Hepatocellular Carcinoma, Hepatoma, Liver Cancer, Adult, Liver Cell Carcinoma, Liver Cell Carcinoma, Adult
Conditions
Keywords
Hepatocellular Carcinoma, Advanced Hepatocellular Carcinoma, Liver Cancer, Liver Cancer, Adult, Liver Cell Carcinoma, Liver Cell Carcinoma, Adult
Brief summary
The purpose of this study is to evaluate the effectiveness and safety of relatlimab in combination with nivolumab in participants with advanced liver cancer who have never been treated with immuno-oncology therapy, after prior treatment with tyrosine kinase inhibitor therapy.
Interventions
BIOLOGICALRelatlimab
Specified dose on specified days
BIOLOGICALNivolumab
Specified dose on specified days
Sponsors
Bristol-Myers Squibb
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
Key Inclusion Criteria: * Must have a diagnosis of hepatocellular carcinoma (HCC) based on histological confirmation * Must have advanced/metastatic HCC * Have to be immunotherapy treatment-naive in the advanced/metastatic setting * Must have at least one Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 measurable untreated lesion * Child-Pugh score of 5 or 6 * Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 for ECOG performance status scale Key
Exclusion criteria
* Known fibrolamellar HCC, sarcomatoid HCC, combined hepatocellular cholangiocarcinoma * Prior organ allograft or allogeneic bone marrow transplantation * No uncontrolled or significant cardiovascular disease * No active known autoimmune disease * Have received one or two lines of tyrosine kinase inhibitor therapies * Evidence of radiographic progression on or after the last line of tyrosine kinase inhibitor therapy Other protocol-defined inclusion/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Objective Response Rate(ORR) Assessed by BICR | From randomization to primary completion date (Approximately 29.5 Months) | Objective Response Rate (ORR) (as per Recists v1.1) is defined as the percentage of participants whose best overall response (BOR) is either confirmed complete response (CR) or confirmed partial response (PR) based on BICR assessments among all participants in the respective analysis set. BOR is defined as the best response, as determined by the BICR, recorded between the date of randomization and the date of first objectively documented progression or death due to any cause or the date of subsequent therapy, whichever occurs first. For participants without documented progression or subsequent therapy, all available response designations will contribute to the BOR determination. Confirmation of response is required at least 4 weeks after the initial response. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Duration of Response Assessed by BICR | From randomization to primary completion date (Approximately 29.5 Months) | Duration of Response (DOR) (as per Recists v1.1) is defined as the time between the date of first documented response (CR or PR) that is subsequently confirmed, to the date of the first objectively documented tumor progression as determined by the BICR, or death due to any cause, whichever occurs first. Participants who die without a reported prior progression will be considered to have an event on the date of their death. Participants who neither progress nor die will be censored on the date of their last evaluable tumor assessment. DOR will be evaluated for responders (confirmed CR or PR) only. |
| Progression Free Survival(PFS) Assessed by BICR | From randomization to primary completion date (Approximately 29.5 Months) | PFS (as per Recists v1.1) is defined as the time between the date of randomization and the date of first documented tumor progression or death due to any cause, whichever occurs first. Participants who die without a reported progression will be considered to have progressed on the date of their death. |
| Objective Response Rate Assessed by Investigator | From randomization to primary completion date (Approximately 29.5 Months) | Objective Response Rate (ORR) (as per Recists v1.1) is defined as the percentage of participants whose best overall response (BOR) is either confirmed complete response (CR) or confirmed partial response (PR) based on investigator assessments among all participants in the respective analysis set. BOR is defined as the best response, as determined by the investigator, recorded between the date of randomization and the date of first objectively documented progression or death due to any cause or the date of subsequent therapy, whichever occurs first. For participants without documented progression or subsequent therapy, all available response designations will contribute to the BOR determination. Confirmation of response is required at least 4 weeks after the initial response. |
