110 Participants Needed

Sacituzumab Govitecan + Pembrolizumab for Triple Negative Breast Cancer

Recruiting at 11 trial locations
SM
AC
Overseen ByAna C Garrido-Castro, MD
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: Dana-Farber Cancer Institute
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial
Breakthrough TherapyThis drug has been fast-tracked for approval by the FDA given its high promise

Trial Summary

Will I have to stop taking my current medications?

The trial protocol does not specify if you must stop taking your current medications. However, you cannot have received any prior chemotherapy or biologic therapy for metastatic breast cancer within 28 days before starting the study treatment. You can continue or start bisphosphonates or RANK ligand inhibitors if needed.

What data supports the effectiveness of the drug Sacituzumab Govitecan for treating triple-negative breast cancer?

Sacituzumab Govitecan has shown effectiveness in treating metastatic triple-negative breast cancer, with a study reporting a 33.3% response rate and a median response duration of 7.7 months. It is well tolerated and has been approved by the FDA for patients who have tried at least two other treatments.12345

What is known about the safety of Sacituzumab Govitecan and Pembrolizumab for human use?

Sacituzumab Govitecan has been studied in patients with advanced solid tumors, showing common side effects like nausea, fatigue, and diarrhea, but is generally well tolerated. Pembrolizumab, also known as KEYTRUDA, is widely used in various cancers and has a known safety profile, but specific safety data for the combination with Sacituzumab Govitecan in triple-negative breast cancer is not detailed in the provided research.12346

How is the drug Sacituzumab Govitecan + Pembrolizumab unique for treating triple-negative breast cancer?

This drug combination is unique because Sacituzumab Govitecan is an antibody-drug conjugate that targets a specific protein (Trop-2) on cancer cells and delivers a potent chemotherapy agent (SN-38) directly to the tumor, while Pembrolizumab is an immunotherapy that helps the immune system attack cancer cells. This combination offers a novel approach by combining targeted therapy with immunotherapy for treating triple-negative breast cancer.12367

What is the purpose of this trial?

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)

Research Team

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Ana C. Garrido-Castro

Principal Investigator

Dana-Farber Cancer Institute

Eligibility Criteria

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.

Inclusion Criteria

My cancer can be measured or seen on scans, including if it's only in my bones.
I have had treatment for brain metastases.
I agree to use birth control during and for 3 months after my treatment.
See 11 more

Exclusion Criteria

I haven't had cancer treatment or experimental drugs in the last 4 weeks, except for bisphosphonates or RANK ligand inhibitors.
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 not in the best interest of the subject to participate
I have not had major surgery in the last 2 weeks.
See 12 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks
1 visit (in-person)

Treatment

Participants receive Sacituzumab Govitecan with or without Pembrolizumab in 21-day cycles

24 weeks or longer
Visits on days 1 and 8 of each 21-day cycle

Follow-up

Participants are monitored for safety and effectiveness after treatment

3 years
Regular follow-up visits

Second Course Phase

Participants who achieve CR after at least 24 weeks of treatment may receive additional therapy if they progress

Treatment Details

Interventions

  • Pembrolizumab
  • Sacituzumab Govitecan
Trial Overview 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.
Participant Groups
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. .

Pembrolizumab is already approved in United States, European Union, United Kingdom for the following indications:

🇺🇸
Approved in United States as KEYTRUDA for:
  • Head and neck squamous cell carcinoma (HNSCC) with PD-L1 CPS ≥1
  • Melanoma
  • Non-small cell lung cancer (NSCLC)
  • Urothelial carcinoma
  • Colorectal cancer
  • Gastric cancer
  • Hepatocellular carcinoma
  • Renal cell carcinoma
  • Cervical cancer
  • Endometrial carcinoma
🇪🇺
Approved in European Union as KEYTRUDA for:
  • Head and neck squamous cell carcinoma (HNSCC) with PD-L1 CPS ≥1
  • Melanoma
  • Non-small cell lung cancer (NSCLC)
  • Urothelial carcinoma
  • Colorectal cancer
  • Gastric cancer
  • Hepatocellular carcinoma
  • Renal cell carcinoma
  • Cervical cancer
  • Endometrial carcinoma
🇬🇧
Approved in United Kingdom as KEYTRUDA for:
  • Untreated metastatic or unresectable recurrent head and neck squamous cell carcinoma (HNSCC) with PD-L1 CPS ≥1

Find a Clinic Near You

Who Is Running the Clinical Trial?

