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A Trial of Tisotumab Vedotin in Cervical Cancer

Primary Purpose

Cervical Cancer

Status

Completed

Phase

Phase 2

Locations

International

Study Type

Interventional

Intervention

tisotumab vedotin

About this trial

This is an interventional treatment trial for Cervical Cancer

Eligibility Criteria

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

Inclusion Criteria

Patients with extra-pelvic metastatic or recurrent cervical cancer including squamous cell, adenocarcinoma or adenosquamous histology who have experienced disease progressed on standard of care chemotherapy in combination with bevacizumab, if eligible.
Measurable disease according to RECIST v1.1 as assessed by IRC.
Age ≥ 18 years.
Acceptable renal function
Acceptable liver function
Acceptable hematological status
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
A negative serum pregnancy test for patients of reproductive potential.
All patients must provide a fresh or archival biopsy during screening.
Following receipt of verbal and written information about the trial, patients must provide signed informed consent before any trial-related activity is carried out.

Exclusion Criteria

Have received no more than 2 prior systemic treatment regimens for recurrent or metastatic cervical cancer.
Known past or current coagulation defects leading to an increased risk of bleeding;
Ongoing major bleeding
Active ocular surface disease
Known past or current malignancy other than the inclusion diagnosis.
Peripheral neuropathy grade ≥ 2

Sites / Locations

University of Alabama
Arizona Oncology Associate - Biltmore Cancer Center
UCLA Dept. of OBGYN
Southern Baptist Hospital of Florida, Inc
University of Miami Miller School of Medicine
University of Gynecologic Oncology
Community Hospital East
Louisville Oncology
Baystate Medical Center
Women's Cancer Center of Nevada
MD Anderson Cancer Center at Cooper University Hospital
University of New Mexico Comprehensive Cancer Center (UNMCCC)
University of Cincinnati
The Ohio State University Wexner Medical Center
Stephenson Cancer Center
Oklahoma Cancer Specialists and Research Institute, LLC
Abington Memorial Hospital
Bon Secours Saint Francis Cancer Center
UT Health McGovern Medical School
Froedtert & Medical College Clinics
AZ Sint-Jan Brugge-Oostende av
Cliniques universitaires Saint-Luc
Grand Hôpital de Charleroi
Algemeen Ziekenhuis Maria MiddelaresMedical Oncology - IKG
Universitair Ziekenhuis Gent
UZLeuvenGynaecologische oncologie
Centre Hospitalier de l'Ardenne
CHU de LIEGE/ Oncologie Médicale, domaine universitaire du Sart Tilman
CHC SAINT Montlegia
CHU UCL Namur site de Sainte Elisabeth
Fakultni Nemocnice Brno
Fakultni nemocnice Olomouc Onkologic
Vseobecna fakultni nemocnice v Praze
Nemocnice Na Bulovce, Gynekologicko-porodnicka kl
Aalborg Universitetshospital
Rigshospitalet
Kliniken Essen-Mitte
Universitaetsklinikum Hamburg-Eppendorf
Klinikum der Universität München
Policlinico S.Orsola-Malpighi, SSD Oncologia Medica Addarii
Irst Irccs
Fondazione IRCCS Istituto Nazionale dei Tumori
Istituto Nazionale Tumori Fondazione G. Pascale
Policlinico Universitario Agostino Gemelli, UOC Patologia Ostetrica e Ginecologica
Hospital Teresa Herrera-CHUAC
Hospital Clinic Barcelona
Hospital Duran I Reynals ICO Hospitalet
Clínica Universidad de Navarra (Sede Madrid)
Hospital Clínico San Carlos
Hospital Universitario 12 de Octubre
Hospital Universitario La Paz, Edificio dotacional de Oncología
Fundacion Hospital Son Llatzer
Skåne University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Single arm

Arm Description

tisotumab vedotin (IV), 2.0 mg/kg, every 3 weeks (1Q3W)

Outcomes

Primary Outcome Measures

Percentage of Participants With Confirmed Objective Response (OR) as Assessed by the Independent Review Committee (IRC)

The confirmed OR is defined as best overall response of confirmed complete response (CR) or confirmed partial response (PR) based upon RECIST v1.1, assessed by the IRC. The CR is disappearance of all target and non-target lesions and no new lesions. A confirmed CR is 2 CRs (CR-CR sequence) that were separated by at least 4 weeks with no evidence of progression in-between. The PR is ≥ 30% decrease in the sum of diameters of target lesions (compared to baseline) and no unequivocal progression of existing non-target lesions and no new lesion. A confirmed PR is PR-PR sequence or PR-CR sequence that were separated by at least 4 weeks. The intermediate missing (Not Evaluable [NE]) scan evaluations between response scan and confirmation scan were allowed, eg, PR-NE-PR and PR-NE-NE-PR was considered PR confirmed (a repeat scan not earlier than 4 weeks after initial scan documenting response). 95% CI was calculated using the Clopper-Pearson method.

