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NCT03786081

PHASE1/PHASE2

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

Sponsor: Seagen, a wholly owned subsidiary of Pfizer

View on ClinicalTrials.gov

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.

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

Key Details

Gender

FEMALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

214

Start Date

2019-02-27

Completion Date

2026-03-31

Last Updated

2026-03-13

Healthy Volunteers

Conditions

Cervical Cancer

Interventions

DRUG

Tisotumab Vedotin

Given into the vein (IV)

DRUG

Bevacizumab

Given via IV

DRUG

Pembrolizumab

Given via IV

DRUG

Carboplatin

Given via IV

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)

Locations (71)

Arizona Oncology Associates

Phoenix, Arizona, United States

Univ California, Irvine Medical Center

Orange, California, United States

Olive View - UCLA Research and Education Institute

Sylmar, California, United States

Baptist MD Anderson Cancer Center

Jacksonville, Florida, United States

Augusta University

Augusta, Georgia, United States

University of Chicago

Chicago, Illinois, United States

Indiana University School of Medicine

Indianapolis, Indiana, United States

University of Kansas Medical Center

Westwood, Kansas, United States

Oschner Clinic

New Orleans, Louisiana, United States

Dana-Farber Cancer Institute

Boston, Massachusetts, United States

Billings Clinic Cancer Center

Billings, Montana, United States

Montana Cancer Consortium

Billings, Montana, United States

SUNY Downstate Medical Center

Brooklyn, New York, United States

Memorial Sloan Kettering Cancer Center

New York, New York, United States

University of North Carolina Chapel Hill

Chapel Hill, North Carolina, United States

University of Cincinnati Physicians Group

Cincinnati, Ohio, United States

Cleveland Clinic

Cleveland, Ohio, United States

Cleveland Clinic

Cleveland, Ohio, United States

Ohio State University Wexner Medical Center

Hilliard, Ohio, United States

Fox Chase Cancer Center

Philadelphia, Pennsylvania, United States

Magee-Womens Hospital of UPMC

Pittsburgh, Pennsylvania, United States

Brown University - Women's and Infant Hospital

Providence, Rhode Island, United States

St Francis Hospital Cancer Center

Greenville, South Carolina, United States

Huntsman Cancer Center

Salt Lake City, Utah, United States

Carilion Clinic

Roanoke, Virginia, United States

AZ Sint-Jan

Bruges, Belgium

Cliniques universitaires Saint-Luc

Brussels, Belgium

Grand Hôpital de Charleroi

Charleroi, Belgium

Universitair Ziekenhuis Antwerpen (UZA)

Edegem, Belgium

Universitair Ziekenhuis Gent

Ghent, Belgium

UZ Leuven

Leuven, Belgium

Universitaire Ziekenhuizen Leuven,

Leuven, Belgium

Centre Hospitalier de l'Ardenne

Libramont, Belgium

Centre Hospitalier Universitaire (CHU) de Liège

Liège, Belgium

Grand Hôpital de Charleroi

Loverval, Belgium

CHU UCL Namur

Namur, Belgium

Sainte-Elisabeth

Namur, Belgium

Fakultni nemocnice Olomouc

Olomouc, Czechia

Fakultni nemocnice Olomouc

Olomouc, Czechia

Fakultni nemocnice Ostrava

Ostrava-Poruba, Czechia

Vseobecna fakultni nemocnice v Praze

Prague, Czechia

Vseobecna fakultni nemocnice v Praze

Prague, Czechia

Fakultni nemocnice Bulovka

Prague, Czechia

Nemocnice Na Bulovce

Prague, Czechia

Rigshospitalet

Copenhagen, Denmark

Cork University Hospital

Cork, Ireland

Mater Misericordiae University Hospital

Dublin, Ireland

Waterford Regional Hospital

Waterford, Ireland

University Hospital Waterford

Waterford, Ireland

Azienda Ospedaliera Cannizzaro

Catania, Italy

IEO Istituto Europeo di Oncologia

Milan, Italy

Istituto Nazionale Tumori Fondazione G. Pascale

Naples, Italy

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Roma, Italy

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Rome, Italy

Amsterdam UMC, Locatie AMC

Amsterdam, Netherlands

AMC Medical Research

Amsterdam, Netherlands

Universitair Medisch Centrum Groningen (UMCG)

Groningen, Netherlands

Radboudumc

Nijmegen, Netherlands

Erasmus Medisch Centrum

Rotterdam, Netherlands

Erasmus University Medical Center Rotterdam

Rotterdam, Netherlands

UMC Utrecht

Utrecht, Netherlands

University Medical Center Utrecht (UMC Utrecht)

Utrecht, Netherlands

Hospital Universitari Vall d'Hebron

Barcelona, Spain

Hospital Universitario Reina Sofia

Córdoba, Spain

Hospital Universitario Virgen de la Arrixaca

El Palmar, Spain

Hospital 12 De Octubre

Madrid, Spain

Baskent University Adana Application and Research Center

Adana, Turkey (Türkiye)

Baskent University Ankara Hospital

Ankara, Turkey (Türkiye)

Velindre Cancer Centre

Cardiff, South Glamorgan, United Kingdom

Beatson West of Scotland Cancer Centre

Glasgow, Strathclyde, United Kingdom

Royal Marsden Hospital- Sutton

Sutton, Surrey, United Kingdom

Clinical Research Directory

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

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (71)