Pembrolizumab + T-DM1 for Breast Cancer

Recruiting at 1 trial location

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Dana-Farber Cancer Institute

Must be taking: Trastuzumab, Taxane

Must not be taking: CYP3A4 inhibitors, Immunosuppressants

Disqualifiers: Brain metastases, Autoimmune disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Breakthrough Therapy This drug has been fast-tracked for approval by the FDA given its high promise

Compensation: Varies

Number of Visits: 1

Duration: 2 years

20 Participants Needed

Trial Summary

What is the purpose of this trial?

This research study is studying a combination of drugs as a possible treatment for metastatic breast cancer. The interventions involved in this study are: * Pembrolizumab * Trastuzumab emtansine (also called T-DM1)

Research Team

Sara Tolaney, MD MPH

Principal Investigator

Dana-Farber Cancer Institute

Eligibility Criteria

This trial is for adults with stage IV breast cancer that has spread, who have previously been treated with trastuzumab and a taxane. They must not be pregnant or breastfeeding, agree to use contraception, and have no severe allergies to the drugs being tested. Participants should not have untreated brain metastases or active infections requiring IV antibiotics.

Inclusion Criteria

Your heart's pumping ability must be normal, as checked by a heart ultrasound or MUGA scan within 28 days before starting the study drug.

The bone abnormalities cannot be accurately measured.

I have had radiation therapy before, either for early-stage or advanced cancer.

Exclusion Criteria

I am not taking strong CYP3A4 inhibitors while on T-DM1 treatment.

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

I have moderate to severe nerve damage.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Pembrolizumab and T-DM1 intravenously on day 1 of each 3-week cycle

2 years

1 visit every 3 weeks (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 years

Long-term follow-up

Participants are monitored for overall survival and disease progression

5 years

Treatment Details

Interventions

• Pembrolizumab
• Trastuzumab-DM1

Trial Overview The study tests Pembrolizumab in combination with Trastuzumab emtansine (T-DM1) as a treatment for metastatic breast cancer. It aims to see if this drug duo can help patients whose tumors are HER2 positive and who may have had prior treatments.

Participant Groups

Group I: Pembrolizumab Combine With Trastuzumab Emtansine Experimental Treatment 2 Interventions

* Pembrolizumab will be administered intravenousely in clinic on day 1 of each 3-week cycle * Pembrolizumab will be administered prior to T-DM1 administration * Pembrolizumab will be given at a predetermine dose * T-DM1 will be administered intravenousely in clinic on day 1 of each 3-week cycle * T-DM1 will be given at a predetermine dose

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

Who Is Running the Clinical Trial?

Dana-Farber Cancer Institute

Lead Sponsor

Trials

1,128

Recruited

382,000+

Merck Sharp & Dohme LLC

Industry Sponsor

Trials

4,096

Recruited

5,232,000+

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

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