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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
Must not have
Pre-existing neuropathy of at least Grade 2
Prior immune-oncology therapy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 18 weeks following last dose; approximately 1 year
Awards & highlights
No Placebo-Only Group

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.
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.
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 below
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My breast cancer is advanced and tests negative for HER2, ER, and PR.
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I can provide a tissue sample for testing.
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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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have moderate to severe nerve pain or numbness.
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I have received immune-oncology therapy before.
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I have or had lung inflammation treated with steroids.
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I haven't fully recovered from my last radiotherapy, which was less than 2 weeks ago.
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I have been treated for an autoimmune disease in the last 2 years.
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I have a history of lung scarring or fibrosis.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 18 weeks following last dose; approximately 1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 18 weeks following last dose; approximately 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Confirmed objective response rate
Secondary study objectives
Disease control rate
Duration of response
Overall survival
+1 more

Side effects data

From 2024 Phase 3 trial • 804 Patients • NCT03040999
64%
Radiation skin injury
63%
Stomatitis
58%
Anaemia
56%
Nausea
48%
Dry mouth
45%
Constipation
45%
Weight decreased
44%
Dysphagia
42%
Neutrophil count decreased
33%
Dysgeusia
33%
Vomiting
32%
Fatigue
31%
White blood cell count decreased
28%
Hypomagnesaemia
26%
Decreased appetite
25%
Hypothyroidism
25%
Hypokalaemia
24%
Lymphocyte count decreased
24%
Platelet count decreased
23%
Oropharyngeal pain
23%
Blood creatinine increased
22%
Diarrhoea
22%
Odynophagia
20%
Hypoacusis
20%
Alanine aminotransferase increased
20%
Hyponatraemia
19%
Tinnitus
19%
Oral candidiasis
19%
Asthenia
16%
Pyrexia
16%
Cough
15%
Aspartate aminotransferase increased
15%
Rash
14%
Insomnia
13%
Acute kidney injury
13%
Pharyngeal inflammation
13%
Pruritus
12%
Dysphonia
12%
Gamma-glutamyltransferase increased
11%
Pneumonia
11%
Dehydration
10%
Hyperthyroidism
10%
Hypoalbuminaemia
10%
Hypocalcaemia
10%
Headache
10%
Productive cough
9%
Neck pain
9%
Peripheral sensory neuropathy
8%
Gastrooesophageal reflux disease
8%
Hiccups
8%
Hyperglycaemia
8%
Hyperuricaemia
8%
Dizziness
8%
Hypophosphataemia
7%
Urinary tract infection
7%
Ear pain
7%
Localised oedema
7%
Hyperkalaemia
7%
Erythema
7%
Oral pain
6%
Abdominal pain upper
6%
Arthralgia
6%
Anxiety
6%
Febrile neutropenia
6%
Dyspepsia
6%
Saliva altered
5%
Back pain
5%
Oedema peripheral
5%
Hypertension
5%
Dyspnoea
4%
Nasopharyngitis
4%
Alopecia
4%
Dry skin
3%
Sepsis
3%
Pneumonia aspiration
3%
Trismus
3%
Pneumonitis
3%
Laryngeal oedema
2%
Malnutrition
2%
Pharyngeal haemorrhage
2%
Cellulitis
1%
Septic shock
1%
Clostridium difficile colitis
1%
Systemic infection
1%
Cardiac arrest
1%
Death
1%
Bronchitis
1%
Hepatitis
1%
Immune-mediated hepatitis
1%
Oesophagitis
1%
General physical health deterioration
1%
Hypophagia
1%
Tumour haemorrhage
1%
Cerebrovascular accident
1%
Syncope
1%
Acute respiratory failure
1%
Aspiration
1%
Colitis
1%
Mouth haemorrhage
1%
Hypersensitivity
1%
Acute myocardial infarction
1%
Abscess neck
1%
Device related infection
1%
Stoma site infection
1%
Vascular device infection
1%
Wound infection
1%
Hypercalcaemia
1%
Pulmonary embolism
1%
Respiratory failure
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo + CRT Followed by Placebo
Pembrolizumab + CRT Followed by Pembrolizumab

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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 3
~2810
ladiratuzumab vedotin
2013
Completed Phase 1
~290

Find a Location

Who is running the clinical trial?

Seagen Inc.Lead Sponsor
210 Previous Clinical Trials
74,244 Total Patients Enrolled
5 Trials studying Breast Cancer
3,066 Patients Enrolled for Breast Cancer
Merck Sharp & Dohme LLCIndustry Sponsor
4,010 Previous Clinical Trials
5,185,041 Total Patients Enrolled
61 Trials studying Breast Cancer
7,538 Patients Enrolled for Breast Cancer
Sinhan Tran, PharmD, MBAStudy DirectorSeagen Inc.
2 Previous Clinical Trials
495 Total Patients Enrolled

Media Library

ladiratuzumab vedotin (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT03310957 — Phase 1 & 2
Breast Cancer Research Study Groups: LV + pembrolizumab
Breast Cancer Clinical Trial 2023: ladiratuzumab vedotin Highlights & Side Effects. Trial Name: NCT03310957 — Phase 1 & 2
ladiratuzumab vedotin (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03310957 — Phase 1 & 2
~26 spots leftby Jan 2026
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