Sacituzumab Govitecan +/- Pembrolizumab in Metastatic TNBC
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|ClinicalTrials.gov Identifier: NCT04468061|
Recruitment Status : Recruiting
First Posted : July 13, 2020
Last Update Posted : May 11, 2021
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)
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer Triple Negative Breast Cancer PD-L1 Negative||Drug: Sacituzumab Govitecan Drug: Pembrolizumab||Phase 2|
This research study is a Phase II clinical trial. Phase II clinical trials test the safety and effectiveness of an investigational drug or a combination of investigational drugs to learn whether the drug or drug combination works in treating a specific disease. "Investigational" means that the drug or drug combination is being studied.
The U.S. Food and Drug Administration (FDA) has approved Sacituzumab Govitecan for metastatic triple-negative breast cancer, but it is currently approved only for patients who have had 2 or more prior regimens for metastatic disease. The U.S. Food and Drug Administration (FDA) has not approved Pembrolizumab for metastatic triple-negative breast cancer but it has been approved for other uses.
In this research study, we are:
- Studying Sacituzumab Govitecan alone or in combination with Pembrolizumab as a possible treatment for patients with metastatic triple-negative breast cancers that are PD-L1-negative.
- Sacituzumab Govitecan is composed of a chemotherapy drug, called Irinotecan, which is attached to an antibody. Antibodies are proteins normally made by the immune system that bind to substances that don't belong in the body to prevent harm. The antibody in this study binds to certain types of cancer tumors, including triple-negative breast tumors.
- Pembrolizumab is an immunotherapy, called an anti-PD-1 or a checkpoint inhibitor, and is an antibody (a type of human protein) designed to allow the body's own immune system to seek out and destroy tumors. It has been used in previous research studies to treat breast cancer, where it has been shown to be effective.
- The overall goal of this study is to evaluate the effectiveness of either Sacituzumab Govitecan alone or in combination with Pembrolizumab, in delaying the worsening of triple-negative breast cancers that are PD-L1-negative.
The research study procedures include: screening for eligibility, research blood collections, at least two research biopsies, paired research stool collections, questionnaires, data collection, and study treatment including evaluations and follow up visits.
Participants will be randomized into one of two groups.
- Group A: Sacituzumab Govitecan on days 1 and 8 and Pembrolizumab on day 1 of a 21-day cycle
- Group B: Sacituzumab Govitecan alone on days 1 and 8 of a 21-day cycle
Participants will receive study treatment for as long as they are benefitting from this therapy. Participants will be followed for the rest of their life.
It is expected that about 110 people will take part in this research study.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||110 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Saci-IO TNBC: Randomized Phase II Study of Sacituzumab Govitecan With or Without Pembrolizumab in PD-L1-negative Metastatic Triple Negative Breast Cancer (TNBC)|
|Actual Study Start Date :||July 20, 2020|
|Estimated Primary Completion Date :||June 1, 2023|
|Estimated Study Completion Date :||June 1, 2026|
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.
Drug: Sacituzumab Govitecan
Other Name: Keytruda
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
Drug: Sacituzumab Govitecan
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:
Drug: Sacituzumab Govitecan
Other Name: Keytruda
- Progression Free Survival (PFS) [ Time Frame: 3 years ]
Compare PFS of patients randomized to receive sacituzumab govitecan in combination with pembrolizumab (Arm A) versus those randomized to receive sacituzumab govitecan monotherapy (Arm B).
Defined as the time from study randomization to disease progression, per RESICT 1.1 or medical judgment, the latter based on established clinical parameters, such as rising tumor markers and physical exam evidence of progression, i.e. worsening chest wall disease, or death due to any cause, whichever occurred first.
- Overall Survival (OS) [ Time Frame: 3 years ]Compare the efficacy of sacituzumab govitecan with pembrolizumab to that of sacituzumab govitecan alone by assessing Overall Survival (OS), defined as the time from randomization (or registration) to death due to any cause, or censored at date last known alive, will be reported with Kaplan Meier estimates.
- Objective Response Rate (ORR) [ Time Frame: 3 years ]Compare the efficacy of sacituzumab govitecan with pembrolizumab to that of sacituzumab govitecan alone by assessing Objective Response Rate by RECIST 1.1
- Duration of response (DOR) [ Time Frame: 3 years ]Compare the efficacy of sacituzumab govitecan with pembrolizumab to that of sacituzumab govitecan alone by assessing the duration of response (the time measurement criteria are met for CR or PR (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented or death due to any cause. Participants without events reported are censored at the last disease evaluation).
- Time to objective response (TTOR) [ Time Frame: 3 years ]Compare the efficacy of sacituzumab govitecan with pembrolizumab to that of sacituzumab govitecan alone by assessing the time to objective response defined as the time from randomization to the date of the first documented CR or PR (whichever is first recorded).
- Time to progression (TTP) [ Time Frame: 3 years ]Compare the efficacy of sacituzumab govitecan with pembrolizumab to that of sacituzumab govitecan alone by assessing Time to progression (TTP) defined as the time from randomization (or registration) to progression, or censored at date of last disease evaluation for those without progression reported.
- Clinical benefit rate (CBR) [ Time Frame: 3 years ]Compare the efficacy of sacituzumab govitecan with pembrolizumab to that of sacituzumab govitecan alone by assessing Clinical benefit rate (CBR) according to RECIST 1.1, defined as CR, PR or stable disease for ≥ 24 weeks
- Number of Participants with Treatment-Related Adverse Events as Assessed by CTCAE v5.0 [ Time Frame: 3 years ]Evaluate the safety and tolerability of sacituzumab govitecan and pembrolizumab compared to sacituzumab govitecan alone by monitoring adverse events, including immune-related adverse events
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04468061
|Contact: Sara M Tolaney, MD, MPHfirstname.lastname@example.org|
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|University of Chicago Medical Center||Recruiting|
|Chicago, Illinois, United States, 60637|
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|Boston, Massachusetts, United States, 02215|
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|South Weymouth, Massachusetts, United States, 02190|
|Contact: Jingjing Hu, MD Jingjing_Hu@DFCI.HARVARD.EDU|
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|Sarah Cannon Research Institute||Recruiting|
|Chattanooga, Tennessee, United States, 37404|
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|Principal Investigator: Brooke R Daniel, MD|
|Principal Investigator:||Sara M Tolaney, MD, MPH||Dana-Farber Cancer Institute|