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

Primary Purpose

Cervical Cancer

Status
Active
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
Tisotumab Vedotin
Bevacizumab
Pembrolizumab
Carboplatin
Sponsored by
Seagen Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cervical Cancer focused on measuring cervical carcinoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Must have squamous, adenosquamous, or adenocarcinoma of the cervix and progressed on or after standard of care treatments or are ineligible or intolerant to standard of care for recurrent or stage IVB cervical cancer (Arms A, B and C only).
  • Must have squamous, adenosquamous, or adenocarcinoma of the cervix and must not have received prior systemic therapy for recurrent or stage IVB cervical cancer (Arms D, E, and H only).
  • Must have squamous, adenosquamous, or adenocarcinoma of the cervix and progressed on or after at least one but no more than two prior systemic therapies for recurrent or stage IVB cervical cancer (Arms F and G only).
  • Must have baseline measurable disease per RECIST v1.1.
  • Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 (All Arms).
  • Is not pregnant, breastfeeding, or expecting to conceive children within the projected duration of the trial and for at least 6 months after the last trial treatment administration
  • Participants of childbearing potential must agree to use adequate contraception during and for 6 months after the last dose of trial treatment administration.
  • Must sign an informed consent form (ICF) indicating the trial subject understands the purpose of and procedures required for the trial and are willing to participate in the trial (All Arms).

Exclusion Criteria:

  • Has clinically relevant bilateral hydronephrosis which cannot be alleviated by ureteral stents or percutaneous drainage. (All Arms)
  • Has clinical signs or symptoms of gastrointestinal obstruction and requires parenteral hydration and/or nutrition. Post-operative obstructions within 4 weeks of abdominal surgery are permitted. (All Arms)

  • Has clinically significant bleeding issues or risks

    • Prior history (within 3 months) or current evidence of hemoptysis (1/2 teaspoon or more) (Arm A and bevacizumab-eligible participants in Arm H)
    • Recent (within 4 weeks of first dose of trial treatment) clinically significant gastrointestinal or vaginal bleeding requiring PRBC transfusion (Arms A and H only)
    • Recent (within 4 weeks of first dose of trial treatment) evidence of wound healing complications that require medical intervention (Arms A and H only)
  • Has active ocular surface disease at baseline. Subjects with prior history of cicatricial conjunctivitis are ineligible (All Arms).
  • Clinically significant cardiac disease
  • Requires anti-coagulation therapy (Arms A and H only)

Sites / Locations

  • Arizona Oncology Associates
  • Univ California, Irvine Medical Center
  • Olive View - UCLA Research and Education Institute
  • Baptist MD Anderson Cancer Center
  • Augusta University
  • University of Chicago
  • Indiana University School of Medicine
  • University of Kansas Medical Center
  • Oschner Clinic
  • Dana-Farber Cancer Institute
  • Billings Clinic Cancer Center
  • Montana Cancer Consortium
  • SUNY Downstate Medical Center
  • Memorial Sloan Kettering Cancer Center
  • University of North Carolina Chapel Hill
  • University of Cincinnati Physicians Group
  • Cleveland Clinic
  • Cleveland Clinic
  • Ohio State University Wexner Medical Center
  • Fox Chase Cancer Center
  • Magee-Womens Hospital of UPMC
  • Brown University - Women's and Infant Hospital
  • St Francis Hospital Cancer Center
  • Huntsman Cancer Center
  • Carilion Clinic
  • AZ Sint-Jan
  • Cliniques universitaires Saint-Luc
  • Cliniques Universitaires Saint-Luc
  • Grand Hôpital de Charleroi
  • Universitair Ziekenhuis Antwerpen (UZA)
  • Universitair Ziekenhuis Gent
  • UZ Leuven
  • Universitaire Ziekenhuizen Leuven,
  • Centre Hospitalier de l'Ardenne
  • Centre Hospitalier Universitaire (CHU) de Liège
  • Grand Hôpital de Charleroi
  • CHU UCL Namur
  • Sainte-Elisabeth
  • Fakultni nemocnice Olomouc
  • Fakultni nemocnice Olomouc
  • Fakultni nemocnice Ostrava
  • Vseobecna fakultni nemocnice v Praze
  • Vseobecna fakultni nemocnice v Praze
  • Fakultni nemocnice Bulovka
  • Nemocnice Na Bulovce
  • Rigshospitalet
  • Cork University Hospital
  • Mater Misericordiae University Hospital
  • Waterford Regional Hospital
  • University Hospital Waterford
  • Azienda Ospedaliera Cannizzaro
  • IEO Istituto Europeo di Oncologia
  • Istituto Nazionale Tumori Fondazione G. Pascale
  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS
  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS
  • Amsterdam UMC, Locatie AMC
  • AMC Medical Research
  • Universitair Medisch Centrum Groningen (UMCG)
  • Radboudumc
  • Erasmus Medisch Centrum
  • Erasmus University Medical Center Rotterdam
  • UMC Utrecht
  • University Medical Center Utrecht (UMC Utrecht)
  • Hospital Universitari Vall d'Hebron
  • Hospital Universitario Reina Sofia
  • Hospital Universitario Virgen de la Arrixaca
  • Hospital 12 De Octubre
  • Baskent University Adana Application and Research Center
  • Baskent University Ankara Hospital
  • Velindre Cancer Centre
  • Beatson West of Scotland Cancer Centre
  • Royal Marsden Hospital- Sutton

