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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

Must not have

Major surgery within 2 weeks prior to study treatment initiation

History of (non-infectious) pneumonitis that required steroids or current pneumonitis

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 years

Awards & highlights

No Placebo-Only Group

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.

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.

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 below

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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.

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My metastatic breast cancer is PD-L1-negative with specific test results.

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My tests clearly show that my cancer has spread.

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I am fully active or able to carry out light work.

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I am 18 years old or older.

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I agree to have a biopsy if my tumor can be safely reached.

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I have not received any treatment for my cancer since it spread.

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My organ and bone marrow functions are normal.

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I am a woman who can have children, tested negative for pregnancy, and will use birth control.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have not had major surgery in the last 2 weeks.

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I have had lung inflammation treated with steroids or have it now.

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I have brain metastases that are either untreated, causing symptoms, or need treatment for symptoms.

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I am currently on steroids or immunosuppressants for an autoimmune disease.

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I have a history of HIV, Hepatitis B, or active Hepatitis C.

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I have previously been treated with specific immunotherapy drugs.

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I do not have any severe illnesses that are not under control.

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I have a genetic condition that increases my risk for certain side effects from irinotecan.

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I am on long-term steroids or other drugs that weaken my immune system.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Progression Free Survival (PFS)

Secondary study objectives

Clinical benefit rate (CBR)

Duration of response (DOR)

Number of Participants with Treatment-Related Adverse Events as Assessed by CTCAE v5.0

+4 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial 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. .

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Pembrolizumab

2017

Completed Phase 3

~3150

Sacituzumab Govitecan

2019

Completed Early Phase 1

~30