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Monoclonal Antibodies
Ladiratuzumab Vedotin + Pembrolizumab for Breast Cancer
Phase 1 & 2
Waitlist Available
Research Sponsored by Seagen Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Metastatic or locally-advanced, histologically documented TNBC (absence of HER2, ER, and PR expression)
Able to provide biopsy tissue for biomarker analysis
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 18 weeks following last dose; approximately 1 year
Awards & highlights
Study Summary
This trial is testing a new cancer treatment involving two drugs. It will study the side effects and if the drugs are effective in treating triple-negative breast cancer.
Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Potential side effects include reactions related to infusion, fatigue, changes in blood counts leading to increased infection risk or bleeding problems, nerve damage causing numbness or pain, as well as possible inflammation in organs such as lungs.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My breast cancer is advanced and tests negative for HER2, ER, and PR.
Select...
I can provide a tissue sample for testing.
Select...
I haven't had chemotherapy for advanced or metastatic breast cancer.
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I am fully active or restricted in physically strenuous activity but can do light work.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 18 weeks following last dose; approximately 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 18 weeks following last dose; approximately 1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Confirmed objective response rate
Incidence of adverse events
Incidence of dose-limiting toxicities
+1 moreSecondary outcome measures
Disease control rate
Duration of response
Overall survival
+1 moreSide effects data
From 2024 Phase 2 trial • 57 Patients • NCT0300418321%
Fatigue
13%
Nausea
11%
Back pain
9%
Shortness of Breath
9%
Anemia
9%
Abdominal pain
9%
Diarrhea
7%
Pneumonia
7%
Kidney Injury and/or Infection
7%
Dyspnea
7%
Weight Loss
5%
Malnutrition, Hypercalcemia and Weakness
5%
Pneumothorax
5%
Intractable pain, back pain, hip pain
5%
Activated partial thromboplastin time prolonged
4%
Pleural effusion
4%
Atrial fibrillation with rapid ventricular response
2%
Thrombocytopenia
2%
Respiratory failure
2%
Skin rash
2%
colitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Single Arm
Trial Design
1Treatment groups
Experimental Treatment
Group I: LV + pembrolizumabExperimental Treatment2 Interventions
LV + pembrolizumab
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
2017
Completed Phase 2
~2010
ladiratuzumab vedotin
2013
Completed Phase 1
~290
Find a Location
Who is running the clinical trial?
Seagen Inc.Lead Sponsor
207 Previous Clinical Trials
68,971 Total Patients Enrolled
6 Trials studying Breast Cancer
3,308 Patients Enrolled for Breast Cancer
Merck Sharp & Dohme LLCIndustry Sponsor
3,886 Previous Clinical Trials
5,054,385 Total Patients Enrolled
59 Trials studying Breast Cancer
7,534 Patients Enrolled for Breast Cancer
Kristel Apolinario, PharmDStudy DirectorSeagen Inc.
1 Previous Clinical Trials
290 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a tumor or lymph node that is at least 10 mm in diameter or 15 mm in short axis.I have moderate to severe nerve pain or numbness.It has been over 6 months since my last treatment aimed at curing my cancer.My breast cancer is advanced and tests negative for HER2, ER, and PR.I have received immune-oncology therapy before.I had brain metastases but have been stable without steroids for 4 weeks.I have or had lung inflammation treated with steroids.Your lab test results need to meet specific requirements before you can participate.My tumor's PD-L1 score is less than 10.I can provide a tissue sample for testing.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 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.I have a history of lung scarring or fibrosis.
Research Study Groups:
This trial has the following groups:- Group 1: LV + pembrolizumab
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What are some of the conditions that Pembrolizumab has been proven to be an effective treatment for?
"Pembrolizumab, while most effective for malignant neoplasms, can also serve as treatment for unresectable melanoma, microsatellite instability high, and disease progression after chemotherapy."
Answered by AI
What are we hoping to learn or achieve from this research?
"The purpose of this study, as it will be evaluated over a 10 month period, is to establish the adverse event rate. Additionally, the trial will secondary measure progress-free survival (PFS), overall survival (OS), and disease control rate (DCR)."
Answered by AI
Are there any open spots left in this trial for new patients?
"Yes, the latest information available on clinicaltrials.gov indicates that this study is still recruiting patients. The study was first posted on February 27th, 2018 and was last updated on October 28th, 2020. A total of 211 participants are needed, and so far 24 sites have agreed to take part."
Answered by AI
Are there similar ongoing Pembrolizumab trials elsewhere?
"City of Hope first researched pembrolizumab in 2010 and there have been 248 trials completed as of now. 1003 additional studies are still active, with a significant portion being conducted in Minneapolis, Minnesota."
Answered by AI
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