| Disease Control Rate Assessed by Investigator | From randomization to primary completion date (Approximately 29.5 Months) | Disease Control Rate (DCR) (as per Recists v1.1) is defined as the number of randomized participants who achieve a BOR of confirmed CR, confirmed PR, or stable disease (SD), based on BICR assessments divided by the number of all randomized participants. |
| Duration of Response Assessed by Investigator | From randomization to primary completion date (Approximately 29.5 Months) | Duration of Response (DOR) (as per Recists v1.1) is defined as the time between the date of first documented response (CR or PR) that is subsequently confirmed, to the date of the first objectively documented tumor progression as determined by the investigator, or death due to any cause, whichever occurs first. Participants who die without a reported prior progression will be considered to have an event on the date of their death. Participants who neither progress nor die will be censored on the date of their last evaluable tumor assessment. DOR will be evaluated for responders (confirmed CR or PR) only. |
| Progression Free Survival(PFS) Assessed by Investigator | From randomization to primary completion date (Approximately 29.5 Months) | PFS (as per Recists v1.1) is defined as the time between the date of randomization and the date of first documented tumor progression or death due to any cause, whichever occurs first. Participants who die without a reported progression will be considered to have progressed on the date of their death. |
| Disease Control Rate Assessed by BICR | From randomization to primary completion date (Approximately 29.5 Months) | Disease Control Rate (DCR) (as per Recists v1.1) is defined as the number of randomized participants who achieve a BOR of confirmed CR, confirmed PR, or stable disease (SD), based on BICR assessments divided by the number of all randomized participants. |
| Number of Participants With Adverse Events | From randomization to primary completion date (Approximately 29.5 Months). Includes events reported between first dose and 30 days after last dose of study therapy. | Number of participants with an Adverse Event. An Adverse Event is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment. |
| Death Summary | From randomization to primary completion date (Approximately 29.5 Months) | Number of participants who died. |
| Number of Participants With Serious Adverse Events | From randomization to primary completion date (Approximately 29.5 Months). Includes events reported between first dose and 30 days after last dose of study therapy. | Number of participants with Serious Adverse Events A serious adverse event is defined as any untoward medical occurrence that, at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is an important medical event. |
| Number of Participants With Adverse Events Leading to Discontinuation | From randomization to primary completion date (Approximately 29.5 Months). Includes events reported between first dose and 30 days after last dose of study therapy. | Number of participants with Adverse Events Leading to Discontinuation |
| Number of Participants With Clinical Laboratory Abnormalities in Specific Liver Tests | From randomization to primary completion date (Approximately 29.5 Months). Includes events reported between first dose and 30 days after last dose of study therapy. | Number of participants with clinical laboratory abnormalities in specific liver tests |
| Number of Participants With Clinical Laboratory Abnormalities in Thyroid Tests | From randomization to primary completion date (Approximately 29.5 Months). Includes events reported between first dose and 30 days after last dose of study therapy. | Number of participants with clinical laboratory abnormalities in thyroid tests |
| Overall Survival (OS) | From randomization to primary completion date (Approximately 29.5 Months) | Overall survival (OS) is defined as the time from randomization to the date of death from any cause. Overall survival will be censored at the date of randomization for participants who were randomized but had no follow-up. |
Countries
Argentina, Brazil, Chile, China, Czechia, France, Hong Kong, Japan, Mexico, New Zealand, Poland, Romania, Singapore, South Korea, Spain, Taiwan, Turkey (Türkiye)
Participant flow
Pre-assignment details
266 Participants Randomized, 264 Treated
Participants by arm
| Arm | Count |
|---|---|
| Treatment A Nivolumab 480mg Q4W | 128 |
| Treatment B Nivolumab 480mg Q4W + Relatlimab 480mg Q4W | 114 |
| Treatment C Nivolumab 480mg Q4W + Relatlimab 960mg Q4W | 24 |