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

A: Tisotumab Vedotin + bevacizumab

B: Tisotumab vedotin + pembrolizumab

C: Tisotumab vedotin + carboplatin

D: Tisotumab vedotin + carboplatin

E: Tisotumab vedotin + pembrolizumab

F: Tisotumab vedotin + pembrolizumab

G: Tisotumab vedotin monotherapy

H: Tisotumab vedotin + pembrolizumab + carboplatin +/- bevacizumab

Arm Description

Dose escalation: Tisotumab vedotin in combination with bevacizumab once every three weeks in previously treated patients

Dose escalation: Tisotumab vedotin in combination with pembrolizumab once every three weeks in previously treated patients

Dose escalation: Tisotumab vedotin in combination with carboplatin once every three weeks in previously treated patients

Dose expansion:Tisotumab vedotin in combination with carboplatin once every three weeks in previously untreated patients

Dose expansion: Tisotumab vedotin in combination with pembrolizumab once every three weeks in previously untreated patients

Dose expansion: Tisotumab vedotin in combination with pembrolizumab once every three weeks in previously treated patients

Dose expansion: Tisotumab vedotin monotherapy weekly for three weeks and 1 week off (28 day treatment cycle) in previously treated patients.

Dose expansion: Tisotumab vedotin in combination with pembrolizumab and carboplatin with or without bevacizumab once every three weeks in previously untreated patients

Outcomes

Primary Outcome Measures

Dose escalation: Dose Limiting Toxicities (DLTs)
To establish the MTD and RP2D of tisotumab vedotin in combination
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)

Secondary Outcome Measures

Number of adverse events (AEs)
Any untoward medical occurrence in a clinical trial participant whether or not considered related to the medicinal product.
Dose escalation: ORR per RECIST v1.1
Objective response is defined as confirmed PR or CR.
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.
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).
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.
Overall Survival (OS)
The time from the date of the first trial drug administration to the date of death due to any cause.
Maximum concentration (Cmax) (All Arms except G)
Pharmacokinetic (PK) parameter
Cmax (Arm G only)
PK parameter
Trough Concentration (Ctrough) (All Arms)
PK parameter
Area under the concentration-time curve (AUC) (All Arms except G)
PK parameter
AUC (Arm G only)
PK parameter
Anti-drug antibodies (ADAs)

Full Information

First Posted
December 13, 2018
Last Updated
October 11, 2023
Sponsor
Seagen Inc.
Collaborators
Genmab, European Network of Gynaecological Oncological Trial Groups (ENGOT), Belgian Gynaecological Oncology Group, GOG Foundation, Merck Sharp & Dohme LLC
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1. Study Identification

