Locally Advanced or Metastatic Disease in Solid Tumors
Conditions
Brief summary
Parts A, B, C and E: o Investigator-determined confirmed ORR as measured by RECIST v.1.1, Part D, F and G: o Investigator-determined confirmed ORR as measured by RECIST v.1.1
Detailed description
Parts A, B, C and E: o Investigator-determined confirmed and unconfirmed ORR as measured by RECIST v.1.1 o Type, incidence, severity, seriousness, and relatedness of AEs, Part D, F and G: o Investigator-determined confirmed and unconfirmed ORR as measured by RECIST v.1.1 o Type, incidence, severity, seriousness, and relatedness of AEs, All parts of the Study: o Investigator-determined disease control rate (DCR) as measured by RECIST v1.1 o Investigator-determined time to response (TTR) as measured by RECIST v1.1 o Investigator-determined PFS as measured by RECIST v1.1 o Overall survival (OS) o Selected PK parameters for tisotumab vedotin, total antibody, MMAE o Incidence of anti-therapeutic antibodies (ATAs) to tisotumab vedotin
Interventions
DRUGCISPLATIN
DRUGHuMax-TF-ADC
DRUGKEYTRUDA 25 mg/mL concentrate for solution for infusion
DRUGCARBOPLATIN
Sponsors
Seagen Inc.
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Parts A, B, C and E: o Investigator-determined confirmed ORR as measured by RECIST v.1.1, Part D, F and G: o Investigator-determined confirmed ORR as measured by RECIST v.1.1 | — |
Secondary
| Measure | Time frame |
|---|---|
| Parts A, B, C and E: o Investigator-determined confirmed and unconfirmed ORR as measured by RECIST v.1.1 o Type, incidence, severity, seriousness, and relatedness of AEs, Part D, F and G: o Investigator-determined confirmed and unconfirmed ORR as measured by RECIST v.1.1 o Type, incidence, severity, seriousness, and relatedness of AEs, All parts of the Study: o Investigator-determined disease control rate (DCR) as measured by RECIST v1.1 o Investigator-determined time to response (TTR) as measured by RECIST v1.1 o Investigator-determined PFS as measured by RECIST v1.1 o Overall survival (OS) o Selected PK parameters for tisotumab vedotin, total antibody, MMAE o Incidence of anti-therapeutic antibodies (ATAs) to tisotumab vedotin | — |
Countries
France, Germany, Italy, Spain
Outcome results
None listed