| Total | 266 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Randomization | Adverse event unrelated to study drug | 0 | 1 | 0 |
| Randomization | Participant withdrew consent | 1 | 0 | 0 |
| Treatment Period | Adverse Event Unrelated to Study Drug | 11 | 6 | 1 |
| Treatment Period | Death | 1 | 2 | 0 |
| Treatment Period | Disease Progression | 85 | 63 | 16 |
| Treatment Period | Lost to Follow-up | 0 | 1 | 0 |
| Treatment Period | Other Reasons | 1 | 2 | 0 |
| Treatment Period | Participant No Longer Meets Study Criteria | 0 | 1 | 0 |
| Treatment Period | Participant Withdrew Consent | 2 | 5 | 1 |
| Treatment Period | Still On-going Treatment | 21 | 22 | 2 |
| Treatment Period | Study Drug Toxicity | 3 | 10 | 4 |
Baseline characteristics
| Characteristic | Treatment A | Treatment B | Treatment C | Total |
|---|---|---|---|---|
| Age, Continuous | 64.0 Years STANDARD_DEVIATION 10.4 | 63.3 Years STANDARD_DEVIATION 11.2 | 68.1 Years STANDARD_DEVIATION 10.9 | 64.1 Years STANDARD_DEVIATION 10.8 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 14 Participants | 16 Participants | 0 Participants | 30 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 65 Participants | 47 Participants | 15 Participants | 127 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 49 Participants | 51 Participants | 9 Participants | 109 Participants |
| Race/Ethnicity, Customized American Indian or Alaska Native | 5 Participants | 6 Participants | 0 Participants | 11 Participants |
| Race/Ethnicity, Customized Asian | 28 Participants | 19 Participants | 2 Participants | 49 Participants |
| Race/Ethnicity, Customized Asian Other | 6 Participants | 8 Participants | 2 Participants | 16 Participants |
| Race/Ethnicity, Customized Black or African American | 2 Participants | 1 Participants | 0 Participants | 3 Participants |
| Race/Ethnicity, Customized Chinese | 16 Participants | 16 Participants | 4 Participants | 36 Participants |
| Race/Ethnicity, Customized Japanese | 7 Participants | 4 Participants | 3 Participants | 14 Participants |
| Race/Ethnicity, Customized Malay | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized Other | 3 Participants | 5 Participants | 0 Participants | 8 Participants |
| Race/Ethnicity, Customized White | 61 Participants | 54 Participants | 12 Participants | 127 Participants |
| Sex: Female, Male Female | 23 Participants | 21 Participants | 2 Participants | 46 Participants |
| Sex: Female, Male Male | 105 Participants | 93 Participants | 22 Participants | 220 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 68 / 128 | 60 / 114 | 18 / 24 |
| other Total, other adverse events | 104 / 127 | 102 / 113 | 22 / 24 |
| serious Total, serious adverse events | 65 / 127 | 65 / 113 | 20 / 24 |
Outcome results
Primary
Objective Response Rate(ORR) Assessed by BICR
Objective Response Rate (ORR) (as per Recists v1.1) is defined as the percentage of participants whose best overall response (BOR) is either confirmed complete response (CR) or confirmed partial response (PR) based on BICR assessments among all participants in the respective analysis set. BOR is defined as the best response, as determined by the BICR, recorded between the date of randomization and the date of first objectively documented progression or death due to any cause or the date of subsequent therapy, whichever occurs first. For participants without documented progression or subsequent therapy, all available response designations will contribute to the BOR determination. Confirmation of response is required at least 4 weeks after the initial response.
Time frame: From randomization to primary completion date (Approximately 29.5 Months)
Population: All Randomized Participants
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Treatment A | Objective Response Rate(ORR) Assessed by BICR | 13.3 Percentage |
| Treatment B | Objective Response Rate(ORR) Assessed by BICR | 10.5 Percentage |
| Treatment C | Objective Response Rate(ORR) Assessed by BICR | 12.5 Percentage |
95% CI: [-10.7, 5.3]
Secondary
Death Summary
Number of participants who died.
Time frame: From randomization to primary completion date (Approximately 29.5 Months)
Population: All Treated Participants
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Treatment A | Death Summary | 67 Participants |
| Treatment B | Death Summary | 60 Participants |
| Treatment C | Death Summary | 18 Participants |
Secondary
Disease Control Rate Assessed by BICR
Disease Control Rate (DCR) (as per Recists v1.1) is defined as the number of randomized participants who achieve a BOR of confirmed CR, confirmed PR, or stable disease (SD), based on BICR assessments divided by the number of all randomized participants.
