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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT05382286




Registration number
NCT05382286
Ethics application status
Date submitted
16/05/2022
Date registered
19/05/2022
Date last updated
9/05/2024

Titles & IDs
Public 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
Scientific 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
Secondary ID [1] 0 0
2021-005742-14
Secondary ID [2] 0 0
GS-US-592-6173
Universal Trial Number (UTN)
Trial acronym
ASCENT-04
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Triple Negative Breast Cancer 0 0
PD-L1 Positive 0 0
Condition category
Condition code
Cancer 0 0 0 0
Breast

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Sacituzumab Govitecan-hziy
Treatment: Drugs - Pembrolizumab
Treatment: Drugs - Paclitaxel
Treatment: Drugs - nab-Paclitaxel
Treatment: Drugs - Gemcitabine
Treatment: Drugs - Carboplatin

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.

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


Treatment: Drugs: Sacituzumab Govitecan-hziy
Administered intravenously

Treatment: Drugs: Pembrolizumab
Administered intravenously

Treatment: Drugs: Paclitaxel
Administered intravenously

Treatment: Drugs: nab-Paclitaxel
Administered intravenously

Treatment: Drugs: Gemcitabine
Administered intravenously

Treatment: Drugs: Carboplatin
Administered intravenously
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Progression-free Survival (PFS) as Assessed by Blinded Independent Central Review (BICR) per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1
Timepoint [1] 0 0
Randomization up to approximately 33 months
Secondary outcome [1] 0 0
Overall Survival (OS)
Timepoint [1] 0 0
Randomization up to approximately 53 months
Secondary outcome [2] 0 0
Objective Response Rate (ORR) as Assessed by BICR per RECIST Version 1.1
Timepoint [2] 0 0
Randomization up to approximately 53 months
Secondary outcome [3] 0 0
Duration of Response (DOR) as Assessed by BICR per RECIST Version 1.1
Timepoint [3] 0 0
Randomization up to approximately 53 months
Secondary outcome [4] 0 0
Time to Response (TTR) as Assessed by BICR per RECIST Version 1.1
Timepoint [4] 0 0
Randomization up to approximately 53 months
Secondary outcome [5] 0 0
Percentage of Participants Experiencing Treatment-emergent Adverse Events (TEAEs)
Timepoint [5] 0 0
First dose date up to 53 months plus 30 days
Secondary outcome [6] 0 0
Percentage of Participants Experiencing Clinical Laboratory Abnormalities
Timepoint [6] 0 0
First dose date up to 53 months plus 30 days
Secondary outcome [7] 0 0
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)
Timepoint [7] 0 0
Randomization up to approximately 53 months
Secondary outcome [8] 0 0
TTD of Pain Score as Measured by EORTC QLQ-C30
Timepoint [8] 0 0
Randomization up to approximately 53 months
Secondary outcome [9] 0 0
TTD of Fatigue Score as Measured by EORTC QLQ-C30
Timepoint [9] 0 0
Randomization up to approximately 53 months
Secondary outcome [10] 0 0
TTD of Physical Functioning Domain Score as Measured by EORTC QLQ-C30
Timepoint [10] 0 0
Randomization up to approximately 53 months
Secondary outcome [11] 0 0
TTD of Role Functioning Score as Measured by EORTC QLQ-C30
Timepoint [11] 0 0
Randomization up to approximately 53 months

Eligibility
Key inclusion criteria
Key

- 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
25/07/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/02/2027
Actual
Sample size
Target
440
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,TAS,VIC,WA
Recruitment hospital [1] 0 0
Border Medical Oncology - Albury
Recruitment hospital [2] 0 0
Saint George Hospital - Australia - Kogarah
Recruitment hospital [3] 0 0
Mater Hospital - North Sydney - North Sydney
Recruitment hospital [4] 0 0
GenesisCare - North Shore - St Leonards
Recruitment hospital [5] 0 0
Mater Misericordiae Limited and Mater Research Limited - South Brisbane
Recruitment hospital [6] 0 0
Princess Alexandra Hospital - Woolloongabba
Recruitment hospital [7] 0 0
Cancer Research SA (CRSA) - Adelaide
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Icon Cancer Centre Hobart - Hobart
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Monash Medical Centre - Clayton
Recruitment hospital [10] 0 0
Austin Hospital - Melbourne
Recruitment hospital [11] 0 0
Peter MacCallum Cancer Centre - Parkville
Recruitment hospital [12] 0 0
Breast Cancer Research Center - Western Australia - Nedlands
Recruitment postcode(s) [1] 0 0
2640 - Albury
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2217 - Kogarah
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2060 - North Sydney
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2065 - St Leonards
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4101 - South Brisbane
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4102 - Woolloongabba
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5000 - Adelaide
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7000 - Hobart
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3168 - Clayton
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3084 - Melbourne
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3050 - Parkville
Recruitment postcode(s) [12] 0 0
6009 - Nedlands
Recruitment outside Australia
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Country [189] 0 0
Netherlands
State/province [189] 0 0
Groningen
Country [190] 0 0
Netherlands
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Leeuwarden
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Netherlands
State/province [191] 0 0
Rotterdam
Country [192] 0 0
Poland
State/province [192] 0 0
Gdansk
Country [193] 0 0
Poland
State/province [193] 0 0
Gliwice
Country [194] 0 0
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Opole
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Poznan
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Warsaw
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Poland
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Warszawa
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Ponce
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Puerto Rico
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San Juan
Country [201] 0 0
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Singapore
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State/province [202] 0 0
Hilton
Country [203] 0 0
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State/province [203] 0 0
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State/province [205] 0 0
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Switzerland
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Winterthur
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Glasgow
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Leeds
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London
Country [239] 0 0
United Kingdom
State/province [239] 0 0
Nottingham

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Gilead Sciences
Address
Country
Other collaborator category [1] 0 0
Commercial sector/Industry
Name [1] 0 0
Merck Sharp & Dohme LLC
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
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).
Trial website
https://clinicaltrials.gov/ct2/show/NCT05382286
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Gilead Study Director
Address 0 0
Gilead Sciences
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Gilead Clinical Study Information Center
Address 0 0
Country 0 0
Phone 0 0
1-833-445-3230 (GILEAD-0)
Fax 0 0
Email 0 0
GileadClinicalTrials@gilead.com
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT05382286