Unique Protocol Identification Number
NCT03786081
Brief Title
Safety and Efficacy of Tisotumab Vedotin Monotherapy & in Combination With Other Cancer Agents in Subjects With Cervical Cancer
Official Title
A Phase 1b/2 Open-Label Trial of Tisotumab Vedotin (HuMax®-TF-ADC) Monotherapy and in Combination With Other Agents in Subjects With Recurrent or Stage IVB Cervical Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
February 27, 2019 (Actual)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Seagen Inc.
Collaborators
Genmab, European Network of Gynaecological Oncological Trial Groups (ENGOT), Belgian Gynaecological Oncology Group, GOG Foundation, Merck Sharp & Dohme LLC

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
Detailed Description
The dose escalation part will occur in participants with cervical cancer who have progressed during or after standard of care therapy and who are intolerant or ineligible to receive standard of care treatments. Arm A will be conducted by escalating doses of both tisotumab vedotin and bevacizumab. Dose escalations of the tisotumab vedotin + pembrolizumab and tisotumab vedotin + carboplatin combinations (Arms B and C, respectively) will be conducted by combining fixed doses of either pembrolizumab or carboplatin with increasing doses of tisotumab vedotin. The dose expansion part of this study (Arms D through H) will be conducted in 2 populations: participants with cervical cancer who have not received prior systemic therapy for recurrent or stage IVB cervical cancer (Arms D, E, and H) and participants with cervical cancer who have progressed on or after at least 1 but no more than 2 prior systemic therapies (Arms F and G). Participants enrolled to Arms D, E, F and H will receive the RP2D of tisotumab vedotin established in the dose escalation part. Participants enrolled to Arm G will receive tisotumab vedotin weekly (at a dose lower than subjects in all other Arms) for three weeks and 1 week off (28-day treatment cycle).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Cancer
Keywords
cervical carcinoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
214 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A: Tisotumab Vedotin + bevacizumab
Arm Type
Experimental
Arm Description
Dose escalation: Tisotumab vedotin in combination with bevacizumab once every three weeks in previously treated patients
Arm Title
B: Tisotumab vedotin + pembrolizumab
Arm Type
Experimental
Arm Description
Dose escalation: Tisotumab vedotin in combination with pembrolizumab once every three weeks in previously treated patients
Arm Title
C: Tisotumab vedotin + carboplatin
Arm Type
Experimental
Arm Description
Dose escalation: Tisotumab vedotin in combination with carboplatin once every three weeks in previously treated patients
Arm Title
D: Tisotumab vedotin + carboplatin
Arm Type
Experimental
Arm Description
Dose expansion:Tisotumab vedotin in combination with carboplatin once every three weeks in previously untreated patients
Arm Title
E: Tisotumab vedotin + pembrolizumab
Arm Type
Experimental
Arm Description
Dose expansion: Tisotumab vedotin in combination with pembrolizumab once every three weeks in previously untreated patients
Arm Title
F: Tisotumab vedotin + pembrolizumab
Arm Type
Experimental
Arm Description
