A Trial of Tisotumab Vedotin in Cervical Cancer

NCT03438396 | Completed Phase 2 Results DMC FDA Drug

• 2 other identifiers: GCT1015-04innovaTV 204
• Study Type: interventional
• Target: 102
• Locations: 8 countries
• Sites: 53

Brief Summary

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

Conditions

Cervical Cancer

Outcome Measures

Primary Outcomes (1)

• 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.

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

Secondary Outcomes (12)

• Duration of Response (DOR) as Assessed by the IRC

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

• Percentage of Participants With Confirmed OR as Assessed by the Investigator

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

• DOR as Assessed by the Investigator

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

• Time to Response (TTR) as Assessed by the IRC

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

• TTR as Assessed by the Investigator

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

Study Arms (1)

Single arm

EXPERIMENTAL

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

Drug: tisotumab vedotin

Interventions

tisotumab vedotin DRUG

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

Also known as: TIVDAK

Single arm

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: cervical cancer
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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
• Peripheral neuropathy grade ≥ 2

Sponsors & Collaborators

• Seagen Inc.: lead
• Genmab: collaborator
• European Network of Gynaecological Oncological Trial Groups (ENGOT): collaborator
• Belgian Gynaecological Oncology Group: collaborator
• Gynecologic Oncology Group: collaborator

Study Sites (53)

University of Alabama

Birmingham, Alabama, 35294, United States

Location

Arizona Oncology Associate - Biltmore Cancer Center

Phoenix, Arizona, 85016, United States

Location

UCLA Dept. of OBGYN

Los Angeles, California, 90095, United States

Location

Southern Baptist Hospital of Florida, Inc

Jacksonville, Florida, 32258, United States

Location

University of Miami Miller School of Medicine

Miami, Florida, 33136, United States

Location

University of Gynecologic Oncology

Atlanta, Georgia, 30342, United States

Location

Community Hospital East

Indianapolis, Indiana, 46219, United States

Location

Louisville Oncology

Louisville, Kentucky, 40207, United States

Location

Baystate Medical Center

Springfield, Massachusetts, 01105, United States

Location

Women's Cancer Center of Nevada

Las Vegas, Nevada, 89169, United States

Location

MD Anderson Cancer Center at Cooper University Hospital

Camden, New Jersey, 08103, United States

Location

University of New Mexico Comprehensive Cancer Center (UNMCCC)