Time frame: From randomization to primary completion date (Approximately 29.5 Months)
Population: All Randomized Participants
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Treatment A | Disease Control Rate Assessed by BICR | 44.5 Percentage |
| Treatment B | Disease Control Rate Assessed by BICR | 44.7 Percentage |
| Treatment C | Disease Control Rate Assessed by BICR | 33.3 Percentage |
Secondary
Disease Control Rate Assessed by Investigator
Disease Control Rate (DCR) (as per Recists v1.1) is defined as the number of randomized participants who achieve a BOR of confirmed CR, confirmed PR, or stable disease (SD), based on BICR assessments divided by the number of all randomized participants.
Time frame: From randomization to primary completion date (Approximately 29.5 Months)
Population: All Randomized Participants
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Treatment A | Disease Control Rate Assessed by Investigator | 48.4 Percentage |
| Treatment B | Disease Control Rate Assessed by Investigator | 50.9 Percentage |
| Treatment C | Disease Control Rate Assessed by Investigator | 41.7 Percentage |
Secondary
Duration of Response Assessed by BICR
Duration of Response (DOR) (as per Recists v1.1) is defined as the time between the date of first documented response (CR or PR) that is subsequently confirmed, to the date of the first objectively documented tumor progression as determined by the BICR, or death due to any cause, whichever occurs first. Participants who die without a reported prior progression will be considered to have an event on the date of their death. Participants who neither progress nor die will be censored on the date of their last evaluable tumor assessment. DOR will be evaluated for responders (confirmed CR or PR) only.
Time frame: From randomization to primary completion date (Approximately 29.5 Months)
Population: All Confirmed Responders
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Treatment A | Duration of Response Assessed by BICR | 5.82 Months |
| Treatment B | Duration of Response Assessed by BICR | NA Months |
| Treatment C | Duration of Response Assessed by BICR | NA Months |
Secondary
Duration of Response Assessed by Investigator
Duration of Response (DOR) (as per Recists v1.1) is defined as the time between the date of first documented response (CR or PR) that is subsequently confirmed, to the date of the first objectively documented tumor progression as determined by the investigator, or death due to any cause, whichever occurs first. Participants who die without a reported prior progression will be considered to have an event on the date of their death. Participants who neither progress nor die will be censored on the date of their last evaluable tumor assessment. DOR will be evaluated for responders (confirmed CR or PR) only.
Time frame: From randomization to primary completion date (Approximately 29.5 Months)
Population: All Confirmed Responders
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Treatment A | Duration of Response Assessed by Investigator | 10.94 Months |
| Treatment B | Duration of Response Assessed by Investigator | NA Months |
| Treatment C | Duration of Response Assessed by Investigator | 12.42 Months |
Secondary
Number of Participants With Adverse Events
Number of participants with an Adverse Event. An Adverse Event is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment.
Time frame: From randomization to primary completion date (Approximately 29.5 Months). Includes events reported between first dose and 30 days after last dose of study therapy.
Population: All Treated Participants
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Treatment A | Number of Participants With Adverse Events | 119 Participants |
| Treatment B | Number of Participants With Adverse Events | 108 Participants |
| Treatment C | Number of Participants With Adverse Events | 22 Participants |
Secondary
Number of Participants With Adverse Events Leading to Discontinuation
Number of participants with Adverse Events Leading to Discontinuation
Time frame: From randomization to primary completion date (Approximately 29.5 Months). Includes events reported between first dose and 30 days after last dose of study therapy.
Population: All Treated Participants
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Treatment A | Number of Participants With Adverse Events Leading to Discontinuation | 13 Participants |
| Treatment B | Number of Participants With Adverse Events Leading to Discontinuation | 14 Participants |
| Treatment C | Number of Participants With Adverse Events Leading to Discontinuation | 5 Participants |
Secondary
Number of Participants With Clinical Laboratory Abnormalities in Specific Liver Tests
Number of participants with clinical laboratory abnormalities in specific liver tests
Time frame: From randomization to primary completion date (Approximately 29.5 Months). Includes events reported between first dose and 30 days after last dose of study therapy.
