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New treatment option for Breast Cancer
Official title Sacituzumab Govitecan +/- Pembrolizumab in Metastatic TNBC
ClinicalTrials.gov ID: NCT04468061
What this study is testing
What is Sacituzumab Govitecan?
Sacituzumab Govitecan is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for breast cancer.
Also referred to as IMMU-132, Trodelvy.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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)
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Participants must have histologically or cytologically confirmed invasive breast cancer with unresectable locally advanced or metastatic disease...
- Estrogen-receptor and progesterone-receptor expression both ≤ 5% by immunohistochemistry (IHC), and HER2-negative status as determined by the current...
- Participants must have PD-L1-negative metastatic breast cancer defined as less than 1% expression of PD-L1 on tumor-infiltrating immune cells (IC) by...
- Participants must be treatment-naïve in the metastatic setting.
- Participants must have evaluable or measurable disease per RECIST 1.1. Patients with bone only disease will be allowed to participate.
You likely can't join if
- Has received prior systemic anti-cancer therapy, including investigational agents, within 4 weeks of study treatment initiation or during the course...
- Prior therapy with any anti-PD-1, PD-L1, or PD-L2 agent or sacituzumab govitecan (IMMU-132). Prior therapy with irinotecan or topoisomerase...
- Prior hypersensitivity to pembrolizumab or the excipients of pembrolizumab or sacituzumab govitecan (IMMU-132 therapy).
- Known history of UDP-glucuronosyltransferase 1A1 (UGT1A1) \ 28 allele homozygosity, which is associated with increased risk for neutropenia and...
- Known brain metastases that are untreated, symptomatic, or require therapy to control symptoms.
- Major surgery within 2 weeks prior to study treatment initiation. Patients must have recovered from any effects of any major surgery.
See the full eligibility criteria
Who can join
- Participants must have histologically or cytologically confirmed invasive breast cancer with unresectable locally advanced or metastatic disease. Participants without pathologic or cytologic confirmation of metastatic...
- Estrogen-receptor and progesterone-receptor expression both ≤ 5% by immunohistochemistry (IHC), and HER2-negative status as determined by the current ASCO/CAP guidelines. If a patient has more than one histological...
- Participants must have PD-L1-negative metastatic breast cancer defined as less than 1% expression of PD-L1 on tumor-infiltrating immune cells (IC) by the PD-L1 IHC SP142 assay or a Combined Positive Score (CPS) less...
- Participants must be treatment-naïve in the metastatic setting.
- Participants must have evaluable or measurable disease per RECIST 1.1. Patients with bone only disease will be allowed to participate.
- Participants must agree to undergo a research biopsy, if tumor is safely accessible, at baseline. Previously collected archival tissue will also be obtained on all participants. Tissue needs to be located and...
- Prior chemotherapy: Participants must have received no prior chemotherapy for metastatic breast cancer and must have discontinued all chemotherapy at least 28 days prior to study treatment initiation. No prior...
- Prior biologic therapy: Patients must have received no prior biologic therapy for metastatic breast cancer and discontinued all biologic therapy at least 28 days prior to study treatment initiation. All toxicities...
- Prior radiation therapy: Patients may have received prior radiation therapy. Radiation therapy must be completed at least 7 days prior to study treatment initiation, and all toxicities related to prior radiation therapy...
- Previously treated brain metastases are permitted, with the following provisions:
- Prior SRS should complete ≥ 7 days before study treatment initiation
- Prior WBRT should complete ≥ 7 days before study treatment initiation.
- Any corticosteroid use for brain metastases must have been discontinued for ≥ 7 days prior to study treatment initiation.
- The subject is ≥ 18 years old.
- ECOG performance status 0-1 (Karnofsky \> 60%, see Appendix A).
- Participants must have normal organ and marrow function as defined below:
- Absolute neutrophil count ≥1,000/mcL
- Platelets ≥100,000/mcL
- Hemoglobin ≥ 9.0 g/dl
- INR/PT/aPTT ≤1.5 × ULN unless participant is receiving anticoagulant therapy as long as PT or aPTT is in therapeutic range of anticoagulant
- Total bilirubin ≤1.5 × institutional upper limit of normal (ULN)(or ≤2.0 x ULN in patients with documented Gilbert's Syndrome)
- AST(SGOT)/ALT(SGPT) ≤2.5 × institutional ULN or ≤5 × institutional ULN for participants with documented liver metastases
- Serum creatinine ≤1.5 × institutional ULN OR creatinine clearance ≥ 30 mL/min/ 1.73m2 for participants with creatinine levels above institutional ULN.
