Safety and Efficacy of SGN-LIV1A Plus Pembrolizumab for Patients With Locally-Advanced or Metastatic Triple-Negative Breast Cancer

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Seagen Inc.
Study ID
NCT03310957
Phase
PHASE1/PHASE2
Status
Completed

Conditions

  • Triple Negative Breast Neoplasms

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • ladiratuzumab vedotin — DRUG
    Given into the vein (IV; intravenously)
  • Pembrolizumab — DRUG
    IV infusion every 3 weeks

Study Details

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.

Key Dates

Start date
Feb 27, 2018
Status verified
Dec 2025
Primary completion
Sep 30, 2024
Completion
Sep 30, 2024

Study Design

Enrollment
185 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: LV + pembrolizumab
    LV + pembrolizumab

Primary Outcome Measure

Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) [ Time Frame: From start of study treatment up to 30 days and up to 90 days post last dose for AEs and SAEs respectively (maximum exposure to any study treatment = 27 months; follow-up: AEs = maximum up to 28 months; SAEs = maximum up to 30 months) ]

Locations (26)

FacilityCityStateZIPSite coordinators
University of Alabama at BirminghamBirminghamAlabama35249-
Cedars Sinai Medical Center / Samuel Oschin Comprehensive Cancer InstituteLos AngelesCalifornia90048-
Chao Family Comprehensive Cancer Center University of California IrvineOrangeCalifornia92868-
University of California Irvine - NewportOrangeCalifornia92868-
Rocky Mountain Cancer Centers - AuroraAuroraColorado80012-
The Whittingham Cancer Center / Norwalk HospitalNorwalkConnecticut06856-
Helen F. Graham Cancer Center / Christiana Care Health SystemsNewarkDelaware19713-
Miami Cancer Institute at Baptist Health, Inc.MiamiFlorida33176-
AdventHealth Cancer InstituteOrlandoFlorida32804-
H. Lee Moffitt Cancer Center and Research InstituteTampaFlorida33612-
Piedmont Cancer InstituteAtlantaGeorgia30309-
Winship Cancer Institute / Emory University School of MedicineAtlantaGeorgia30322-
Ingalls Cancer Care / Ingalls Memorial HospitalHarveyIllinois60426-
Cardinal Bernardin Cancer Center / Loyola University Medical CenterMaywoodIllinois60153-
University of MarylandBaltimoreMaryland21201-
Allina Health Cancer InstituteMinneapolisMinnesota55407-
Saint Luke's Cancer Institute LLCKansas CityMissouri64111-
Summit Medical GroupFlorham ParkNew Jersey07932-
New Mexico Cancer CenterAlbuquerqueNew Mexico87131-
Weill Cornell MedicineNew YorkNew York10065-
University of Pittsburgh Medical Center (UPMC)/Hillman Cancer CenterPittsburghPennsylvania15232-
Texas Oncology - DFWDallasTexas75246-
Texas Oncology - Houston Memorial CityHoustonTexas77024-
Texas Oncology - San Antonio Medical Center NortheastSan AntonioTexas78212-
University of VirginiaCharlottesvilleVirginia22903-
Fred Hutchinson Cancer Center / Seattle Cancer Care Alliance / University of WashingtonSeattleWashington98109-1023-

Related coverage on Hipa.ai

Find similar trials in Birmingham, AL

By research site
University of Alabama at Birmingham· Birmingham, ALCedars Sinai Medical Center / Samuel Oschin Comprehensive Cancer Institute· Los Angeles, CAChao Family Comprehensive Cancer Center University of California Irvine· Orange, CAUniversity of California Irvine - Newport· Orange, CARocky Mountain Cancer Centers - Aurora· Aurora, COThe Whittingham Cancer Center / Norwalk Hospital· Norwalk, CT

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