Dose expansion: Tisotumab vedotin in combination with pembrolizumab once every three weeks in previously treated patients
Arm Title
G: Tisotumab vedotin monotherapy
Arm Type
Experimental
Arm Description
Dose expansion: Tisotumab vedotin monotherapy weekly for three weeks and 1 week off (28 day treatment cycle) in previously treated patients.
Arm Title
H: Tisotumab vedotin + pembrolizumab + carboplatin +/- bevacizumab
Arm Type
Experimental
Arm Description
Dose expansion: Tisotumab vedotin in combination with pembrolizumab and carboplatin with or without bevacizumab once every three weeks in previously untreated patients
Intervention Type
Drug
Intervention Name(s)
Tisotumab Vedotin
Other Intervention Name(s)
TIVDAK
Intervention Description
Given into the vein (IV)
Intervention Type
Drug
Intervention Name(s)
Bevacizumab
Other Intervention Name(s)
Avastin
Intervention Description
Given via IV
Intervention Type
Drug
Intervention Name(s)
Pembrolizumab
Other Intervention Name(s)
Keytruda
Intervention Description
Given via IV
Intervention Type
Drug
Intervention Name(s)
Carboplatin
Other Intervention Name(s)
Paraplatin
Intervention Description
Given via IV
Primary Outcome Measure Information:
Title
Dose escalation: Dose Limiting Toxicities (DLTs)
Description
To establish the MTD and RP2D of tisotumab vedotin in combination
Time Frame
DLTs will be identified during the first treatment cycle (21 day cycles)
Title
Dose expansion: Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1)
Description
Objective response is defined as confirmed partial response (PR) or complete response (CR)
Time Frame
approximately 2 years
Secondary Outcome Measure Information:
Title
Number of adverse events (AEs)
Description
Any untoward medical occurrence in a clinical trial participant whether or not considered related to the medicinal product.
Time Frame
up to 2 years
Title
Dose escalation: ORR per RECIST v1.1
Description
Objective response is defined as confirmed PR or CR.
Time Frame
approximately 2 years
Title
Duration of Response (DOR) per RECIST v1.1 by investigator assessment
Description
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.
Time Frame
approximately 2 years
Title
Time to Response (TTR) per RECIST v1.1 by investigator assessment
Description
Will be calculated from the date of the first dose to the date of the initial documentation of response (CR or PR).
Time Frame
approximately 2 years
Title
Progression free survival (PFS) per RECIST v1.1 by investigator assessment
Description
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.
Time Frame
approximately 2 years
Title
Overall Survival (OS)
Description
The time from the date of the first trial drug administration to the date of death due to any cause.
Time Frame
approximately 2 years
Title
Maximum concentration (Cmax) (All Arms except G)
Description
Pharmacokinetic (PK) parameter
Time Frame
Up to 42 days
Title
Cmax (Arm G only)
Description
PK parameter
Time Frame
Up to 2 years
Title
Trough Concentration (Ctrough) (All Arms)
Description
PK parameter
Time Frame
Up to 2 years
Title
Area under the concentration-time curve (AUC) (All Arms except G)
Description
PK parameter
Time Frame
Through 21 days after first dose
Title
AUC (Arm G only)
Description
PK parameter
Time Frame
Through 8 days after first dose
Title
Anti-drug antibodies (ADAs)
Time Frame
Up to 2 years

