Study of Sacituzumab Govitecan-hziy and Pembrolizumab Ver... | NCT05382286

NCT05382286

Secondary IDs

ID	Type	Description
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
2023-504194-21	Other Identifier	European Medicines Agency

Status Module

Sponsor/Collaborators Module

Name	Class
Merck Sharp & Dohme LLC	INDUSTRY

Oversight Module

Description Module

Conditions Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Sacituzumab Govitecan-hziy (SG) + Pembrolizumab	Experimental	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 Drug: Pembrolizumab
Pembrolizumab + Treatment of Physician's Choice (TPC)	Active Comparator	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 Drug: Paclitaxel Drug: nab-Paclitaxel Drug: Gemcitabine Drug: Carboplatin

Name	Type	Description	Arm Group Labels	Other Names
Sacituzumab Govitecan-hziy	Drug	Administered intravenously	Sacituzumab Govitecan-hziy (SG) + Pembrolizumab

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Progression-free Survival (PFS) as Assessed by Blinded Independent Central Review (BICR) per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1	PFS is defined as the time from the date of randomization until the date of objective progressive disease (PD) or death (whichever comes first).	Randomization up to approximately 33 months

Secondary Outcomes

Measure	Description	Time Frame
Overall Survival (OS)	OS is defined as the time from the date of randomization until death due to any cause.	Randomization up to approximately 53 months
Objective Response Rate (ORR) as Assessed by BICR per RECIST Version 1.1

Eligibility Module

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.

Contacts/Locations Module

Name	Affiliation	Role
Gilead Study Director	Gilead Sciences	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Alaska Oncology and Hematology		Anchorage	Alaska	99508	United States
Arizona Oncology Associates, PC-Hope,1845 W Orange Grove Rd

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
41564397	Derived	Tolaney SM, de Azambuja E, Kalinsky K, Loi S, Kim SB, Yam C, Rapoport B, Im SA, Pistilli B, Mchayleh W, Cescon DW, Watanabe J, Banuelas MAL, Freitas-Junior R, Salvador Bofill J, Afshari M, Gary D, Wang L, Lai C, Schmid P; ASCENT-04/KEYNOTE-D19 Clinical Trial Investigators. Sacituzumab Govitecan plus Pembrolizumab for Advanced Triple-Negative Breast Cancer. N Engl J Med. 2026 Jan 22;394(4):354-366. doi: 10.1056/NEJMoa2508959.

Label	URL
Gilead Clinical Trials Website	View source

IPD Sharing Statement Module

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

Intervention Browse Module

Masking Info

IMMU-132
Trodelvy™
GS-0132

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.

ID	Term
D064726	Triple Negative Breast Neoplasms

ID	Term
C000608132	sacituzumab govitecan
C582435	pembrolizumab
D017239	Paclitaxel
C520255	130-nm albumin-bound paclitaxel
D000068196	Albumin-Bound Paclitaxel
D000093542	Gemcitabine
D016190	Carboplatin

Ancestor Terms

ID	Term
D043823	Taxoids
D043822	Cyclodecanes
D003516	Cycloparaffins
D006840	Hydrocarbons, Alicyclic
D006844	Hydrocarbons, Cyclic
D006838	Hydrocarbons
D009930	Organic Chemicals
D004224	Diterpenes
D013729	Terpenes
D000418	Albumins
D011506	Proteins
D000602	Amino Acids, Peptides, and Proteins
D006571	Heterocyclic Compounds
D003841	Deoxycytidine
D003562	Cytidine
D011741	Pyrimidine Nucleosides
D011743	Pyrimidines
D006573	Heterocyclic Compounds, 1-Ring
D056831	Coordination Complexes

ID	Term
D001943	Breast Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D001941	Breast Diseases
D012871	Skin Diseases
D017437	Skin and Connective Tissue Diseases