Safety and Efficacy of Tisotumab Vedotin Monotherapy & in Combination With Other Cancer Agents in Subjects With Cervical Cancer

Part of paid clinical trials in Phoenix, Arizona.

Sponsor
Seagen, a wholly owned subsidiary of Pfizer
Study ID
NCT03786081
Phase
PHASE1/PHASE2
Status
Terminated

Conditions

Eligibility Criteria

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

Interventions

  • Tisotumab Vedotin — DRUG
    Given into the vein (IV)
  • Bevacizumab — DRUG
    Given via IV
  • Pembrolizumab — DRUG
    Given via IV
  • Carboplatin — DRUG
    Given via IV

Study Details

This is an open label, multi-center trial of tisotumab vedotin monotherapy and in combination with bevacizumab, pembrolizumab, or carboplatin in subjects with recurrent or stage IVB cervical cancer. The trial consists of two-parts a dose escalation part and an expansion part. The expansion part of the trial will be initiated once the Recommended Phase 2 Dose (RP2D) of the combinations have been determined in the dose escalation part.

Key Dates

Start date
Feb 27, 2019
Status verified
Mar 2026
Primary completion
Mar 19, 2026
Completion
Mar 19, 2026

Study Design

Enrollment
214 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: A: Tisotumab Vedotin + bevacizumab
    Dose escalation: Tisotumab vedotin in combination with bevacizumab once every three weeks in previously treated patients
  • Experimental: B: Tisotumab vedotin + pembrolizumab
    Dose escalation: Tisotumab vedotin in combination with pembrolizumab once every three weeks in previously treated patients
  • Experimental: C: Tisotumab vedotin + carboplatin
    Dose escalation: Tisotumab vedotin in combination with carboplatin once every three weeks in previously treated patients
  • Experimental: D: Tisotumab vedotin + carboplatin
    Dose expansion:Tisotumab vedotin in combination with carboplatin once every three weeks in previously untreated patients
  • Experimental: E: Tisotumab vedotin + pembrolizumab
    Dose expansion: Tisotumab vedotin in combination with pembrolizumab once every three weeks in previously untreated patients
  • Experimental: F: Tisotumab vedotin + pembrolizumab
    Dose expansion: Tisotumab vedotin in combination with pembrolizumab once every three weeks in previously treated patients
  • Experimental: G: Tisotumab vedotin monotherapy
    Dose expansion: Tisotumab vedotin monotherapy weekly for three weeks and 1 week off (28 day treatment cycle) in previously treated patients.
  • Experimental: H: Tisotumab vedotin + pembrolizumab + carboplatin +/- bevacizumab
    Dose expansion: Tisotumab vedotin in combination with pembrolizumab and carboplatin with or without bevacizumab once every three weeks in previously untreated patients

Primary Outcome Measure

Dose escalation: Dose Limiting Toxicities (DLTs) [ Time Frame: DLTs will be identified during the first treatment cycle (21 day cycles) ]

Locations (25)

FacilityCityStateZIPSite coordinators
Arizona Oncology AssociatesPhoenixArizona85016-
Univ California, Irvine Medical CenterOrangeCalifornia92868-
Olive View - UCLA Research and Education InstituteSylmarCalifornia91342-
Baptist MD Anderson Cancer CenterJacksonvilleFlorida32207-
Augusta UniversityAugustaGeorgia30912-
University of ChicagoChicagoIllinois60525-
Indiana University School of MedicineIndianapolisIndiana46202-
University of Kansas Medical CenterWestwoodKansas66205-
Oschner ClinicNew OrleansLouisiana70121-
Dana-Farber Cancer InstituteBostonMassachusetts02215-
Billings Clinic Cancer CenterBillingsMontana59101-
Montana Cancer ConsortiumBillingsMontana59102-
SUNY Downstate Medical CenterBrooklynNew York11203-
Memorial Sloan Kettering Cancer CenterNew YorkNew York10065-
University of North Carolina Chapel HillChapel HillNorth Carolina27514-
University of Cincinnati Physicians GroupCincinnatiOhio45206-
Cleveland ClinicClevelandOhio44106-
Cleveland ClinicClevelandOhio44195-
Ohio State University Wexner Medical CenterHilliardOhio43026-
Fox Chase Cancer CenterPhiladelphiaPennsylvania19111-
Magee-Womens Hospital of UPMCPittsburghPennsylvania15213-
Brown University - Women's and Infant HospitalProvidenceRhode Island02905-
St Francis Hospital Cancer CenterGreenvilleSouth Carolina29607-
Huntsman Cancer CenterSalt Lake CityUtah84112-
Carilion ClinicRoanokeVirginia24016-

Find similar trials in Phoenix, AZ

By condition
Cervical cancer
By specialty
OncologyGynecologic oncologyWomen's health
By research site
Arizona Oncology Associates· Phoenix, AZUniv California, Irvine Medical Center· Orange, CAOlive View - UCLA Research and Education Institute· Sylmar, CABaptist MD Anderson Cancer Center· Jacksonville, FLAugusta University· Augusta, GAUniversity of Chicago· Chicago, IL

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