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Monoclonal Antibodies
Sacituzumab Govitecan + Pembrolizumab for Triple Negative Breast Cancer
Phase 2
Recruiting
Led By Ana C Garrido-Castro, MD
Research Sponsored by Dana-Farber Cancer Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Males who are sexually active with women of childbearing potential 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
Estrogen-receptor and progesterone-receptor expression both ≤ 5% by immunohistochemistry (IHC), and HER2-negative status as determined by the current ASCO/CAP guidelines
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 years
Awards & highlights
Study Summary
This trial is testing whether sacituzumab govitecan or pembrolizumab are safe and effective for treating triple negative breast cancer that has spread to other parts of the body and is PD-L1-negative.
Who is the study for?
This trial is for adults with PD-L1-negative metastatic triple-negative breast cancer (TNBC). Participants must have not received treatment for metastasis, be in good physical condition, and have normal organ/marrow function. They should agree to a research biopsy if possible. Pregnant women or those breastfeeding are excluded, as well as anyone with certain medical conditions or recent treatments that could interfere with the study.Check my eligibility
What is being tested?
The trial tests Sacituzumab Govitecan (Trodelvy) alone or combined with Pembrolizumab (Keytruda) in patients whose TNBC has spread and doesn't respond to PD-L1 targeting therapies. It aims to determine the safety and effectiveness of these drugs in managing advanced TNBC.See study design
What are the potential side effects?
Possible side effects include allergic reactions to medication components, immune system complications like inflammation of organs, fatigue, digestive issues such as diarrhea from irinotecan-related risks especially in individuals with UGT1A1*28 allele homozygosity, blood disorders including neutropenia which is a low white blood cell count.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I agree to use birth control during and for 3 months after my treatment.
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My breast cancer is not driven by estrogen, progesterone, or HER2.
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My breast cancer is advanced and cannot be removed by surgery.
Select...
My metastatic breast cancer is PD-L1-negative with specific test results.
Select...
My tests clearly show that my cancer has spread.
Select...
I am fully active or able to carry out light work.
Select...
I am 18 years old or older.
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I agree to have a biopsy if my tumor can be safely reached.
Select...
I have not received any treatment for my cancer since it spread.
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My organ and bone marrow functions are normal.
Select...
I am a woman who can have children, tested negative for pregnancy, and will use birth control.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Progression Free Survival (PFS)
Secondary outcome measures
Clinical benefit rate (CBR)
Duration of response (DOR)
Number of Participants with Treatment-Related Adverse Events as Assessed by CTCAE v5.0
+4 moreTrial Design
3Treatment groups
Experimental Treatment
Group I: Sacituzumab Govitecan + PembrolizumabExperimental Treatment2 Interventions
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.
Group II: Sacituzumab GovitecanExperimental Treatment1 Intervention
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
Group III: RetreatmentExperimental Treatment2 Interventions
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.
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Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
2017
Completed Phase 2
~2010
Find a Location
Who is running the clinical trial?
Gilead SciencesIndustry Sponsor
1,084 Previous Clinical Trials
848,369 Total Patients Enrolled
16 Trials studying Breast Cancer
6,344 Patients Enrolled for Breast Cancer
Merck Sharp & Dohme LLCIndustry Sponsor
3,892 Previous Clinical Trials
5,060,561 Total Patients Enrolled
58 Trials studying Breast Cancer
7,388 Patients Enrolled for Breast Cancer
Dana-Farber Cancer InstituteLead Sponsor
1,079 Previous Clinical Trials
340,870 Total Patients Enrolled
141 Trials studying Breast Cancer
22,507 Patients Enrolled for Breast Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My cancer can be measured or seen on scans, including if it's only in my bones.I haven't had cancer treatment or experimental drugs in the last 4 weeks, except for bisphosphonates or RANK ligand inhibitors.I have had treatment for brain metastases.I agree to use birth control during and for 3 months after my treatment.I have not had major surgery in the last 2 weeks.I have had lung inflammation treated with steroids or have it now.I have not had another type of cancer, or if I did, it meets certain conditions.I am taking or can start taking bone-strengthening drugs during the study.My breast cancer is not driven by estrogen, progesterone, or HER2.My breast cancer is advanced and cannot be removed by surgery.I understand the study requirements and agree to participate.My metastatic breast cancer is PD-L1-negative with specific test results.My tests clearly show that my cancer has spread.I have brain metastases that are either untreated, causing symptoms, or need treatment for symptoms.I am currently on steroids or immunosuppressants for an autoimmune disease.I am fully active or able to carry out light work.I am 18 years old or older.I have a history of HIV, Hepatitis B, or active Hepatitis C.I agree to have a biopsy if my tumor can be safely reached.You had a bad reaction to pembrolizumab or its ingredients, or to sacituzumab govitecan (IMMU-132 therapy).I have previously been treated with specific immunotherapy drugs.I do not have any severe illnesses that are not under control.I have not received any treatment for my cancer since it spread.I have a genetic condition that increases my risk for certain side effects from irinotecan.My organ and bone marrow functions are normal.I am on long-term steroids or other drugs that weaken my immune system.I have not received a live vaccine in the last 28 days.I am a woman who can have children, tested negative for pregnancy, and will use birth control.
Research Study Groups:
This trial has the following groups:- Group 1: Sacituzumab Govitecan
- Group 2: Retreatment
- Group 3: Sacituzumab Govitecan + Pembrolizumab
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What medical condition does Sacituzumab Govitecan typically address?
"Sacituzumab Govitecan is a viable option for treating malignant tumours, unresectable melanoma, and high microsatellite instability."
Answered by AI
How many geographically dispersed locations are testing this experiment?
"Eight clinical trial sites are currently recruiting participants for this medical study, including the Dana Farber Cancer Institute in Boston, University of Pennsylvania-Abramson Cancer Center in Philadelphia and Sarah Cannon Research Institute in Chattanooga. Additionally, there are a number of other locations that may be utilized."
Answered by AI
How many participants are currently enrolled in this research study?
"This study requires 110 volunteers that satisfy the designated criteria. Participants can partake in this trial at Dana Farber Cancer Institute located in Boston, Pennsylvania and University of Pennsylvania-Abramson Cancer Center found in Philadelphia, Tennessee."
Answered by AI
Has Sacituzumab Govitecan been tested in other research studies before?
"Currently, Sacituzumab Govitecan is being examined in 990 live trials with 127 of those at the Phase 3 stage. This drug study has a substantial presence within Houston, Texas and its scope extends to over 37000 locations across the globe."
Answered by AI
Are there any opportunities to participate in this experiment currently available?
"Affirmative, the information on clinicaltrials.gov points to this clinical trial still requiring patients with 110 participants needed from 8 sites. This research endeavor was initially advertised on July 20th 2020 and last modified November 14th 2022."
Answered by AI
How reliable is Sacituzumab Govitecan in providing effective treatment?
"Data surrounding sacituzumab govitecan's safety is available, so it has been assigned a score of 2. Nevertheless, the lack of efficacy data at this stage prevents us from giving it a higher rating."
Answered by AI
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