The safety and efficacy of this agent(s), or use in this setting, has not been established or is subject to confirmation. For an agent(s) whose safety and efficacy has not been established or confirmed, future regulatory approval or commercial availability is not guaranteed.
Active Not-enrolling
United States, Belgium, Czechia, Denmark, Ireland, Italy, Netherlands, Spain, Turkey, United Kingdom
for more information at clinicaltrials.gov
EXPERIMENTAL: A: Tisotumab Vedotin + bevacizumab
Dose escalation: Tisotumab vedotin in combination with bevacizumab once every three weeks in previously treated patients
DRUG: Tisotumab Vedotin
Given into the vein (IV)
DRUG: Bevacizumab
Given via IV
EXPERIMENTAL: B: Tisotumab vedotin + pembrolizumab
Dose escalation: Tisotumab vedotin in combination with pembrolizumab once every three weeks in previously treated patients
DRUG: Tisotumab Vedotin
Given into the vein (IV)
DRUG: Pembrolizumab
Given via IV
EXPERIMENTAL: C: Tisotumab vedotin + carboplatin
Dose escalation: Tisotumab vedotin in combination with carboplatin once every three weeks in previously treated patients
DRUG: Tisotumab Vedotin
Given into the vein (IV)
DRUG: Carboplatin
Given via IV
EXPERIMENTAL: D: Tisotumab vedotin + carboplatin
Dose expansion:Tisotumab vedotin in combination with carboplatin once every three weeks in previously untreated patients
DRUG: Tisotumab Vedotin
Given into the vein (IV)
DRUG: Carboplatin
Given via IV
EXPERIMENTAL: E: Tisotumab vedotin + pembrolizumab
Dose expansion: Tisotumab vedotin in combination with pembrolizumab once every three weeks in previously untreated patients
DRUG: Tisotumab Vedotin
Given into the vein (IV)
DRUG: Pembrolizumab
Given via IV
EXPERIMENTAL: F: Tisotumab vedotin + pembrolizumab
Dose expansion: Tisotumab vedotin in combination with pembrolizumab once every three weeks in previously treated patients
DRUG: Tisotumab Vedotin
Given into the vein (IV)
DRUG: Pembrolizumab
Given via IV
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.
DRUG: Tisotumab Vedotin
Given into the vein (IV)
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
DRUG: Tisotumab Vedotin
Given into the vein (IV)
DRUG: Bevacizumab
Given via IV
DRUG: Pembrolizumab
Given via IV
DRUG: Carboplatin
Given via IV
Dose escalation: Dose Limiting Toxicities (DLTs)
To establish the MTD and RP2D of tisotumab vedotin in combination
DLTs will be identified during the first treatment cycle (21 day cycles)
Dose expansion: Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1)
Objective response is defined as confirmed partial response (PR) or complete response (CR)
approximately 2 years
Number of adverse events (AEs)
Any untoward medical occurrence in a clinical trial participant whether or not considered related to the medicinal product.
up to 2 years
Dose escalation: ORR per RECIST v1.1
Objective response is defined as confirmed PR or CR.
approximately 2 years
Duration of Response (DOR) per RECIST v1.1 by investigator assessment
Will be calculated from the date of initial documentation of a response (CR or PR) to the date of first documented evidence of progressive disease (PD) or death.
approximately 2 years
Time to Response (TTR) per RECIST v1.1 by investigator assessment
Will be calculated from the date of the first dose to the date of the initial documentation of response (CR or PR).
approximately 2 years
Progression free survival (PFS) per RECIST v1.1 by investigator assessment
The time from the date of the first trial drug administration to the date of the first documented disease progression or death due to any cause.
approximately 2 years
Overall Survival (OS)
The time from the date of the first trial drug administration to the date of death due to any cause.
approximately 2 years
Maximum concentration (Cmax) (All Arms except G)
Pharmacokinetic (PK) parameter
Up to 42 days
Cmax (Arm G only)
PK parameter
Up to 2 years
Trough Concentration (Ctrough) (All Arms)
PK parameter
Up to 2 years
Area under the concentration-time curve (AUC) (All Arms except G)
PK parameter
Through 21 days after first dose
AUC (Arm G only)
PK parameter
Through 8 days after first dose
Anti-drug antibodies (ADAs)
Up to 2 years
214
Sponsor: Seagen Inc.
Collaborator: Genmab, European Network of Gynaecological Oncological Trial Groups (ENGOT), Belgian Gynaecological Oncology Group, GOG Foundation, Merck Sharp & Dohme LLC
For more information, call or email the Pfizer Clinical Trial Contact Center:
When calling, please reference this study number:
NCT# stands for National Clinical Trial number. This is a unique identification code given to each clinical trial registered on ClinicalTrials.gov. The format is "NCT" followed by an 8-digit number (for example, NCT00000419). Also called the ClinicalTrials.gov identifier.
NCT03786081
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