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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 (ASCENT-04)

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ClinicalTrials.gov Identifier: NCT05382286
Recruitment Status : Recruiting
First Posted : May 19, 2022
Last Update Posted : March 28, 2024
Sponsor:
Collaborator:
Merck Sharp & Dohme LLC
Information provided by (Responsible Party):
Gilead Sciences

Tracking Information
First Submitted Date  ICMJE May 16, 2022
First Posted Date  ICMJE May 19, 2022
Last Update Posted Date March 28, 2024
Actual Study Start Date  ICMJE July 25, 2022
Estimated Primary Completion Date February 2027   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 16, 2022)
Progression-free Survival (PFS) as Assessed by Blinded Independent Central Review (BICR) per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 [ Time Frame: Randomization up to approximately 33 months ]
PFS is defined as the time from the date of randomization until the date of objective progressive disease (PD) or death (whichever comes first).
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 16, 2022)
  • Overall Survival (OS) [ Time Frame: Randomization up to approximately 53 months ]
    OS is defined as the time from the date of randomization until death due to any cause.
  • Objective Response Rate (ORR) as Assessed by BICR per RECIST Version 1.1 [ Time Frame: Randomization up to approximately 53 months ]
    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.
  • Duration of Response (DOR) as Assessed by BICR per RECIST Version 1.1 [ Time Frame: Randomization up to approximately 53 months ]
    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).
  • Time to Response (TTR) as Assessed by BICR per RECIST Version 1.1 [ Time Frame: Randomization up to approximately 53 months ]
    TTR is defined as the time from the date of randomization until the first documentation of CR or PR.
  • Percentage of Participants Experiencing Treatment-emergent Adverse Events (TEAEs) [ Time Frame: First dose date up to 53 months plus 30 days ]
  • Percentage of Participants Experiencing Clinical Laboratory Abnormalities [ Time Frame: First dose date up to 53 months plus 30 days ]
  • 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) [ Time Frame: Randomization up to approximately 53 months ]
    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).
  • TTD of Pain Score as Measured by EORTC QLQ-C30 [ Time Frame: Randomization up to approximately 53 months ]
    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).
  • TTD of Fatigue Score as Measured by EORTC QLQ-C30 [ Time Frame: Randomization up to approximately 53 months ]
    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).
  • TTD of Physical Functioning Domain Score as Measured by EORTC QLQ-C30 [ Time Frame: Randomization up to approximately 53 months ]
    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).
  • TTD of Role Functioning Score as Measured by EORTC QLQ-C30 [ Time Frame: Randomization up to approximately 53 months ]
    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).
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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
Official Title  ICMJE 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
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).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Triple Negative Breast Cancer
  • PD-L1 Positive
Intervention  ICMJE
  • Drug: Sacituzumab Govitecan-hziy
    Administered intravenously
    Other Names:
    • IMMU-132
    • Trodelvy™
    • GS-0132
  • Drug: Pembrolizumab
    Administered intravenously
    Other Name: KEYTRUDA®
  • Drug: Paclitaxel
    Administered intravenously
    Other Name: Taxol®
  • Drug: nab-Paclitaxel
    Administered intravenously
    Other Name: Abraxane®
  • Drug: Gemcitabine
    Administered intravenously
    Other Name: Gemzar
  • Drug: Carboplatin
    Administered intravenously
Study Arms  ICMJE
  • Experimental: Sacituzumab Govitecan-hziy (SG) + Pembrolizumab

    Participants will receive SG 10 mg/kg on Days 1 and 8 of 21-day cycles and pembrolizumab 200 mg on Day 1 of 21-day cycles

    Pembrolizumab will be administered for a maximum of 35 cycles.

    Interventions:
    • Drug: Sacituzumab Govitecan-hziy
    • Drug: Pembrolizumab
  • Active Comparator: Pembrolizumab + Treatment of Physician's Choice (TPC)

    Participants will receive pembrolizumab 200 mg on Day 1 of each 21-day cycle (maximum 35 cycles) plus TPC determined prior to randomization from 1 of the 3 allowed regimens:

    • Paclitaxel 90 mg/m^2 on Days 1, 8, and 15 of 28-day cycles
    • nab-Paclitaxel 100 mg/m^2 on Days 1, 8, and 15 of 28-day cycles
    • Gemcitabine 1000 mg/m^2 + carboplatin area under the curve (AUC) 2 on Days 1 and 8 of 21-day cycles
    Interventions:
    • Drug: Pembrolizumab
    • Drug: Paclitaxel
    • Drug: nab-Paclitaxel
    • Drug: Gemcitabine
    • Drug: Carboplatin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 16, 2022)
440
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE February 2027
Estimated Primary Completion Date February 2027   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Gilead Clinical Study Information Center 1-833-445-3230 (GILEAD-0) GileadClinicalTrials@gilead.com
Listed Location Countries  ICMJE Argentina,   Australia,   Austria,   Belgium,   Brazil,   Canada,   Chile,   Czechia,   France,   Germany,   Hong Kong,   Hungary,   Israel,   Italy,   Japan,   Korea, Republic of,   Malaysia,   Mexico,   Netherlands,   Poland,   Puerto Rico,   Singapore,   South Africa,   Spain,   Switzerland,   Taiwan,   Turkey,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05382286
Other Study ID Numbers  ICMJE GS-US-592-6173
2021-005742-14 ( EudraCT Number )
KEYNOTE-D19 ( Other Identifier: Merck Sharp & Dohme LLC )
jRCT2041220123 ( Registry Identifier: Japan Registry of Clinical Trials )
MK-3475-D19 ( Other Identifier: Merck Sharp & Dohme LLC )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Gilead Sciences
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Gilead Sciences
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Merck Sharp & Dohme LLC
Investigators  ICMJE
Study Director: Gilead Study Director Gilead Sciences
PRS Account Gilead Sciences
Verification Date March 2024

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP