Sacituzumab Govitecan +/- Pembrolizumab in Metastatic TNBC

Part of paid clinical trials in Stamford, Connecticut.

Sponsor
Dana-Farber Cancer Institute
Study ID
NCT04468061
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Sacituzumab Govitecan — DRUG
    Intravenous Infusion
  • Pembrolizumab — DRUG
    Intravenous Infusion

Study Details

This research study involves testing the safety and efficacy of an investigational intervention for patients with triple-negative breast cancer (TNBC) that has spread, or metastasized, to other parts the body and is PD-L1-negative. The names of the study interventions involved in this study are: * Sacituzumab govitecan (Trodelvy™;IMMU-132) * Pembrolizumab (Keytruda®; MK-3475)

Key Dates

Start date
Jul 20, 2020
Status verified
Apr 2026
Primary completion
Apr 1, 2027
Completion
Apr 1, 2029

Study Design

Enrollment
110 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Sacituzumab Govitecan + Pembrolizumab
    Participants will receive Sacituzumab Govitecan + Pembrolizumab at a pre-determined dose during a 21 day cycle. Sacituzumab Govitecan will be given on days 1 and 8 of the 21 day cycle Pembrolizumab will be given on day 1 of the 21 day cycle.
  • Experimental: Sacituzumab Govitecan
    Participants will receive Sacituzumab Govitecan at a pre-determined dose during a 21 day cycle. Sacituzumab Govitecan will be given on days 1 and 8 of a 21-day cycle
  • Experimental: Retreatment
    Participants randomized to the combination arm (Sacituzumab Govitecan + Pembrolizumab) who stop with CR after at least 24 weeks of treatment may be eligible for additional pembrolizumab and/or sacituzumab govitecan therapy if they progress after stopping study treatment. This is termed the Second Course Phase and is only available if the study remains open and the subject meets conditions. .

Primary Outcome Measure

Progression Free Survival (PFS) [ Time Frame: 3 years ]

Central Contacts

Locations (15)

FacilityCityStateZIPSite coordinators
Stamford HospitalStamfordConnecticut06904
K.M. Steve Lo, MD
[email protected]
K.M. Steve Lo, MD (PRINCIPAL_INVESTIGATOR)
Miami Cancer Institute at Baptist Health (Kendall)MiamiFlorida33176
Lauren Carcas, MD
[email protected]
Lauren Carcas, MD (PRINCIPAL_INVESTIGATOR)
Miami Cancer Institute at Baptist HealthPlantationFlorida33324
Lauren Carcas, MD
[email protected]
Lauren Carcas, MD (PRINCIPAL_INVESTIGATOR)
University of Chicago Medical CenterChicagoIllinois60637
Rita Nanda, MD
[email protected]
Rita Nanda, MD (PRINCIPAL_INVESTIGATOR)
Eastern Maine Medical CenterBrewerMaine04412
Sarah Sinclair, DO
[email protected]
Sarah Sinclair, DO (PRINCIPAL_INVESTIGATOR)
Dana Farber Cancer InstituteBostonMassachusetts02215
Ana C. Garrido-Castro, MD
[email protected]
617-632-6409
Ana C. Garrido-Castro, MD (PRINCIPAL_INVESTIGATOR)
DFCI @ FoxboroughFoxboroughMassachusetts02035
Natalie Sinclair, MD
[email protected]
Natalie Sinclair, MD (PRINCIPAL_INVESTIGATOR)
DFCI @ Milford Regional HospitalMilfordMassachusetts01757
Natalie Sinclair, MD
[email protected]
Natalie Sinclair, MD (PRINCIPAL_INVESTIGATOR)
DF/BWCC in Clinical Affiliation with South Shore HospitalSouth WeymouthMassachusetts02190
Thomas P O'Connor, MD
ThomasP_O'[email protected]
Thomas P O'Connor, MD (PRINCIPAL_INVESTIGATOR)
The University of North Carolina at Chapel HillChapel HillNorth Carolina27599
Emily Ray, MD
[email protected]
Emily Ray, MD (PRINCIPAL_INVESTIGATOR)
The Christ Hospital Cancer CenterCincinnatiOhio45219
Julie Specht, MD
[email protected]
Julie Specht, MD (PRINCIPAL_INVESTIGATOR)
Ohio State University Medical CenterColumbusOhio43212
Margaret Gatti-Mays, MD
[email protected]
Margaret Gatti-Mays, MD (PRINCIPAL_INVESTIGATOR)
University of Pennsylvania-Abramson Cancer CenterPhiladelphiaPennsylvania19104
Payal Shah, MD
[email protected]
Payal Shah, MD (PRINCIPAL_INVESTIGATOR)
Medical University of South CarolinaCharlestonSouth Carolina29425
Abirami Sivapiragasam, MD
[email protected]
Abirami Sivapiragasam, MD (PRINCIPAL_INVESTIGATOR)
Sarah Cannon Research InstituteChattanoogaTennessee37404
Brooke R Daniel, MD
[email protected]
Brooke R Daniel, MD (PRINCIPAL_INVESTIGATOR)

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