Secondary Outcome Measures

Duration of Response (DOR) as Assessed by the IRC

The DOR is defined as the duration from the first documented response of CR or PR (the start date of response, not the date when response was confirmed) to the date of the first documented progression disease (PD) verified by IRC or death. Based upon RECIST v1.1, the CR is defined as disappearance of all target and non-target lesions and no new lesions; the PR is defined as ≥ 30% decrease in the sum of diameters of target lesions (compared to baseline) and no unequivocal progression of existing non-target lesions and no new lesion; and the PD is defined as at least 20% increase in the sum of diameters of target lesions (compared to baseline), unequivocal progression of existing non-target lesions, and/or new lesion. The DOR was estimated using Kaplan-Meier method.

Percentage of Participants With Confirmed OR as Assessed by the Investigator

The confirmed OR is defined as best overall response of confirmed CR or confirmed PR based upon RECIST v1.1, assessed by the investigator. The CR is defined as disappearance of all target and non-target lesions and no new lesions. A confirmed CR is defined as 2 CRs (CR-CR sequence) that were separated by at least 4 weeks with no evidence of progression in-between. The PR is defined as ≥ 30% decrease in the sum of diameters of target lesions (compared to baseline) and no unequivocal progression of existing non-target lesions and no new lesion. A confirmed PR is defined as PR-PR sequence or PR-CR sequence that were separated by at least 4 weeks. The intermediate missing (NE) scan evaluations between the response scan and the confirmation scan were allowed, eg, PR-NE-PR and PR-NE-NE-PR was considered PR confirmed (a repeat scan not earlier than 4 weeks after initial scan documenting response). 95% CI was calculated using the Clopper-Pearson method.

DOR as Assessed by the Investigator

The DOR is defined as the duration from the first documented response of CR or PR (the start date of response, not the date when response was confirmed) to the date of the first documented PD verified by investigator or death. Based upon RECIST v1.1, the CR is defined as disappearance of all target and non-target lesions and no new lesions; the PR is defined as ≥ 30% decrease in the sum of diameters of target lesions (compared to baseline) and no unequivocal progression of existing non-target lesions and no new lesion; and the PD is defined as at least 20% increase in the sum of diameters of target lesions (compared to baseline), unequivocal progression of existing non-target lesions, and/or new lesion. The DOR was estimated using Kaplan-Meier method.

Time to Response (TTR) as Assessed by the IRC

The TTR is defined as the duration from the start of study drug to the first documented response of either CR or PR based on RECIST v1.1, assessed by the IRC. A confirmed CR is defined as 2 CRs (disappearance of all target and non-target lesions and no new lesions) that were separated by at least 4 weeks with no evidence of progression in-between. A confirmed PR is defined as 2 PRs (≥ 30% decrease in the sum of diameters of target lesions compared to baseline and no unequivocal progression of existing non-target lesions and no new lesion) or an un-confirmed PR and an un-confirmed CR or achieved PR-NE-PR or PR-NE-NE-PR that were separated by at least 4 weeks with no evidence of progression in-between.

TTR as Assessed by the Investigator

The TTR is defined as the duration from the start of study drug to the first documented response of either CR or PR based on RECIST v1.1, assessed by the investigator. A confirmed CR is defined as 2 CRs (disappearance of all target and non-target lesions and no new lesions) that were separated by at least 4 weeks with no evidence of progression in-between. A confirmed PR is defined as 2 PRs (≥ 30% decrease in the sum of diameters of target lesions compared to baseline and no unequivocal progression of existing non-target lesions and no new lesion) or an un-confirmed PR and an un-confirmed CR or achieved PR-NE-PR or PR-NE-NE-PR that were separated by at least 4 weeks with no evidence of progression in-between.

Progression Free Survival (PFS) as Assessed by the IRC

The PFS is defined as the time from the start of study drug until the first documentation of PD based on RECIST v1.1, as assessed by the IRC or death due to any cause, whichever occurred first. The PD based upon RECIST v1.1 is defined as at least 20% increase in the sum of diameters of target lesions (compared to baseline), unequivocal progression of existing non-target lesions, and/or new lesion. The PFS was estimated using Kaplan-Meier method.

