cycle 1: Maximum Serum Concentration (Cmax) of Pembrolizumab After the First Dose | 141.9 µg/ml | Geometric Coefficient of Variation 16.4 |
Secondary
Cycle 1: Trough Serum Concentration (Ctrough) of Pembrolizumab After the First Dose
Ctrough was defined as the lowest serum concentration of pembrolizumab reached after first dose. Blood samples were collected at pre-specified timepoints for the determination of Ctrough. Per protocol, geometric mean Ctrough value of pembrolizumab after the first dose of pembrolizumab formulated with berahyaluronidase alfa in arm 1 and after first dose of pembrolizumab in arm 2 was presented.
Time frame: At designated time points (Up to ~28 months)
Population: All Japanese participants who were randomized to the global study (NCT05722015) or to the extension portion who received a dose in Cycle 1 with at least 1 valid postdose PK sample available in Cycle 1 and for whom a model-based assessment of Ctrough could be made.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Arm 1: Pembrolizumab Formulated With Berahyaluronidase Alfa + Platinum Doublet Chemotherapy | Cycle 1: Trough Serum Concentration (Ctrough) of Pembrolizumab After the First Dose | 23.62 µg/ml | Geometric Coefficient of Variation 27.9 |
| Arm 2: Pembrolizumab + Platinum Doublet Chemotherapy | Cycle 1: Trough Serum Concentration (Ctrough) of Pembrolizumab After the First Dose | 16.27 µg/ml | Geometric Coefficient of Variation 29.7 |
Secondary
Cycle 3: Area Under the Curve From Time 0 to 6 Weeks (AUC0-6 Weeks) of Pembrolizumab at Steady State
AUC0-6 weeks was defined as a measure of pembrolizumab exposure that was calculated as the product of serum drug concentration and time from zero to 6 weeks. Blood samples were collected at pre-specified timepoints to determine AUC0-6 weeks. Per protocol, geometric mean AUC0-6 weeks value of pembrolizumab at steady state of pembrolizumab formulated with berahyaluronidase alfa in arm 1 and pembrolizumab in arm 2 was presented.
Time frame: At designated time points (Up to ~28 months)
Population: All Japanese participants who were randomized to the global study (NCT05722015) or to the extension portion who received a dose in Cycle 1 and Cycle 3 with at least 1 valid postdose PK sample available in Cycle 1 through Cycle 3 and for whom a model-based assessment of AUC0-6 weeks could be made.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Arm 1: Pembrolizumab Formulated With Berahyaluronidase Alfa + Platinum Doublet Chemotherapy | Cycle 3: Area Under the Curve From Time 0 to 6 Weeks (AUC0-6 Weeks) of Pembrolizumab at Steady State | 3116 µg•day/ml | Geometric Coefficient of Variation 27.3 |
| Arm 2: Pembrolizumab + Platinum Doublet Chemotherapy | Cycle 3: Area Under the Curve From Time 0 to 6 Weeks (AUC0-6 Weeks) of Pembrolizumab at Steady State | 2514 µg•day/ml | Geometric Coefficient of Variation 17.3 |
Secondary
Cycle 3: Maximum Serum Concentration (Cmax) of Pembrolizumab at Steady State
Cmax was defined as the maximum serum concentration of pembrolizumab reached at steady state. Blood samples were collected at pre-specified timepoints to determine Cmax. Per protocol, geometric mean Cmax value of pembrolizumab at steady state of pembrolizumab formulated with berahyaluronidase alfa in arm 1 and pembrolizumab in arm 2 was presented.
Time frame: Cycle 3: Arm 1: Day 1: Predose and Days 4, 10, and 42 postdose; Arm 2: Day 1: Predose and at the end of infusion, Days 4 and 42 postdose (cycle length = 42 days)
Population: All Japanese participants who were randomized to the global study (NCT05722015) or to the extension portion who received a dose in Cycle 1 and Cycle 3 with at least 1 valid postdose PK sample available in Cycle 1 through Cycle 3 and for whom a model-based assessment of Cmax could be made.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Arm 1: Pembrolizumab Formulated With Berahyaluronidase Alfa + Platinum Doublet Chemotherapy | Cycle 3: Maximum Serum Concentration (Cmax) of Pembrolizumab at Steady State | 108.1 µg/mL | Geometric Coefficient of Variation 25.3 |
| Arm 2: Pembrolizumab + Platinum Doublet Chemotherapy | Cycle 3: Maximum Serum Concentration (Cmax) of Pembrolizumab at Steady State | 159.8 µg/mL | Geometric Coefficient of Variation 13.2 |
Secondary
Cycle 3: Trough Serum Concentration (Ctrough) of Pembrolizumab at Steady State
Ctrough is defined as the trough concentration at steady-state. Blood samples collected pre-dose and at multiple timepoints post-dose will be used to determine Ctrough.
Time frame: Cycle 3: Arm 1: Day 1: Predose and Days 4, 10, and 42 postdose; Arm 2: Day 1: Predose and at the end of infusion, Days 4 and 42 postdose (cycle length = 42 days)
Population: All Japanese participants who were randomized to the global study (NCT05722015) or to the extension portion who received a dose in Cycle 1 and Cycle 3 with at least 1 valid postdose PK sample available in Cycle 1through Cycle 3 and for whom a model-based assessment of Ctrough could be made.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Arm 1: Pembrolizumab Formulated With Berahyaluronidase Alfa + Platinum Doublet Chemotherapy | Cycle 3: Trough Serum Concentration (Ctrough) of Pembrolizumab at Steady State | 45.11 µg/ml | Geometric Coefficient of Variation 35.58 |
| Arm 2: Pembrolizumab + Platinum Doublet Chemotherapy | Cycle 3: Trough Serum Concentration (Ctrough) of Pembrolizumab at Steady State | 30.86 µg/ml | Geometric Coefficient of Variation 24.93 |
95% CI: [1.14, 1.88]
Secondary
Duration of Response (DOR) Per Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST 1.1)
For participants who show confirmed CR or PR, DOR is defined as the time from the first documented evidence of CR or PR until disease progression or death due to any cause, whichever occurs first.
Time frame: Up to ~59 months
Secondary
Number of Participants Who Discontinued Study Treatment Due to an Adverse Event (AE)
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who discontinue study treatment due to an AE will be reported for Arms 1 and 2.
Time frame: Up to~25 months
Secondary
Number of Participants Who Experienced at Least One Adverse Event (AE)
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants with an AE will be reported for Arms 1 and 2.
Time frame: Up to~28 months
Secondary
Number of Participants Who Test Positive for Anti-Drug Antibodies (ADAs) for Pembrolizumab
Blood samples are to be collected at designated time points for the determination of the presence or absence of anti-pembrolizumab antibodies. The percentage of participants who develop anti pembrolizumab antibodies will be reported.
Time frame: At designated time points (Up to ~28 months)
Secondary
Overall Survival (OS)
OS is defined as the time from randomization to death due to any cause.
Time frame: Up to ~59 months
Secondary
Progression-free Survival (PFS) Per Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST 1.1)
PFS is defined as the time from randomization to the first documented disease progression per RECIST 1.1 by BICR or death due to any cause, whichever occurs first.
Time frame: Up to ~59 months