Brief Summary
The primary objective of this study is to compare the progression-free survival (PFS) between sacituzumab govitecan-hziy (SG) and pembrolizumab versus treatment of physician's choice (TPC) and pembrolizumab in participants with previously untreated, locally advanced inoperable or metastatic triple-negative breast cancer, whose tumors express programmed cell death ligand 1 (PD-L1).
Brief Title
Study of Sacituzumab Govitecan-hziy and Pembrolizumab Versus Treatment of Physician's Choice and Pembrolizumab in Patients With Previously Untreated, Locally Advanced Inoperable or Metastatic Triple-Negative Breast Cancer
Categories
Completion Date
Completion Date Type
Estimated
Conditions
Triple Negative Breast Cancer
PD-L1 Positive
Eligibility Criteria
Key Inclusion Criteria:
* Individuals with locally advanced, inoperable, or metastatic triple-negative breast cancer (TNBC) who have not received previous systemic therapy for advanced disease and whose tumors are programmed cell death ligand 1 (PD-L1) positive at screening.
* Individuals must have completed treatment for Stage I to III breast cancer, if indicated, and ≥ 6 months must have elapsed between completion of treatment with curative intent and first documented local or distant disease recurrence.
* Individuals presenting with de novo metastatic TNBC are eligible for this study.
* TNBC status and tumor PD-L1 combined positive score (CPS) will be confirmed centrally on a recent or archival tumor specimen.
* Individuals must have measurable disease by computed tomography (CT) or magnetic resonance imaging (MRI) as per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 criteria as evaluated locally.
* Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.
* Demonstrates adequate organ function
* Male and female individuals of childbearing potential who engage in heterosexual intercourse must agree to use protocol-specified method(s) of contraception.
* Individuals with HIV must be on antiretroviral therapy (ART) and have a well-controlled HIV infection/disease.
Key Exclusion Criteria:
* Positive serum pregnancy test or women who are lactating.
* Received prior therapy with an agent directed to another stimulatory or coinhibitory T-cell receptor.
* Individuals may not have received systemic anticancer treatment (with the exception of endocrine therapy) within the previous 6 months or radiation therapy within 2 weeks prior to enrollment.
* Individuals may not be participating in a study with an investigational agent or investigational device within 4 weeks prior to randomization. Individuals participating in observational studies are eligible.
* Have previously received topoisomerase 1 inhibitors or antibody drug conjugates containing a topoisomerase inhibitor.
* Have an active second malignancy.
* Have active serious infection requiring antibiotics.
* Individuals positive for HIV-1 or 2 with a history of Kaposi sarcoma and/or Multicentric Castleman Disease.
* Have active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection.
* Has an active autoimmune disease that has required systemic treatment in the past 2 years.
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
* Individuals with locally advanced, inoperable, or metastatic triple-negative breast cancer (TNBC) who have not received previous systemic therapy for advanced disease and whose tumors are programmed cell death ligand 1 (PD-L1) positive at screening.
* Individuals must have completed treatment for Stage I to III breast cancer, if indicated, and ≥ 6 months must have elapsed between completion of treatment with curative intent and first documented local or distant disease recurrence.
* Individuals presenting with de novo metastatic TNBC are eligible for this study.
* TNBC status and tumor PD-L1 combined positive score (CPS) will be confirmed centrally on a recent or archival tumor specimen.
* Individuals must have measurable disease by computed tomography (CT) or magnetic resonance imaging (MRI) as per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 criteria as evaluated locally.
* Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.
* Demonstrates adequate organ function
* Male and female individuals of childbearing potential who engage in heterosexual intercourse must agree to use protocol-specified method(s) of contraception.
* Individuals with HIV must be on antiretroviral therapy (ART) and have a well-controlled HIV infection/disease.
Key Exclusion Criteria:
* Positive serum pregnancy test or women who are lactating.
* Received prior therapy with an agent directed to another stimulatory or coinhibitory T-cell receptor.
* Individuals may not have received systemic anticancer treatment (with the exception of endocrine therapy) within the previous 6 months or radiation therapy within 2 weeks prior to enrollment.
* Individuals may not be participating in a study with an investigational agent or investigational device within 4 weeks prior to randomization. Individuals participating in observational studies are eligible.
* Have previously received topoisomerase 1 inhibitors or antibody drug conjugates containing a topoisomerase inhibitor.
* Have an active second malignancy.
* Have active serious infection requiring antibiotics.