PFS as Assessed by the Investigator

The PFS is defined as the time from the start of study drug until the first documentation of PD based on RECIST v1.1, as assessed by the investigator or death due to any cause, whichever occurred first. The PD based upon RECIST v1.1 is defined as at least 20% increase in the sum of diameters of target lesions (compared to baseline), unequivocal progression of existing non-target lesions, and/or new lesion. The PFS was estimated using Kaplan-Meier method.

Overall Survival (OS)

The OS is defined as the time from the start of study treatment until death due to any cause. The OS was estimated using Kaplan-Meier method.

Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)

An adverse event (AE) is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A SAE is defined as an AE that meets one of the following criteria: fatal or life-threatening; results in persistent or significant disability/incapacity; constitutes a congenital anomaly/birth defect; medically significant (an event that jeopardizes the participant or may require medical or surgical intervention to prevent one of the outcomes listed above [medical and scientific judgment must be exercised in deciding whether an AE is "medically important"]); required inpatient hospitalization or prolongation of existing hospitalization. A TEAE is defined as an AE occurring or worsening between the first dose of tisotumab vedotin and 30 days after the last dose received.

Number of Participants With Abnormal Clinical Laboratory Parameters Reported as TEAEs

Laboratory abnormalities that induced clinical signs or symptoms, required concomitant therapy or required changes during treatment emergent period were reported as TEAEs. Number of participants with abnormal clinical laboratory parameters reported as TEAEs are reported.

Plasma Concentrations of Tisotumab Vedotin (HuMax-TF), Tisotumab Vedotin Antibody-drug Conjugate (HuMax-TF-ADC), and Free Monomethyl Auristatin E (MMAE)

Plasma concentrations of HuMax-TF, HuMax-TF-ADC, and Free MMAE measures on Cycle 1 Day 1 (predose and end of infusion) and Cycle 6 Day 1 (predose and end of infusion) are reported.

Number of Participants With Positive Anti-drug Antibodies (ADA) to Tisotumab Vedotin

Number of participants with positive ADA titer to tisotumab vedotin at baseline and post-baseline are reported. Baseline is defined as the latest available measurement made before the first dose of tisotumab vedotin. For post-baseline results, a participant was considered ADA positive if either ADA is negative at baseline and at least one post-baseline result is positive or positive at baseline and at least one positive post-baseline result with a titer higher than baseline.

Full Information

NCT ID

NCT03438396

First Posted

February 8, 2018

Last Updated

July 11, 2023

Sponsor

Seagen Inc.

Collaborators

Genmab, European Network of Gynaecological Oncological Trial Groups (ENGOT), Belgian Gynaecological Oncology Group, Gynecologic Oncology Group

1. Study Identification

Unique Protocol Identification Number

NCT03438396

Brief Title

A Trial of Tisotumab Vedotin in Cervical Cancer

Official Title

A Single Arm, Multicenter, International Trial of Tisotumab Vedotin (HuMax®-TF-ADC) in Previously Treated, Recurrent or Metastatic Cervical Cancer

Study Type

Interventional

2. Study Status

Record Verification Date

July 2023

Overall Recruitment Status

Completed

Study Start Date

June 12, 2018 (Actual)

Primary Completion Date

February 6, 2020 (Actual)

Study Completion Date

August 2, 2022 (Actual)

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, Gynecologic Oncology Group

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

A Single arm, Multicenter, International Trial of Tisotumab Vedotin (HuMax®-TF-ADC) in Previously Treated, Recurrent or Metastatic Cervical Cancer.

Detailed Description

The purpose of the trial is to evaluate the efficacy and safety/tolerability of tisotumab vedotin in patients with previously treated, recurrent or metastatic cervical cancer. Tisotumab vedotin is an antibody-drug conjugate (ADC) targeting tissue factor (TF), a protein aberrantly expressed in a wide number of tumors including cervical cancer. Preliminary safety and efficacy data observed in a cohort of previously treated cervical cancer patients suggest a positive benefit risk profile for this population of high unmet need.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cervical Cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

102 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Single arm

Arm Type

Experimental

Arm Description

tisotumab vedotin (IV), 2.0 mg/kg, every 3 weeks (1Q3W)

Intervention Type

Drug

Intervention Name(s)

tisotumab vedotin

Other Intervention Name(s)

TIVDAK

Intervention Description

All patients will be treated with tisotumab vedotin once every three weeks until progression or toxicity