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Must have squamous, adenosquamous, or adenocarcinoma of the cervix and progressed on or after standard of care treatments or are ineligible or intolerant to standard of care for recurrent or stage IVB cervical cancer (Arms A, B and C only). Must have squamous, adenosquamous, or adenocarcinoma of the cervix and must not have received prior systemic therapy for recurrent or stage IVB cervical cancer (Arms D, E, and H only). Must have squamous, adenosquamous, or adenocarcinoma of the cervix and progressed on or after at least one but no more than two prior systemic therapies for recurrent or stage IVB cervical cancer (Arms F and G only). Must have baseline measurable disease per RECIST v1.1. Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 (All Arms). Is not pregnant, breastfeeding, or expecting to conceive children within the projected duration of the trial and for at least 6 months after the last trial treatment administration Participants of childbearing potential must agree to use adequate contraception during and for 6 months after the last dose of trial treatment administration. Must sign an informed consent form (ICF) indicating the trial subject understands the purpose of and procedures required for the trial and are willing to participate in the trial (All Arms). Exclusion Criteria: Has clinically relevant bilateral hydronephrosis which cannot be alleviated by ureteral stents or percutaneous drainage. (All Arms) Has clinical signs or symptoms of gastrointestinal obstruction and requires parenteral hydration and/or nutrition. Post-operative obstructions within 4 weeks of abdominal surgery are permitted. (All Arms) Has clinically significant bleeding issues or risks Prior history (within 3 months) or current evidence of hemoptysis (1/2 teaspoon or more) (Arm A and bevacizumab-eligible participants in Arm H) Recent (within 4 weeks of first dose of trial treatment) clinically significant gastrointestinal or vaginal bleeding requiring PRBC transfusion (Arms A and H only) Recent (within 4 weeks of first dose of trial treatment) evidence of wound healing complications that require medical intervention (Arms A and H only) Has active ocular surface disease at baseline. Subjects with prior history of cicatricial conjunctivitis are ineligible (All Arms). Clinically significant cardiac disease Requires anti-coagulation therapy (Arms A and H only)
Facility Information:
Facility Name
Arizona Oncology Associates
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85016
Country
United States
Facility Name
Univ California, Irvine Medical Center
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
Olive View - UCLA Research and Education Institute
City
Sylmar
State/Province
California
ZIP/Postal Code
91342
Country
United States
Facility Name
Baptist MD Anderson Cancer Center
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32207
Country
United States
Facility Name
Augusta University
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30912
Country
United States
Facility Name
University of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60525
Country
United States
Facility Name
Indiana University School of Medicine
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
University of Kansas Medical Center
City
Westwood
State/Province
Kansas
ZIP/Postal Code
66205
Country
United States
Facility Name
Oschner Clinic
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70121
Country
United States
Facility Name
Dana-Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Billings Clinic Cancer Center
City
Billings
State/Province
Montana
ZIP/Postal Code
59101
Country
United States
Facility Name
Montana Cancer Consortium
City
Billings
State/Province
Montana
ZIP/Postal Code
59102
Country
United States
Facility Name
SUNY Downstate Medical Center
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11203
Country
United States
Facility Name
Memorial Sloan Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
University of North Carolina Chapel Hill
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27514
Country
United States
Facility Name
University of Cincinnati Physicians Group
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45206
Country
United States
Facility Name
Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Ohio State University Wexner Medical Center
City
Hilliard
State/Province
Ohio
ZIP/Postal Code
43026
Country
United States
Facility Name
Fox Chase Cancer Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19111
Country
United States
Facility Name
Magee-Womens Hospital of UPMC
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
Brown University - Women's and Infant Hospital
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02905
Country
United States
Facility Name
St Francis Hospital Cancer Center
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29607
Country
United States
Facility Name