* Individuals positive for HIV-1 or 2 with a history of Kaposi sarcoma and/or Multicentric Castleman Disease.
* Have active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection.
* Has an active autoimmune disease that has required systemic treatment in the past 2 years.
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Inclusion Criteria
Inclusion Criteria:
* Individuals with locally advanced, inoperable, or metastatic triple-negative breast cancer (TNBC) who have not received previous systemic therapy for advanced disease and whose tumors are programmed cell death ligand 1 (PD-L1) positive at screening.
* Individuals must have completed treatment for Stage I to III breast cancer, if indicated, and ≥ 6 months must have elapsed between completion of treatment with curative intent and first documented local or distant disease recurrence.
* Individuals presenting with de novo metastatic TNBC are eligible for this study.
* TNBC status and tumor PD-L1 combined positive score (CPS) will be confirmed centrally on a recent or archival tumor specimen.
* Individuals must have measurable disease by computed tomography (CT) or magnetic resonance imaging (MRI) as per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 criteria as evaluated locally.
* Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.
* Demonstrates adequate organ function
* Male and female individuals of childbearing potential who engage in heterosexual intercourse must agree to use protocol-specified method(s) of contraception.
* Individuals with HIV must be on antiretroviral therapy (ART) and have a well-controlled HIV infection/disease.
Inclusion/
* Individuals with locally advanced, inoperable, or metastatic triple-negative breast cancer (TNBC) who have not received previous systemic therapy for advanced disease and whose tumors are programmed cell death ligand 1 (PD-L1) positive at screening.
* Individuals must have completed treatment for Stage I to III breast cancer, if indicated, and ≥ 6 months must have elapsed between completion of treatment with curative intent and first documented local or distant disease recurrence.
* Individuals presenting with de novo metastatic TNBC are eligible for this study.
* TNBC status and tumor PD-L1 combined positive score (CPS) will be confirmed centrally on a recent or archival tumor specimen.
* Individuals must have measurable disease by computed tomography (CT) or magnetic resonance imaging (MRI) as per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 criteria as evaluated locally.
* Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.
* Demonstrates adequate organ function
* Male and female individuals of childbearing potential who engage in heterosexual intercourse must agree to use protocol-specified method(s) of contraception.
* Individuals with HIV must be on antiretroviral therapy (ART) and have a well-controlled HIV infection/disease.
Inclusion/
Gender
All
Gender Based
false
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Minimum Age
18 Years
NCT Id
NCT05382286
Org Class
Industry
Org Full Name
Gilead Sciences
Org Study Id
GS-US-592-6173
Overall Status
Active, not recruiting
Phases
Phase 3
Primary Completion Date
Primary Completion Date Type
Estimated
Official Title
A Randomized, Open-label, Phase 3 Study of Sacituzumab Govitecan and Pembrolizumab Versus Treatment of Physician's Choice and Pembrolizumab in Patients With Previously Untreated, Locally Advanced Inoperable or Metastatic Triple-Negative Breast Cancer, Whose Tumors Express PD-L1
Primary Outcomes
Outcome Description
PFS is defined as the time from the date of randomization until the date of objective progressive disease (PD) or death (whichever comes first).
Outcome Measure
Progression-free Survival (PFS) as Assessed by Blinded Independent Central Review (BICR) per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1
Outcome Time Frame
Randomization up to approximately 33 months
Secondary Ids
Secondary Id
2021-005742-14
Secondary Id
KEYNOTE-D19
Secondary Id
jRCT2041220123
Secondary Id
MK-3475-D19
Secondary Id
2023-504194-21
Secondary Outcomes
Outcome Description
OS is defined as the time from the date of randomization until death due to any cause.
Outcome Time Frame
Randomization up to approximately 53 months
Outcome Measure
Overall Survival (OS)
Outcome Description
ORR is defined as the proportion of participants who achieve complete response (CR) or partial response (PR) that is confirmed at least 4 weeks after initial documentation of response.
Outcome Time Frame
Randomization up to approximately 53 months
Outcome Measure
Objective Response Rate (ORR) as Assessed by BICR per RECIST Version 1.1
Outcome Description
DOR is defined as the time from the first documentation of CR or PR to the earlier of the first documentation of objective PD or death from any cause (whichever comes first).
Outcome Time Frame
Randomization up to approximately 53 months
Outcome Measure
Duration of Response (DOR) as Assessed by BICR per RECIST Version 1.1
Outcome Description
TTR is defined as the time from the date of randomization until the first documentation of CR or PR.