Population: All Treated Participants
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Treatment A | Number of Participants With Clinical Laboratory Abnormalities in Specific Liver Tests | ALT OR AST> 5XULN | 25 Participants |
| Treatment A | Number of Participants With Clinical Laboratory Abnormalities in Specific Liver Tests | ALT OR AST> 10XULN | 7 Participants |
| Treatment A | Number of Participants With Clinical Laboratory Abnormalities in Specific Liver Tests | TOTAL BILIRUBIN > 2XULN | 17 Participants |
| Treatment A | Number of Participants With Clinical Laboratory Abnormalities in Specific Liver Tests | CONCURRENT ALT OR AST ELEVATION > 3XULN WITH TOTAL BILIRUBIN >2XULN WITHIN 30 DAYS | 14 Participants |
| Treatment B | Number of Participants With Clinical Laboratory Abnormalities in Specific Liver Tests | CONCURRENT ALT OR AST ELEVATION > 3XULN WITH TOTAL BILIRUBIN >2XULN WITHIN 30 DAYS | 10 Participants |
| Treatment B | Number of Participants With Clinical Laboratory Abnormalities in Specific Liver Tests | ALT OR AST> 5XULN | 41 Participants |
| Treatment B | Number of Participants With Clinical Laboratory Abnormalities in Specific Liver Tests | TOTAL BILIRUBIN > 2XULN | 14 Participants |
| Treatment B | Number of Participants With Clinical Laboratory Abnormalities in Specific Liver Tests | ALT OR AST> 10XULN | 16 Participants |
| Treatment C | Number of Participants With Clinical Laboratory Abnormalities in Specific Liver Tests | CONCURRENT ALT OR AST ELEVATION > 3XULN WITH TOTAL BILIRUBIN >2XULN WITHIN 30 DAYS | 1 Participants |
| Treatment C | Number of Participants With Clinical Laboratory Abnormalities in Specific Liver Tests | ALT OR AST> 10XULN | 2 Participants |
| Treatment C | Number of Participants With Clinical Laboratory Abnormalities in Specific Liver Tests | TOTAL BILIRUBIN > 2XULN | 2 Participants |
| Treatment C | Number of Participants With Clinical Laboratory Abnormalities in Specific Liver Tests | ALT OR AST> 5XULN | 6 Participants |
Secondary
Number of Participants With Clinical Laboratory Abnormalities in Thyroid Tests
Number of participants with clinical laboratory abnormalities in thyroid tests
Time frame: From randomization to primary completion date (Approximately 29.5 Months). Includes events reported between first dose and 30 days after last dose of study therapy.
Population: All Treated Participants with at least on on-treatment TSH measurement
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Treatment A | Number of Participants With Clinical Laboratory Abnormalities in Thyroid Tests | TSH > ULN | 38 Participants |
| Treatment A | Number of Participants With Clinical Laboratory Abnormalities in Thyroid Tests | TSH <LLN WITH TSH ≥ LLN AT BASELINE | 16 Participants |
| Treatment A | Number of Participants With Clinical Laboratory Abnormalities in Thyroid Tests | TSH > ULN WITH TSH ≤ ULN AT BASELINE | 14 Participants |
| Treatment B | Number of Participants With Clinical Laboratory Abnormalities in Thyroid Tests | TSH > ULN | 42 Participants |
| Treatment B | Number of Participants With Clinical Laboratory Abnormalities in Thyroid Tests | TSH <LLN WITH TSH ≥ LLN AT BASELINE | 26 Participants |
| Treatment B | Number of Participants With Clinical Laboratory Abnormalities in Thyroid Tests | TSH > ULN WITH TSH ≤ ULN AT BASELINE | 18 Participants |
| Treatment C | Number of Participants With Clinical Laboratory Abnormalities in Thyroid Tests | TSH <LLN WITH TSH ≥ LLN AT BASELINE | 2 Participants |
| Treatment C | Number of Participants With Clinical Laboratory Abnormalities in Thyroid Tests | TSH > ULN WITH TSH ≤ ULN AT BASELINE | 1 Participants |
| Treatment C | Number of Participants With Clinical Laboratory Abnormalities in Thyroid Tests | TSH > ULN | 2 Participants |
Secondary
Number of Participants With Serious Adverse Events
Number of participants with Serious Adverse Events A serious adverse event is defined as any untoward medical occurrence that, at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is an important medical event.