Huntsman Cancer Center
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84112
Country
United States
Facility Name
Carilion Clinic
City
Roanoke
State/Province
Virginia
ZIP/Postal Code
24016
Country
United States
Facility Name
AZ Sint-Jan
City
Brugge
ZIP/Postal Code
8000
Country
Belgium
Facility Name
Cliniques universitaires Saint-Luc
City
Brussels
ZIP/Postal Code
1200
Country
Belgium
Facility Name
Cliniques Universitaires Saint-Luc
City
Bruxelles
ZIP/Postal Code
1200
Country
Belgium
Facility Name
Grand Hôpital de Charleroi
City
Charleroi
ZIP/Postal Code
6000
Country
Belgium
Facility Name
Universitair Ziekenhuis Antwerpen (UZA)
City
Edegem
ZIP/Postal Code
2650
Country
Belgium
Facility Name
Universitair Ziekenhuis Gent
City
Gent
ZIP/Postal Code
9000
Country
Belgium
Facility Name
UZ Leuven
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
Universitaire Ziekenhuizen Leuven,
City
Leuven
Country
Belgium
Facility Name
Centre Hospitalier de l'Ardenne
City
Libramont
ZIP/Postal Code
6800
Country
Belgium
Facility Name
Centre Hospitalier Universitaire (CHU) de Liège
City
Liège
ZIP/Postal Code
4000
Country
Belgium
Facility Name
Grand Hôpital de Charleroi
City
Loverval
ZIP/Postal Code
6280
Country
Belgium
Facility Name
CHU UCL Namur
City
Namur
ZIP/Postal Code
5000
Country
Belgium
Facility Name
Sainte-Elisabeth
City
Namur
ZIP/Postal Code
5000
Country
Belgium
Facility Name
Fakultni nemocnice Olomouc
City
Olomouc
ZIP/Postal Code
775 20
Country
Czechia
Facility Name
Fakultni nemocnice Olomouc
City
Olomouc
ZIP/Postal Code
77520
Country
Czechia
Facility Name
Fakultni nemocnice Ostrava
City
Ostrava-Poruba
ZIP/Postal Code
70852
Country
Czechia
Facility Name
Vseobecna fakultni nemocnice v Praze
City
Praha 2
ZIP/Postal Code
128 51
Country
Czechia
Facility Name
Vseobecna fakultni nemocnice v Praze
City
Praha 2
ZIP/Postal Code
12851
Country
Czechia
Facility Name
Fakultni nemocnice Bulovka
City
Praha
ZIP/Postal Code
180 81
Country
Czechia
Facility Name
Nemocnice Na Bulovce
City
Praha
ZIP/Postal Code
18081
Country
Czechia
Facility Name
Rigshospitalet
City
Copenhagen
ZIP/Postal Code
5072
Country
Denmark
Facility Name
Cork University Hospital
City
Cork
Country
Ireland
Facility Name
Mater Misericordiae University Hospital
City
Dublin
ZIP/Postal Code
D07 R2WY
Country
Ireland
Facility Name
Waterford Regional Hospital
City
Waterford
ZIP/Postal Code
X91 ER8E
Country
Ireland
Facility Name
University Hospital Waterford
City
Waterford
Country
Ireland
Facility Name
Azienda Ospedaliera Cannizzaro
City
Catania
ZIP/Postal Code
95100
Country
Italy
Facility Name
IEO Istituto Europeo di Oncologia
City
Milano
ZIP/Postal Code
20141
Country
Italy
Facility Name
Istituto Nazionale Tumori Fondazione G. Pascale
City
Napoli
ZIP/Postal Code
80131
Country
Italy
Facility Name
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
City
Roma
ZIP/Postal Code
00168
Country
Italy
Facility Name
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
City
Rome
ZIP/Postal Code
00168
Country
Italy
Facility Name
Amsterdam UMC, Locatie AMC
City
Amsterdam
ZIP/Postal Code
1105 AZ
Country
Netherlands
Facility Name
AMC Medical Research
City
Amsterdam
Country
Netherlands
Facility Name
Universitair Medisch Centrum Groningen (UMCG)
City
Groningen
ZIP/Postal Code
9713 GZ
Country
Netherlands
Facility Name
Radboudumc
City
Nijmegen
ZIP/Postal Code
6525 GA
Country
Netherlands
Facility Name
Erasmus Medisch Centrum
City
Rotterdam
ZIP/Postal Code
3015 CC
Country
Netherlands
Facility Name
Erasmus University Medical Center Rotterdam
City
Rotterdam
ZIP/Postal Code
3015
Country
Netherlands
Facility Name
UMC Utrecht
City
Utrecht
ZIP/Postal Code
3508 GA
Country
Netherlands
Facility Name
University Medical Center Utrecht (UMC Utrecht)
City
Utrecht
ZIP/Postal Code
3584
Country
Netherlands
Facility Name
Hospital Universitari Vall d'Hebron
City
Barcelona
ZIP/Postal Code
8035
Country
Spain
Facility Name
Hospital Universitario Reina Sofia
City
Cordoba
ZIP/Postal Code
14004
Country
Spain
Facility Name
Hospital Universitario Virgen de la Arrixaca
City
El Palmar
ZIP/Postal Code
30120
Country
Spain
Facility Name
Hospital 12 De Octubre
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Facility Name
Baskent University Adana Application and Research Center
City
Adana
ZIP/Postal Code
01220
Country
Turkey
Facility Name
Baskent University Ankara Hospital
City
Ankara
ZIP/Postal Code
06490
Country
Turkey
Facility Name
Velindre Cancer Centre
City
Cardiff
State/Province
South Glamorgan
ZIP/Postal Code
CF14 2TL
Country
United Kingdom
Facility Name
Beatson West of Scotland Cancer Centre
City
Glasgow
State/Province
Strathclyde
ZIP/Postal Code
G12 OYN
Country
United Kingdom
Facility Name
Royal Marsden Hospital- Sutton
City
Sutton
State/Province
Surrey
ZIP/Postal Code
SM2 5PT
Country
United Kingdom

12. IPD Sharing Statement

Learn more about this trial

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

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