This is the classic website, which will be retired eventually. Please visit the modernized ClinicalTrials.gov instead.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
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

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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).

Condition or disease Intervention/treatment Phase
Triple Negative Breast Cancer PD-L1 Positive Drug: Sacituzumab Govitecan-hziy Drug: Pembrolizumab Drug: Paclitaxel Drug: nab-Paclitaxel Drug: Gemcitabine Drug: Carboplatin Phase 3

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 440 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : July 25, 2022
Estimated Primary Completion Date : February 2027
Estimated Study Completion Date : February 2027

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
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.

 Drug: Sacituzumab Govitecan-hziy
Administered intravenously
Other Names:
  • IMMU-132
  • Trodelvy™
  • GS-0132

Drug: Pembrolizumab
Administered intravenously
Other Name: KEYTRUDA®
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
 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


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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).

  4. 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.

  5. Percentage of Participants Experiencing Treatment-emergent Adverse Events (TEAEs) [ Time Frame: First dose date up to 53 months plus 30 days ]
  6. Percentage of Participants Experiencing Clinical Laboratory Abnormalities [ Time Frame: First dose date up to 53 months plus 30 days ]
  7. 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).

  8. 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).

  9. 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).

  10. 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).

  11. 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).


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05382286


Contacts
Layout table for location contacts
Contact: Gilead Clinical Study Information Center 1-833-445-3230 (GILEAD-0) GileadClinicalTrials@gilead.com

Locations
Show Show 509 study locations
Sponsors and Collaborators
Gilead Sciences
Merck Sharp & Dohme LLC
Investigators
Layout table for investigator information
Study Director: Gilead Study Director Gilead Sciences
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Additional Information:

Layout table for additonal information
Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT05382286    
Other Study ID Numbers: 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 )
First Posted: May 19, 2022    Key Record Dates
Last Update Posted: March 28, 2024
Last Verified: March 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Breast Neoplasms
Triple Negative Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Paclitaxel
Albumin-Bound Paclitaxel
Carboplatin
Gemcitabine
Pembrolizumab
Sacituzumab govitecan
Antineoplastic Agents, Phytogenic
 Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antimetabolites
Antineoplastic Agents, Immunological
Immune Checkpoint Inhibitors
Immunoconjugates
Immunologic Factors
Physiological Effects of Drugs