Ladiratuzumab Vedotin + Pembrolizumab for Breast Cancer
Recruiting in Palo Alto (17 mi)
+59 other locations
Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Phase 1 & 2
Waitlist Available
Sponsor: Seagen Inc.
No Placebo Group
Breakthrough Therapy
Trial Summary
What is the purpose of this trial?This trial studies ladiratuzumab vedotin (LV) with pembrolizumab in patients with triple-negative breast cancer. It will find out what side effects happen when participants get these two drugs. A side effect is anything the drugs do besides treating cancer. Pembrolizumab is a drug that can be used to treat triple-negative breast cancer. The trial will also find out if these drugs work to treat this type of cancer. Participants in this study have metastatic breast cancer. This means the cancer has spread to other parts of the body.
Eligibility Criteria
This trial is for patients with triple-negative breast cancer that has spread, who haven't had cytotoxic therapy for advanced stages or metastasis. They should have measurable tumors, be in good physical condition (ECOG 0-1), and not have received certain prior treatments like immune-oncology therapies. Those with a history of severe lung issues or active brain metastases are excluded.Inclusion Criteria
My breast cancer is advanced and tests negative for HER2, ER, and PR.
I can provide a tissue sample for testing.
I haven't had chemotherapy for advanced or metastatic breast cancer.
I am fully active or restricted in physically strenuous activity but can do light work.
Exclusion Criteria
I have moderate to severe nerve pain or numbness.
I have received immune-oncology therapy before.
I have or had lung inflammation treated with steroids.
I haven't fully recovered from my last radiotherapy, which was less than 2 weeks ago.
I have been treated for an autoimmune disease in the last 2 years.
I have a history of lung scarring or fibrosis.
Participant Groups
The study tests the combination of ladiratuzumab vedotin (LV) and pembrolizumab to treat advanced triple-negative breast cancer. It aims to understand the side effects and effectiveness of this drug duo on participants whose cancer has spread beyond the initial site.
1Treatment groups
Experimental Treatment
Group I: LV + pembrolizumabExperimental Treatment2 Interventions
LV + pembrolizumab
Find A Clinic Near You
Research locations nearbySelect from list below to view details:
Ingalls Cancer Care / Ingalls Memorial HospitalHarvey, IL
Helen F. Graham Cancer Center / Christiana Care Health SystemsNewark, DE
Cardinal Bernardin Cancer Center / Loyola University Medical CenterMaywood, IL
Texas Oncology - Baylor Sammons Cancer CenterDallas, TX
More Trial Locations
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Who is running the clinical trial?
Seagen Inc.Lead Sponsor
Merck Sharp & Dohme LLCIndustry Sponsor