Dana-Farber Cancer Institute

Lead Sponsor

Trials
1,128
Recruited
382,000+

Gilead Sciences

Industry Sponsor

Trials
1,150
Recruited
878,000+
Daniel O'Day profile image

Daniel O'Day

Gilead Sciences

Chief Executive Officer since 2019

MBA from Columbia University

Dietmar Berger profile image

Dietmar Berger

Gilead Sciences

Chief Medical Officer

MD and PhD from Albert-Ludwigs University School of Medicine

Merck Sharp & Dohme LLC

Industry Sponsor

Trials
4,096
Recruited
5,232,000+
Chirfi Guindo profile image

Chirfi Guindo

Merck Sharp & Dohme LLC

Chief Marketing Officer since 2022

Degree in Engineering from Ecole Centrale de Paris, MBA from New York University Stern School of Business

Robert M. Davis profile image

Robert M. Davis

Merck Sharp & Dohme LLC

Chief Executive Officer since 2021

JD from Northwestern University Pritzker School of Law, MBA from Northwestern University Kellogg Graduate School of Management, Bachelor's in Finance from Miami University

Findings from Research

Sacituzumab govitecan (IMMU-132) has been shown to prolong progression-free survival in patients with advanced triple-negative breast cancer, indicating its efficacy as a treatment option.
The treatment is well tolerated, resulting in fewer and more manageable side effects compared to traditional irinotecan, suggesting a safer profile for patients.
An ADC for Triple-Negative Breast Cancer.[2018]
Sacituzumab govitecan is an antibody-drug conjugate that targets Trop-2 and has shown a 33.3% overall response rate in patients with metastatic triple-negative breast cancer (mTNBC) who have received at least two prior therapies, based on a phase I/II study with 108 participants.
The treatment has a median duration of response of 7.7 months, and while it is generally well-tolerated, common side effects include nausea, neutropenia, and fatigue, indicating a need for monitoring during treatment.
Sacituzumab Govitecan-hziy: An Antibody-Drug Conjugate for the Treatment of Refractory, Metastatic, Triple-Negative Breast Cancer.Seligson, JM., Patron, AM., Berger, MJ., et al.[2021]
In a study of 43 patients with metastatic triple-negative breast cancer (mTNBC) treated with sacituzumab govitecan, the median overall survival was 13.1 months, indicating its effectiveness in a real-world setting.
Common adverse events included alopecia, diarrhea, and neutropenia, with 27.9% of patients experiencing Grade 3 neutropenia, highlighting the need for careful management of side effects during treatment.
Safety and effectiveness of sacituzumab govitecan in patients with metastatic triple-negative breast cancer in real-world settings: first observations from an interdisciplinary breast cancer centre in Germany.Reinisch, M., Bruzas, S., Spoenlein, J., et al.[2023]

References

An ADC for Triple-Negative Breast Cancer. [2018]
Sacituzumab Govitecan-hziy: An Antibody-Drug Conjugate for the Treatment of Refractory, Metastatic, Triple-Negative Breast Cancer. [2021]
Safety and effectiveness of sacituzumab govitecan in patients with metastatic triple-negative breast cancer in real-world settings: first observations from an interdisciplinary breast cancer centre in Germany. [2023]
FDA Approval Summary: Accelerated Approval of Sacituzumab Govitecan-hziy for Third-line Treatment of Metastatic Triple-negative Breast Cancer. [2022]
ADC Could Benefit Some with Breast Cancer. [2020]
Sacituzumab Govitecan for Treatment of Refractory Triple-Negative Metastatic Breast Cancer. [2021]
Sacituzumab Govitecan-hziy in Refractory Metastatic Triple-Negative Breast Cancer. [2019]
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