Primary Outcome Measure Information:

Title

Percentage of Participants With Confirmed Objective Response (OR) as Assessed by the Independent Review Committee (IRC)

Description

Time Frame

From Day 1 through IRC verified disease progression, initiation of new anticancer therapy, study withdrawal, or death, whichever occurred first (approximately 20 months)

Secondary Outcome Measure Information:

Title

Duration of Response (DOR) as Assessed by the IRC

Description

Time Frame

From Day 1 through IRC verified disease progression, initiation of new anticancer therapy, study withdrawal, or death, whichever occurred first (approximately 49 months)

Title

Percentage of Participants With Confirmed OR as Assessed by the Investigator

Description

Time Frame

From Day 1 through investigator verified disease progression, initiation of new anticancer therapy, study withdrawal, or death, whichever occurred first (approximately 49 months)

Title

DOR as Assessed by the Investigator

Description

The DOR is defined as the duration from the first documented response of CR or PR (the start date of response, not the date when response was confirmed) to the date of the first documented PD verified by investigator or death. Based upon RECIST v1.1, the CR is defined as disappearance of all target and non-target lesions and no new lesions; the PR is defined as ≥ 30% decrease in the sum of diameters of target lesions (compared to baseline) and no unequivocal progression of existing non-target lesions and no new lesion; and the PD is defined as at least 20% increase in the sum of diameters of target lesions (compared to baseline), unequivocal progression of existing non-target lesions, and/or new lesion. The DOR was estimated using Kaplan-Meier method.

Time Frame

From Day 1 through investigator verified disease progression, initiation of new anticancer therapy, study withdrawal, or death, whichever occurred first (approximately 49 months)

Title

Time to Response (TTR) as Assessed by the IRC

Description

Time Frame

From Day 1 through IRC verified disease progression, initiation of new anticancer therapy, study withdrawal, or death, whichever occurred first (approximately 49 months)

Title

TTR as Assessed by the Investigator

Description

Time Frame

From Day 1 through investigator verified disease progression, initiation of new anticancer therapy, study withdrawal, or death, whichever occurred first (approximately 49 months)

Title

Progression Free Survival (PFS) as Assessed by the IRC

Description

Time Frame

From Day 1 through IRC verified disease progression, initiation of new anticancer therapy, study withdrawal, or death, whichever occurred first (approximately 49 months)

Title

PFS as Assessed by the Investigator

Description

Time Frame

From Day 1 through investigator verified disease progression, initiation of new anticancer therapy, study withdrawal, or death, whichever occurred first (approximately 49 months)

Title

Overall Survival (OS)

Description

The OS is defined as the time from the start of study treatment until death due to any cause. The OS was estimated using Kaplan-Meier method.

Time Frame

From Day 1 until death or withdrawal from the study, whichever occurred first (approximately 49 months)

Title

Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)

Description

Time Frame

From Day 1 through 30 days after the last dose of study drug (approximately 49 months)

Title

Number of Participants With Abnormal Clinical Laboratory Parameters Reported as TEAEs

Description

Time Frame

From Day 1 through 30 days after the last dose of study drug (approximately 49 months)

Title

Plasma Concentrations of Tisotumab Vedotin (HuMax-TF), Tisotumab Vedotin Antibody-drug Conjugate (HuMax-TF-ADC), and Free Monomethyl Auristatin E (MMAE)

Description

Plasma concentrations of HuMax-TF, HuMax-TF-ADC, and Free MMAE measures on Cycle 1 Day 1 (predose and end of infusion) and Cycle 6 Day 1 (predose and end of infusion) are reported.

Time Frame

Predose and end of infusion of Cycle 1 Day 1 (C1D1) and Cycle 6 Day 1 (C6D1)

Title

Number of Participants With Positive Anti-drug Antibodies (ADA) to Tisotumab Vedotin

Description

Time Frame

Predose of each treatment cycle (Cycle 1 to 21) and end of treatment visit (approximately 49 months)

10. Eligibility

Sex

Female

Gender Based

Yes

Gender Eligibility Description

cervical cancer

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria Patients with extra-pelvic metastatic or recurrent cervical cancer including squamous cell, adenocarcinoma or adenosquamous histology who have experienced disease progressed on standard of care chemotherapy in combination with bevacizumab, if eligible. Measurable disease according to RECIST v1.1 as assessed by IRC. Age ≥ 18 years. Acceptable renal function Acceptable liver function Acceptable hematological status Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 A negative serum pregnancy test for patients of reproductive potential. All patients must provide a fresh or archival biopsy during screening. Following receipt of verbal and written information about the trial, patients must provide signed informed consent before any trial-related activity is carried out. Exclusion Criteria Have received no more than 2 prior systemic treatment regimens for recurrent or metastatic cervical cancer. Known past or current coagulation defects leading to an increased risk of bleeding; Ongoing major bleeding Active ocular surface disease Known past or current malignancy other than the inclusion diagnosis. Peripheral neuropathy grade ≥ 2

