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