Albuquerque, New Mexico, 87102, United States

Location

University of Cincinnati

Cincinnati, Ohio, 45267, United States

Location

The Ohio State University Wexner Medical Center

Hilliard, Ohio, 43210, United States

Location

Stephenson Cancer Center

Oklahoma City, Oklahoma, 73104, United States

Location

Oklahoma Cancer Specialists and Research Institute, LLC

Tulsa, Oklahoma, 74146, United States

Location

Abington Memorial Hospital

Willow Grove, Pennsylvania, 19090, United States

Location

Bon Secours Saint Francis Cancer Center

Greenville, South Carolina, 29607, United States

Location

UT Health McGovern Medical School

Houston, Texas, 77030, United States

Location

Froedtert & Medical College Clinics

Milwaukee, Wisconsin, 53226, United States

Location

AZ Sint-Jan Brugge-Oostende av

Bruges, 8000, Belgium

Location

Cliniques universitaires Saint-Luc

Brussels, 1200, Belgium

Location

Grand Hôpital de Charleroi

Charleroi, 6000, Belgium

Location

Algemeen Ziekenhuis Maria MiddelaresMedical Oncology - IKG

Ghent, 9000, Belgium

Location

Universitair Ziekenhuis Gent

Ghent, 9000, Belgium

Location

UZLeuvenGynaecologische oncologie

Leuven, 3000, Belgium

Location

Centre Hospitalier de l'Ardenne

Libramont, 6800, Belgium

Location

CHC SAINT Montlegia

Liège, 4000, Belgium

Location

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

Liège, 4000, Belgium

Location

CHU UCL Namur site de Sainte Elisabeth

Namur, 5000, Belgium

Location

Fakultni Nemocnice Brno

Brno, 62500, Czechia

Location

Fakultni nemocnice Olomouc Onkologic

Olomouc, 77900, Czechia

Location

Vseobecna fakultni nemocnice v Praze

Prague, 12851, Czechia

Location

Nemocnice Na Bulovce, Gynekologicko-porodnicka kl

Prague, 18081, Czechia

Location

Aalborg Universitetshospital

Aalborg, 9000, Denmark

Location

Rigshospitalet

Copenhagen, 2100, Denmark

Location

Kliniken Essen-Mitte

Düsseldorf, 45147, Germany

Location

Universitaetsklinikum Hamburg-Eppendorf

Hamburg, 20246, Germany

Location

Klinikum der Universität München

Münich, 81377, Germany

Location

Policlinico S.Orsola-Malpighi, SSD Oncologia Medica Addarii

Bologna, 40138, Italy

Location

Irst Irccs

Meldola, Italy

Location

Fondazione IRCCS Istituto Nazionale dei Tumori

Milan, 20133, Italy

Location

Istituto Nazionale Tumori Fondazione G. Pascale

Naples, 80131, Italy

Location

Policlinico Universitario Agostino Gemelli, UOC Patologia Ostetrica e Ginecologica

Rome, 00168, Italy

Location

Hospital Teresa Herrera-CHUAC

A Coruña, 15006, Spain

Location

Hospital Clinic Barcelona

Barcelona, 08036, Spain

Location

Hospital Duran I Reynals ICO Hospitalet

L'Hospitalet de Llobregat, 08908, Spain

Location

Clínica Universidad de Navarra (Sede Madrid)

Madrid, 28027, Spain

Location

Hospital Clínico San Carlos

Madrid, 28040, Spain

Location

Hospital Universitario 12 de Octubre

Madrid, 28041, Spain

Location

Hospital Universitario La Paz, Edificio dotacional de Oncología

Madrid, 28046, Spain

Location

Fundacion Hospital Son Llatzer

Palma de Mallorca, 07198, Spain

Location

Skåne University Hospital

Lund, 22185, Sweden

Location

Related Publications (3)

• Feng S, Gunawan R, Passey C, Voellinger J, Polhamus D, Gerritsen A, O'Day C, Carret AS, Soumaoro I, Gupta M, Hanley WD. Exposure-safety Markov modeling of ocular adverse events in patient populations treated with tisotumab vedotin. J Pharmacokinet Pharmacodyn. 2025 Oct 3;52(5):55. doi: 10.1007/s10928-025-10003-w.

  PMID: 41044356 DERIVED

• Passey C, Voellinger J, Gibiansky L, Gunawan R, Nicacio L, Soumaoro I, Hanley WD, Winter H, Gupta M. Exposure-safety and exposure-efficacy analyses for tisotumab vedotin for patients with locally advanced or metastatic solid tumors. CPT Pharmacometrics Syst Pharmacol. 2023 Sep;12(9):1262-1273. doi: 10.1002/psp4.13007. Epub 2023 Jul 26.

  PMID: 37496366 DERIVED

• 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.

  PMID: 33845034 DERIVED

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Interventions

tisotumab vedotin

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Results Point of Contact

• Title: Ibrahima Soumaoro
• Organization: Genmab A/S

clinicaltrials@genmab.com

+1 609 430 2481

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 8, 2018
• First Posted: February 19, 2018
• Study Start: June 12, 2018
• Primary Completion: February 6, 2020
• Study Completion: August 2, 2022
• Last Updated: July 25, 2023
• Results First Posted: November 4, 2021

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

BE (10); ES (8); US (20); DE (3); IT (5); SE (1); DK (2); CZ (4)