Outcome Time Frame
Randomization up to approximately 53 months
Outcome Measure
Time to Response (TTR) as Assessed by BICR per RECIST Version 1.1
Outcome Time Frame
First dose date up to 53 months plus 30 days
Outcome Measure
Percentage of Participants Experiencing Treatment-emergent Adverse Events (TEAEs)
Outcome Time Frame
First dose date up to 53 months plus 30 days
Outcome Measure
Percentage of Participants Experiencing Clinical Laboratory Abnormalities
Outcome Description
The EORTC QLQ-C30 is a questionnaire to assess quality of life of cancer patients, it is composed of 30 questions (items) resulting in 5 functional scales, 1 global health status scale, 3 symptom scales, and 6 single items. Scoring of the QLQ-C30 is performed according to QLQ-C30 Scoring manual. All of the scales and single-item measures range in score from 0 to 100. Higher score for the functioning scales and global health status denote a better level of functioning (i.e. a better state of the participant), while higher scores on the symptom and single-item scales indicate a higher level of symptoms (i.e. a worse state of the participant).
Outcome Time Frame
Randomization up to approximately 53 months
Outcome Measure
Time to Deterioration (TTD) in Global Health Status/Quality of Life (QoL) Scale as Measured by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire, Core Questionnaire, Version 3.0 (EORTC QLQ-C30)
Outcome Description
The EORTC QLQ-C30 is a questionnaire to assess quality of life of cancer patients, it is composed of 30 questions (items) resulting in 5 functional scales, 1 global health status scale, 3 symptom scales, and 6 single items. Scoring of the QLQ-C30 is performed according to QLQ-C30 Scoring manual. All of the scales and single-item measures range in score from 0 to 100. Higher score for the functioning scales and global health status denote a better level of functioning (i.e. a better state of the participant), while higher scores on the symptom and single-item scales indicate a higher level of symptoms (i.e. a worse state of the participant).
Outcome Time Frame
Randomization up to approximately 53 months
Outcome Measure
TTD of Pain Score as Measured by EORTC QLQ-C30
Outcome Description
The EORTC QLQ-C30 is a questionnaire to assess quality of life of cancer patients, it is composed of 30 questions (items) resulting in 5 functional scales, 1 global health status scale, 3 symptom scales, and 6 single items. Scoring of the QLQ-C30 is performed according to QLQ-C30 Scoring manual. All of the scales and single-item measures range in score from 0 to 100. Higher score for the functioning scales and global health status denote a better level of functioning (ie, a better state of the participant), while higher scores on the symptom and single-item scales indicate a higher level of symptoms (ie, a worse state of the participant).
Outcome Time Frame
Randomization up to approximately 53 months
Outcome Measure
TTD of Fatigue Score as Measured by EORTC QLQ-C30
Outcome Description
The EORTC QLQ-C30 is a questionnaire to assess quality of life of cancer patients, it is composed of 30 questions (items) resulting in 5 functional scales, 1 global health status scale, 3 symptom scales, and 6 single items. Scoring of the QLQ-C30 is performed according to QLQ-C30 Scoring manual. All of the scales and single-item measures range in score from 0 to 100. Higher score for the functioning scales and global health status denote a better level of functioning (ie, a better state of the participant), while higher scores on the symptom and single-item scales indicate a higher level of symptoms (ie, a worse state of the participant).
Outcome Time Frame
Randomization up to approximately 53 months
Outcome Measure
TTD of Physical Functioning Domain Score as Measured by EORTC QLQ-C30
Outcome Description
The EORTC QLQ-C30 is a questionnaire to assess quality of life of cancer patients, it is composed of 30 questions (items) resulting in 5 functional scales, 1 global health status scale, 3 symptom scales, and 6 single items. Scoring of the QLQ-C30 is performed according to QLQ-C30 Scoring manual. All of the scales and single-item measures range in score from 0 to 100. Higher score for the functioning scales and global health status denote a better level of functioning (ie, a better state of the participant), while higher scores on the symptom and single-item scales indicate a higher level of symptoms (ie, a worse state of the participant).
Outcome Time Frame
Randomization up to approximately 53 months
Outcome Measure
TTD of Role Functioning Score as Measured by EORTC QLQ-C30
See Also Links
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Actual
First Submit Date
First Submit QC Date
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Jesus Anampa Mesias
Investigator Email
janampa@montefiore.org
Investigator Phone
718-920-4826/718-405-8505/646-757-0997