Facility Information:

Facility Name

University of Alabama

City

Birmingham

State/Province

Alabama

ZIP/Postal Code

35294

Country

United States

Facility Name

Arizona Oncology Associate - Biltmore Cancer Center

City

Phoenix

State/Province

Arizona

ZIP/Postal Code

85016

Country

United States

Facility Name

UCLA Dept. of OBGYN

City

Los Angeles

State/Province

California

ZIP/Postal Code

90095

Country

United States

Facility Name

Southern Baptist Hospital of Florida, Inc

City

Jacksonville

State/Province

Florida

ZIP/Postal Code

32258

Country

United States

Facility Name

University of Miami Miller School of Medicine

City

Miami

State/Province

Florida

ZIP/Postal Code

33136

Country

United States

Facility Name

University of Gynecologic Oncology

City

Atlanta

State/Province

Georgia

ZIP/Postal Code

30342

Country

United States

Facility Name

Community Hospital East

City

Indianapolis

State/Province

Indiana

ZIP/Postal Code

46219

Country

United States

Facility Name

Louisville Oncology

City

Louisville

State/Province

Kentucky

ZIP/Postal Code

40207

Country

United States

Facility Name

Baystate Medical Center

City

Springfield

State/Province

Massachusetts

ZIP/Postal Code

01105

Country

United States

Facility Name

Women's Cancer Center of Nevada

City

Las Vegas

State/Province

Nevada

ZIP/Postal Code

89169

Country

United States

Facility Name

MD Anderson Cancer Center at Cooper University Hospital

City

Camden

State/Province

New Jersey

ZIP/Postal Code

08103

Country

United States

Facility Name

University of New Mexico Comprehensive Cancer Center (UNMCCC)