Time frame: From randomization to primary completion date (Approximately 29.5 Months). Includes events reported between first dose and 30 days after last dose of study therapy.
Population: All Treated Participants
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Treatment A | Number of Participants With Serious Adverse Events | 43 Participants |
| Treatment B | Number of Participants With Serious Adverse Events | 46 Participants |
| Treatment C | Number of Participants With Serious Adverse Events | 14 Participants |
Secondary
Objective Response Rate Assessed by Investigator
Objective Response Rate (ORR) (as per Recists v1.1) is defined as the percentage of participants whose best overall response (BOR) is either confirmed complete response (CR) or confirmed partial response (PR) based on investigator assessments among all participants in the respective analysis set. BOR is defined as the best response, as determined by the investigator, recorded between the date of randomization and the date of first objectively documented progression or death due to any cause or the date of subsequent therapy, whichever occurs first. For participants without documented progression or subsequent therapy, all available response designations will contribute to the BOR determination. Confirmation of response is required at least 4 weeks after the initial response.
Time frame: From randomization to primary completion date (Approximately 29.5 Months)
Population: All Randomized Participants
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Treatment A | Objective Response Rate Assessed by Investigator | 14.1 Percentage |
| Treatment B | Objective Response Rate Assessed by Investigator | 13.2 Percentage |
| Treatment C | Objective Response Rate Assessed by Investigator | 20.8 Percentage |
95% CI: [-9.2, 7.4]
Secondary
Overall Survival (OS)
Overall survival (OS) is defined as the time from randomization to the date of death from any cause. Overall survival will be censored at the date of randomization for participants who were randomized but had no follow-up.
Time frame: From randomization to primary completion date (Approximately 29.5 Months)
Population: All Randomized Subjects
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Treatment A | Overall Survival (OS) | 12.68 Months |
| Treatment B | Overall Survival (OS) | 12.19 Months |
| Treatment C | Overall Survival (OS) | 8.21 Months |
95% CI: [0.74, 1.49]
Secondary
Progression Free Survival(PFS) Assessed by BICR
PFS (as per Recists v1.1) is defined as the time between the date of randomization and the date of first documented tumor progression or death due to any cause, whichever occurs first. Participants who die without a reported progression will be considered to have progressed on the date of their death.
Time frame: From randomization to primary completion date (Approximately 29.5 Months)
Population: All Randomized Subjects
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Treatment A | Progression Free Survival(PFS) Assessed by BICR | 2.00 Months |
| Treatment B | Progression Free Survival(PFS) Assessed by BICR | 2.00 Months |
| Treatment C | Progression Free Survival(PFS) Assessed by BICR | 1.94 Months |
95% CI: [0.75, 1.33]
Secondary
Progression Free Survival(PFS) Assessed by Investigator
PFS (as per Recists v1.1) is defined as the time between the date of randomization and the date of first documented tumor progression or death due to any cause, whichever occurs first. Participants who die without a reported progression will be considered to have progressed on the date of their death.
Time frame: From randomization to primary completion date (Approximately 29.5 Months)
Population: All Randomized Subjects
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Treatment A | Progression Free Survival(PFS) Assessed by Investigator | 3.32 Months |
| Treatment B | Progression Free Survival(PFS) Assessed by Investigator | 3.65 Months |
| Treatment C | Progression Free Survival(PFS) Assessed by Investigator | 1.94 Months |
95% CI: [0.75, 1.33]