- Female people of childbearing potential must have a negative serum or urine pregnancy test within 2 weeks prior to study treatment initiation. Childbearing potential is defined as participants who have not reached a...
- Women of childbearing potential (WOCBP) must agree to use an adequate method of contraception. Contraception is required starting with the first dose of study medication through 180 days (6 months) after the last dose...
- Males who are sexually active with WOCBP must agree to follow instructions for method(s) of contraception for the duration of study treatment with pembrolizumab and 3 months after the last dose of study treatment
- Participants on bisphosphonates or RANK ligand inhibitors may continue receiving therapy during study treatment and also may initiate therapy with these agents on study if clinically indicated.
- The participant must be capable of understanding and complying with the protocol and willing to sign a written informed consent document.
What rules you out
- Has received prior systemic anti-cancer therapy, including investigational agents, within 4 weeks of study treatment initiation or during the course of this study (bisphosphonates and RANK ligand inhibitors are allowed).
- Prior therapy with any anti-PD-1, PD-L1, or PD-L2 agent or sacituzumab govitecan (IMMU-132). Prior therapy with irinotecan or topoisomerase I-containing antibody drug conjugates at any time for early stage or metastatic...
- Prior hypersensitivity to pembrolizumab or the excipients of pembrolizumab or sacituzumab govitecan (IMMU-132 therapy).
- Known history of UDP-glucuronosyltransferase 1A1 (UGT1A1) \ 28 allele homozygosity, which is associated with increased risk for neutropenia and diarrhea related to irinotecan. Note: Concurrent administration of strong...
- Known brain metastases that are untreated, symptomatic, or require therapy to control symptoms.
- Major surgery within 2 weeks prior to study treatment initiation. Patients must have recovered from any effects of any major surgery.
- Uncontrolled, significant intercurrent or recent illness including, but not limited to, ongoing or active infection, uncontrolled non-malignant systemic disease, uncontrolled seizures, or psychiatric illness/social...
- Participant has a medical condition that requires chronic systemic steroid therapy (\> 10 mg of prednisone daily or equivalent) or any other form of immunosuppressive medication (including disease modifying agents) and...
- Participant has documented history of autoimmune disease or syndrome that currently requires systemic steroids or immunosuppressive agents.
- History of (non-infectious) pneumonitis that required steroids or current pneumonitis.
- Individuals with a history of a second malignancy are ineligible except for the following circumstances. Individuals with a history of other malignancies are eligible if they have been disease-free for at least 3 years...
- Participant has a known history of human immunodeficiency virus (HIV), Hepatitis B (defined as Hepatitis B surface antigen [HBsAg] reactive) or known active Hepatitis C virus (defined as detected HCV RNA [qualitative])...
- The participant has received a live vaccine within 28 days prior to study treatment initiation. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella/zoster, yellow...
- Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the subject's participation for the full duration of the study, or is...
- It is unknown whether pembrolizumab is excreted in human milk. Since many drugs are excreted in human milk, and because of the potential for serious adverse reactions in the nursing infant, participants who are...
The study team makes the final eligibility decision.
Where it's taking place
- Stamford, Connecticut, United States
- Miami, Florida, United States
- Plantation, Florida, United States
- Chicago, Illinois, United States
- Brewer, Maine, United States
- Boston, Massachusetts, United States
- Foxborough, Massachusetts, United States
- Milford, Massachusetts, United States
- South Weymouth, Massachusetts, United States
- Chapel Hill, North Carolina, United States
- Cincinnati, Ohio, United States
- Columbus, Ohio, United States
- Philadelphia, Pennsylvania, United States
- Charleston, South Carolina, United States
- Chattanooga, Tennessee, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Stamford, Connecticut, United States; Miami, Florida, United States; Plantation, Florida, United States; Chicago, Illinois, United States; Brewer, Maine, United States; Boston, Massachusetts, United States and 9 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.