A Study of Ladiratuzumab Vedotin in Advanced Solid Tumors

Part of paid clinical trials in Chandler, Arizona.

Sponsor
Seagen Inc.
Study ID
NCT04032704
Phase
PHASE2
Status
Terminated

Conditions

Eligibility Criteria

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

Interventions

  • ladiratuzumab vedotin — DRUG
    Intravenous (into the vein; IV) infusion
  • pembrolizumab — DRUG
    200mg given by IV on Day 1 of each 21-day cycle

Study Details

This trial will study ladiratuzumab vedotin (LV) alone and with pembrolizumab to find out if it works to treat different types of solid tumors. It will also find out what side effects may occur. A side effect is anything the drug does besides treating cancer.

Key Dates

Start date
Oct 9, 2019
Status verified
Feb 2025
Primary completion
Nov 28, 2023
Completion
Nov 28, 2023

Study Design

Enrollment
205 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Part A: Non-randomized LV monotherapy
    Monotherapy dosing schedule 1.
  • Experimental: Part B: Non-randomized LV monotherapy
    Monotherapy dosing schedule 2.
  • Experimental: Part C - Arm 1: Randomized LV monotherapy
    Monotherapy dosing schedule 3.
  • Experimental: Part C - Arm 2: Randomized LV combination therapy
    Combination dosing schedule 1.
  • Experimental: Part C - Arm 3: Randomized LV combination therapy
    Combination dosing schedule 2.

Primary Outcome Measure

Part A: Confirmed Objective Response Rate (ORR) as Determined by Investigator According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) [ Time Frame: From the first dose of study treatment until the first documented CR or PR or new anticancer therapies or death, whichever occurred first (maximum up to 8.3 months) ]

Locations (27)

FacilityCityStateZIPSite coordinators
Ironwood Cancer & Research Centers - ChandlerChandlerArizona85224-
Adventist Health White MemorialLos AngelesCalifornia90033-
Providence Medical FoundationSanta RosaCalifornia95403-
Eastern CT Hematology and Oncology AssociatesNorwichConnecticut06360-
GenesisCare USAJacksonvilleFlorida32204-
AdventHealth Cancer InstituteOrlandoFlorida32804-
IACT HealthColumbusGeorgia31904-
Northwestern UniversityChicagoIllinois60611-
Decatur Memorial Hospital - IllinoisDecaturIllinois62526-
Fort Wayne Medical Oncology and HematologyFort WayneIndiana46804-
University of MarylandBaltimoreMaryland21201-
University of Michigan Comprehensive Cancer CenterAnn ArborMichigan48109-
HealthPartners InstituteSaint Louis ParkMinnesota55416-
Comprehensive Cancer Centers of NevadaLas VegasNevada89169-
Valley Hospital, The / Luckow PavilionParamusNew Jersey07652-
San Juan Oncology AssociatesFarmingtonNew Mexico87401-
Weill Cornell MedicineNew YorkNew York10065-
Stony Brook University Cancer CenterStony BrookNew York11794-7263-
FirstHealth of the CarolinasPinehurstNorth Carolina28374-
Gabrail Cancer Center Research, LLCCantonOhio44718-
Providence Portland Medical CenterPortlandOregon97213-
Saint Francis Hospital / Bon Secours - South CarolinaGreenvilleSouth Carolina29601-
Erlanger Oncology and HematologyChattanoogaTennessee37403-
Tennessee Oncology-Nashville/Sarah Cannon Research InstituteNashvilleTennessee37203-
Joe Arrington Cancer Research and Treatment CenterLubbockTexas79410-
UT Health East Texas Hope Cancer CenterTylerTexas75701-
Carbone Cancer Center / University of WisconsinMadisonWisconsin53792-

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Ironwood Cancer & Research Centers - Chandler· Chandler, AZAdventist Health White Memorial· Los Angeles, CAProvidence Medical Foundation· Santa Rosa, CAEastern CT Hematology and Oncology Associates· Norwich, CTGenesisCare USA· Jacksonville, FLAdventHealth Cancer Institute· Orlando, FL

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