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NCT03310957 · ClinicalTrials.gov registry record · Phase 1
Safety and Efficacy of SGN-LIV1A Plus Pembrolizumab for Patients With Locally-Advanced or Metastatic Triple-Negative Breast Cancer
A Phase 1 study, sponsored by Seagen.
- Completed
- Registry status
- Phase 1
- Development phase
- 185
- Enrollment target
NCT03310957: Completed Phase 1 study, sponsored by Seagen.
NCT03310957 is a Phase 1 study that has completed, run by Seagen. The registered enrollment target is 185 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (208% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03310957, a Phase 1 study, has completed, sponsored by Seagen.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 185 participants
- Enrollment target
Study Summary
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.
Primary Outcome
An adverse event (AE) was any untoward medical occurrence in a study participant administered a medicinal product and which did not necessarily have a causal relationship with the study treatment. SAEs was defined as any untoward medical occurrence that, at any dose, meets one or more of the criteria: death, life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, congenital anomaly or birth def
Interventions
- DRUG Pembrolizumab
- DRUG ladiratuzumab vedotin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 185 participants |
| Start Date | 2018-02-27 |
| Est. Completion | 2024-09-30 |
| Phase | Phase 1 |
What the finished NCT03310957 record still lists
NCT03310957 is an interventional study that assigns participants to a tested intervention. The registered 185 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (208% higher).
The record links to 0 conditions, and to 2 interventions - of which Pembrolizumab is the first listed.
NCT03310957 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03310957 about?
NCT03310957 is a clinical study titled "Safety and Efficacy of SGN-LIV1A Plus Pembrolizumab for Patients With Locally-Advanced or Metastatic Triple-Negative Breast Cancer". 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 t...
What is the current status of trial NCT03310957?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 185 participants. The study started on 2018-02-27. Estimated completion is 2024-09-30.
What interventions are being tested in trial NCT03310957?
The interventions under investigation include: Pembrolizumab (DRUG), ladiratuzumab vedotin (DRUG).
Who is sponsoring clinical trial NCT03310957?
This trial is sponsored by Seagen, which has 84 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03310957's enrollment target sits among peer trials
185 294th of 2000 higher than 1,707 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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