Efficacy and Safety Study of Tisotumab Vedotin for Patients With Solid Tumors
Condition(s) studied
Investigational drug(s) / intervention(s)
tisotumab vedotin: Given into the vein (IV; intravenously)
pembrolizumab: 200mg or 400mg given by IV
carboplatin: AUC 5mg/mL per minute or AUC 3.3mg/mL per minute given by IV
cisplatin: 100mg/m\^2 given by IV
Study summary
This trial will study tisotumab vedotin to find out whether it is an effective treatment alone or with other anticancer drugs for certain solid tumors and what side effects (unwanted effects) may occur. There are seven parts to this study.
* In Part A, participants will receive tisotumab vedotin every 3 weeks (3-week cycles).
* In Part B, participants will receive tisotumab vedotin on Days 1, 8, and 15 every 4-week cycle.
* In Part C, participants will receive tisotumab vedotin on Days 1 and 15 of every 4-week cycle.
* In Part D, participants will be given treatment on Day 1 of every 3-week cycle.
* Participants in Part D will get tisotumab vedotin with either:
* Pembrolizumab or,
* Pembrolizumab and carboplatin, or
* Pembrolizumab and cisplatin
* In Part E, participants will receive tisotumab vedotin on Days 1 and 15 of every 4-week cycle.
* In Part F, participants will receive tisotumab vedotin on Days 1, 15, and 29 of every 6-week cycle. Participants in Part F will get tisotumab vedotin with pembrolizumab.
* In Part G, participants will receive tisotumab vedotin on Days 1, 15, and 29 of every 6-week cycle. Participants in Part G will get tisotumab vedotin with pembrolizumab and carboplatin.
The objectives of the study have been achieved. Therefore, the study will transition to a long-term extension phase (LTEP).
* In LTEP, participants still receiving clinical benefit based on the investigator's assessment and remaining on treatment may continue receiving treatment.
* Participants will still receive tisotumab vedotin with either:
* Pembrolizumab or,
* Pembrolizumab and carboplatin, or
* Pembrolizumab and cisplatin
Eligibility
Primary outcome measure(s)
- Confirmed Objective Response Rate (ORR) (Parts A, B, C, D, E, F, and G) — Up to approximately 3 years
Proportion of patients who achieve a confirmed complete response (CR) or partial response (PR) according to RECIST v1.1 as assessed by the investigator
Trial sites (175)
| Facility | City | Region | Status |
|---|---|---|---|
| UCSD Medical Center - Encinitas | Encinitas | California | |
| UC San Diego Medical Center - La Jolla (Jacobs Medical Center / Thornton Pavilion) | La Jolla | California | |
| UC San Diego Moores Cancer Center | La Jolla | California | |
| UCSD Koman Family Outpatient Pavilion | La Jolla | California | |
| UC San Diego/Moores Cancer Center | La Jolla | California | |
| UCSD Shiley Eye Institute | La Jolla | California | |
| University of California Davis Medical Center | Sacramento | California | |
| University of California, Davis Comprehensive Cancer Center | Sacramento | California | |
| UC San Diego Medical Center- Hillcrest | San Diego | California | |
| UC San Diego Health - Rancho Bernardo | San Diego | California | |
| Stanford Cancer Center South Bay | San Jose | California | |
| UCSD Medical Center - Vista | Vista | California | |
| Poudre Valley Hospital | Fort Collins | Colorado | |
| Eye Center of Northern Colorado | Fort Collins | Colorado | |
| Cancer Care & Hematology - Fort Collins | Fort Collins | Colorado | |
| Eye Center of Northern Colorado | Fort Collins | Colorado | |
| Cancer Care & Hematology - Greeley | Greeley | Colorado | |
| Cancer Care & Hematology - Loveland | Loveland | Colorado | |
| Simlow Cancer Hospitalat Yale-New Haven | New Haven | Connecticut | |
| Yale-New Haven Hospital- Yale Cancer Center | New Haven | Connecticut | |
| C/O Thomas Ferenez.RPh,BCOP,Smilow Cancer Hospital at Yale-New Haven | New Haven | Connecticut | |
| Family Focus Eye Care - Gainesville | Gainesville | Florida | |
| UF Health Davis Cancer Pavilion and Shands Med Plaza | Gainesville | Florida | |
| UF Health Shands Cancer Hospital | Gainesville | Florida | |
| UF Health Shands Hospital | Gainesville | Florida | |
| Family Focus Eye Care - Lake City | Lake City | Florida | |
| Moffitt Cancer Center McKinley Hospital | Tampa | Florida | |
| Moffitt Cancer Center | Tampa | Florida | |
| Richard M Schulze Family Foundation Outpatient Center at McKinley Campus | Tampa | Florida | |
| Emory University Hospital Midtown | Atlanta | Georgia | |
| Emory University Hospital | Atlanta | Georgia | |
| Investigational Drug Service, Emory University Clinic | Atlanta | Georgia | |
| The Emory Clinic | Atlanta | Georgia | |
| Winship Cancer Institute, Emory University | Atlanta | Georgia | |
| Northwestern Medical Group | Chicago | Illinois | |
| Northwestern Memorial Hospital | Chicago | Illinois | |
| UChicago Medicine - River East | Chicago | Illinois | |
| University of Chicago Medical Center | Chicago | Illinois | |
| Northwestern Medicine Cancer Center Kishwaukee | DeKalb | Illinois | |
| Northwestern Medicine Kishwaukee Hospital | DeKalb | Illinois |
+ 135 more sites — see the full list on the official registry below.
On this site
📄 Keytruda (pembrolizumab) drug profile →More Seagen, a wholly owned subsidiary of Pfizer trials in Spain
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT03485209 on ClinicalTrials.gov ↗ ← All trials in Spain