City

Albuquerque

State/Province

New Mexico

ZIP/Postal Code

87102

Country

United States

Facility Name

University of Cincinnati

City

Cincinnati

State/Province

Ohio

ZIP/Postal Code

45267

Country

United States

Facility Name

The Ohio State University Wexner Medical Center

City

Hilliard

State/Province

Ohio

ZIP/Postal Code

43210

Country

United States

Facility Name

Stephenson Cancer Center

City

Oklahoma City

State/Province

Oklahoma

ZIP/Postal Code

73104

Country

United States

Facility Name

Oklahoma Cancer Specialists and Research Institute, LLC

City

Tulsa

State/Province

Oklahoma

ZIP/Postal Code

74146

Country

United States

Facility Name

Abington Memorial Hospital

City

Willow Grove

State/Province

Pennsylvania

ZIP/Postal Code

19090

Country

United States

Facility Name

Bon Secours Saint Francis Cancer Center

City

Greenville

State/Province

South Carolina

ZIP/Postal Code

29607

Country

United States

Facility Name

UT Health McGovern Medical School

City

Houston

State/Province

Texas

ZIP/Postal Code

77030

Country

United States

Facility Name

Froedtert & Medical College Clinics

City

Milwaukee

State/Province

Wisconsin

ZIP/Postal Code

53226

Country

United States

Facility Name

AZ Sint-Jan Brugge-Oostende av

City

Brugge

ZIP/Postal Code

8000

Country

Belgium

Facility Name

Cliniques universitaires Saint-Luc

City

Brussels

ZIP/Postal Code

1200

Country

Belgium

Facility Name

Grand Hôpital de Charleroi

City

Charleroi

ZIP/Postal Code

6000

Country

Belgium

Facility Name

Algemeen Ziekenhuis Maria MiddelaresMedical Oncology - IKG

City

Gent

ZIP/Postal Code

9000

Country

Belgium

Facility Name

Universitair Ziekenhuis Gent

City

Gent

ZIP/Postal Code

9000

Country

Belgium

Facility Name

UZLeuvenGynaecologische oncologie

City

Leuven

ZIP/Postal Code

3000

Country

Belgium

Facility Name

Centre Hospitalier de l'Ardenne

City

Libramont

ZIP/Postal Code

6800

Country

Belgium

Facility Name

CHU de LIEGE/ Oncologie Médicale, domaine universitaire du Sart Tilman

City

Liege

ZIP/Postal Code

4000

Country

Belgium

Facility Name

CHC SAINT Montlegia

City

Liège

ZIP/Postal Code

4000

Country

Belgium

Facility Name

CHU UCL Namur site de Sainte Elisabeth

City

Namur

ZIP/Postal Code

5000

Country

Belgium

Facility Name

Fakultni Nemocnice Brno

City

Brno

ZIP/Postal Code

62500

Country

Czechia

Facility Name

Fakultni nemocnice Olomouc Onkologic

City

Olomouc

ZIP/Postal Code

77900

Country

Czechia

Facility Name

Vseobecna fakultni nemocnice v Praze

City

Prague

ZIP/Postal Code

12851

Country

Czechia

Facility Name

Nemocnice Na Bulovce, Gynekologicko-porodnicka kl

City

Prague

ZIP/Postal Code

18081

Country

Czechia

Facility Name

Aalborg Universitetshospital

City

Aalborg

ZIP/Postal Code

9000

Country

Denmark

Facility Name

Rigshospitalet

City

Copenhagen

ZIP/Postal Code

2100

Country

Denmark

Facility Name

Kliniken Essen-Mitte

City

Duesseldorf

ZIP/Postal Code

45147

Country

Germany

Facility Name

Universitaetsklinikum Hamburg-Eppendorf

City

Hamburg

ZIP/Postal Code

20246

Country

Germany

Facility Name

Klinikum der Universität München

City

Münich

ZIP/Postal Code

81377

Country

Germany

Facility Name

Policlinico S.Orsola-Malpighi, SSD Oncologia Medica Addarii

City

Bologna

ZIP/Postal Code

40138

Country

Italy

Facility Name

Irst Irccs

City

Meldola

Country

Italy

Facility Name

Fondazione IRCCS Istituto Nazionale dei Tumori

City

Milan

ZIP/Postal Code

20133

Country

Italy

Facility Name

Istituto Nazionale Tumori Fondazione G. Pascale

City

Naples

ZIP/Postal Code

80131

Country

Italy

Facility Name

Policlinico Universitario Agostino Gemelli, UOC Patologia Ostetrica e Ginecologica

City

Rome

ZIP/Postal Code

00168

Country

Italy

Facility Name

Hospital Teresa Herrera-CHUAC

City

A Coruna

ZIP/Postal Code

15006

Country

Spain

Facility Name

Hospital Clinic Barcelona

City

Barcelona

ZIP/Postal Code

08036

Country

Spain

Facility Name

Hospital Duran I Reynals ICO Hospitalet

City

Hospitalet de Llobregat

ZIP/Postal Code

08908

Country

Spain

Facility Name

Clínica Universidad de Navarra (Sede Madrid)

City

Madrid

ZIP/Postal Code

28027

Country

Spain

Facility Name

Hospital Clínico San Carlos

City

Madrid

ZIP/Postal Code

28040

Country

Spain

Facility Name

Hospital Universitario 12 de Octubre

City

Madrid

ZIP/Postal Code

28041

Country

Spain

Facility Name

Hospital Universitario La Paz, Edificio dotacional de Oncología

City

Madrid

ZIP/Postal Code

28046

Country

Spain

Facility Name

Fundacion Hospital Son Llatzer

City

Palma de Mallorca

ZIP/Postal Code

07198

Country

Spain

Facility Name

Skåne University Hospital

City

Lund

ZIP/Postal Code

22185

Country

Sweden

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

33845034

Citation

Coleman RL, Lorusso D, Gennigens C, Gonzalez-Martin A, Randall L, Cibula D, Lund B, Woelber L, Pignata S, Forget F, Redondo A, Vindelov SD, Chen M, Harris JR, Smith M, Nicacio LV, Teng MSL, Laenen A, Rangwala R, Manso L, Mirza M, Monk BJ, Vergote I; innovaTV 204/GOG-3023/ENGOT-cx6 Collaborators. Efficacy and safety of tisotumab vedotin in previously treated recurrent or metastatic cervical cancer (innovaTV 204/GOG-3023/ENGOT-cx6): a multicentre, open-label, single-arm, phase 2 study. Lancet Oncol. 2021 May;22(5):609-619. doi: 10.1016/S1470-2045(21)00056-5. Epub 2021 Apr 9.

Results Reference

derived

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A Trial of Tisotumab Vedotin in Cervical Cancer

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